Media – Biopharmaceutical Industry Discusses Product Transport Validation

Media – Biopharmaceutical Industry Discusses Product Transport Validation

Written by Modality Solutions

Posted on: November 15, 2017

Biopharmaceutical Industry Discusses Product Transport Validation
Modality Solutions
Pharmaceutical Outsourcing
July / August 2013

Media – Modality Solutions Announces New Advantage Transport Simulation Laboratory

Media – Modality Solutions Announces New Advantage Transport Simulation Laboratory

Written by Modality Solutions

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Modality Solutions Announces New Advantage Transport Simulation Laboratory
Modality Solutions
Pharmaceutical Outsourcing
July / August 2012

Media – Cold Chain Management Company Launches

Media – Cold Chain Management Company Launches

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Cold Chain Management Company Launches
What’s New
PharmaVOICE
April 2012

Modality Solutions Appoints Robert Battista as Consulting Engineer

Modality Solutions Appoints Robert Battista as Consulting Engineer

Written by Modality Solutions

Posted on: November 14, 2017

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Robert Battista Consulting Engineer.

HOUSTON, Tex., April 4, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated and tightly controlled life sciences and food industries, has hired Robert Battista as one of the firm’s consulting engineers. Battista attended The Ohio State University where he received his Bachelor of Science degree in chemical engineering with a minor in physical geography.

Battista works with the cold chain management firm’s clients to ensure proper design and use of cold chain systems. He writes standard operating procedures for cold chain related processes that meet regulatory requirements, drafts protocols and reports for the qualification of equipment and the validation of processes, reviews data packages for reports, and conducts in-person training for cold chain systems.

Prior to joining Modality Solutions, Battista completed the Gas Quality Internship at National Fuel Gas Co. in West Seneca, New York. His responsibilities included characterizing the accuracy and precision of a network of gas chromatographs and using trend analysis to determine the efficiency of the network using Six Sigma methodologies. In addition, he took on-site samples, readings and measurements of chromatographs as well as examined upper and lower BTU competency of machines based on archived data.

In addition, Battista’s expertise and research include reclamation of energy from pollutant bodies of water, operating characteristics of fuel cells, reaction kinetics of acetic anhydride, operating characteristics of a CO2 absorption column, and desalination of water through reverse osmosis. His research ranges from determining statistical significance of trace heavy metal concentrations in a water shed in northern Peru to using chemical characteristics of water to determine the sourcing to a watershed in Great Basin National Park in northeastern Nevada.

“With the addition of Rob to our Modality Solutions team of cold chain management experts we’re on track to continue to grow,” said Modality Solutions President, Gary Hutchinson. “We want to be the preferred partner to provide engineering assistance as it relates to thermal packaging engineering solutions for highly-regulated and tightly-controlled industries. Rob will be instrumental in helping us achieve these objectives for our clients.”

To learn more about Modality Solutions visit http://www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions’ Daniel Littlefield Leads Roundtable at the 17th Annual World Vaccine Congress Wa

Modality Solutions’ Daniel Littlefield Leads Roundtable at the 17th Annual World Vaccine Congress Wa

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Modality Solutions is a sponsor and roundtable leader at the April 10-12, 2017 World Vaccine Congress in Washington, DC.

HOUSTON, Tex., March 14, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly-regulated public health and life science industries, is pleased to announce its sponsorship and roundtable leadership at the 17th Annual World Vaccine Congress, April 10-12 at the Grand Hyatt in Washington, DC. The Congress promotes research, development and strategic partnering for the global vaccine industry.

Daniel Littlefield, Principal at Modality Solutions, will lead an interactive roundtable discussion on WVC Day 1 at 11:20 a.m. Titled: Managing Your Cold Chain – Lessons Learned from the Ebola Clinical Trials. Littlefield will cover the topic of: Are you effectively managing temperature requirements in your clinical trials in Zone 4 climate zones? The discussion will include the management of multiple temperature ranges from <-60 °C to 2 °C to 8 °C, the transport and storage with minimal infrastructure to remote depots and clinical trial sites and compliance by partnering with the local regulatory authorities.

“I invite Congress attendees to join my interactive roundtable,” said Modality Solutions Principal, Daniel Littlefield. “Come learn practical solutions for the real-world challenges that led to a flawless execution of the STRIVE Ebola clinical trial in sub-Saharan Africa with zero temperature excursions.” “Our sponsorship and participation in the WVA supports our continued commitment to work with vaccine experts from top pharmaceutical and biotechnology companies worldwide,” said Modality Solutions President Gary Hutchinson. “The Congress will cover some of the crucial technological developments that are changing how vaccines are researched, manufactured and distributed.”

The World Vaccine Congress Washington is well-established as the leading event on vaccines each year. Now in its seventeenth year, attendees are guaranteed the best experience on-site ever. The Congress will cover the crucial topics which are affecting the whole sector. Leadership anticipates more than 700 senior vaccine executives will take advantage of the World Vaccine Congress as well as the eight co-located streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines, and Bioprocessing & Manufacturing. For more information and to register for the 2017 World Vaccine Congress, visit https://goo.gl/5I6XtF

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions Names Gabrielle Mosiniak Consulting Engineer

Modality Solutions Names Gabrielle Mosiniak Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Gabrielle Mosiniak Consulting Engineer.

Houston, Tex. January 31, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated life sciences and food industries, has hired Gabrielle Mosiniak as one of the firm’s consulting engineers. Mosiniak attended The Ohio State University where she received her Bachelor of Science degree in biomedical engineering with a minor in biology. She was awarded the Provost Scholarship and graduated cum laude.

Mosiniak assists with laboratory testing and completes protocols and reports for distribution and thermal testing at the Modality Solutions’ Advantage Transport Simulation Laboratory™. She also writes and updates standard operating procedures, and she assembles data packages for reporting. Through these responsibilities, Mosiniak consistently works with clients to listen to their needs so that she can design and develop cold chain packaging based on their parameters and objectives.

Prior to joining the Modality Solutions team, Mosiniak worked for The Ohio State University Biomedical Engineering Department’s Summer Design Experience, where she implemented the Engineering Design Process to improve prototypes of past senior design projects. Working in a team-based environment, she focused on sensory prosthesis and red blood cell filter projects as well as gained experience with machining parts, simple circuit design, and Arduino programming.

Mosiniak’s academic engineering projects expanded to Nanjing, China where she was selected to participate in international design research focused on heparin nanoparticles for cancer treatment at Nanjing University. Locally, as part of her senior year design project, the Lower Extremity Postural Support, she has been part of the interdisciplinary team collaborating with clinical and community mentors to reach the goal of designing and building a wheelchair to support residual limbs of patients with amputations.

“Gabrielle joining our team of cold chain management experts supports our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “We are excited to have Gabrielle bring her experience to our proprietary transport simulation lab. She works independently and in collaboration with others to provide program management assistance as it relates to thermal packaging engineering solutions for our clients from highly-regulated industries such as life sciences, food, and biotechnology.”

To learn more about Modality Solutions visit www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

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Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

Modality Solutions is a sponsor and presenter at the December 7 – 9, 2016 Global Cold Chain Exchange in Miami, Florida

Houston, Tex. (PRWEB) December 5, 2016 Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life science and food industries, is pleased to announce its sponsorship and presentation at the 2016 Global Cold Chain Exchange. The three-day IQPC Exchange event will be held December 7 – 9 at the JW Marriott Marquis in Miami, Florida.

On day one of the Exchange, Modality Solutions’ President Gary Hutchinson will present a case study titled: Preparing for Your Biosimilar Cold Chain for a FDA Biologics Licensing Application (BLA). During this interactive session, attendees will learn the necessary steps and the differences in approach required for filing a biosimilar cold chain.

Gary Hutchinson shared, “Regulatory expectations for filing a biosimilar BLA are significantly more challenging for biologics targeting an unmet clinical need. The qualification of the technology, the validation of cold chain processes, and even the stress testing of drug product formulations for suitability for use in a cold chain are under stricter scrutiny.”

The Global Cold Chain Exchange is a premier event on maintaining compliance, safety, and security throughout the cold chain. The program is specifically designed for supply chain, packaging and logistics executives in the pharmaceutical and biotechnology industries. Attendance is exclusive, participation is strictly limited to senior executives from leading corporations to facilitate true peer-level networking for delegation and speakers.

This year’s Exchange program covers procedural, substantive and legislative issues that impact cold chain logistics, including: increased globalization and International regulations; standardized data monitoring; supply chain efficiency; handover delays with product sensitivity and risk management; quality agreements with carriers and 3PL’s; the future direction of global cold chain matters, and other pharmaceutical and biotechnology industry cold chain challenges.

“We are excited to sponsor and present at this year’s Global Cold Chain Exchange. It provides one of the most credible interactive forums for supply chain, logistics and distribution executives to share ideas and cold chain solutions,” said Hutchinson. “At Modality Solutions, we are committed to helping life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity. Exchange participants take away actionable insights to stay ahead in the evolving cold chain environment.”

In addition, the Exchange offers a variety of unique learning styles and sessions. Attendees can select and build a customized itinerary that reflects their current initiatives, priorities, and future strategic objectives. These opportunities include: conference sessions, one-on-one meetings, master classes and BrainWeave® discussions.

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions is a Presenter and Sponsor at 9th Annual BSMA USA Supply Chain Management Forum

Modality Solutions is a Presenter and Sponsor at 9th Annual BSMA USA Supply Chain Management Forum

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is a sponsor and presenter at the Bio Supply Management Alliance (BSMA) Conference.

Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life science and food industries, is pleased to announce its sponsorship and panel participation at the 9th Annual Bio Supply Management Alliance (BSMA) Conference titled “Preparing the Biotech Supply Chain for 2025, The Onward March.”

Modality Solutions’ President Gary Hutchinson will be a panelist on the Track 1: Clinical Supply Chain & Cold Chain topic — “Cold Chain Realities: Keeping Executives Awake at Night.” Hutchinson joins panelists Doug Wettegren, Global Key Account Manager, Envirotainer; Alex Guillen, Global Cold Chain Director, Fisher Clinical Services; Jim Peyton, Associate Director, Supply Chain, Gilead Science; Wahiba Hall, Leader, Global Transportation and Cold Chain, Pharmacy Group, Bayer Health; and moderator Vishal Singal, Principal Real World Insights, QuintilesIMS.

During the session, the industry stakeholders will present solutions for the successful deployment of the emerging temperature-controlled logistics and cold chain technology. Assessments will be made of packaging, engineering standards, business processes, information systems and monitoring mechanisms. Attendees will take away a blueprint for the global manufacturing, logistics and distribution of temperature-sensitive materials and finished products.

“Our sponsorship and participation on the BSMA supply chain and cold-chain panel supports our continued commitment to help life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity,” said Gary Hutchinson.

Conference organizer, BSMA, was born out of a need to create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharma, and biomedical device industries. Based in the San Francisco Bay Area, home to more than 400 bio firms, the alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industries. This year’s conference is incorporating a town hall environment to promote shared learning and collaboration.

For more information, go to http://biosupplyalliance.com

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions Announces Partnership with IQPC for the 14th Annual Cold Chain GDP & Temperature

Modality Solutions Announces Partnership with IQPC for the 14th Annual Cold Chain GDP & Temperature

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is a sponsor of the worldís largest event for temperature controlled life science supply chains.

HOUSTON, Tex. September 15, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, is pleased to announce they are once again sponsoring and presenting an innovative approach to understanding thermal passive shipper performance at the 14th Annual Cold Chain GDP & Temperature Management Logistics Global Forum. Modality Solutions will be joined by 850 temperature controlled life science leaders, September 26-30 at the Hynes Veterans Memorial Convention Center in Boston, Massachusetts.

Modality Solutions will host and present the Day 2: Pre-Conference Workshop titled ìUsing Performance Curves to Define OQ Test Profiles and Optimal Designs for Passive Shipping Containers.î Paul Harber, Principal, Modality Solutions and Bernard McGarvey, Senior Engineering Advisor, Eli Lilly & Company will examine the current approaches to selection of passive shippers and how they can fail. A description of how to evaluate lane data and compile it into a thermal profile for use in qualification will be presented. Performance curves for passive shippers, how they can be used and the methodologies of development will be explained in- depth. Participants will take away tools and a methodology for defining shipper capabilities with a performance curve and quantifying the risk of failure within specified lanes.

In its 14th installment, the Cold Chain Global Forum has significantly expanded the topic focuses, session formats, speaking faculty and vendor options to help meet the industryís emerging and ongoing challenges for 2016 and beyond. The event is designed to include eight pre-conference workshops, two in-depth master classes, two days of main conference sessions, roundtable discussions and panel discussions, and more than 14 hours of networking to discuss the most important challenges and most effective strategies and solutions within the cold chain industry.

ìWe encourage attendees to stop by our conference booth 425 to ask questions about their cold chain thermal packaging, transport validation, and logistics challenges,î said Modality Solutions President Gary Hutchinson. ìWe are committed to helping life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity.

ìWeíre thrilled to head back to Boston once again for the Cold Chain Global Forum,î said Claudia Rubino, Divisional Director ñ Cold Chain Portfolio, IQPC. ìThe Global Forum continues to be the leading event for temperature-controlled life science supply chains, and weíre pleased to have Modality Solutions partner with us to help make the event a success.

Subscribers of Modality Solutions receive 20% off rates with code: 14CCGF_MSOLUTIONS.
Visit registration: http://bit.ly/23eK10e

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratoryô tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Cold Chain Management Firm Modality Solutions Names Andrew Larrigan Consulting Engineer

Cold Chain Management Firm Modality Solutions Names Andrew Larrigan Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Andrew Larrigan, Consulting Engineer. In his position, Larrigan works in part at the Modality Solutions’ Advantage Transportation Simulation Laboratory™.

Houston, Tex. July 19, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, has hired Andrew Larrigan as consulting engineer. In his position with Modality Solutions, Larrigan works with other dedicated project engineers.

As a component of his position, Andrew works in part at the Advantage Transportation Simulation Laboratory™, which provides valuable data on the impact of five environmental hazards (temperature, humidity, pressure, shock and vibration) on the critical-to-quality attributes of products. He helps with writing protocols and reports for a variety of distribution and thermal testing. His main tasks include: conducting transportation simulation testing; designing and/or implementing thermal packaging applications; updating Standard Operating Procedures and Forms; and writing protocols and reports for testing.

Modality Solutions’ key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and manage clinical trial operations’ cold chain.

Prior to joining Modality Solutions, Larrigan worked for Camelot Trucking, a trucking business in Alvada, Ohio. In Operations & Dispatch, he used his organizational and communication skills to coordinate jobs with drivers and logistic companies.

“Andrew’s high levels of organization and teamwork were part of what attracted Modality Solutions to invite Andrew to join the team,” said Modality Solutions Principal and CFO, Daniel J. Littlefield.

Larrigan attended The Ohio State University where he received his degree in Chemical Engineering. While at The Ohio State University, Larrigan immersed himself in the following elective courses: Air Pollution, Experimental Design, Modeling & Simulation, Fuel Cells. It was in these courses that he found his passion for learning and educating about the environment.

About BioConvergence
BioConvergence is a contract service provider to the life sciences industry, offering outsourcing partnerships for formulation development, testing, labeling and kitting, and supply chain services. Headquartered in Bloomington, Indiana, BioConvergence has over 50 employees with many years of valuable experience in the pharmaceutical and biotechnology industries. The unique E-Transparency® System provides transparency and flexibility to clients, while offering superior, quality-driven outsourcing services. For more information, visit www.bioc.us

To learn more about Modality Solutions, visit www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Contact
Susan Almon-Pesch
for Modality Solutions, LLC
Phone: (858) 205-0516
Email: sue@speschialpr.com

One of Modality Solutions’ Partners, BioConvergence®, Expands Services and Rebrands as Singota™ Solutions

One of Modality Solutions’ Partners, BioConvergence®, Expands Services and Rebrands as Singota™ Solutions

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BioConvergence LLC, a life sciences contract service provider, makes a big change to respond to client needs. 

Bloomington, Indiana (PRWEB) June 09, 2016 — BioConvergence LLC announces a major initiative that includes a transition to a new name and an expansion of its services consistent with the company’s strategic plan and vision of CEO Alisa Wright. “We continually seek new ways to improve patients’ lives by helping our clients accelerate their product development process. This has been our mission from the start of the company ten years ago. This project, like our past expansions, fills a critical need expressed by our clients,” Wright said.

The service expansion will require construction of clean rooms and installation of equipment necessary to fill injectable drug products into vials, syringes, and cartridges for clients in the pharmaceutical industry. This added capability complements the company’s existing services that span from formulation development to finished product for use in clinical trials. Senior Director of Operations Brent Lieffers said, “This expansion not only brings innovative technology to our clients, but also creates new employment opportunities in our community.”

Concurrent with the expansion, the company name will transition to Singota™ Solutions. This reflects the company’s continued growth as a Contract Development and Manufacturing Organization (CDMO) and its commitment to accelerating the drug development process through innovative solutions.

