Sterility testing is a vital requirement when bringing new products to market or assessing the safety of a drug product or medical device post-launch. Utilising our purpose-built clean room, we can offer a fast and flexible sterility testing service, supporting you in meeting these requirements.
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.
Our flexible turnaround times aim to meet your needs. We offer: