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.
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.
- ASTM F3287
- USP 1207
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.
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.