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Temperature Testing ISTA Standards

Categories: Pharmaceutical Cold Chain
Tags: ISTA, Qualification

The International Safe Transit Association (ISTA) is a nonprofit organization that researches and tests various packaging formats. It develops also standards for the packaging transport industry.  The ISTA is the industry leader in package performance testing and is at the forefront of Responsible Transport Packaging. With extensive research and testing behind the ISTA standards, many companies are requesting that their packaging be tested to specific ISTA standards. Most importantly manufacturers of cold chain packaging can test with ISTA ambient profiles and demonstrate the performance of their systems.  As a result, customers can then compare alternative suppliers’ packaging performance with the same ambient challenge.

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.

More Information

Environmental chambers are used to create a challenging ambient temperature to qualify the cold chain shippers.
CoolPac are specialists in pharmaceutical cold chain.  We consult, test, manufacture and source the best aspects of cold chain products while keeping a pharmaceutical perspective.  It’s with these key competencies that bring added value to your business.   Want to know more about CoolPac click here.
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