Lynn Coyne, president of the Bloomington Economic Development Corporation, commented, “This major expansion of an already successful life science company signals a very bright future for BioConvergence. BioConvergence’s creativity and innovation make it a market leader and we are grateful that BioConvergence has chosen to stay and grow in Monroe County.”

Wright added, “On behalf of everyone at the company, we are excited about the future, and we deeply appreciate the support from the local community.” The company will make further announcements as to its progress over the coming months.

About BioConvergence
BioConvergence is a contract service provider to the life sciences industry, offering outsourcing partnerships for formulation development, testing, labeling and kitting, and supply chain services. Headquartered in Bloomington, Indiana, BioConvergence has over 50 employees with many years of valuable experience in the pharmaceutical and biotechnology industries. The unique E-Transparency® System provides transparency and flexibility to clients, while offering superior, quality-driven outsourcing services. For more information, visit www.bioc.us

Amber Riley, Marketing Specialist
BioConvergence LLC
http://www.bioc.us
(812) 961-1722

Cold Chain Management Firm Modality Solutions Names Hannah Anderson Technical Consulting Engineer

Cold Chain Management Firm Modality Solutions Names Hannah Anderson Technical Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Hannah Anderson, Technical Consulting Engineer. Anderson is currently assisting one of Modality Solutions’ pharmaceutical clients with onsite program management of its thermal package engineering services.

HOUSTON, Tex. June 7, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, has hired Hannah Anderson as technical consulting engineer. In her position with Modality Solutions, Anderson will serve as one of the firm’s specialized project consultants.

Modality Solutions’ key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and manage clinical trial operations’ cold chain.

Anderson is currently assisting one of Modality Solutions’ pharmaceutical clients with onsite program management of its thermal package engineering services. In her position, she forecasts and determines personnel project resource requirements and manages resource allocations. She writes up procedures, specifications and reports. She conducts project update meetings, manages schedules, and ensures all deliverable are being completed on time.

In addition, Anderson implements and monitors communication plans for every project to make sure outside vendors and internal customers are meeting all filing requirements and deadlines. She develops thermal packaging qualification and Value Stream Maps (VSMs) to identify areas of improvement in process and project communications. Her responsibilities also include improving process and controls, justifying the use of qualified thermal shippers, and identifying team user requirements for new product launches. She is responsible for the technical justification of thermal packaging to meet specific product requirements and design, verify and qualification activities when new thermal packaging is required.

“Hannah joining our Modality Solutions team of experts underscores our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “We want to be the preferred partner to provide program management assistance as it relates to thermal packaging engineering solutions for highly-regulated and tightly-controlled industries such as life sciences, food, and biotechnology. Hannah will be instrumental in helping us achieve these objectives for our client.”

Prior to joining Modality Solutions, Anderson was a thermal packaging engineer with Amgen. She performed all project management duties for the department. She was responsible for tracking the department’s budget and developed implementation plans for all projects. In addition, she delivered and presented thermal packaging monthly reports to executive management.

Anderson attended University of Wisconsin – River Falls where she received her B.S. degree with Biomedical Sciences emphasis with a Biology and Chemistry minor. She is a member of the Project Management Institute.

To learn more about Modality Solutions visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Click here to view the online release.

Shipper Perspectives on the Cold Chain

Shipper Perspectives on the Cold Chain

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Modality Solutions’ Gary Hutchinson Joins “Shipper Perspectives on the Cold Chain” Panel at TPM Annual Conference

Modality Solutions’ President Gary Hutchinson will be a panelist for the “Shipper Perspectives on the Cold Chain” conference session on Monday, February 29, 2016 at the 16th TPM Annual Conference in Long Beach, California.

Houston, Texas February 23, 2016 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce President, Gary Hutchinson, will be a panelist at the 16th Annual TPM (Trans-Pacific Maritime) Conference in Long Beach, California from February 28 – March 2, 2016.  The conference continues to be the must-attend conference for the trans-Pacific and global container shipping and logistics community.

Lara Sowinski, Editorial Director, Supply Chain Network, AC Business Media will chair the Monday, February 29 conference session titled: “Shipper Perspectives on the Cold Chain.” Modality Solutions’ President, Gary Hutchinson joins panelists Steve Schommer, Director of Logistics and Transportation, The Sun Valley Group and Perry M. Bourne, Director of International Transportation and Rail Operations, Tyson Foods.

The panelists represent three industry verticals — food, pharmaceuticals and floral. They will share their insights, challenges and strategies for shipping time and temperature-sensitive commodities around the world. Food shippers see an expanding supply chain that is more complex and subject to regulations, such as the U.S. Food and Drug Administration’s Food Safety Modernization Act, which impacts temperature monitoring and tracking/tracing of products from farm to store shelf.

At the same time, a dynamic modal shift is occurring in the pharmaceutical sector as major drug companies commit more shipments to ocean rather than air cargo. Even floral shippers are capitalizing on the ability of new technologies and reefer equipment designed to support ocean transportation of delicate floral shipments.

“I look forward to sharing how pharma is migrating from air to ocean. I’ll share some of the unique challenges in qualifying ocean lanes for pharmaceutical products,” said Modality Solutions Gary Hutchinson.

Additional challenges in attracting food, pharma and floral shipments, however, range from labor disruptions at gateway ports affecting imports and exports, to inconsistent and improper handling of reefer shipments, compounded by multiple touch points during the ocean journey. Still, the opportunities are ripe for carriers and logistics providers with cold chain capabilities. A panel of seasoned reefer shippers will offer valuable information, best practices and unique perspectives on the global reefer market in this highly anticipated session.

The overall TPM conference objective is to provide major customers of international containerized shipping services — including retailers, manufacturers, consumer product firms and agribusiness companies — with an understanding of the potential solutions to the major challenges they and their ocean carrier, intermodal rail, trucking and logistics vendors face when shipping containerized products between Asia and North America.

For more information on the TPM Conference, visit the conference website at: http://events.joc.com/tpm2016/
For more information on Modality Solutions, visit http://www.modality-solutions.com

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.
Click here to view the online release.

Modality Solutions Names Judy Tempel Principal Consulting Engineer

Modality Solutions Names Judy Tempel Principal Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Judy Tempel Principal Consulting Engineer for vaccine clinical trial operations.

HOUSTON, Tex. (PRWEB) July 21, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce it has hired pharmaceutical veteran Judy Tempel as a principal consulting engineer. In her position as a Modality Solutions’ Principal Consulting Engineer, Judy is working on cold chain technical support, storage, distribution, and accountability for clinical trials. She is currently responsible for clinical trial operations for vaccines for infectious diseases in challenging emerging markets.

Tempel is a supply chain operations expert specializing in cold chain, warehouse systems and packaging. Prior to joining Modality Solutions, she completed a 23-year career at Eli Lilly and Company. In a series of roles with increasing scope and global responsibilities, she was instrumental in driving improvements in warehouse operations management, distribution and manufacturing. During her Lilly tenure, she held positions with technical and management responsibilities in both operations and global packaging engineering support.

During Tempel’s years in operations at Lilly, her responsibilities included finished pharmaceutical product warehousing, distribution and customer service for the entire US market from three regional distribution centers (Indiana, California and Connecticut). This position also included responsibility for central warehousing of API (active pharmaceutical ingredient), raw materials and packaging materials for Indianapolis-area GMP/GDP operations. Tempel’s other roles at Lilly included responsibility for antibiotic purification operations at an API manufacturing facility in Lafayette, Indiana, along with leading a team of engineers and scientists who provided packaging support for new product launch teams and approximately 20 global GMP packaging operations.

Tempel attended University of Notre Dame where she received her bachelor’s degree in Civil Engineering. She went on to obtain her Master of Science degree in Civil (Environmental) Engineering from Purdue University.

“We are pleased to have Judy join our team in overseeing clinical trials in high risk regions. She brings considerable experience in equipment qualification and process validation, packaging container closure system design and qualification, and technical transfer of product packaging to new locations,” said Modality Solutions President Gary Hutchinson. “Her individual contributions include development and implementation of common work practices globally, packaging process improvements, product protection initiatives (anti-counterfeiting and tamper evidence), and global IT systems implementation.”

For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Additional information can be found at http://www.modality-solutions.com.

Click here to view the online release.

Modality Solutions Gary Hutchinson Named Columnist for Cold Chain IQ

Modality Solutions Gary Hutchinson Named Columnist for Cold Chain IQ

Written by Modality Solutions

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Cold chain subject matter expert, Gary Hutchinson, president of Modality Solutions has been named a columnist for Cold Chain IQ – Temperature Control Logistics and Quality Network.

Houston, Tex. April 16, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce its President, Gary Hutchinson, has been name a monthly columnist for Cold Chain IQ – Temperature Control Logistics and Quality Network (www.coldchainiq.com). His column titled, Global Cold Chain Connections, is dedicated to sharing important cold chain information for today’s life sciences, pharmaceutical and healthcare supply chains.

Cold Chain IQ, part of International Quality & Productivity Center (IQPC), maintains the largest cool chain pharmaceutical international database, offering strategic partners, its members and contributors an opportunity to network, share ideas and disseminate best practice information across the globe. As an international resource center for the temperature control life science professional, Cold Chain IQ delivers insightful, unbiased information about today’s hot topics. It focuses on all areas of temperature controlled logistics, distribution and quality in pharmaceuticals and biotechnology.

As a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. His first article, “Today’s Pharmaceutical Cold Chain Network is Increasingly Complex and Involves Many Players” was released on April 9 and can be viewed at http://www.coldchainiq.com/supply-chain-security/columns/today-s-pharmaceutical-cold-chain-network-is-incre/

Hutchinson’s columns will focus on competing priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets – all of the challenges facing cold chain management professionals every day. He will cover solutions that deliver value in the supply chain and enhance a company’s regulatory reputation by ensuring compliance, product quality and safety. Engineers and manufacturers face economic and regulatory pressures, accelerating costs, technology changes, and the need to constantly adapt their business models. The advent of more widely distributed supply chains and many other influences demand greater investment in tools and expertise.

“As we gear up for the life sciences cold chain market’s growth to an estimated $307 billion in 2018 — up from today’s $237 billion as listed in Pharmaceutical Commerce, our collective efforts in best practices will drive the next wave of pharma’s decisions and actions,” said Hutchinson. “I am excited about this opportunity to share how to integrate quality systems, risk management, product requirements, and validation activities.”

“Pharmaceutical and healthcare supply chains today are international, rife with risk and are comprised of many stakeholders,” said ColdChain IQ Editor, Andrea Charles. “Bringing Gary on board to share his insights on efficient supply chain integration and processes was a natural for our network.”

For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Gary Hutchinson 
Gary Hutchinson was recognized by his peers as a 2012 Temperature Controlled Logistic Leader by the international pharmaceutical cold chain community, as compiled and reported by Cold Chain IQ. Prior to co-founding Modality Solutions in 2011, Hutchinson was Amgen’s director of global transportation where he designed logistics networks and solutions for biologics and solid oral dosages — including cold-chain clinical and commercial logistics networks, import/export compliance, packaging qualification, and transport validation. As an industry thought leader, Hutchinson is a sought-after podcast/webcast presenter and conference speaker where he covers cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the supply chain. He holds a MBA in logistics and finance from The Ohio State University and has been designing and implementing controlled environment logistics networks in the global life sciences industry for more than 20 years.

About Modality Solutions 
Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com.

Additional information can be found at http://www.modality-solutions.com.

Click Here to view the online release.

Modality Solutions Names Brian Brazill Consulting Engineer

Modality Solutions Names Brian Brazill Consulting Engineer

Written by Modality Solutions

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Brian Brazill Consulting Engineer.

Houston, Tex. February 17, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce it has hired Brian Brazill as a consulting engineer. In his position with Modality Solutions, Brazill programs and runs one of the company’s signature cold chain industry services — its Advantage Transport Simulation Laboratory™.

Modality Solutions has validated to current cGMP standards the only independent, third-party, multi-modal transport simulation laboratory in the world. It allows clients to concurrently study the impact of the following five environmental hazards: temperature, humidity, pressure, shock and vibration on the critical-to-quality attributes of products.

Prior to joining the company, Brazill attended Purdue University where he received his degree in Chemical Engineering. While at Purdue, he was on the 2014 AIChE Chem-E-Car Team. He assisted in the design of a model car that runs on thermoelectric generators. In addition, Brazill served as an engineering intern for Northern Indiana Public Service Company (NIPSCO). In this position he collected field data from utility pipelines regarding the cathodic protection from corrosion and conducted remedial studies on pipelines which did not test within acceptable boundaries for protection.

Brazill also served as an intern at Dow AgroSciences LLC, a wholly owned subsidiary of the Dow Chemical Company specializing in not only agricultural chemicals such as pesticides, but also seeds and biotechnology solutions. While at Dow, Brian supervised a team performing field studies and a variety of other activities, such as maintaining the integrity of test fields through elimination of weeds, rogue plants, and plants with genetic anomalies.

In his current Modality Solutions’ consulting engineer position, Brazill has mastered the laboratory’s SolidWorks, a 3D software tool that enables him to create, simulate, publish, and manage data. His observational skills help him evaluate crucial client product design issues and come up with creative solutions. One simulated transport study generates data that would take 100 actual shipments to achieve. Brian works together with clients to help them design products better, faster, and more cost-effectively. His responsibilities also include completing client protocols and reports. Brazill is a member of the AlChE (American Institute of Chemical Engineers).

Most recently, Brazill explained and demonstrated the Advantage Transport Simulation Laboratory™ software at the 12th Annual Cold Chain GDP & Temperature Management Logistics Global Forum during the conference’s technology demo drive session.

“We are pleased to have Brian join our team. His observational skills and attention to detail allow him to evaluate customer issues and provide innovative solutions,” said Modality Solutions President Gary Hutchinson. “He brings his study and passion in chemical engineering to the study of environmental stresses on biologics and vaccines, diagnostics, solid oral formulations, and combination medical devices during each stage of the development process.”
For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

enVista Announces Strategic Partnership With Modality Solutions

enVista Announces Strategic Partnership With Modality Solutions

Written by Modality Solutions

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Alliance brings robust biopharmaceutical cold chain solutions & expansion of enVista’s cold chain capabilities.

Indianapolis, IN; February 17, 2015 – enVista, a leading supply chain consulting and IT services firm, announced today it is partnering with Modality Solutions, a solution provider that integrates cold chain management systems for highly regulated industries. The partnership creates a powerful biopharmaceutical cold chain offering, coupling enVista’s exceptionally deep supply chain expertise with Modality Solutions’ innovative cold chain and packaging optimization solutions.

For cold chain companies, Modality Solutions provides insight into cold chain thermal package engineering, transport validation, and controlled-environment logistics. The company’s Advantage Transport Simulation Laboratory™ is validated to current cGMP standards and is the only independent, third party transport simulation lab in the world. Package simulation testing serves to define and minimize or eliminate transportation’s five environmental hazards – temperature, humidity, pressure, shock and vibration throughout the supply chain.

enVista’s expertise covers all areas across the extended supply chain, including global supply chain network design, strategic facility design, international and domestic transportation management, labor management, and supporting supply chain and execution technology.

enVista President and CEO Jim Barnes said, “There are several synergies between enVista and Modality Solutions and, more importantly, significant opportunities to drive additional value for our shared cold chain clients. We look forward to expanding how we jointly help our clients manage their cold chains. Together, we are providing some of the most robust best-of-breed cold chain services and solutions in the industry.”

Modality Solutions President Gary Hutchinson said, “Today’s biopharmaceutical cold chain requires comprehensive one-source supply chain management for true optimization. enVista has a proven track record of deploying supply chain and enterprise solutions as well as synchronizing all of the information generated during the process. We are pleased to bring our cold chain consulting, process validation, and thermal package engineering design experience to help expand enVista’s supply chain services, as well as our own.”

Combined, the companies’ principals bring more than a hundred years of pharmaceutical and life science experience to the alliance.

About Modality Solutions
Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. It enhances clients’ reputations by ensuring regulatory compliance, product quality, and consumer safety around the globe. Its Advantage Transportation Simulation Laboratory™ concurrently tests the effects of environmental hazards on products. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design/qualification and controlled-environment logistics solutions; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications.
www.modality-solutions.com

About enVista
enVista is a leading supply chain consulting and IT services firm, delivering innovative solutions that improve profitability, enhance customer service and reduce waste from source to consumption. enVista’s unrivaled consulting experience, deep vertical industry expertise and comprehensive solutions portfolio, enable clients to leverage one strategic partner that consults, implements and operates across Supply Chain, Transportation, Retail, IT and ERP.
www.envistacorp.com

For more information about enVista, please call 877-684-7700 FREE or contact info@envistacorp.com.
PRESS CONTACT: Jessica Money, (317) 208-9100 x322, jmoney@envistacorp.com

For more information about Modality Solutions, please call 888-219-6317 or contact info@modality-solutions.com.
PRESS CONTACT: Susan Almon-Pesch, (858) 205-0516, sue@speschialpr.com

Consulting Engineer Brian Brazill to Demonstrate Modality Solutions Advantage Transport Simulation LaboratoryTM Software at the 12th Annual Cold Chain Global Forum

Consulting Engineer Brian Brazill to Demonstrate Modality Solutions Advantage Transport Simulation LaboratoryTM Software at the 12th Annual Cold Chain Global Forum

Written by Modality Solutions

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Modality Solutions’ Consulting Engineer Brian Brazill will demonstrate the company’s proprietary transport simulation lab’s software during the12th Annual Cold Chain Global Forum Technology Demo Drive presentations at Booth 509.

