Biocompatibility of Pharmaceutical Packaging Systems

Recommendation

4-6 March 2025

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The USP published the general chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction. The chapter will become official on 1 December 2024.

Risk-Based Approach for Classification of Polymeric Materials

The revised USP chapter <1031> was published for comment in Pharmacopeial Forum in May 2023. Amongst others, the title of the chapter has been changed (previous title: The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants). In addition, the scope of the current chapter has been expanded to include polymeric materials for pharmaceutical packaging/delivery systems (i.e., plastic and elastomeric components).

The chapter outlines a risk-based approach, starting with a chemical risk assessment of supplier information and prior knowledge, as well as responses to an in vitro test in <87> for cytotoxicity plus the in-vitro Reconstructed Skin Epidermis (RhE) Test for irritation. Obtaining a passing result for all in vitro tests permits application of the term "Pharmaceutical Grade Polymeric Packaging Materials".

The term "Pharmaceutical Grade Polymeric Packaging Materials" replaces the Classification of Plastics Classes I–VI and is designed to facilitate communication among suppliers, users, and manufacturers of polymeric materials by summarizing the tests to be performed for prospective polymeric packaging materials.

Failure of any of the in vitro tests may be investigated by chemical characterization (according to USP <1663> Assessment of Extractables) with toxicological assessment of extractables, followed by performance of the <88> Systemic Injection Test for which extracts, materials, and routes of administration are specified. However, this test is not required for polymeric packaging materials and systems for oral or topical use. Elastomeric components for packaging materials and systems that meet the requirements of <87> are not required to undergo <88> testing.

More information is available in the USP-NF.