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Mass Extraction makes FDA Consensus List

The Mass Extraction test is a container closure integrity test (CCI) primarily used for detecting small leaks in rigid containers such as vials, syringes, and auto-injector drug delivery systems.  Mass Extraction is a deterministic test which is on the UPS 1207 preferred CCI test methods list. The governing test standard is ASTM F3287-17 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method.

The Mass Extraction test method was just added to the latest revision of the FDA consensus list. These methods have been reviewed by the FDA and found to meet the agency requirements for an acceptable test method before being placed on the list.  Using an FDA approved test method reduces the documentation requirements in your submission packet since the agency  has already approved the test method. The FDA consensus standards list can be found here.

Nelson Labs is one of few independent test labs currently offering Mass Extraction testing.

If you would like to learn more about this test method, please watch our webinar HERE.  To speak to a sales associate, contact [email protected] or call +1 (800) 826-2088

Jennifer Gygi

Jennifer Gygi

BS, 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....