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Distribution Simulation Testing - D4169 & ISTA

Distribution Simulation Testing

Packages must be able to withstand the typical events associated with distribution of the product without defect or loss of sterility. Manufacturers are responsible for evaluating and documenting the package’s ability to protect the product throughout handling, distribution as well as within the storage environment. ASTM and ISTA provide a majority of the industry guidance on distribution simulation testing. ASTM D4169, ISTA 2 Series and ISTA 3 Series are the primary test standards that are used for distribution simulation. As members of ASTM and ISTA, DDL’s engineers are well versed in these sometimes difficult to understand test standards. DDL consults with customers during the quotation process so that test sequencing and methods are understood and the proper testing is selected as dictated by the package design and intended distribution environment.