Temperature Testing ISTA Standards
Cold Chain Packaging Operational Qualification
The ISTA ambient profiles are a great place to start Operational Qualification (OQ) testing. Many cold chain packaging manufacturers “pre-qualify” the shipping system using representative payloads and test to ISTA’a summer and winter profiles. The ISTA is an international organisation with a heavy influence from the USA. It has a broad scope that encompasses packaging and transport standards but pertinent to this conversation is a sub-group focusing on pharmaceuticals. This sub-group is active in the preparation of guidelines that can be useful in the industry. Some of the more informative are:-- Temperature profiles for summer and winter in North America
- Temperature profiles for summer and winter in Europe
Why use ISTA Standards?
We recommend using the ISTA standards because they allow performance comparison between different types of packaging and between different types of pack-outs. It allows companies to test packaging from one supplier against the standard and to compare packaging from one supplier against another supplier.
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