RSSL offers two sterility testing methods, both of which are compliant to Ph. Eur. 2.6.1, JP 4.06 and USP <71>. We will work with you to determine the best test method to use based on your product:
Membrane filtration is designed for aqueous, alcohol, solvent and oil-based products. This sterilisation method passes test material through a size exclusion membrane, which is designed to retain microbial contaminants.
Direct inoculation is designed for non-soluble products and medical devices. In this method, test material is aseptically added to inoculate the media.