5/6 October 2022
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
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:
Appendix 3: Best Practice Examples
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.