Boston, Mass. September 29, 2014 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce Consulting Engineer, Brian Brazill, will present the company’s Advantage Transport Simulation LaboratoryTM software at the 12th Cold Chain GDP & Temperature Management Logistics Global Forum in Boston. Brazill will explain and demonstrate the company’s lab software on October 2, day two of the conference, during the Technology Demo Drive between 10:40 a.m. and 11:05 a.m. at Booth 509.

As a conference sponsor and exhibitor, Modality Solutions will participate in the live demo of one of its signature cold chain industry services. Modality Solutions has validated to current cGMP standards the only independent, third-party, multi-modal transport simulation laboratory in the world. In his demonstration, Brazill will explain how the lab allows clients to concurrently study the impact of the following five environmental hazards: temperature, humidity, pressure, shock and vibration.

In his position as consulting engineer with Modality Solutions, Brian Brazill, programs and runs the transport simulation laboratory. He graduated from Purdue University with a Bachelor of Science degree in Chemical Engineering. His observational skills and attention to detail allow him to evaluate customer issues and provide innovative solutions.

Modality Solutions invites conference attendees to learn about the Advantage Transport Simulation Laboratory’s software during the networking break on Thursday. Brazill will give his seven-minute presentation during Demo Drive 1, 10:40 – 10:50 .a.m. and Demo Drive 2, 10:55 – 11:05 a.m.

With the Modality Solutions simulation lab, clients can: execute transport simulation studies for all types of packaging and presentations; compare results to expiry date stability studies; and identify and confirm which of the candidate product formulations can withstand the rigors of the global supply chain.

“Brian will explain during his software demonstration how temperature and humidity testing on the critical-to-quality attributes of drug formulation are not enough,” said Modality Solutions President Gary Hutchinson. “Developers and regulators agree thorough testing of biologics, tablets, capsules and medical device combination products before filing is essential. Formulators need to ask — is our stability data sufficient to address storage, product handling and transport?”

For more information about Modality Solutions, visit http://www.modality-solutiuons.com.

About Modality Solutions

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions and DeltaTrak® Partner to Provide Life Science Cold Chain Monitoring Solution

Modality Solutions and DeltaTrak® Partner to Provide Life Science Cold Chain Monitoring Solution

Written by Modality Solutions

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As approved business partners, Modality Solutions and DeltaTrak® will offer their life science customers implementation and validation services in conjunction with cold chain monitoring device technology in order to ensure regulatory compliance.

Houston, Texas August 27, 2014 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce its approved business partnership with DeltaTrak®. The companies identified the need for life science companies using cold chain monitoring device technology to have both an implementation plan and validation process in place to ensure regulatory compliance.

Life science cold chain management is the plan, process, monitoring technology and validation of the supply and distribution of pharmaceuticals, vaccines, biologics, and medical device combination products. All of which must be kept at optimum temperature and humidity levels throughout storage and shipping cycles in order to maintain their efficacy. If, at any time a temperature-sensitive product is exposed to temperatures outside its defined range, irreversible damage can occur, resulting in loss of product, profit and ultimately patient safety.

Based on more than 100 combined years of career experience in the biotechnology and life science arena, Modality Solutions’ subject-matter experts play a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ASTM). They integrate cold chain management solutions by providing insight into cold chain thermal package engineering, transport validation, and controlled-environment logistics. Modality Solutions delivers solutions that define and then minimize or eliminate transportation environmental hazards in the supply chain.

DeltaTrak® offers front end devices and solutions for monitoring temperatures during storage, shipping and handling. Its in-transit data loggers record critical time and temperature data during transportation, with Shadow Log TM , a fail-safe feature that guarantees data recording even if the operator fails to activate the unit. In addition, DeltaTrak’s® ColdTrak® Data Central is a cloud-based software solution that provides validation and quality assurance functionality. It helps customers retrieve, view, analyze and share critical temperature data during transportation or facility storage throughout the world, 24/7, and it can send alerts to designated personnel via text message, email or voice mail when temperature excursions occur. The company’s FlashPDF software is designed to help download data loggers to PCs and then upload this information into a client’s ColdTrak account. This service allows a client to integrate data from its data loggers into existing 3rd party enterprise resource planning (ERP) and material requirements planning (MRP) systems used for purchasing, inventory control and manufacturing processes.

Having a value-added partner like Modality Solutions provides DeltaTrak® clients with an applications solutions partner. Their implementation services ensure a compliant transition of technology, including qualification/validation, change control, and corrective actions and preventive actions (CAPA) management. In addition Modality Solutions can identify and validate new global routes and shipping lanes, as well as help with audit preparations and assistance on CAPAs from previous audits.

“Any temperature abuse, either above or below the safe limit, can result in compromised efficacy or even total loss of products,” said Modality Solutions President Gary Hutchinson. “DeltaTrak® has the technology, and we have the expertise in cold chain implementation and validation. Partnering with DeltaTrak® allows us to provide cost-effective in-transit monitoring solutions to help improve cold chain management from manufacturing to distribution.”

“Assuring the integrity of temperature sensitive products in all of the critical control points of a cold chain is imperative in today’s business world,” said DeltaTrak® Director of Business Development, Peter Norton. “With Modality Solutions as an approved business partner, we are now able to enhance our clients’ reputations by ensuring regulatory compliance, product quality and consumer safety from discovery to distribution.”

For more information about real-time cold chain integration and monitoring solutions, visit the partners’ websites http://www.modality-solutiuons.com and http://www.deltatrak.com.

About Modality Solutions

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

About DeltaTrak®

Founded in 1989, DeltaTrak® is a leading innovator offering end-to-end cold chain management, environmental monitoring and food safety solutions for the food, pharmaceutical, life sciences and chemical industries. These include high quality instruments and cloud-based software and services, providing visibility of temperature conditions during storage, transport and handling of temperature sensitive commodities. Contact DeltaTrak® at (800) 962-6776 or email salesinfo@deltatrak.com. Additional information can be found at http://www.deltatrak.com.

Contact:

Susan Almon-Pesch
For Modality Solutions
(858) 205-0516
sue@speschialpr.com

Click here to view this press release online.

Modality Solutions Releases New White Paper on Thermal Shipping Technologies

Modality Solutions Releases New White Paper on Thermal Shipping Technologies

Written by Modality Solutions

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Modality Solutions today released its white paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies” at the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum.

CHICAGO, IL (PRWEB) October 01, 2013 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, released its white paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies” at the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum held in Chicago, Illinois from September 30 through October 4, 2013.

Authored by Modality Solutions’ President, Gary Hutchinson, this white paper presents highlights from a thermal performance study conducted by Modality Solutions. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry-accepted temperature profile standard.

The Modality Solutions thermal shipping white paper study’s purpose was twofold. First, to evaluate five commonly used shipping technologies for thermal control performance to assess how well they maintained a specific temperature range within a 24-hour period. Second, to assess the value of a visual indicator to show conformance to a predetermined temperature range and threshold; if a shipment took longer than the 24 hours the shipping system claimed for temperature control, an indicator technology could provide additional monitoring. The following commonly used shipping systems were tested: insulated bubble bag; insulated envelope; insulated box liner; EPS panel sheet cooler; and EPS molded cooler.

The study examined performance of the technologies during seasonal extremes of winter and summer as simulated by ISTA 7D thermal profiles. An additional 6-hour interval was added to the test to evaluate performance in the event the package was not delivered in the allotted 24-hour time frame.

“None of the five tested thermal packaging systems typically used by specialty pharmacies to protect temperature-sensitive products for direct-to-patient delivery maintained the specified temperature in the first 24 hours,” said author Gary Hutchinson. “All five performed below expectations when tested to the ISTA 7D industry standard. Most did not perform against their own published claims. The lack of performance in the first 24 hours highlights the need to look at new packaging technologies and visual controls for use by specialty pharmacies.”

Hutchinson along with Modality Solutions’ principals, Paul Harber and Brian Wallin are presenting “Integrate Your Cold Chain Management Systems” at the Cold Chain Global Forum on October 1, 2013. In addition, as a conference sponsor and exhibitor, they will be available to discuss the specifics of the thermal shipping technologies white paper at Booth 618 during the 5-day forum.

To download the free Modality Solutions White Paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies,” go to: http://www.modality-solutions.com/download-landing/.

About the Author

Gary M. Hutchinson is President of Modality Solutions. He is a controlled-environment logistics subject-matter expert. His time-definite delivery networks deliver product around the world in a regulatory compliant and cost-effective way. He accomplishes this complex process by understanding environment and infrastructure challenges, designing controls, and creating monitoring systems that work. Hutchinson was recognized by his peers as a 2012 Temperature Controlled Logistic Leader by the international pharmaceutical cold chain community, as compiled and reported by Cold Chain IQ. Prior to co-founding Modality Solutions in 2011, as Director of Global Transportation for Amgen, he designed logistics networks and solutions for biologics and solid oral dosages — including cold-chain clinical and commercial logistics networks, import/export compliance, and transport validation.

About Modality Solutions

Modality Solutions is a privately-held company that delivers engineered solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information about Modality Solutions and alliance partner, BioConvergence, visit http://www.modality-solutions.com and http://www.bioc.us.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

Brian Wallin Named a 2013 Top Rising Star in Temperature Controlled Logistics

Brian Wallin Named a 2013 Top Rising Star in Temperature Controlled Logistics

Written by Modality Solutions

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Brian Wallin, a Principal of Modality Solutions, was recognized by Cold Chain IQ as a 2013 Top Rising Star in Temperature Controlled Logistics.

HOUSTON, Tex. (PRWEB) August 20, 2013 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce Principal Brian Wallin was named a 2013 Top Rising Star in Temperature Controlled Logistics by Cold Chain IQ, Temperature Control Logistics & Quality Network.

According to Andrea Charles, Editor Cold Chain IQ, “2013 will see a great deal of investment in new and existing technologies for improving supply chain visibility and packaging for the life sciences. However, the cold chain is only as strong as the people who manage it. We reached out to our advisory board to recommend rising stars in temperature controlled logistics for life sciences.”

Brian Wallin was one of seven cold chain pharma professionals singled out by the Cold Chain IQ advisory board to receive the Top Rising Star distinction. Wallin was recognized as a leader who is “making waves in cold chain management and temperature controlled logistics.” A key achievement cited was the fact that Wallin was the primary author of the International Safe Transit Association ISTA 7E Standard 20 (Version 1 and 2). As the first industry standard on insulted shipper qualification, ISTA Standard 20 details the process and procedural requirements for thermal testing laboratories to be certified to perform the design, testing, and validation of Insulated Shipping Containers (ISCs).

In addition, during his 10 year tenure with Amgen (2002-2012), Wallin received its Excellence in Science and Engineering Award for his work in shipper development and an honorable mention for his development of novel shock and vibration profiles and multi-modal transport simulation system.

“One of the greatest challenges facing the biopharmaceutical industry is the designing, building, and maintaining of cGMP-compliant biopharmaceutical insulated shipping containers to ship temperature-sensitive pharmaceuticals safely and compliantly around the world,” said Gary Hutchinson, president of Modality Solutions. “Brian deserves the ‘Top Rising Star’ honor. He has designed more than three dozen Insulated Shipping Containers (ISCs) to ISTA 7E standards, and he is a key member of our cold chain management solutions’ team.”

“I was humbled to learn I was chosen as a ‘rising star in temperature controlled logistics.’ It was especially rewarding to have my work in the area of shock and vibration recognized by my industry peers. This is my passion,” said Brian Wallin. “Product transport simulation testing is the junction of the package engineer, the formulation scientist and quality assurance. Over the past 10 years, vast advancements have been made in industry guidance and shipper technology to ensure temperature is maintained during transport. Helping the industry understand transport environment effects and ultimately develop more stable products for transport will lead to a much more cost effective cold chain, speed up the drug product development cycle, and more importantly, help get lifesaving medicines to the patient, who lives at the end of the supply chain.”

Wallin attended the University of Wisconsin Stout where he received his Bachelor of Science in Packaging Engineering with a concentration in research, design and development. He is a frequent industry speaker on the topic of transport packaging. Wallin is a member of ISTA (International Safe Transit Association), PDA (Parenteral Drug Association) and IoPP (Institute of Packaging Professionals).

Cold Chain IQ, part of IQPC, maintains the largest global temperature control / cold chain pharmaceutical professionals’ network, offering strategic partners, members, and contributors opportunities to collaborate, share ideas and disseminate best practice information with global peers. As an online expertise hub, ColdChain IQ provides industry professionals with in-depth content designed to facilitate members’ work.

To learn more about Modality Solutions, call (214) 919-4629 or visit http://www.modality-solutions.com/.

About Modality Solutions

Modality Solutions is a privately-held company that delivers engineered solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information about Modality Solutions and alliance partner, BioConvergence, visit http://www.modality-solutions.com and http://www.bioc.us

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516
Click here to view this press release online.

LoJack Supply Chain Integrity and Modality Solutions Partner in Cold Chain and Critical Supply Chain

LoJack Supply Chain Integrity and Modality Solutions Partner in Cold Chain and Critical Supply Chain

Written by Modality Solutions

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DALLAS, Tex.  March 19, 2013 — LoJack SCI, the leading supplier of supply chain integrity and tracking solutions, and Modality Solutions, a recognized innovator in cold chain and supply chain environmental assessment and engineering solutions, have announced a program to jointly provide integrated solutions to select high value cargo and highly-regulated supply chain markets.  The parties will provide comprehensive cold chain assessment, turnkey program implementation, monitoring, tracking, and informational feedback services to assure that high value, critical goods in transit are protected and meet specified regulatory shipping requirements.

Modality Solutions has extensive experience in modeling critical shipment parameters through their proprietary Advantage Transport Simulation Laboratory™ (ATSL).  ATSL significantly reduces product development cycle times by providing advance notice of prospective risks in various factors and modalities.  LoJack SCI’s extensive range of cellular GPS-based tracking technology in concert with the LoJack InTransit web portal monitoring system will serve as the eyes and ears to ensure that sensitive shipment protocols are maintained and that a wide range of compliance requirements are assured, on a 24 hour / 7 day a week basis.

LoJack SCI and Modality Solutions have agreed to develop a suite of unique technology and service solutions for cold chain and related environmentally sensitive shipment applications.  “We understand that this market has requirements which are much more stringent than general cargo transport, and our partnership with Modality Solutions brings a quantum leap in our ability to bring solutions that are comprehensive and address all risk factors in this specialized market.  The integration of the engineering, environment simulation and quality management systems expertise of Modality Solutions, coupled with LoJack SCI’s complete set of security and environmental monitoring capabilities, is aimed at customers needing a turnkey approach to these challenges,” stated Ted Wlazlowski, president and CEO, LoJack SCI.

“We see the addition of LoJack SCI’s real time tracking and monitoring capabilities to be a logical extension to Modality Solutions’ promise of what we engineer and recommend for our clients.  By having an onboard environmental monitoring technology to assure that critical-to-quality parameters are carefully monitored and carrier quality agreements are rigorously enforced, we can provide management information that will be both valuable and compliance supportive.  This feedback loop is critical for any world-class quality management system. We will provide continuous updates on status and provide chain of custody information to meet all current cGDP regulatory requirements which will serve as the basis for continuous improvement in validated controlled environment logistics networks,” said Gary Hutchinson, president of Modality Solutions.

The companies will provide seamless turnkey solution packages for the cold chain market, alleviating customers from having to construct extensive protection and compliance monitoring programs.

About LoJack SCI

LoJack Supply Chain Integrity (LoJack SCI) provides integrated solutions for supply chain protection that includes shared supply chain intelligence and analytics, covert cargo tracking, monitoring, and recovery services.  The LoJack SCI solutions feature proactive alert based security and increased visibility across all modes of transportation with clear chain of custody management utilizing active sensing of the cargo’s environment while in-transit.  For more information, go to http://www.lojacksci.com.

About Modality Solutions

Modality Solutions delivers integrated cold chain management solutions for highly regulated industries: such as biopharmaceutical, medical devices, animal health, food and beverage, and agriculture industries. The privately-held company provides solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. Consultants provide engineering / logistics consulting, systems integration and simulation laboratory services from discovery through distribution. For more information, go to http://www.modality-solutions.com.

