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Article: A holistic strategy to ensure CCI of sterile vials

Posted: 30 March 2021 | | No comments yet

A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.

Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. Implementation of deterministic analytical methods for CCI testing enables deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI goes beyond CCI testing. A science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required.












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