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Published Article


Rigid Container Integrity Testing – Mass Extraction Simplified

Published In: American Pharmaceutical Review

There are many options available for Container Closure Integrity (CCI) testing of glass vials and syringes. From traditional probabilistic methods like Dye Immersion (tracer dye) or Bacterial or Microbial Challenge testing, to a variety of deterministic methods like Vacuum Leak, Headspace Analysis, Mass Extraction, Voltage Leak, and Tracer Gas there should be an option for any need. Each method has pros and cons that should be considered when choosing an appropriate test method for a particular container type. Not all options are suitable for all sample configurations and some methods particularly shine in certain applications, but fall short in others. With the newest edition of USP 1207, the pharmaceutical industry is moving away from traditional dye and bacterial immersion test methods and moving toward deterministic methods for CCI testing.

While there is no “one size fits all” CCI option, Mass Extraction is proving itself a strong contender for many different applications. Like most deterministic CCI methods, Mass Extraction is nondestructive. This allows for 100% in-line testing to be performed in a manufacturing setting. In a laboratory setting, non-destructive testing is a major advantage because failed samples can be investigated for cause of failure. Like other deterministic methods, Mass Extraction is faster, more sensitive, and not prone to contamination as compared to traditional dye or bacterial immersion methods. Some additional advantages of Mass Extraction include leak detection in both the headspace and liquid, testing with ambient air, evaluation of the entire container for leaks, suitability for rigid and some flexible applications, independence of part volume or configuration, and direct leak measurement (vs. indirect) which increases test sensitivity.

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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.