Package redesign on International Bulk Shipments of Pharmaceuticals.

BioMarin Pharmaceutical Inc. (BioMarin) is a multinational biotechnology firm based in Novato, CA that specializes in providing first-to-market therapeutics to patients with rare genetic diseases. It has offices and facilities in the US, South America, Asia and Europe. BioMarin's core business and research is in enzyme replacement therapies (ERTs). Physical damage was observed to several cases of Kuvan® shipped. The damage was reported upon receipt at the Cardinal SPS Tennessee (CTN) shipping and receiving facility.  A Deviation Record Report was opened to assess the incident.  The damaged cases were placed on hold and were not released to market.  The investigation plan had several elements:
  •  Verify the shipping procedure was performed correctly by the contract manufacturer in Germany (Excella)
  • Request shipping instructions and stacking plan from freight forwarder (DHL)
  • Verify damaged goods and determine what constitutes a damaged good by BioMarin personnel
  • Determine disposition and disposal of damaged goods and disposition of remaining units by BioMarin personnel
  • Check impact of shipment of cases to pharmacies (i.e. product shortage)
The Corrective and Preventative Action (CAPA) plan mandated the pallets of Kuvan product be placed inside an Envirotainer (RKN or RAP) for physical protection. The effectiveness verification plan required the monitoring for the next ten (10) shipments over approximately the next 18 months to determine if the assigned corrective action is effective. The supply chain management team wanted to design and implement an alternative solution as proposed in the current CAPA record for the next scheduled shipment.
The focus of the packaging redesign was to:
  • Review recent improvements to routing of Kuvan® from point of manufacture to point of distribution to baseline process redesign
  • Evaluate current handling procedures for Kuvan® and propose cost-effective pallet configuration, packaging design, and appropriate LEAN techniques (e.g. ‘mistake proofing’ (poka-yoke), visual controls, etc.) to minimize risk of damage during transport
  • Improve and ensure training on revised handling procedures and packaging design with DHL Global Forwarding to ensure proper implementation
  • Update CAPA record and effectiveness verification plan to reflect changes for review and approval by BioMarin quality unit personnel
The objectives of our consulting assistance will included:
  •  Design a transportation lane that maintains product quality of Kuvan®
  • Identify various packaging options available in market to optimize lowest total delivered cost of Kuvan® from Excella to CTN
  • Implement any approved alterations in transportation lane and packaging
  • Update all quality management system documents required
The value of this project was multifold, including:
  • Cost-effective and integrated solution to minimize risk of damage to product in transit
  • Learning opportunity across organization to better understand current best practices for root cause analysis, packaging alternatives, and quality management system to document changes to a validated controlled-environment logistics process
  • Resolve a‘burning platform’ issue for BioMarin and position the Supply Chain organization to build on success byreevaluating changes across their controlled-environment logistics network
The assistance that we can provide to BioMarin for packaging redesign follows:
  1.  Review recent improvements to transport lane design. A review of the current transport lane improvements was conducted to baseline packaging redesign project.  This baseline review drove the recommendations for improvements in package design and handling procedures. 
  2. Evaluate package design alternatives.  Packaging design changes will be evaluated based on transport lane improvements and product quality requirements.  Alternatives were reviewed on product protection capabilities, ease of use, and cost effectiveness. A minimum of three types of packaging designs will be evaluated:
    • Active refrigeration (current mandate)
    • Uncontrolled ambient (e.g. corner protectors, pallet configuration, etc.)
    • Passive packaging (EPS/polyurethane and gel ice for protection and thermal/humidity control)
  3. Recommend and implement approved packaging design.  The package design approved by BioMarin will be implemented.  The recommended packaging design will be provided with a suggested provider and pack out procedures for training at contract manufacturing sites.
  4. Review current handling procedures.  A review of current handling procedures of the freight forwarder (i.e. DHL Global Forwarding) will be conducted to minimize risk of damage during transport based on approved packaging design.
  5. Recommend and implement changes to current handling procedures. Recommend changes to current handling procedures with freight forwarder based on appropriate LEAN techniques will be reviewed and approved by BioMarin.  The forwarder will be required to revise any necessary documentation based on approved recommendations.  New handling procedures will be reviewed by Modality Solutions and approved by BioMarin.
  6. Revise current CAPA record and verification effectiveness plan to document new approach.  The appropriate documentation in the BioMarin quality management system will be updated and approved by the BioMarin quality unit to document new approach.