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Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging

CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches.  This presentation will review all the common CCIT methods found in USP <1207> to compare the testing options. The presentation then explores CCIT method validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.

  • Deterministic vs. probabilistic methods (why choose one over the other)?
  • How do the different methods work?
  • How do you set up a validation for a CCIT method?
  • What are some pitfalls to avoid during the validation?

Speaker:

Jennifer Gygi
Expert Technical Consultant
Nelson Labs

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