The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum PF 49(2). The deadline for comments is May 31, 2023.
Proposed Revision of <1031>
The proposal is based on the currently official version of USP´s general chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants. The Packaging and Distribution Expert Committee (PDEC) proposes the following revisions to update and expand the scope of the current chapter:
Change the title to "The Biocompatibility of Pharmaceutical Packaging Systems and Their Materials of Construction".
Expand the scope of the chapter to encompass plastic materials of construction and plastic and elastomeric components for pharmaceutical packaging/delivery systems and for packaging of combination products.
Replace the Classification of Plastics Classes I–VI by the term "Pharmaceutical Grade Plastic Packaging Materials" to facilitate communication among suppliers, users, and manufacturers of plastic materials by summarizing the tests to be performed for plastic packaging materials based on several steps, beginning with - a chemical risk assessment of supplier information and prior knowledge, - 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 Plastic Packaging Materials". Failure of any of the in vitro tests may be investigated by chemical characterization (see USP chapter <1663> Assessment of Extractables) with toxicological assessment of extractable chemical entities, followed by performance of the <88>, Systemic Injection Test for which extracts, materials, and routes of administration are specified. The test is not required for plastic packaging materials and systems for oral or topical use, or for manufacturing components.
Include the following significant additions: - Current Regulatory Expectations for Biocompatibility - A risk-based approach to biocompatibility evaluation - Assessment of test methods - Chemical characterization as a key part of the overall safety assessment process - Biological reactivity test failure analysis - Overall biocompatibility evaluation
The proposed USP General Chapter <1031> is available after registration to the Pharmacopeial Forum.