Click here to view this press release online.

Modality Solutions Names Shubhra Kochar Consulting Engineer

Modality Solutions Names Shubhra Kochar Consulting Engineer

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Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Shubhra Kochar Consulting Engineer.

HOUSTON, Tex. (PRWEB) August 27, 2012 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has hired Shubhra Kochar as a consulting engineer. In her position with Modality Solutions, Kochar will serve as one of the firm’s specialized project consultants.

In 2011 five cold chain subject-matter experts partnered to launch Modality Solutions. Gary M. Hutchinson, Paul J. Harber, Daniel J. Littlefield, Brian Wallin, and Donald Wilson identified a need for their cold chain management expertise in the biopharmaceutical, health, nutrition and wellness business sectors. With a high demand for its specialized consulting services, the executive team has looked to identify and attract key industry talent. In her position, Kochar will help the company deliver its integrated cold chain management solutions—utilizing quality engineering / logistics consulting, systems integration, and simulation laboratory services.

Prior to joining Modality Solutions, Kochar attended The Ohio State University where she received her degree in Biomedical Engineering. While at OSU, Kochar served as the project lead and point of contact for the Board of Regent’s Environmental Scan Project for the Centers of Excellence in Biomedicine and Healthcare. Kochar was recognized with 2011 and 2012 Women in Engineering Outstanding Academic Awards. Her senior design project, a Knee Ankle Foot Orthotic (KAFO), was awarded the Ethel Louise Armstrong Student Poster Competition Award from the 2012 Multiple Perspectives Conference hosted by the American Disability Association at The Ohio State University. In addition the KAFO design project won first place in the socially disabled category of the OSU Annual Senior Engineers Capstone Showcase.

“Shubhra Kochar joining Modality Solutions underscores our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “From discovery to distribution, we want to be the ‘go to’ firm to ensure regulatory compliance and to decrease development cycle times. Today’s challenges require a diverse mix of engineering, process knowledge and validation approaches. Shubhra will be instrumental in helping us achieve our objectives for our clients.”

To learn more about Modality Solutions visit http://www.modality-solutions.com/.

About Modality Solutions

Modality Solutions delivers integrated cold chain management solutions for highly regulated industries, such as biopharmaceutical, health, nutrition and wellness. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information, visit http://www.modality-solutions.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

Sustainability in Biopharmaceutical Thermal Packaging Webcast to Feature Drug-Packaging Experts

Sustainability in Biopharmaceutical Thermal Packaging Webcast to Feature Drug-Packaging Experts

Written by Modality Solutions

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Modality Solutions cold chain management experts will discuss packaging and process on June 18, 2012

HOUSTON, Texas June 14, 2012 — Modality Solutions, LLC ) President Gary M. Hutchinson and Principal Daniel J. Littlefield will present an exclusive one-hour Webcast titled “Sustainability in Thermal Packaging and Controlled-Environment Logistics Design for the Biopharmaceutical Industry” during Pharmaceutical & Medical Packaging News’ Supply Chain Week. PMP News Editor Daphne Allen will moderate the free, live presentation on June 18 at 2:00 p.m. ET. Register for the online event at http://tinyurl.com/cgv4k61.

Cold chain management experts, Hutchinson and Littlefield will address:

  • Understanding the opportunities for cold chain sustainability
  • Assessing a sustainability program in cold chain against industry standards
  • Putting together a cold sustainability program — packaging and process

Hutchinson, former Director of Global Transportation at Amgen, designed logistics networks and solutions for biologics and solid oral dosages — including cold chain logistics networks, import/export compliance, and transport validation. As a member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG), Hutchinson has been a featured speaker at three of the organization’s annual conferences.

Littlefield is an expert in process improvement, safety and security with experience in a wide variety of industries. During his tenure at DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner. Littlefield is a two-time recipient of DuPont’s Engineering Excellence Award.

The Webcast is presented by Pharmaceutical & Medical Packaging News (PMP News) and will be moderated by Editor Daphne Allen. The Modality Solutions Webcast is one of three to be offered at no charge during the PMP News Supply Chain Week Virtual Events held June 18 through June 22, 2012.

“In today’s global marketplace, the biopharmaceutical industry faces complex controlled-environment logistics problems. The challenges require a diverse mix of compliance, engineering, process knowledge and innovative validation approaches,” said Hutchinson. “Dan and I plan to share key information and answer attendees’ and Daphne Allen’s questions as time permits.”

To register for the PMP News Hutchinson-Littlefield Thermal Packaging Webcast, go to: http://tinyurl.com/cgv4k61.

About Modality Solutions, LLC

Modality Solutions, LLC delivers integrated cold chain management solutions for highly regulated industries: such as biopharmaceutical, health, nutrition and wellness. The privately held company provides solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. The consultants provide engineering / logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.

About Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News (PMP News) is a comprehensive resource for medical and pharmaceutical manufacturing professionals who need focused, reliable, and timely information to make intelligent packaging decisions. PMP News is a BPA-audited publication reaching 20,040 packaging professionals in the pharmaceutical and medical packaging industries. For more information, go to http://www.pmpnews.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

Cold Chain Management Experts Launch Modality Solutions, LLC

Cold Chain Management Experts Launch Modality Solutions, LLC

Written by Modality Solutions

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Five cold chain subject-matter experts launch Modality Solutions, LLC. The privately-held company delivers integrated cold chain management solutions for highly regulated industries –biopharmaceutical, health, nutrition and wellness sectors. Modality Solutions provides engineering / logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.
HOUSTON, Tex. (PRWEB) January 24, 2012 — With more than 100 combined years of career experience in the biotechnology and life science arena, five cold chain subject-matter experts have partnered to launch Modality Solutions, LLC. Paul J. Harber, Gary M. Hutchinson, Daniel J. Littlefield, Brian Wallin, and Donald Wilson identified a demand for their expertise in highly regulated industries, such as the biopharmaceutical, health, nutrition and wellness business sectors. The privately-held company delivers integrated cold chain management solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. Modality Solutions provides engineering / logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.
As a comprehensive team of cold chain logistics experts, Modality Solutions is positioned to:
Ensure regulatory compliance in highly regulated industries.
Deliver cold chain management / thermal packaging design / qualification and controlled-environment logistics solutions.
Conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure.
Decrease development cycle times for a faster route-to-market.
Develop transport validation strategies to support global regulatory applications.
Modality Solutions’ founders utilize their business and engineering experience to focus on solutions that work for their clients. They play a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ASTM). Their body of work demonstrates an ability to solve complex controlled-environment logistics problems. The challenges they tackle require a diverse mix of compliance savvy, engineering expertise, along with process knowledge and innovative validation approaches.
Paul J. Harber is a founding member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG). Harber co-authored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is the definitive reference source for best-demonstrated practices in transport validation. Harber is the 2008 recipient of the Eli Lilly Engineering Excellence Award.
Gary M. Hutchinson, former Director of Global Transportation at Amgen, has designed logistics networks and solutions for biologics and solid oral dosages — including cold-chain logistics networks, import/export compliance, and transport validation. As a member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG), Hutchinson has been a featured speaker at three of the organization’s annual conferences.
“Until now, innovators needed to work with a variety of companies to deliver cold chain management solutions. Our clients leverage years of biotech subject-matter experience in three critical areas: regulatory compliance guidance, package engineering, and controlled-environment logistics execution,” said Gary Hutchinson. “We encourage a collaborative relationship with current and potential clients. They are free to call us at any time, during a current engagement or not, to discuss their issues, concerns and opportunities.”
Daniel J. Littlefield is an expert in process improvement, safety and security with experience in a wide variety of industries. During his tenure at DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner. Littlefield is a two-time recipient of DuPont’s Engineering Excellence Award.
Brian Wallin co-authored with ISTA the first global standards of insulated shipping container performance (Standard 7E) and testing methodology and lab certification (Standard 20). Wallin received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
Donald Wilson focuses his considerable engineering skills on primary packaging. He designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, needle-free syringe technologies, and container closure integrity testing. Wilson received Amgen’s Excellence in Science and Engineering Award for his work in shipper development.
In addition, Rafik H. Bishara, Ph.D. serves as a Technical Advisor to Modality Solutions, he is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA).
To learn more about Modality Solutions visit http://www.modality-solutions.com.
About Modality Solutions, LLC

Modality Solutions, LLC delivers cold chain management solutions for highly regulated industries, such as biopharmaceutical, health, nutrition and wellness. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information, visit http://www.modality-solutions.com.
Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516
Click here to view this press release online.

Case Study: Meeting Cold Chain Logistics Challenges In Global Clinical Trials

Case Study: Meeting Cold Chain Logistics Challenges In Global Clinical Trials

Written by Modality Solutions

Posted on: September 5, 2017

First published on June 29, 2016 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/clinical-supply/columns/case-study-meeting-cold-chain-logistics-challenges

Highly sensitive cold chain clinical trial products demand operational excellence. Variations in temperature can void a shipment and lead to millions in loss for the manufacturers as well as dramatically raise the costs of the trials. The need for reliable and environmentally controlled cold chain solutions is more critical than ever. Quality cold chain management reduces risk and includes thermal package engineering, data collection / monitoring, and global transportation logistics’ experience to ensure medical treatments maintain their efficacy and safely reach the patient. In addition, during distribution a temperature excursion can also affect the overall data generated for the clinical trial evaluation.

Clinical trial material (CTM) or investigational medicinal products (IMP) are an important part of the early stages of the life science supply chain. As trials are being run on a global scale, in markets with less than ideal infrastructure, there is a dire need for companies to work with specialized cold chain experts to engineer and design innovative distribution processes.

Cold chain failure may lead to: the patient being administered an unsafe product; liability based on compliance infractions; inconsistent data results; or an entire shipment’s product integrity could be rejected by the quality department, resulting in costly delays.

The industry has progressed from shipping “as usual” to exacting controls on products in-transit with proof of custody at the final destination. Control and documentation for the storage, handling and distribution of temperature-sensitive products is best addressed with comprehensive shipping qualification.

When biopharmaceutical companies partner with providers and consultants that specialize in the packaging, shipping, distribution, delivery, and monitoring of temperature-sensitive vaccines, clinical trial logistics operations can be streamlined and be more effective for all concerned.

One such example is that of a life-saving CDC-sponsored clinical trial operation for the Ebola vaccination. In April 2015, Daniel “Dan” Littlefield, a co-founder and principal of Modality Solutions, traveled to Sierra Leone, West Africa to provide operational and technical support for the first Ebola outbreak to reach epidemic proportions. Dan trained and worked hand-in-hand with another Modality Solutions project employee, Judy Tempel and local staff at three locations, as well as with our partners FHI360, the CDC and BARDA. The project was funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

One such example is that of a life-saving CDC-sponsored clinical trial operation for the Ebola vaccination. In April 2015, Daniel “Dan” Littlefield, a co-founder and principal of Modality Solutions, traveled to Sierra Leone, West Africa to provide operational and technical support for the first Ebola outbreak to reach epidemic proportions. Dan trained and worked hand-in-hand with another Modality Solutions project employee, Judy Tempel and local staff at three locations, as well as with our partners FHI360, the CDC and BARDA. The project was funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

Modality Solutions’ clinical trial operation services include: ongoing monitoring, staff training, data query resolution, drug supply accountability, and regulatory document preparation, review and collection. Every member of our team works to maximize clinical trial performance, clinical excellence, data integrity, and patient safety.

With less than two weeks’ notice, Dan worked to use controlled environment logistics for a very difficult vaccine. He knew he’d be working in a complex Zone 4 emerging market environment. The vaccine had a temperature storage requirement of less than minus 60 degrees Centigrade in a location without a reliable infrastructure of water and electricity.

Dan, an expert in cold chain logistics, with his on-site assembled team, helped coordinate the vaccination of 8,650 healthcare and other frontline workers including: doctors and nurses; cleaning, laboratory, pharmacy, security, and administrative health facility staff; ambulance teams; workers responsible for swabbing deceased people; surveillance teams; and burial workers. In this effort, Dan and his team members were dealing with the potential for issues discussed earlier (namely unsafe product and patient danger) if they did not maintain utmost consistency in their cold chain management.

To assess such risk, Dan initially applied the use of appropriate Six Sigma tools, including statistical analysis, process mapping, and GDP and risk assessment to identify potential issues. When it came to risk analysis, Dan initiated a ground-breaking strategy drawn from his previous experience. Rather than doing the typical Failure Mode Effect Analysis (FMEA), he called for using a Hazard and Operability Analysis (HAZOP). The HAZOP risk analysis focuses on essentials like running water, electricity, and Internet.

Recognizing the limitations early, Dan used his engineering skills to import into the country of Sierra Leone items to build the cold chain. The Ebola vaccine had to be reconstituted, then stored and shipped from the depot to the field sites with monitored refrigerated temperatures the entire time. Using specialized packaging and modern technology, Dan put together a holistic cold chain management approach.  He demonstrated what we talk about as far as integrating the cold chain management system with processes and procedures, risk assessment, modern technologies, training the partner, and packaging qualification. He put it all together very quickly without missing a beat. As a result, no vaccine was lost to temperature excursion.

With the common goal of providing the correct pharmaceutical product safely, clinical supply chain partners have to ensure that items like medications are carefully monitored throughout the supply chain process. Achieving the right conditions through various global conditions, which often change with unexpected weather or problems along the way, requires a deep understanding of not only the regulatory environment of the bio-pharmaceutical market but also the local requirements and at-point options during transport and clinical trials. Handling, storing, and distributing such temperature-sensitive items relies heavily on the individuals who understand the regulations in the big picture and can also meticulously engineer solutions for the product to maintain those standards in complicated or less-than-desirable situations.

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

Written by Modality Solutions

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First published on May 24, 2016 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/packaging-shipping-systems/columns/it-is-never-too-late-to-document-your-cold-chain

Documentation strategy for your cold chain management validation practices has evolved over the last several years. The FDA and other regulatory agencies are requesting more and more specific information in the filing to confirm the impact to drug product during transport, and the effect transportation hazards have on shelf life. An overall strategy of providing minimal documentation in the Biologic License Application (BLA) has evolved to provide a more complete and comprehensive review of the stability data, verification studies, packaging qualification and process validation activities in the BLA to support questions in the pre-approval inspection (PAI). The outdated “don’t ask, don’t tell” approach has given way to provide cold chain qualification and validation data that is reviewable by regulators and is expected to be discussed in the PAI process. More and more, data that has not been submitted and reviewed in the BLA is more difficult to use as justification for temperature ranges set outside of labelled storage conditions or justification for drug product release after excursions in distribution outside of labelled storage conditions.

Documentation for sections 3.2.P.3.5 Process Validation as it pertains to distribution and cold chain activities should include the following elements:

Packaging Qualification

Primary packaging – container closure integrity, sterile barrier, physical integrity, and leachables and extractables after agitation

Secondary packaging – physical integrity and label legibility Thermal packaging – physical integrity and thermal control (after physical integrity testing)

Process Validation

Performance qualification in qualified packaging in representative transport lanes

Drug product physical stability studies with release testing

Documentation for sections 3.2.P.8.3 Stability Data as it pertains to distribution and cold chain activities should include the following elements:

  • Long-term stability studies per ICH Q1A Stability Testing of New Drug Substances and Products for confirmation of shelf life
  • Accelerated stability studies per ICH Q1A Stability Testing of New Drug Substances and Products for justification of effects of temperature exposure outside recommended storage conditions
  • Additional temperature-stress studies to evaluate the effect of short-term excursions of temperature outside recommended label conditions per ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products

The BLA submission is the opportunity to show the qualification and validation data and support stability studies. The PAI inspection process is the opportunity to show process controls. The focus at the PAI is to review the validation master plan documentation to show the proper process controls are in place to confirm the product quality limits demonstrated in the BLA are achievable. The focus in the PAI should be in two key areas:

Standard Operating Procedures

  • Product put-away and storage
  • Inventory control
  • Drug product picking
  • Pack-out instructions for thermal packaging

Nonconformance Management

  • Monitoring and controls
  • Allowable exposure limits outside of labelled storage conditions
  • Material traceability / inventory control processes

A medicinal product can take a variety of paths from the manufacturer to the patient. In some instances, a drug product can route directly to the patient. In others, there are a series of lanes in the distribution chain where the drug product may be subject to variable environments. Principles of process validation (including design, operational and performance qualifications) can be applied with good distribution practices (GDPs) to confirm portions of the supply chain are validated (excluding unforeseen transport events and the impact of extreme weather conditions).

An Implementation Strategy is Key

Your implementation strategy for preparing for BLA submission and the subsequent PAI should be well- defined and understood by all key stakeholders in the cold chain as quickly as possible. Your approach should be documented in a validation master plan. Some keys to success to consider are:

Network Design and Partner Selection:

  1. Confirm expected channels of distribution as soon as possible
  2. Select channel partners and physical location(s) for each channel of distribution
  3. Conduct site assessment and quality management systems review
  4. Prepare assessment report and track improvement against recommendations
  5. Execute quality agreement as part of commercial terms
  6. Implement management review metrics as part of management review process

Packaging Qualification:

  1. Clearly define your temperature profiles and your justification for use
  2. Perform operational qualification (OQ) study designed to expose the drug product to an approved composite (or representative) simulation of the distribution environment
  3. Confirm or conduct operational and performance qualification (PQ) on the shipping systems as required (active vs. passive) after vendor data evaluation

  4. Design monitoring and controls strategy based on qualification data

Process Validation and Shipping Studies:

  1. Create validation master plan for drug product validation activities
  2. Examine the interaction of each primary container type with the product for possible interactions.
  3. Generate physical stability at the earliest possible opportunity in development with bulk secondary packaging
  4. Apply to all subsequent secondary packaging since hazard exposure will exceed any within the commercial supply chain

A validation master plan for distribution along with specific product annexes can align the disparate activities already completed into a comprehensive and cohesive approach to distribution process validation. The validation master plan gives an opportunity to discuss risks and mitigation strategies, qualification approach, validation approach, and monitors and controls. Sections can include discussion on warehousing and storage, product transportation, shipping configurations, methods of temperature control, and packaging.

Shipping studies must include both physical packaging integrity and drug product quality. Any proposed shipping qualification plan that does not include any testing of drug quality post shipping compared to specifications and/or control samples will be challenged. The regulatory agencies are expecting to see some post-shipment drug product studies to confirm quality after transport.

Protocols for shipping studies should be split into operational qualification (OQ) and performance qualification (PQ) – each type of protocol achieves difference results. The OQ protocols show in controlled laboratory conditions that the control in the proposed design space is achievable. The PQ protocols show in field conditions the process is robust and repeatable.

A Potential Revolution For Passive Shipper Selection

A Potential Revolution For Passive Shipper Selection

Written by Modality Solutions

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First published on April 20, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/quality-management/columns/a-potential-revolution-for-passive-shipper

Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps (e.g. bulk transport, filling and packaging operations, final product distribution operations, end user administration) intentionally (i.e. exposure) or not (i.e. excursion). The allowable time and temperature exposure to ranges outside of the long- term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines.

However, these accelerated registration (or static) stability studies may be inadequate for the transport process especially when dealing with protein formulations in solution. The accelerated studies are normally terminated without returning samples of the exposed product to normal storage conditions and conduct assay testing to the end of shelf life to confirm product. The cumulative effects of other environmental hazards on product outside long-term storage recommendations are essentially unknown with standard static stability studies as currently recommended under ICH guidelines.

Product stability for distribution is a relatively new concept for biopharmaceuticals. Driven by increasing complex regulations, the more typical registration or ‘static’ stability studies used to set expiry date are being augmented with ‘dynamic’ stability studies for distribution. These distribution stability studies typically stress the drug product formulation is either an extreme ‘real world’ shipment of is a controlled laboratory setting.

The same stability indicating assays used to set expiry date are executed on these ‘stressed’ samples. At each time points, the degradation, if any, is compared to the registration stability study. If the degradation pathway is comparable, these studies can show that temperature exposures outside of labeled storage conditions do not have an impact on product quality. These types of studies are powerful in an integrated approach which allows the operating range of the temperature-controlled network to be significantly broadened – reducing costs, increasing service levels, and diminishing non-conformances.

Without dynamic stability testing for distribution, the manufacturer is left with a difficult choice: either significantly slow down the flow of final drug product to allow critical information to be made available for proper product disposition of potentially compromised drug product or scrap the potentially compromised drug product and reship. Either choice will add significant costs in the logistics network and potentially ration or ‘short’ the supply to patients. Continuous review of potentially compromised drug product during transport could lead to FDA review, review of the manufacturing process, or looking for tighter and tighter logistics controls: all these options are very time consuming and costly.

How should dynamic stability studies be conducted to provide us with the answers to these concerns?

These studies need to be designed and conducted based on expected shipment durations, possible product temperature exposure ranges outside labeled storage conditions, and coupled with other hazards during transport and distribution. The cumulative effects of these hazards on product quality, potency, and efficacy must be determined to the end of shelf life. Most importantly, dynamic stability studies for distribution should show the drug product is not impacted by the following environmental hazards in the controlled-environment logistics network:

  • Temperature
  • Shock
  • Vibration
  • Pressure
  • Humidity

Paths to degradation of product should be established through dynamic stability testing by defining variables clearly and establishing ranges of acceptable variances to support temperature excursions experienced during transport concurrently with the other environmental hazards listed above. Once these degradation paths are understood, the required shipping conditions, appropriate handling techniques, specialized packaging should be defined and communicated to all parties in the controlled-logistics network, and any required maintenance and monitoring of such procedures. Appropriate means of control (e.g. procedural, visual, marking and labeling, etc.) and monitoring (e.g. data loggers, threshold indicators, time/temperature indicators, etc.) should be implemented once the potential hazards are understood.

The concerns during transport are many: the risk of compromised or diverted product in a global contracted third-party network allow little direct control, the variables in equipment, facilities, and controls in a global controlled-environment logistics network make consistent handling difficult, and the effects of product temperatures outside of long-term storage recommendations combined with environmental hazards unique to the transport environment. These effects are hard to predict and have offered continuous challenges for the traditional drug formulation processes. . Understanding the environmental hazards especially to protein formulations that are relatively new but increasingly wide spread, and conducting product testing specifically for the hazards encountered during distribution are the best way to alleviate product quality concerns during transport.

Forecasted Cold Chain Trends for 2016

Forecasted Cold Chain Trends for 2016

Written by Modality Solutions

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First published on January 5, 2016 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/transportation-logistics/columns/forecasted-cold-chain-trends-for-2016

Specialized packaging and network designs for specific drugs

We are seeing a trend in pharmaceutical manufacturers to start designing their cold chain networks specifically to the drug platform or modality based on therapeutical area. The ability to tackle a whole range of chronic diseases and illnesses with exciting new technologies has driven more and more specialization in not only the cold chain but the entire logistics network. For example, stable and better characterized drugs with an exemplary safety record are using deferred shipping lanes, new transport modes including ocean freight, and an increased allowable range in shipping temperatures. However, more fragile platforms like a monoclonal antibodies require greater characterization of the drug product not only for temperature hazards, but a full range of environmental hazards including shock, vibration, temperature and humidity. The characterization of these synthesized human proteins in solution has shown a fragility that requires complex and specialized logistics networks supported by cushioning thermal packaging with tight control on temperature ranges. Coupled with the controlled temperature requirements for small molecule drugs, the depth and complexity of modern pharmaceutical supply chains will grow exponentially in 2016.

Tighter controls on clinical trial operations in extreme environments

Tighter controls seen in clinical trial operations, especially in vaccine trials, will be seen in 2016. Ongoing concerns in handling of clinical trial materials and vaccines has prompted a renewed look at the monitoring and controls in place for each step of the clinical trial operational management. These controls are going to extend to beyond just standard temperature monitoring, but a top-to-bottom review of processes, procedures, and packaging to ensure end-to-end control of the cold chain in extreme environments. Trial operations, especially vaccine trials, are becoming focused in areas of the world where temperature extremes and lack of logistics infrastructure translate into difficult challenges for both the trial sponsor and the healthcare professionals. This focus on end-to-end monitoring of clinical trials in the most challenging of logistical environment is significant trend that will only increase in 2016.

Greater scrutiny on BLA submission for cold chain products

The trend for greater regulatory scrutiny on the cold chain management processes by regulators as part of the approval process will accelerate in 2016. This trend to confirm that all the elements of your cold chain management processes – characterization, qualification/validation and tech transfer/implementation – are fully integrated and well documented in your quality system prior to submission will grow. We expect the scrutiny that has challenged many new molecules – unique therapies and biosimilars – to continue to delay and frustrate the submission process unless the manufacturer is properly prepared. The regulators are better versed on the potential dangers and have seen best practices in cold chain for years. Now the expectation to deliver a world-class cold chain will only grow in 2016.

A Process Validation Guide for Cold Chain Logistics

A Process Validation Guide for Cold Chain Logistics

Written by Modality Solutions

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First published on September 16, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/regulatory-resources/columns/a-process-validation-guide-for-cold-chain-logistic

Process validation for cold chain logistics (packaging, storage, and distribution) is required part of the Common Technical Document (CTD) for any Biologics License Application (BLA) for monoclonal antibodies. Any review of the submitted dossier and subsequent pre-approval inspection on site will most likely review the following areas:

  • Stability testing
  • Thermal packaging qualification
  • Process validation
  • Validation master planning

The strategies focused on the packaging qualification and do not consider validating the process of drug product transport and the potential impact on the potency, efficacy, or purity of the drug product as compared to the specification will be challenged by regulatory agencies around the world. The best practices identified and current expectation from regulatory agencies globally is drug product quality will be confirmed after transport.

The confirmation of drug product quality can be confirmed by a variety of methods. Either simulated or actual shipments of drug product can be used to confirm quality. However, in both cases the confirming test must be justified. The justification can be either a comparison of a proposed testing standard (e.g. ASTM-4169) to actual shipping lanes or the choice of a representative lane that provides a suitable challenge based on the expected channels of distribution. A simulation strategy is ideally shared with the regulatory agencies at the “End of 2A” meeting; otherwise actual shipments within longest lanes may be the expectation. However, any proposed testing methodology that is justifiable and sufficient for the BLA and can be used as supporting documentation for PAI.

Stability Testing

Tying your distribution studies back to your excellent stability studies results provide excellent justification for either:

  • Extending shipping temperature ranges outside of labeled storage conditions of 2 to 8°C to a range as expansive as 0 to 25°C or
  • Preparing a shipping exposure matrix for temperature and durations outside of label storage conditions to close any non-conformance and make product disposition decisions quickly.

Recombinant produced monoclonal antibody (mAb) products usually contain size variants (e.g., aggregates, fragments) that are generated during manufacture, storage and distribution. Because aggregates and fragments may potentially affect immunogenicity and potency, their levels are typically monitored during lot release, stability, and characterization. These size variants can be exaggerated during transport at elevated temperatures. Any proposed engineering study or follow on process validation should include enough data points to confirm trending on this key stability indicating method.

Thermal Packaging Qualification

Thermal packaging qualification testing for the BLA submission should demonstrate that the selected thermal shipping system provides adequate thermal protection for the entire manufacturing process including shipments to the distribution centers. The FDA regulatory scope starts at point of manufacturer and ends at the point of distribution for the BLA. Representative shipping points that can be justified can be used. The recommended critical-to-quality attributes are:

  • Temperature range and allowable exposures
  • Duration

Qualification of the shipping system to maintain thermal and payload integrity during the distribution process requires a several components:

  • Component qualification (i.e. gel packs in passive systems) or installation qualification (i.e. factory acceptance testing for the C-SAFE refrigerated pallet system),
  • Operational qualification in a controlled environment (i.e. testing laboratory), and
  • Performance qualification with multiple field tests to confirm suitability for use.

Distribution Process Validation Best Practices

The principles of qualification for the transport of temperature-sensitive medicinal products closely follow established guidelines and regulations for qualifying the manufacture of these same products as outlined in the PDA Technical Report #39: Guidance for Temperature-Controlled Pharmaceuticals. These include:

  • Development of specifications, processes, systems, and components
  • Written procedures
  • Approved protocols and reports
  • Justified test methods and acceptance criteria
  • Qualification testing that challenges “anticipated extremes”
  • Ongoing monitoring and/or periodic evaluation
  • Change control

Medicinal products are transported in a commercial environment as opposed to a controlled laboratory environment. Factors such as unforeseen transport events and the weather affect the actual conditions a specific shipment may encounter. These factors should be considered when designing test protocols and in understanding “anticipated extreme” challenges. Utilizing this type of information (i.e. typical transportation extremes) to support widening shipping temperature range versus label claim storage conditions is beneficial when supported by product stability data. The last two elements (ongoing monitoring and/or periodic evaluation and change control) are not addressing the shipping study plan, but should be addressed procedurally as part of an integrated cold chain management quality system. A comparison of your current testing approach to the recommended approach the Technical Report #39 is a good place to start any initial assessment. You can use a checklist to determine you preparedness. Table 1 below shows the elements of the shipping qualification and compares them to the proposed test plan.

The two requirements (justified test methods and “anticipated extremes” challenge) are symptoms of the same root cause. Your testing methodology must be justified as the proper testing approach for the distribution environment. Since a specific testing approach (e.g. ASTM D 4169) may be a generally accepted test procedure, the lack of justification of the test method and the associated acceptance criteria is low risk. Separating the engineering study from the OQ in any testing plan is recommended. DO NOT START QUALIFICATION until you have confirmed results in with engineering studies. These studies can be already executed as part of characterization or may have to be designed from scratch if the previously executed studies

Validation Master Planning

The Validation Master Plan for Product Distribution (VMP) describes the policies and strategies of the qualification program for product shipment qualification and defines the requirements for the storage and transport of Drug Substance (DS), Bulk Drug Product (BDP), and finished Drug Product (DP) manufactured at company-operated sites or approved contracted manufacturing sites. While there is no explicit statutory requirement by the FDA for a VMP, the 2011 Guidance for Industry for Process Validation implicitly recommends one. A VMP is an expectation in the EU jurisdictions.

The scope of the VMP includes the storage and transport of DS, BDP, and DP originating from facilities, contract manufacturing sites, and/or contract storage facilities to contract manufacturing facilities, commercial packaging facilities, distribution centers, commercial customers (pharmacies), and clinical packaging facilities. Shipping qualification activities include, but are not limited to, the qualification of packaging configurations, temperature profiles, shipping carriers and the use of temperature monitoring devices. In general the VMP includes the storage and transportation activities for each transport segment. Good practice in a VMP is to include a figure representing the distribution process.

The validation master plan overall must justify how DS, BDP, and DP are shipped and stored in a manner that prevents damage and minimizes exposure to temperatures outside of their recommended storage conditions that could potentially impact the safety, quality and effectiveness of the drug product. A validation master plan provides guidelines, requirements and scope for all existing and future shipping configurations, carriers and distributors managed by the manufacturer. The VMP reflects the external and internal standards and guidance documents to comply with Good Distribution Practices (GDP) in addition to other regulations and guidance for the distribution points in the supply chain. Overall, the VMP describes the documentation and qualification activities for all shipping configurations including DS, BDP, and DP. The principles of process validation (including design, operational and performance qualifications) are applied to GDPs such that the portions of the supply chain are qualified (excluding unforeseen transport events and the impact of extreme weather conditions).

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

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First published on June 15, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. Join Cold Chain IQ today to access informative cold chain articles.

By Gary Hutchinson 

Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps (e.g. bulk transport, filling and packaging operations, final product distribution operations, end user administration) intentionally (i.e. exposure) or not (i.e. excursion). The allowable time and temperature exposure to ranges outside of the long-term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines.

However, these accelerated registration (or static) stability studies may be inadequate for the transport process especially when dealing with protein formulations in solution. The accelerated studies are normally terminated without returning samples of the exposed product to normal storage conditions and conduct assay testing to the end of shelf life to confirm product. The cumulative effects of other environmental hazards on product outside long-term storage recommendations are essentially unknown with standard static stability studies as currently recommended under ICH guidelines.

Product stability for distribution is a relatively new concept for biopharmaceuticals. Driven by increasing complex regulations, the more typical registration or ‘static’ stability studies used to set expiry date are being augmented with ‘dynamic’ stability studies for distribution. These distribution stability studies typically stress the drug product formulation is either an extreme ‘real world’ shipment of is a controlled laboratory setting.

The same stability indicating assays used to set expiry date are executed on these ‘stressed’ samples. At each time points, the degradation, if any, is compared to the registration stability study. If the degradation pathway is comparable, these studies can show that temperature exposures outside of labeled storage conditions do not have an impact on product quality. These types of studies are powerful in an integrated approach which allows the operating range of the temperature-controlled network to be significantly broadened – reducing costs, increasing service levels, and diminishing non-conformances.

Without dynamic stability testing for distribution, the manufacturer is left with a difficult choice: either significantly slow down the flow of final drug product to allow critical information to be made available for proper product disposition of potentially compromised drug product or scrap the potentially compromised drug product and reship. Either choice will add significant costs in the logistics network and potentially ration or ‘short’ the supply to patients. Continuous review of potentially compromised drug product during transport could lead to FDA review, review of the manufacturing process, or looking for tighter and tighter logistics controls: all these options are very time consuming and costly.

