Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use. USP <661.1> <661.2> & <382> will be official by the end 2025. This whitepaper provides an overview of the changes that these new general chapters will bring to CCIT.
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