Saturday, February 23, 2008
Container & Closure Integrity in Lieu of Sterility Testing in Stability Protocol
The FDA CBER website has yesterday (22/02/2008) published another guidance for industry titled 'Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products'.This guidance applies only to the replacement of the sterility test with an appropriate container and closure system integrity test in the stability testing program, recommending an alternative to sterility testing for supporting continued capability of containers to maintain sterility. The guidance does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility.Alternatives to sterility testing as part of the stability protocol,such as replacing the sterility test with container and closure system integrity testing, might include any properly validated physical or chemical container and closure system integrity test(e.g., bubble tests, pressure/vacuum decay, trace gas permeation/leak tests, dye penetration tests, seal force or electrical conductivity and capacitance tests, etc.),microbiological container and closure system integrity tests (e.g.,microbial challenge or immersion tests). The guidance can be dowloaded from:http://www.fda.gov/cber/gdlns/contain.htm . While the summary or review of this guidance can be read at: My reviews.