How should dynamic stability studies be conducted to provide us with the answers to these concerns? 
These studies need to be designed and conducted based on expected shipment durations, possible product temperature exposure ranges outside labeled storage conditions, and coupled with other hazards during transport and distribution. The cumulative effects of these hazards on product quality, potency, and efficacy must be determined to the end of shelf life. Most importantly, dynamic stability studies for distribution should show the drug product is not impacted by the following environmental hazards in the controlled-environment logistics network:
• Temperature
• Shock
• Vibration
• Pressure
• Humidity

Paths to degradation of product should be established through dynamic stability testing by defining variables clearly and establishing ranges of acceptable variances to support temperature excursions experienced during transport concurrently with the other environmental hazards listed above. Once these degradation paths are understood, the required shipping conditions, appropriate handling techniques, specialized packaging should be defined and communicated to all parties in the controlled-logistics network, and any required maintenance and monitoring of such procedures. Appropriate means of control (e.g. procedural, visual, marking and labeling, etc.) and monitoring (e.g. data loggers, threshold indicators, time/temperature indicators, etc.) should be implemented once the potential hazards are understood.

The concerns during transport are many: the risk of compromised or diverted product in a global contracted third-party network allow little direct control, the variables in equipment, facilities, and controls in a global controlled-environment logistics network make consistent handling difficult, and the effects of product temperatures outside of long-term storage recommendations combined with environmental hazards unique to the transport environment. These effects are hard to predict and have offered continuous challenges for the traditional drug formulation processes. . Understanding the environmental hazards especially to protein formulations that are relatively new but increasingly wide spread, and conducting product testing specifically for the hazards encountered during distribution are the best way to alleviate product quality concerns during transport.

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Why Is Pharmaceutical Transportation a Major Concern?

Why Is Pharmaceutical Transportation a Major Concern?

Written by Modality Solutions

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pharmaceutical transport, image of engineers working on pharmaceutical transport

First published on May 11, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. Join Cold Chain IQ today to access informative cold chain articles. 

By Gary Hutchinson

A drug can take a variety of paths from the manufacturer to the patient. Most often, the product leaves the manufacturer’s direct control and enters a complex system of handoffs (see chart from US Pharmacopoeia). Distribution systems that deliver pharmaceutical products require special handling based on the conditions clearly indicated in the labeling for the product. The Prescription Drug Marketing Act of 1987 and the ensuing regulations in 21 CFR Part 203, Prescription Drug Marketing, and Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, provide the necessary regulations and guidance for several legs of the distribution chain for the prescription drug.

Manufacturers are obligated to include distribution as part of their overall quality system and should be continuously monitored and updated to adhere to industry best practices. Current Good Distribution Practices (cGDPs) for the pharmaceutical supply chain have been divided into seven different categories (Stability, Distribution Control Management, Performance Management, Supply Chain Partner Management, Qualification / Validation, Continuous Improvement, and Import / Export Compliance) in PDA Technical Report #52.

Distribution Control Management in a comprehensive cGDP quality system covers the logistics management for final drug product in four key ways:

• Qualifications and training of personnel
• Facilities, material handling, and storage and inventory control
• Non-conformance or exceptions, returns, and product disposition
• Transportation, third-party distribution, and product protection

Maintaining the cGDP quality system for transportation, third-party distribution, and product protection is a difficult challenge because of the distributed nature and contracted third-party relationships found across most modern controlled-environment logistics networks.

Coupled with the increased focus on high-growth protein products that are environmentally sensitive, the concerns during transportation are heightened for several reasons:

• Risk of introduction of adulterated and/or counterfeit product and product diversion
• Variances in equipment, facilities, skills, and experience across locations
• Significant and cumulative hazards to product quality — temperature with shock, vibration, pressure and humidity

Pharmaceutical products are the most vulnerable during transport. Managing supply chain security risks during transport is important to mitigate the potential loss of revenue and reputation for manufacturers, distributors, and logistics providers. Training to detect and deter potential adulteration or diversion of drug product is needed.

Variances in equipment, material handling, personnel skills, and experience in handling pharmaceuticals for in-transit drug products are important to consider when preparing a validation master plan. These variances make the process validation of the controlled-environment logistics network at a high degree confidence (greater than 95%) difficult, especially when transporting protein-based products. Additional in-transit monitoring, procedural controls, visual indicators, and most importantly stability testing for distribution becomes necessary since validating to a high confidence interval is difficult to achieve.

Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. The potential product impact in the distribution environment is not addressed. Shock and vibration testing have a role, particularly in the transportation of solution formulations of certain large proteins. Stability testing for distribution is needed: these tests are ‘dynamic’ when compared to current ‘static’ testing per ICH guidelines and should be designed to understand the cumulative and significant hazards to drug quality during transport.


Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps. The allowable time and temperature exposure to ranges outside of the long-term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines.

However, these accelerated registration (or static) stability studies may be inadequate for the transport process, especially when dealing with protein formulations in solution. The accelerated studies are normally terminated without returning samples of the exposed product to normal storage conditions and conducting assay testing to the end of shelf life to confirm product. The cumulative effects of other environmental hazards on product outside long-term storage recommendations are essentially unknown with standard static stability studies as recommended under ICH guidelines. A gap in understanding exists on protein in solution formulation behavior after exposure to significant and cumulative hazards during transport. This gap should be a cause for concern.

One of the biggest risks to drug product in a controlled-logistics network is the freezing of final drug product. Even the temporary storage of a thermal packaging system into forced-air refrigeration cooler within its qualification time period will most likely cause low temperature exposures and potential freezing. Proper testing of drug products in freeze-thaw conditions for distribution is critical. Most freeze-thaw stability testing does not consider the effect of ‘supercooling’ on solutions.

The suppression of the freeze point or ‘supercooling’ and subsequent ‘flash’ freezing in current freeze-thaw stability testing guarantees a homogenous solid is formed. In the distribution environment, the vibration and shock events inherent in the logistics network practically guarantees freezing of a solution at its freezing point. The frozen solution is rarely homogenous and can be observed as slurry of frozen and liquid solutions. These conditions are detrimental to proteins in solutions because of the risk of increased protein concentration, and how it can cause protein denaturation, aggregation, degradation or inactivation. These conditions are not properly tested by current static stability studies.

The transport of final drug products is one the most difficult tasks in the pharmaceutical supply chain because of the sensitive nature of the product and the complexity in a modern logistics network. An integrated process management and product characterization approach using dynamic stability testing for distribution is required to minimize risks to drug product quality during transport.

The risks of not taking an integrated process management or conducting dynamic studies on final drug products can lead to significant compliance and business issues:

• Supply chain security measures across global and contracted third-party logistics networks are required to ensure protection against adulterated and/or counterfeit product and product diversion.
• The confidence interval possible during process validation of complex and highly variable controlled-environment logistics network require either robust product testing specifically for distribution or a significant increase in monitoring and controls and flexibility.
• The environmental hazards in the logistics network and potential impact to product quality at end of shelf life may not be adequately covered in the current product testing approach.

Any cGDP quality system focused on the controlled-environment logistics network will be continually challenged by non-conformances and exception management. This is a characteristic of a modern pharmaceutical logistics network. Dynamic stability testing of the final drug product specifically for distribution is a prerequisite in the development of a modern, world-class pharmaceutical supply chain.

View online at http://www.coldchainiq.com/transportation-logistics/columns/why-is-pharmaceutical-transportation-a-major-conce/

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Pharmaceutical Cold Chain Is Complex

Pharmaceutical Cold Chain Is Complex

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First published on April 9, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. It can also be viewed at http://www.coldchainiq.com/supply-chain-security/columns/today-s-pharmaceutical-cold-chain-network-is-incre/   Join Cold Chain IQ today to access informative cold chain articles.

By Gary Hutchinson

Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets — these are the challenges facing cold chain management professionals every day. Solutions that deliver value in the supply chain and enhance your regulatory reputation by ensuring compliance, product quality and safety are required every day, around the globe.

Today, engineers and manufacturers face economic and regulatory pressures, accelerating costs, technology changes, and the need to constantly adapt their business models. The advent of more widely distributed supply chains and many other influences demand greater investment in tools, expertise, and most importantly the human capital to succeed with some of the toughest challenges:

  • Appropriate expertise and techniques to assess, control and communicate risk as part of an on-going management review process.
  • A lifecycle approach to process validation including design, qualification, and verification.
  • Better integration of product formulation, controlled environment logistics, and packaging design.
  • Innovative, forward-looking quality controls, corrective and preventive actions (CAPAs) strategies, and root cause analyses for once straightforward processes that are highly complex today.
  • The application of technology to achieve greater gains in all areas, including compliance, quality and safety.

Integrate your cold chain management systems. 
The appropriate tools, expertise, and experience are critical when coordinating your activities to ensure safety, safeguard quality, maintain regulatory compliance, and prevent falsified, adulterated, and counterfeit product from entering the legal supply chain.

  • Ensure compliance for high-value products in highly-regulated industries.
  • Deliver packaging design and qualification.
  • Conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration, and pressure.
  • Develop transport validation strategies to support global regulatory requirements. Design controlled-environment logistics solutions that ensure product quality during transport.

Get results by focusing on implementation, not just on defining regulatory requirements. A properly integrated cold chain ensures regulatory compliance, product quality, and patient safety by providing a multi-layered approach that combines best practices of process validation, systems qualification and risk assessment with the most applicable monitoring and controls for qualified packaging.

What systems encompass an integrated cold chain management system? 
A compliant cold chain management system is composed of a variety of components working in concert. An integrated cold chain management system ensures control of the distribution chain and consequently maintains the quality and the integrity of products. The seven components are: quality systems; risk management; product stability; qualification / validation; logistics management; partner management; and compliance management.

Systems – The First Pillar 
Developing mature quality systems is one of the biggest challenges and one of the most effective tools to manage a world-class cold chain logistics network. Making the systems work for you, and not the other way around, is the key to your success. Quality systems at their best establish, implement, and maintain a set of processes to provide the highest quality service to customers, highest level of effectiveness for management, and most robust compliance approach for regulators. At their worst, they just get in the way — adding only administrative burden and redundant reviews to an already complex and fast-moving network. I know. I have seen the value of an effective quality system that facilitates continual improvement, and I’ve seen the effects of a nominal one that provides only delays, derailments, and disasters!

An effective guide is needed to conduct a thorough review of your quality management system processes and tools to identify opportunities to provide structure and clarity to assist in the continual improvement of your controlled-environment logistics network. A review of the following elements of your quality systems should ensure these foundational capabilities are in place for your cold chain:

  • Quality Manual, Standards, and SOPs – A review of your quality system structure focused on regulatory requirements, best practices, and ease of use. Match the size and complexity of the activities you are managing to the complexity of your documentation.
  • Good Documentation Practices – Standardized templates, revision controls, and approval signatures are the cornerstones of an effective quality management system. Placing the appropriate practices in place for your technical documents, protocols, and reports are required for a successful audit.
  • NCs and Exception Management – Non-conformances (NCs) and management of exceptions is an uncomfortable reality in a global controlled-environment logistics network. The proper documentation of non-conformances coupled with an effective way to manage and document the exception requires a well-defined and streamlined approach. Coupled with an effective management review, the handling of NCs is a key to continual improvement.
  • CAPA and Change Control – Procedures for implementing corrective and preventative action (CAPA) help analyze processes, operations, records, complaints and other sources of data to confirm root cause and is one of the main roles of quality systems. A robust CAPA process uses appropriate statistical methods to identify trends and reoccurring non-conformances and provides investigational procedures. Controlling change in your organization and identifying a planned approach to CAPA resolution, including effectiveness verification, is necessary to drive continuous improvement.
  • Management Review – Quality systems need management support to enact change. A management review process requires the identification of key performance indicators with process control limits in place to determine when action is required. Along with self-assessments and audits, guideposts for the executive team to understand quality failures, process needs and updates on improvements is an essential feedback loop needed to build into your quality system.

Use these tools to assess your capabilities, create time-bound improvement plans, and mentor your team on the opportunities for improved profitability and efficiency. Conducting a quality systems maturity assessment can lead the way to breakthrough performance.

The New and Improved ISTA Standard 20 v2

The New and Improved ISTA Standard 20 v2

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The International Safe Transit Association (ISTA) is a member-driven standards organization. A revised version of ISTA Standard 20 is now available. The original Standard 20 was developed to assist suppliers and users of passive thermal shippers in defining the necessary elements for data packages. When assembled correctly, the data elements are presented in a consistent form by all suppliers and benefit users. They can easily compare their needs with the documented performance of each shipper.

Modality Solutions was proud to play a role in leading ISTA members in the development of Standard 20 v2. Together the team of experts reduced the size and complexity of the original Standard 20. The new version has been simplified, clarified, and streamlined. It benefits both suppliers with an easy to implement approach to documenting shipper qualification.

What Hasn’t Changed in Standard 20 v2? The original guiding principle of Standard 20 has not changed. The premise is still the same — to have an industry standard so that users have a qualified insulated shipper that meets regulatory expectations.

The ISTA Standard 20 v2 process is the same. Some parts are now optional or best practice. User feedback indicated that depending on who qualified a shipper dictated what should be done. Suppliers should not be executing a PQ. End users should perform the PQ. ISTA Standard 20 v2 still incorporates CDER’s principles of validation, and Quality By Design is still a key component of the new version.

What Has Changed in Standard 20 v2? Simplified and streamlined the entire program by reducing the size and number of documents in the entire Standard 20 v2 program: Reduced: Total # of docs from 25 to 15; Reduced: From 45 pages to 26 pages; Reduced: Data package examples from 1000 pages to one 17-page manual; Clarified: Protocol templates by moving from an outline format to a table format; Clarified: Thermal sensor locations by creating a table to precisely specify how many and where thermal sensors shall be located in an ISC — based on the ISC design and payload configuration

Additional Standard 20 v2 Change Highlights: Added flexibility around thermal profiles. Removed qualified air temperature (QAT) to reduce confusion. Parts of the process are now optional depending on who is qualifying an ISC. Now requires a physical test as part of DQ. Clarified that physical testing may take place at an ISTA lab certified to execute ISTA 2B or 3A. Provided clear direction on what to do if a test fails. Removed all company-specific references. Incorporated a process flow diagram to clarify the process flow. Provided more flexibility across the entire Standard to make it easier to use. Tightened up thermal chamber performance requirements so the mean of errors shall not be greater than a (+or-) 1.0°C and no single error greater than a 3.0°C — providing a more accurate test.

At Modality Solutions we strongly recommend you take advantage of Standard 20 v2. Become an ISTA Member. For more information, visit www.ista.org and/or contact ISTA today at (517) 999-3437.

How to Use USP and ASTM to Evaluate Thermal Test Results

How to Use USP and ASTM to Evaluate Thermal Test Results

Written by Modality Solutions

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To set the stage for this blog post, a thermometer is a device that converts physical changes (of heat) into a numerical value. How to evaluate this value is the topic of this article.

Rather simple on its face, there seems to be confusion in the application. Look no further than  to the assessment of data from a thermal experiment and the applied results to a specific range. The first thermometers had scales that corresponded to each manufacturer. By 1742 Anders  Celsius proposed a scale with zero at the boiling point and 100 degrees at the freezing point of  water, though the scale that now bears his name has the boiling and freezing points the other way  around.

The USP (United States Pharmacopeia) has definitions of multiple storage temperature conditions.  For instance, a refrigerator “is a cold place in which temperature is thermostatically maintained  between 2° and 8°C degrees.”

Current digital temperature recorders document the history of thermal exposure to the tenths of a degree. Typical thermocouple systems record temperature values to the hundredths of a degree.  What method(s) does one use to compare the measured data with the listed range in a given  standard? The method that follows is based on common methodologies expressed in the USP  general chapters on significant figures and rounding, as well as the ASTM (American Society for  Testing & Materials) Standard E29-13, “Standard Practice for Using Significant Digits in Test Data  to Determine Conformance with Specifications.”

Getting back to the refrigerator reference of a cold place in which temperature is thermostatically  maintained between 2° and 8°C degrees, it should be noted that this is a range commonly used  as an acceptance criteria for passive shippers. When the recorder documents a value of 1.8°C,  is this considered within the specification of “refrigerated?” The USP and ASTM standards agree  that it depends on the specification. The values for USP refrigerated contain one significant digit.  All calculations should use the general rules of retaining significant figures when performing  calculations that summarize or convert values. However, when these calculations are completed,  in order to assess the result, the final calculated value should be rounded to the same number of  significant digits as used by the limit in order to determine whether the test data conforms to the  respective limit. Table 1 contains examples.

Table 1. Illustration of Rounding Numerical Values for Comparison with Requirements

Requirement Observed or Calculated Value Rounded Result Conforms
Limit ≤ 3 ppm  3.5 ppm 4 ppm No
Limit ≤ 3 ppm  3.4 ppm  3 ppm Yes
Limit ≤ 2°C  2.5°C  3°C No
Limit ≤ 2°C  2.4°C  2°C Yes

Therefore, in the example of USP and the range for refrigerated materials, acceptable unrounded test values ranging from 1.5° to 8.4°C would be considered conforming to the range of between 2° and 8°C.

I’ve seen countless qualification attempts fail because of a recorded data point that registers 0.1°C  outside of a limit with one significant figure. Hopefully, the references cited within this blog will find widespread application.

