BRIEFING
〈1031〉 The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants. This proposal is based on the version of the chapter official as of December 1, 2020. The previous proposal in PF 47(4) has been canceled. The Packaging and Distribution Expert Committee 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.
Add an overview of the USP classification of plastics, as described in Biological Reactivity Tests, In Vivo 〈88〉, which identified six different classes of plastics (Classes I–VI). The classes were differentiated by the number and types of solvent used for extraction and the biological reactivity tests performed. A review of the utilization of the classification system found that typically only the most stringent category (Class VI) was used by suppliers of plastic materials of construction and components, and pharmaceutical manufacturers. This classification system has been replaced by the term "pharmaceutical grade polymeric materials", which is defined as materials that are in compliance with specific in vitro tests.
Include the following significant additions:
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
Add sections for Glossary, Appendix, and References.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
The following Briefing list includes monographs and/or chapters that both reference the General Chapter under revision and require revision to keep references to the General Chapter accurate. Other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles.
Source from USP and Please refer to USP for details:
effervescent tablet packaging
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