Industry feedback on USP bioreactivity draft monographs

Bioreactivity is a mandatory test for plastics used in the composition of primary packaging for parenterals and implanted devices. It is typically tested using an in vivo test where extracts from the plastic are injected into live animals, or an in vitro test where extracts are exposed to cultured cells.

USP <87> describes in vitro tests, USP <88> in vivo tests, and USP <1031> provides the strategy for testing plastics either way or both ways depending on the risk to the patient. The USP is revising these three monographs to update the bioreactivity compendial tests and the decision-making process to ensure the safety of plastics used for the packaging or administration of pharmaceuticals. It has asked for industry comments.

This BioPhorum paper contains feedback on the USP document grouped into strategy, application of the bioreactivity monographs to plastics used for manufacturing, and the use of resources. It also comments on the potential in vitro tests that should be included in <87>, the removal of the implantation test and safety in <88>, the removal of Class I to VI from <88>, and the topics for omission or inclusion into the <1031> chapter outline.

The expert feedback provided in these documents aims to support the USP and, ultimately, produce documents that improve patient safety – but with adequate use of finite analytical resources, which would not be the case with divergent expectations.