Blog

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

First published on June 29, 2016 on Cold Chain IQ – as a contributor,...

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

First published on May 24, 2016 on Cold Chain IQ – as a contributor,...

A Potential Revolution For Passive Shipper Selection

First published on April 20, 2015 on Cold Chain IQ – as a contributor,...

Forecasted Cold Chain Trends for 2016

First published on January 5, 2016 on Cold Chain IQ – as a contributor,...

A Process Validation Guide for Cold Chain Logistics

First published on September 16, 2015 on Cold Chain IQ – as a contributor,...

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

First published on June 15, 2015 on Cold Chain IQ – as a contributor,...

Why Is Pharmaceutical Transportation a Major Concern?

First published on May 11, 2015 on Cold Chain IQ – as a contributor,...

Pharmaceutical Cold Chain Is Complex

First published on April 9, 2015 on Cold Chain IQ – as a contributor,...

The New and Improved ISTA Standard 20 v2

The International Safe Transit Association (ISTA) is a member-driven standards organization. A revised version...

How to Use USP and ASTM to Evaluate Thermal Test Results

To set the stage for this blog post, a thermometer is a device that...

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

Note to readers: I wanted to share the following email and reply, since it...

Cold Chain Integrity Challenges Biopharmaceutical Industry

Cold chain integrity is a growing concern in the biopharmaceutical industry. High value cargos...

Transport Process Validation – Performance Qualification (Part 4 of 4)

Part four of a four part post on the validation of the transport process...

Transport Process Validation – Operational Qualification (Part 3 of 4)

Part three of a four part post focuses on the Operational Qualification (OQ) portion...

Define Your User Requirements Specifications Upfront to Ensure Success!

Different people have different expectations while developing a drug product shipping solution – for...

Transport Process Validation – Component/Installation Qualification (Part 2 of 4)

Part two of this four part post will focus on the Component/Installation Qualification (CQ/IQ)...

Transport Process Validation – Outlining the Process Steps (Part 1 of 4)

The US FDA, EMEA, ICH, and host of other regulatory agencies have issued guidance...

Correct Cold Chain Standards Are First Step Transport Validation Simulation Testing

Many of the projects Modality Solutions works on for clients not only require qualification...

Three Departments Working Together for Cold Chain Success

How do you go about integrating your cold chain and what is involved? To...

Solid User Requirements Is First Step in Supplier Selection

Did you know there are at least 30 different suppliers of thermal packaging and...

Deviation Torture; Part 2.

Okay, if you’ve read part one of deviation torture, you know the terror of...

Deviation Torture; Part 1

January and August were busy months when I worked in a large pharma company...

User Requirements Specification (URS) Matrix Tool

The beginning of any good engineering project — be it an insulated shipper, designing...

2012 Annual Meeting AAPS – Chicago

The American Association of Pharmaceutical Scientists (AAPS) conference is four days of meetings and...

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

The ISTA established a set of standard thermal profiles known as 7E using sound...

Does ISTA 3A Really Simulate Transport?

There were concerns voiced over whether ISTA 3A is working for our industry at...

How old is that trailer?

That’s a question that needs to be known before you load it with temperature...

Trailer Definition

First steps to Trailer Qualification…know what you’re using! It sounds simple, maybe even trite,...

Every Quality Agreement Needs A Great Investigative Reporter

Admit it – We all wanted to be great investigative reporters like Bob Woodward...

Integrate cold chain management systems?

“We integrate cold chain management systems.” I was struggling for a ‘tag line’ for...