Perform the in vitro biological tests according to the procedures set forth under Biological Reactivity Tests, In Vitro 87. Materials that meet the requirements of the in vitro tests are not required to undergo further testing. No plastic class designation is assigned to these materials. Materials that do not meet the requirements of the in vitro tests are not suitable for containers for drug products.

If a plastic class designation is needed for plastics and other polymers that meet the requirements under Biological Reactivity Tests, In Vitro 87, perform the appropriate in vivo tests specified for Classification of Plastics under Biological Reactivity Tests, In Vivo 88.