The mass extraction leak test is a deterministic test method for the Container Closure Integrity (CCI) test. CCI test methods are used in stability studies, routine production quality control tests 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 automatic injector devices up to 19.5 cm long. The verified leak size is 2 or 5 microns depending on the method.
The test substance is placed under vacuum in a Mass Extraction Tester and checks for leaks. Mass flow values below a predetermined leakage threshold are reported as “pass” and values above a predetermined leak threshold are reported as “failed”. This test represents a decisive process for evaluating container closure integrity.
Advantages of 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 sample required), and nondestructive testing that enables retesting and validation of failed ones. Test result and mass flow value are reported.
EUROLAB, with its highly expert team and internationally accredited laboratories, Mass Extraction Leak Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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