Container Closure Integrity (CCI)

In this workstream we engage in technical and scientific exchange on CCI methods, technologies and testing strategies, sharing best practices and regulatory-driven questions/demands to lead the industry towards a ‘quality built-in’ approach to CCI rather than a ‘testing to compliance’ paradigm.

Lack of consistent approach

Traditionally there has been a lack of a consistent industry approach to the application of new CCI technology with minimal end-user input into guidance and guidance updates. A similar observation can be made with regard to consistency in regulatory expectations, especially between the competent authorities.

A concern that technology developments can raise expectations unnecessarily combined with an uncertainty about when/how to apply and validate/qualify new technologies can result in an erosion of confidence in CCIT. Differing interpretation of guidance and increased perception of risk has led to variable approaches to CCIT across the industry including a progression towards 100% testing within a batch.

Better industry alignment

The goal of this team has been to develop industry best practices and collaborate on technical and scientific exchange related to CCI methods, technologies and testing strategies between companies.

The aim is to influence regulatory guidance/standards with an aligned response to regulatory expectations with respect to the application of new technologies.

Container Closure Integrity (CCI) deliverables

DeliverableDateDetailsDownload

Limitations and benefits of benchtop CCI methods

1 February, 2024Member only

Limitations and benefits of inline CCI methods

1 February, 2024Member only

BioPhorum’s holistic approach to container closure integrity

17 January, 2024
970.58 KB
586 downloads

Impact of Annex 1 on container closure integrity

14 November, 2023Member only

Sample sizing approaches for container closure integrity (CCI) testing

25 February, 2021Link

Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment

18 November, 2020
182.17 KB
347 downloads

Container Closure Integrity: How to solve the CCI puzzle

30 June, 2020Link

Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper

15 September, 2018Link

Container closure integrity (CCI): Container closure integrity control versus integrity testing during routine manufacturing

7 June, 2017
241.57 KB
622 downloads

Container closure integrity (CCI): Response to the publication of USP<1207>

19 January, 2017Link

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