This paper provides some considerations and guidance on defining a justifiable sample size for CCIT when required for parenteral biopharmaceutical finished products. This is a particularly important consideration when using destructive test method. It also summarizes a practical and risk-based strategy, both representing scientifically justified approaches. These approaches prevent unnecessary sampling and testing while retaining high product quality. Where the integrity of each individual container is assured by a suitably qualified process, additional CCI sampling and testing would not normally be required.
Container Closure Integrity
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Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment
Nov 2020 | Annex 1, Container Closure Integrity, Deliverable, Fill Finish, POI - Fill Finish, Publication
The paper highlights a long-term desired view of CCIT to help develop equipment that can better meet end-user requirements. It will also provide confidence that CCIT methods can effectively demonstrate container integrity, such as microbial, headspace (gas, vacuum and moisture) and product integrity. It provides a long-term goal for companies that often use multiple CCIT technologies, with varied capabilities, to support the requirements of an expanding product portfolio. The URS will help overcome the significant inefficiencies that companies face. It will also help resolve the problem that the range of deterministic CCIT methods currently available do not represent a panacea for CCIT.