From the Mailbox…When is good enough, good enough?

From the Mailbox…When is good enough, good enough?

Written by Modality Solutions

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Note to readers: I wanted to share the following email and reply, since it really gets to the heart of Quality by Design in the Biotech world. It underscores the need to have a process in place, and someone accountable for tracking progress.

Dear Paul,
Our company is looking to formalize our shipping validation efforts and the question has arisen, How Much is Enough? Consider the following:

At the time of BLA submission, where do you draw the line with shipping validation studies? Can you just do the primary container? No, because you would need to demonstrate that temperature, shock & vibration don’t affect delivery from the auto injector. Can you just do the primary container in the auto injector and call it worst case? Do you even need pallet shipment data as long as you qualify shipping lanes? What are firms doing? What kind of feedback have you seen?

Signed,

Perplexed
My reply….

Dear Perplexed,

Since 2003, the regulatory expectation for BLA filings has been to include the process validation in the filing, as you know, distribution is considered part of manufacturing. So you are right, you need to formalize a process, but how?

First, I would suggest a wider view. Terms matter. I have found the term “shipping validation” hinders this wider view required to commercialize an NCE. In many companies, the term “shipping” tends to single out one functional area, i.e., distribution. Another challenge within well-established companies such as yours is the “silo” structure that effectively isolates the development, regulatory and operations groups.

The any formalized process must have the ability to scale. The largest and fastest growing companies have formalized processes that are scalable because resources are not available to support “one off” approaches for each NCE.The process must define the phase and gate appropriate deliverables to be shared between regulatory, development and operations. In order for this to occur, a point person within the company who owns and manages a defined process is needed to make sure the phase appropriate data is generated and shared across the organization to assure commercial success.

I have written a chapter on this subject in a soon to be published book on Quality by Design for Biotech Development. The emphasis is on a rigorous application of phase appropriate DoE beginning in formulation development and following through to administration of the final product to the patient. I know you already do formulation DoEs and in use testing, but there are gaps between these studies.

As you know, the DoEs establish the design space for the NCE. The design space is compared with the process capability. In the case of distribution, process capability consists of the documented transport hazards of shock, vibration, pressure and temperature. This process capability can be collected over specific lanes. Alternatively, industry standards from ISTA exist and can be applied to generalized lanes. The FAA published regulations for pressure levels within aircraft.

I’d be happy to visit with you and your team to discuss the advantages of a gap assessment and follow up with specific suggestions that would fit within your company.

Best regards,

The Modality Solutions Team

Cold Chain Integrity Challenges Biopharmaceutical Industry

Cold Chain Integrity Challenges Biopharmaceutical Industry

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Cold chain integrity is a growing concern in the biopharmaceutical industry. High value cargos are becoming more frequent targets for theft. The US Federal Bureau of Investigation (FBI) reports that it is the costliest crime in the United States. This article will provide helpful guidance to improve your cold chain integrity (and more generally supply chain integrity) as well as some simple tasks you can do today to enhance security for your organization.

The security portion of cold chain integrity can be broadly separated into fixed site security and rolling site security. This is a good logical separation that is also used for force protection and counterterrorism. It is commonly believed that fixed site security is the easier of the two, but I disagree. The two categories of security-fixed and rolling stock, are different, but one is not necessarily more challenging than the other. This is how they differ:

Fixed Site
– Static target; easier to observe threats
– Higher value target
– Easier to implement physical security measures

Rolling Stock
– Moving target; more difficult to observe threat
– lower value target
– Easier to implement intelligent security measures

Fixed site strategies should focus on maximizing the security advantages and minimizing the vulnerabilities. Because a fixed site is easier to ‘case’ by a threat, security planning should address that concern. For example, if guards are expected to patrol the perimeter fence, varying their routes and timing defeats observers who are trying to discover a pattern to their patrol routes. Fixed sites are usually higher value targets because of the quantity of inventory at the facility. Minimizing inventory is a good business practice as well as a method to reduce the potential loss in case of a theft at the facility. Finally, application of effective physical security measures is very cost effective for fixed sites. If you are responsible for a fixed site in pharmaceutical distribution, now would be a great time to check your perimeter:

  • Is the fence in good repair?
  • Are all gates locked?
  • Are shrubs and other vegetation cut back at or near the fence?
  • Is lighting adequate so there are no blind spots around the perimeter at night?

If your perimeter is the outside wall of the storage building:

  • Are all points of access in good repair and secured? (windows and doors)
  • Are shrubs and vegetation cut back at or near the building?
  • Is exterior lighting adequate so there are no blind spots?

Contact your local law enforcement agency. Many of them will offer a free security assessment. Ask for additional business check patrols around your building over the next week.

If you have trucks/rolling stock and you want to improve security, there are several techniques to address security vulnerabilities. GPS/geo tracking with geo fencing is excellent, and I highly recommend it. Ensure your drivers do not stop for any reason within 200 miles of the pickup location. When a driver picks up a load, they should have a full tank of gas and be ready for the trip. Areas close to the pickup location are the highest risk for truck theft. Have your drivers vary their route, especially locations where they stop for bathroom breaks, meals, or refueling. Drivers should always turn off their truck and lock it whenever they are away from it. Tractor and trailer should never be separated. Review these procedures with your drivers frequently; their expertise and attention will significantly reduce their vulnerability to theft.

These are just a few simple ways to enhance your cold chain integrity. In coming weeks, I’ll delve deeper into enhancement of security for fixed site and rolling site security. In addition, I’ll discuss use of appropriate risk assessment tools to provide improved guidance on how to efficiently address security vulnerabilities.

Define Your User Requirements Specifications Upfront to Ensure Success!

Define Your User Requirements Specifications Upfront to Ensure Success!

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Different people have different expectations while developing a drug product shipping solution – for some keeping the final cost low is the most important factor, others measure success by the capability of a shipping solution to keep the drug products within the desired temperature range for the entire expected duration of shipment. Most ask for both!

Defining user requirements is a specification document is an important first step to ensure that everyone involved in a project is working towards achieving the same goal. The packaging is designed and qualified deliver life saving drugs using are variety of modes – air, ground, and even ocean transport – to maintain the safety, quality and effectiveness of the product. User Requirements Specifications (URS) help translate your needs into quantitative and qualitative attributes of a shipping solution that must be met in order to meet the regulatory standards associated with shipping and distribution of drug products. Laying out these requirements upfront also helps customers better understand their own needs and bridge the gaps in their specifications for shipping a product. A few common requirements that must be defined while developing insulated shipping solutions include:

  • Acceptable product temperature range,
  • Allowable thermal exposures based on product stability data,
  • Duration for which the shipping solution is expected to hold the product,
  • Thermal profile against which the shipper will be tested, and
  • Minimum and maximum payload dimensions and the cost of the solution.

It is also important to specify any special constraints that the shipper might be subjected, such as keeping product in a specific orientation and rough physical handling, at the beginning of the project. Keeping the expected date of delivery in mind is also recommended. Taking the time to accurately state and discuss the user requirements not only helps design an effective solution but helps also reduce the cycle time. Too often the design and qualification of a shipper is hampered by poor definition of true user requirements in the beginning of the project. Changes in specifications, additional requirements, and sometimes competing priorities increase shipper cost and design time needlessly.

It is not always possible to meet all user requirements – in such cases, prioritizing becomes crucial. One way of doing this is by classifying the requirements as “high”, “medium” and “low” and working on achieving them in order of decreasing priority. As a project progresses, any changes in the scope of the expected shipping solution should be recorded with corresponding changes in the user requirements. The final solution can be compared against the user requirements to evaluate its effectiveness in delivering what the customer demanded. User requirements guide the development of a cost-effective and regulatory compliant solution from start to the end.

Correct Cold Chain Standards Are First Step Transport Validation Simulation Testing

Correct Cold Chain Standards Are First Step Transport Validation Simulation Testing

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Many of the projects Modality Solutions works on for clients not only require qualification of insulated shippers for their cold chain, but also require transport simulation testing to determine the effects of transport on their product. To date, many clients request a test plan from ASTM D4169 for transport simulation testing. Interestingly, the decision to use of ASTM D4169 was made before many of latest GDP guidance and country-specific regulations were published. No one in their organization knows why the chose the ASTM standards and if it is the right for transport simulation design of experiment (DofE) they are developing.

For that reason they ask us what we think the right standard for their packaging systems, product formulation, and most importantly the interaction between the two.

While ASTM D4169 has been used for many years and is a good standard to use for transport simulation testing, Modality Soltuions does not think it is the best standard for use in the Biotechnology, Pharmaceutical, or Medical Device industry.

Modality Solutions recommends the use of ISTA 4AB custom built transport simulation test plan. These methods allow for the creation of a test plan that is tailored directly to the transport environment of our clients. The Modality Solutions methodology use ISTA 4AB test profiles and test plan creation as its foundation, but we recommend changes based on our knowhow we have developed through years of experience in transport simulation testing.

Another advantage Modality Solutions see in using ISTA is the prolific number of test profiles. ISTA has more profiles that represent the regions of the world our client’s ship to which allows for a more accurate transport simulation test plan to be created for our clients.

For this reason Modality Solutions supports the use of ASTM D4169 but thinks ISTA 4AB custom test plan allows more accurate simulations and better results for our clients.

Three Departments Working Together for Cold Chain Success

Three Departments Working Together for Cold Chain Success

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How do you go about integrating your cold chain and what is involved? To fully integrate your cold chain there are three (3) departments that need to be working together:

  • Package Engineering
  • Transportation / Distribution
  • Product development

Start with the end in mind. Transport validation. Answer the question “What will it take to validate transport”? Look at transport validation just like you would validating a filling line. Treat transportation as an extension of manufacturing. Once you know what the end should look like the key is to not get overwhelmed and try to do everything at once.

Start easy; develop a smart, platforms based packaging qualification program that includes primary, secondary, devices, and cold chain shippers. From there move on to supporting your packaging qualification program by integrating your transport and distribution processes. Develop systems and processes, which provide control over the process and feedback/metrics of your transport environment, “close the loop”.

Finally take on the toughest of them all. Integrate product development into the entire process. While this may be the toughest it will have largest positive impact on your company’s operations. Integrating your product development into your cold chain or controlled environment logistics network will do many things such as:

  • Increase speed to market by removing transport validation off the critical path.
  • Perform multi-modal transport simulation studies and know that your product formulation is optimized for the transport environment
  • Develop a stability program which not only meets regulatory requirements, but also takes into account the realities of the cold chain transport
  • Reduce packaging development costs.

Solid User Requirements Is First Step in Supplier Selection

Solid User Requirements Is First Step in Supplier Selection

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Did you know there are at least 30 different suppliers of thermal packaging and insulated shippers available globally? Those are just the ones that I personally have worked with and have a relationship with. While this number is shrinking over the past couple years due to mergers and acquisitions, there also always seems to be the next big, “disruptive technology” from a new supplier. That is just too many for any one company to sift through to find the best supplier to meet your needs.

With over 30 different suppliers of all offering a wide range of cold chain solutions how do you choose? Which is the best shipper, which is the best supplier for you? You could just wait years for mergers and acquisitions to dwindle the number of suppliers down or you could develop objective methods and tools for weeding through the piles of foam.

The first step is to develop a solid set of user requirements, and then rank those user requirements on importance to you. Once you have your user requirements you can now evaluate suppliers in the following 3 areas:

• Engineering Requirements o Packaging Qualification methods and process o Thermal Profile used • Cost • Supply base

By looking at these three areas objectively you can remove the emotion of supplier and insulated shipper selection.

Brian Wallin Principal Modality Solutions LLC

Deviation Torture; Part 2.

Deviation Torture; Part 2.

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Okay, if you’ve read part one of deviation torture, you know the terror of losing control of your calendar when the highly urgent demand to investigate a seasonal temperature deviation occurs.

What I’m recommending here is a foundational test as part of a product development plan. For this example we are going to examine drug product labeled as refrigerated.

Step 1. Determine exposure temperature

Look for data from past shipments. What is regrettable is that many development programs may look at results of -20°C exposures and translate the data to a label statement of “Do Not Freeze”. In practice, the product is much more likely be exposed to conditions in the range of +1 to -2°C and the only option is to recommend disposal of the product because no other data exists at this more common aberrant exposure temperature. On the high end of exposure range, the same thing happens. There is data at room temperature, but none at +15°C for example.

Step 2. Select exposure time

Based on PDA TR 53, and common industry practice, start with 5 handoffs. The length of time may be variable, but a 36-hour duration with 5 handoffs is about 8 days.

Step 3. Expose the product to both the high and low temperature exposures for eight days.

Step 4. Assay the product for its stability indicating properties and place some of the exposed product on either accelerated or long-term stability.

Step 5. Write the report and regain control of your calendar.

This process is a lot easier to execute during the development phase and will pay dividends as early as Phase III clinical trials. Commercial product could be evaluated, too and I would suggest obtaining samples that are coming off of long-term stability.

Paul Harber

Deviation Torture; Part 1

Deviation Torture; Part 1

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January and August were busy months when I worked in a large pharma company as a technical lead in cold chain. Those were the most likely times that shipments of temperature sensitive goods would experience thermal excursions. Short of taking long vacations during those times, there seemed to be no way to avoid what I called deviation torture.

By deviation torture, I mean repeated meetings with molecule stewards and time in the lab to try and replicate in the lab the thermal effects reported from the field. Then assay the product and assess the risk. Finally, have the quality folks sign off.

Then…repeat – repeat – repeat.

Many times, when the exposure was short and shallow, the product showed no evidence of degradation. Other times the product had to be replaced. The time from discovery of the incident to resolution was much too long. Thankfully, when the instances occurred with commercial products, we were only replenishing stock so there was no direct impact of supply to the patients. That was not the case with more scarce clinical trial materials that contained study-specific packaging.

Deviation torture can be avoided by some well-designed foundational studies. These studies establish the thermal conditions outside of the long-term storage conditions that will impact product quality. These studies have two or three steps. I will cover them in Deviation Torture Part 2.

User Requirements Specification (URS) Matrix Tool

User Requirements Specification (URS) Matrix Tool

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The beginning of any good engineering project — be it an insulated shipper, designing a building or bridge, building a car, space shuttle, or stealth fighter, all need to begin in the same place, defining user requirements. Engineering projects begin because there’s a need for something. Since there’s a need, the need is a requirement or set of requirements.

I’ve seen many projects go sideways or spin due to a ‘lack of’ or ‘poor’ user requirements. When you don’t have clearly defined user requirements, it allows ‘what ifs’ and ‘what abouts’ to creep in. People show up in the middle of a project and just add more because they think it’s a good idea. Never asking “do we really need this?”  How many times have we all seen this scenario? By the time the project is over, did you end up with the best solution — a solution that does everything you needed it to?

User requirements can put an end to this madness and help you meet a regulatory requirement of quality by design. Defining what you require up front, and then clearly communicating those requirements to suppliers dramatically speeds up project timelines. It builds quality into the final product, and ultimately gives you a picture of what success looks like before you start. By first outlining what you require, you will know when you’ve found what you need.

Modality Solutions has developed a User Requirements Specification (URS) and decision matrix tool to expedite this process. It’s accomplished in five easy steps. The tool clearly turns your requirements into acceptance criteria.

1. The user clearly defines their requirements.*

2. Input how the vendor’s product meets each requirement.

3. Weigh the criticality of each requirement by applying a multiplier.

4. Score how well a vendor’s product meets that requirement.

5. Develop an overall score to compare against other competing products to find the product that best meets your needs.

*Having collectively designed and qualified more than 75 shippers in the past 10 years, our team at Modality Solutions can also help you set your requirements.

To summarize why at the beginning of every engineering project you need user requirements — Major League Baseball catcher and manager, Yogi Berra, said it best, “You got to be careful if you don’t know where you’re going, because you might not get there.”

2012 Annual Meeting AAPS – Chicago

2012 Annual Meeting AAPS – Chicago

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The American Association of Pharmaceutical Scientists (AAPS) conference is four days of meetings and presentations primarily focused on the needs of formulators and regulatory.  A large section of the sizable exhibitor floor dedicated to displays presenting specific findings from members in their specialized areas. They detail the work done in creating novel formulations that enhance the effectiveness of a variety of drugs.  I was overwhelmed by the exciting and informative presentations focused on new technology and processes!

What was missing? While there is an acknowledgement of the distributed nature of drug manufacture and filling to sites all over the globe, there is little to no recognition of the risks involved in distributing these products from the point of manufacturer to the point of use. Clinical trials with adaptive studies to strategies for commercialization presuppose that neither heat, nor shock, pressure, nor vibration will in any way be present to damage the structure or potency of these compounds.

From experience, the industry knows otherwise and so do regulators. Over 60 countries have published laws mandating the means and methods that comprise their expectations regarding the importation and distribution of temperature sensitive products into their respective countries.

