What is Mass Extraction Integrity Testing?
The Mass Extraction Container Leak Test is a deterministic test method for Container Closure Integrity (CCI) testing. CCI test methods are used in stability studies, routine production QC testing, and new product validations. Mass extraction is strong contender for a large array of different applications. Unlike Dye Immersion and Bacterial Immersion Testing, Mass Extraction Testing is non-destructive which allows for 100% in-line testing to be performed in a manufacturing setting. This testing is not prone to contamination and is faster and more sensitive than its Dye & Bacterial Immersion counterparts.
Our Container Closure Integrity Testing is done in conformance with criteria from:
- ASTM F3287
- USP 1207
What Container Closure Integrity Testing does Nelson Labs Perform?
At Nelson Labs, we provide all of the required testing to determine the efficacy of container closure integrity. Bacterial and Dye Immersion Integrity Tests are widely used across the pharmaceutical industry. However, Mass Extraction Integrity testing is on the rise due to its quicker and more sensitive techniques of testing while offering a broader use of application. Our industry leading expert, Jennifer Gygi covered the differences and advantages of these tests in her collaborative article with American Pharmaceutical Review.
Study Outline
The test article is placed under vacuum in a Mass Extraction Test Instrument and checked for leaks. Mass flow values below the predetermined leak threshold are reported as “pass,” and values above the predetermined leak threshold are reported as “fail.” This test represents a deterministic process for evaluating container closure integrity. Advantages to performing Mass Extraction include fast turnaround time, minimized cross-contamination potential, reduced drug matrix and test system compatibility issues, reduced sampling requirement (no additional control samples needed), and non-destructive testing, which allows for retest and confirmation of failed articles (containers can be returned intact for failure investigations). The test result and mass flow value are reported.
The test is suitable for containers up to a maximum diameter of 42 mm and a maximum length of 78 mm, 1-3 mL syringes, and auto-injector devices up to 19.5 cm in length. The validated leak size is either 2 or 5 microns, depending on the method.
In addition to our Mass Extraction – Container Leak Test we provide Dye Immersion & Bacterial Immersion Leak Tests. These leak tests mimic the worst-case conditions for testing to ensure product safety and integrity.
