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Understanding Container Closure Integrity Test Failures

September 27, 2022

11:00 am CT

Jennifer Gygi and Logan Luke

Does a container closure integrity test (CCIT) failure always mean a defective closure? In this webinar, failure modes that can occur on a perfectly sealed container will be discussed along with how to determine if a CCIT failure is a true container leak or something else. Additionally, learn about the value of product-specific method qualifications to ensure the test method and fixturing are suitable for your product, as using a less-than-ideal test setup can lead to false failures.

Key Learning Objectives:

  • Understanding of CCI test methodology and validation
  • Common failure modes that are not true leaks
  • Benefits of individual method qualification and cost

Jennifer Gygi

Jennifer Gygi has over 25 years of medical device laboratory experience. She has worked in the Microbiology, Bioburden, IDs, and Packaging sections at Nelson Labs. Jennifer has experience with various microbial tests, including microbial limits, plate counts, Biological Indicator population verifications, organism ID tests and bioburden tests. Jennifer has spent the last 15 years working in the Packaging group. As one of the original packaging group members at Nelson Labs, Jennifer was heavily involved in validating all the packaging test methods and equipment and writing the test procedures for the packaging tests performed at Nelson Labs.


Logan Luke

Logan holds a degree in microbiology and has most recently taking on the role of laboratory operations manager at Nelson Labs. He has worked in the sterilization, IDs, and packaging departments. Logan has extensive knowledge in the packaging section, as he has aided many customers with their package testing needs, from the benchtop to trouble shooting and validation design.