Correct Cold Chain Standards Are First Step Transport Validation Simulation Testing

Correct Cold Chain Standards Are First Step Transport Validation Simulation Testing

Written by Modality Solutions

Posted on: September 5, 2017

Many of the projects Modality Solutions works on for clients not only require qualification of insulated shippers for their cold chain, but also require transport simulation testing to determine the effects of transport on their product. To date, many clients request a test plan from ASTM D4169 for transport simulation testing. Interestingly, the decision to use of ASTM D4169 was made before many of latest GDP guidance and country-specific regulations were published. No one in their organization knows why the chose the ASTM standards and if it is the right for transport simulation design of experiment (DofE) they are developing.

For that reason they ask us what we think the right standard for their packaging systems, product formulation, and most importantly the interaction between the two.

While ASTM D4169 has been used for many years and is a good standard to use for transport simulation testing, Modality Soltuions does not think it is the best standard for use in the Biotechnology, Pharmaceutical, or Medical Device industry.

Modality Solutions recommends the use of ISTA 4AB custom built transport simulation test plan. These methods allow for the creation of a test plan that is tailored directly to the transport environment of our clients. The Modality Solutions methodology use ISTA 4AB test profiles and test plan creation as its foundation, but we recommend changes based on our knowhow we have developed through years of experience in transport simulation testing.

Another advantage Modality Solutions see in using ISTA is the prolific number of test profiles. ISTA has more profiles that represent the regions of the world our client’s ship to which allows for a more accurate transport simulation test plan to be created for our clients.

For this reason Modality Solutions supports the use of ASTM D4169 but thinks ISTA 4AB custom test plan allows more accurate simulations and better results for our clients.

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