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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

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

Published Date: August 2, 2023

Container closure integrity testing (CCIT) is used to evaluate pharmaceutical packaging, such as vials, syringes, auto injectors, and IV bags for breaches of sterile-barrier integrity. This webinar reviews the common CCIT methods found in USP <1207> and compares the testing options. It also explores CCIT-method-validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.

The following issues in particular are discussed:

  • 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?

Learn more about the presenter below.

Jennifer Gygi

Jennifer Gygi

SM (NRCM)
Packaging Expert

Jennifer Gygi is an Expert Technical Consultant at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional. Jennifer has over 26 years of laboratory experience at Nelson Labs. She has worked in the Microbiology, Bioburden, Organism IDs, Packaging and QC Validations groups....

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