Innovators need to create the necessary design space and to build product knowledge at the front end of the lifecycle. This design space should address the need for physical stability of the formulation to withstand the rigors of shipping and handling. Gaining this knowledge early in the lifecycle will accelerate the development at all critical stages of scale-up. These stages are prior to the product being produced in the quantities needed to supply Phase 3 clinical trials. Stability studies should assure that the product will retain its critical quality parameters from the point of manufacture to the point of use, wherever the location.

How to start? Just as the formulation and process design-of-experiment (DoE) are standard elements of the development lifecycle, an assessment of the risks during shipping and handling should be performed. Following the assessment, a distribution DoE should be employed to increase the confidence in the formulation selected. Key elements in the distribution DoE are exposure to the environmental hazards of temperature, pressure, shock, and vibration that are known to work in concert.  These concurrent hazards create aggregates, sub-visible particles and denatured proteins.

Some companies use test shipments along the routes they intend to use for the distribution. These results may provide some insight to the expected damage, but they take time and are expensive to execute. Due to the inherent variability in distribution, there is a need for many such shipments in specific seasons to separate the normal variation from special cause events.  And if damage occurs, it is difficult to determine the root cause.

A second option would be to expose the formulation to distribution hazards in a controlled fashion. This practice is new.  It conserves the amount of product necessary for the study. Not only is the study repeatable, extremes can be selected by the formulator to reflect the intended severity of the distribution environment and can be incorporated into a stability program. The quality attributes from the point of manufacture to the point of use at the end of shelf life can be tested to provide assurance that the product would be retained.

The ISTA 7E Thermal Profiles and How to Make Them Work Regionally

The ISTA 7E Thermal Profiles and How to Make Them Work Regionally

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The ISTA established a set of standard thermal profiles known as 7E using sound science and engineering.   Protocols were written and followed: detailing exactly how, when, and where data was to be collected and clarifying the data analysis approach. Most importantly, the protocols explained why it was being done this way.  The ISTA 7E profiles are the first profiles developed under control and with transparency.

Concerns have been voiced across the industry. By industry, I mean the pharmaceutical companies, the insulated box manufacturers and related suppliers. Many say they are not hot or cold enough to be a significant challenge or the data was only gathered in the U.S. and, therefore, can only represent a specific region.

The purpose of offering a standard is clear – standardize tribal knowledge and give an informed consumer a way of comparing offerings from different suppliers. In addition, data derived in a controlled and transparent manner can be used as part of a qualification data package by the manufacturer. What it cannot do, and was never intended to do, is to replace the performance qualification (PQ) element in order to have fully qualified shipper and supporting procedures. Suppliers that advertise a ‘pre-qualified’ solution ignore this last critical element, but can supply meaningful data if they adhere to a standard.

Because of the significant commitment of resources and skills required to generate a thermal profile, the development is no small task. Start to finish it takes about 18 months – summer and winter – to write the protocols, perform the shipments, analyze the data, and write the report. The financial commitment in shippers, temperature data loggers, and freight is significant.. Another important detail is to find locations that are willing to cooperate in returning the test shipments. In order to successfully execute the process, the ISTA 7E project required funding and cooperation from a number of the large pharmaceutical companies and UPS.

What did the program provide? A significant amount of data that has never been collected under controlled conditions like this before. The ISTA 7E profile provides a “diurnal shape” showing the effects of daytime heating and an ever-decreasing cooling trend. What should be the peaks and valleys of those diurnal cycles in other regions around the world?

For instance, when it comes to the northern European region, the concern is that the current profiles do not take into account a more severe exposure – especially in the winter, as well as the differences in how small parcel operators transfer goods. For example, fabric-sided trucks common in Europe will be colder/warmer than a solid-sided and insulated trucks used in the U.S. Without re-executing the entire 7E protocol for northern Europe, what can be done?

I propose a shipping study into northern Europe in both the summer and winter to perform “data verification.”

Data verification will not require nearly the number of data points required to build the profile the first time. Yet, when combined with the existing data, a statistically significant confidence interval can be built.

Data verification can test the validity of the ISTA 7E heat and cold profile region by region, lane by lane.  Differences to the current diurnal cycles can be changed by adjusting the confidence interval.  The adjusted profile could then be used as ‘regional’ ISTA 7E hot and cold profiles.  In the end, profiles with different confidence intervals to the current 7E profile could represent different regions of the world — allowing the right packaging (insulated shippers) to be developed for shipment into those specific regions.

As an industry, we should build upon the existing data by using lane verification as a technique to identify and take into account regional differences. This approach would be far more cost effective and require far less resources.  Most importantly, we can continue a “standards-based” methodology founded on data.

Does ISTA 3A Really Simulate Transport?

Does ISTA 3A Really Simulate Transport?

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There were concerns voiced over whether ISTA 3A is working for our industry at the recent 2012 ISTA International Transport Packaging Forum held at the Disney Yacht and Beach Club Resort in Orlando. While we were in the land of fantasy and make believe, topics on the latest ideas and advancement of responsible transport packaging and the physical distribution of products were seriously presented to ISTA Forum attendees.

My presentation titled, “Does ISTA 3A Really Simulate Transport in the Parcel Delivery Environment?” covered the topic of the validity of the ISTA 3A drop test profile. The profile has been in place for many years. My findings indicate that we, as an industry, may want to revisit the assumptions and consider updating the test plan. As our understanding of the transport environment continues to improve, it should be a given to review and update standards. It was interesting to note that there were two other speakers making the same point on other ISTA standards.

  • Michael Sek, Associate Professor, Victoria University presented “What Happens to the Critical Element in a Product During a Vibration Test?” He covered the limitations of time-compressed or time-accelerated vibration testing.
  • Luther “Chip” Stone, Senior Packaging Test Specialist, Hershey Company presented “Stacked Versus Traditional Compression Testing.” In his talk he suggested that current test methods available for compression testing do not generate accurate data on the type of compression damage a company may see in real world transport.

While I went into the conference with the narrow goal of gaining agreement to update to the ISTA 3A drop test profile, I found other engineers have looked into the standards, and we have common concerns. Our goal is one of making sure that our field-to-lab simulations remain vital through a constant review and update cycle.

In brief, as we see the changes in the transport environment and the evolution of data collection tools and methods, updates to ISTA standards should be considered normal.

How old is that trailer?

How old is that trailer?

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That’s a question that needs to be known before you load it with temperature sensitive pharmaceutical product. A reefer trailer’s capacity to thermally insulate the load from ambient extremes will naturally lessen over time. The capacity to insulate in called the overall heat transmission rate in Btu/hr-°F (UA). At the time of manufacture the values for each trailer are certified and posted at the time of manufacture following Recommended Practice #38 (Method for Heat Transmission of Refrigerated Vehicles) from the Truck Trailer Manufactures Association.

Most controlled temperature trailers on the road today are insulated with prefabricated panels that are comprised of a sprayed in place polyurethane core. Normal road stresses combine with the natural outgassing of the polyurethane panel core to contribute to an increase in UA (a reduction in R-value). To understand how outgassing happens, it is important to understand the structure of the foam form of polyurethane.

Polyurethane is a mixture of multiple component elements; the liquids are polyol, and isocyanate. These two liquids combine to form the polyurethane plastic. The foam form is accomplished by blowing bubbles into the plastic. The bubbles consist of two gases. One is R-22, which is expensive, and CO2, which is much less expensive. Over time, think years, CO2, the smaller molecule, migrates out of the foam. When CO2 migrates out, it is replaced by atmospheric air and water in vapor form; the result is degradation in the R-value of the panel.

What is R-value the degradation rate? It is generally accepted that this rate is about 5% per year. Over a five-year span, the trailer has a theoretical reduction of 25% from its original value. In order to account for this normal aging, the trailer manufacturer compensates by matching the trailer to a heating and cooling unit that has excess capacity. If, for example, the temperature control unit (TCU) is over-sized by 35%, the implication, in this example, is that you would want to be concerned about trailers over 7 years old. When operating under ambient extremes at the end of seven years, the TCU would be at its operational limit to maintain temperature.

How can the capabilities be determined? Make sure the trailers you use have a TMC certification plate so you can know the age of the trailer, and the excess cooling (heating) capacity. See the previous post on trailer classification.

For those of you who would like to learn more about polyurethane, I can recommend the Polyurethane Handbook by Gunter OertelISBN-10: 1569901570 | ISBN-13: 978-1569901571

Trailer Definition

Trailer Definition

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First steps to Trailer Qualification…know what you’re using!

It sounds simple, maybe even trite, but as a distribution stakeholder in your organization, are you confident that your trailer selection is suitable for your product? How can you tell?

It begins with leveraging your extended team. Your 3PL partner is an important player. When they order trailers you need to let them what you need. Don’t worry, it doesn’t cost much if anything, and it can be done on the existing trailers in the fleet. In the Americas, the classification comes from the Technology Maintenance Council, (TMC) a technology council of the American Trucking Association. They designate each trailer into one of four of the following classifications; C65, C35, F or DF. Specifically, it’s a three-step process. Referencing the figure below, the data comes from (1) the existing insulation data plate and (2) refrigeration unit certification installed on the trailer. The manufacturer creates the classification tag (3) based on the insulation and size of the refrigeration unit. The basis for this data is testing according to TMC RP 718A. This report is an industry standard, based on testing data at +100F and 0F ambient conditions. The trailer is certified to maintain the set points (65F, 35F, 0F, or -20F) at the stated ambient extremes.

When working with a 3PL that is ordering new equipment, let them know you want the “Combined Equipment Certification Plate” affixed to the trailer. As I mentioned it is possible to have these applied post delivery, just work with your 3PL and they will contact the trailer manufacturer for the appropriate designation. Wabash National and Great Dane, for instance, are good examples of the reputable manufacturers that will provide these certification plates for their trailers.

As far as next steps, we can help with that. Modality Solutions has created an executable data package that includes the following.

  1. A technical report explaining the standards used by the trailer manufacturers to assure that the trailer is properly classified and is suitable for the intended use.
  2. A quality standard based on the technical report that can be adopted by the company’s quality unit.
  3. A quality agreement that supports the quality standard, including directives on expected maintenance.
  4. An executable protocol to assure that the proper quantity and location of monitors.

No matter who develops and executes the qualification drill for temperature-controlled trailers, it is important to understand and document the system capability using the proper TMC classification.

Every Quality Agreement Needs A Great Investigative Reporter

Every Quality Agreement Needs A Great Investigative Reporter

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Admit it – We all wanted to be great investigative reporters like Bob Woodward and Carl Bernstein after seeing the 1976 Academy Award-winning movie “All the President’s Men”. How did Bob Woodward get Robert Redford to play him on screen anyway? Some people have all the luck… As Woodward was famously instructed by ‘Deep Throat’ (revealed later to be FBI Assistant Director Mark Felt), you need to ‘follow the money’. Similar to getting to the bottom of the Watergate scandal, every good quality agreement needs a sound ‘investigative reporter’ that provides some great instincts and sound journalist techniques…

Why ‘Follow the Money’? As noted in the 2011 Healthcare Supply Handbook (available for download on our ‘Solutions & Technology’ page of this web site), understanding and evaluating the opportunity costs in controlled environment logistics in supply chain is as important, or even more so, than managing the direct costs. Super new product launches, reaching new markets, and ensuring brand integrity with proper security are key in evaluating opportunity costs.

What about the cost of failure? Loss of control of shipment, either temperature excursions or chain of custody, can have huge opportunity costs that typically don’t hit the transportation budget. These costs include product scrap, rework and testing, or just the mundane administration costs of managing a non-conformance record…

Quality agreements with your logistics providers are great way to reduce the risk of unintended opportunity costs. When setting up a quality agreement, always remember to be a great investigative reporter and remember to ask your five W’s and one H: Who? What? Where? When? Why? And How?

Why have quality agreements in the first place? The use of quality agreements is a well-established business practice, but their use with logistics providers is a fairly recent phenomenon. Their implementation is further complicated by the regulatory framework of the industry. Advance agreement to terms and conditions of the relationship is not only a concern of regulatory bodies, but is advantageous to the companies themselves. Quality agreements are useful documents from a business perspective as well as from a GDP perspective. In the EU, quality agreements are a requirement – one that is regulated by legislation. In the US, however, quality agreements are an expectation, but not a requirement, of the Food and Drug Administration (FDA). While FDA has neither specific guidelines for pharmaceutical and biopharmaceutical industries nor a final rule on the subject, expectations of having implemented quality agreements for ALL service providers are now relatively common, and violations have been recorded.

When is a Quality Agreement needed? A formal corporate policy document should clearly indicate the types of vendors and services that will require a Quality Agreement. However, many times the corporate policy is silent on logistics providers. Quality Agreements are typically be in place with all vendors of critical materials for vendors of large quantities (e.g., methyl cellulose for capsules, column resins, etc.). But logistics providers are just as critical to manufacturing and delivering medicine to patients are the raw materials. The service providers need a quality agreement, too. The Quality Agreement should be drafted and mutually accepted by the logistics provider BEFORE the rate agreement to ensure identification of all costs and any capability limitations. Neither party should take ANYTHING for granted. Where are Quality Agreements needed? A misconception exists that quality agreements are only needed for the use of contract manufacturing organizations (CMOs), raw material suppliers, or when operating in a different regulatory environment (e.g. EU). Not so – any outsourcing contract arrangement should have an associated quality agreement including logistics providers.

What should be included in a quality agreement? A quality agreement should define specific quality parameters AND who is responsible for the execution of those parameters. Items addressed include all critical to quality aspects of the service provided – equipment, personnel, preventative/predictive maintenance, quality management systems, audit schedules, etc. Additionally, include aspects that may affect the compliance status of either party. One of the most overlooked sections is the Definitions section – it is critical that everyone knows what is meant by every term used in the quality agreement especially when contracting with non-U.S. parties because terminology can vary widely. Include abbreviations and acronyms, identify documents required, and don’t forget to define “subcontracting,” and if/when it is acceptable.

What to exclude from a Quality Agreement is also worth mentioning. Certain items that should never appear in a quality agreement include: pricing, general business terms and conditions, forecasting, delivery terms, confidentiality obligations, liability limitations, etc. These items belong in the master service agreement. The quality agreement should be a separate document from the master services agreement, but should be incorporated by reference. These agreements are two very different documents. If they are created as a single document the reviewer list will include many individuals on each side of the fence that have no real reason or time to review issues unrelated to their area of expertise.

Who should prepare/review/approve a quality agreement? Quality agreements should be prepared by both parties’ operational personnel, with the involvement of their QA function. Both parties’ QA function and Operations manage should approve. Legal may or may not be involved in the Quality Agreement to make sure it agrees with the master services agreement. However, it can delay execution of the Quality Agreement if the legal department wants to add unnecessary legal verbiage that does not belong.

How do you enforce the parameters once a quality agreement is in effect? Quality agreements should be reviewed as part of a regular management review at least on a quarterly basis. Each of the parameters agreed upon between the parties should be assessed, non-conformances reviewed, and progress on any corrective and preventative actions (CAPAs) should be described. A summary of conclusions should be forwarded for assessment by executive management like any other subsystem of the quality management system.

As with any great story, following your leads and gathering all the facts is important, but the right technique to deliver the storyline adds the punch! A quality agreement that clearly outlines each party’s roles and responsibilities, delineates the critical-to-quality parameters, and is reviewed quarterly and shared with executive management can help avoid opportunity cost of failures. Follow the money!

Integrate cold chain management systems?

Integrate cold chain management systems?

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“We integrate cold chain management systems.”

I was struggling for a ‘tag line’ for Modality Solutions for some time, trying to explain what we do. Something pithy, something edgy… Controlled-environment logistics or ‘cold chain management’ means many things to many different people. As a professional logistician for almost twenty years, I have had the great privilege to meet a lot of passionate people who are committed to providing exceptional service in high value, highly regulated supply chains. What could we add to an industry filled with dedicated, intelligent, and passionate people? Then it hit me – we integrate cold chain management systems! But what does that really mean?

When I hit my fellow principals up with this idea, and they had already heard a lot of bad ideas already, they looked at me as only an engineer can – “Duh! Of course we do…”

However, there is an underlying complexity to great engineering work my principals do every day. A balance between perfection and pragmatism, design and decision tradeoffs, budgets and timelines… Like any tightly integrated system, a variety of subsystems in any controlled-environment logistics network must be fine-tuned to ensure optimal performance, cost control, and regulatory compliance. Over the next several weeks, we will be sharing some of our insights on how to integrate your cold chain management systems.

The first step will be defining these sub-systems. We have a pretty good idea on the systems we focus on, but we are going to be asking for some help! I love the LinkedIn community and their ability to gather information and focus like a laser on specific issues… With the help of ‘social media’, I am going to start several conversations on this topic and see what our peers in industry think about cold chain management systems integration and distill their best ideas here. Stay tuned!

P.S. I tried to capture this idea for an interview with SupplyChainBrain (www.supplychainbrain.com) in November 2011. Robert Bowman, managing editor for SupplyChainBrain.com, helped me tremendously to organize my thoughts… Enjoy!