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

Container closure integrity testing (CCIT) is critical for ensuring the safety and efficacy of parenteral drug product presentations. Unfortunately, current technology has many deficiencies in testing capability and cannot meet all user needs or test the increasing range of products most companies routinely support. To encourage the development of optimized technologies for CCIT, BioPhorum has written a User requirements specification (URS) for optimized container closure integrity testing equipment.

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.

The paper 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 in:

  • Reliability (accuracy, precision, repeatability and robustness of results)
  • Location of a defect, selectivity and sensitivity
  • Speed and capacity
  • Simplicity/ease of use (and how easy it is to validate/integrate)
  • Connectivity (e.g. integration into network data gathering systems and electronic laboratory environments).

It will also help resolve the problem that the range of deterministic CCIT methods currently available do not represent a panacea for CCIT. Current deterministic methods also do not apply to a broad range of product presentations, from simple to complex.

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URS for CCIT November 2020.pdf
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  • Create Date 18th November 2020
  • DOI https://doi.org/10.46220/2020FF001
  • Last Updated