Defect Catalog for Films and Foils

Recommendation

7/8 May 2024

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Challenges and Solutions for Packaging and Single Use Systems

A technical guide on commonly used insulation materials (e.g. polystyrene, polyurethane) has been provided in form of a stimuli article in Pharmacopeial Forum (PF) 45(2) in March 2019. The article has been prepared by members of an Industry Guidance Task Force, comprised of both pharmaceutical companies (users) and the companies that manufacture reusable passive qualified insulated shipping container solutions (vendors).

The guidance contains a "Glossary" and, in particular, images / photos of the most commonly used insulation materials and protective layers (e.g. molded plastic). In addition, example defects for films and foils are included in the 4 appendices provided:

Appendix 1: Material Guide

• Table A-1. Insulation Materials (e.g. expanded polystyrene (EPS), polyurethane)
• Table A-2. Protective Layers (e.g. molded plastic)
• Table A-3. Refrigerants

Appendix 2: Example Defect Catalog

A defect catalog for common thermal system components with detailed examples of potential failures that may need to be understood to ensure system suitability is provided:

• Table A-4. showing photos with unacceptable tear / puncture / hole /discoloration in outer film (e.g. EVOH, metalized outer film, EPS)

Appendix 3: Best Practice Examples

• Example 1: for a change moving from wider, excursion-based acceptance criteria to the narrower label claim.
• Example 2: for a clinical trial packaging with four different-size parcel thermal shipping systems for three temperature ranges.
• Example 3: for considering switching from a single-use EPS 2° to 8° C parcel shipper to a reusable shipper.

Appendix 4: Additional Sources of Information

The authors of the article state that "a successful reuse process can improve the customer experience, offer environmental sustainability, and maintain product quality while lowering the total cost of ownership for the qualified thermal packaging solution".

Access to the Pharmacopeial Forum (PF) online is free of charge. More information can be found in the stimuli article Reusable Passive Thermal Packaging System: Best Practice Guideline.