Following the opening of its state-of-the-art microbiology laboratory earlier this year, RSSL has launched a sterility testing service in response to sustained client demand and market growth.
The new offering is a fast, responsive and flexible sterility testing service for pharmaceutical and medical device companies.
The move enables the global contract research organisation (CRO) to further enhance the scope of its biopharmaceutical services and increase testing capacity.
Reginald Fernandes, microbiology laboratory manager at RSSL, explained: “Over the last five years, our pharmaceutical analytical services have experienced tremendous growth, so entering the sterility market is a strategically sound step."
Fernandes said the new offering builds on the company's already diverse range of services, which together with RSSL's reputation for quality and scientific excellence, "is a compelling combination".
“In addition to a standard 21-day timeframe for this service, we are also offering clients an expedited 16-day and 14-day, which we believe to be one of the quickest available on the market today,” Fernandes added.
Sterility methods
RSSL’s new service encompasses two sterility test methods; membrane filtration for aqueous, alcohol, solvent and oil-based products, as well as direct inoculation for non-solubles.
Both are used to determine the presence or absence of contaminating micro-organisms in terminally sterilised or aseptic filtered drug products, in accordance with Ph. Eur, JP and USP regulations.
New cleanrooms
RSSL's latest launch has been facilitated by further investment in a purpose-designed sterility testing suite, featuring a Grade D cleanroom installed by Connect2Cleanrooms with Grade A Bioquell isolators.
The new laboratory is expected to be fully operational from February 2020.
“To mark the launch, we are pleased to offer an exclusive cost-saving offer to every client who engages our sterility test services in the first 12 months," Fernandes commented, adding: "We would also like to extend an open invitation to visit our new facilities and discuss how our full-service microbiology offering can help to achieve individual safety goals."
RSSL’s new sterility testing service is part of its comprehensive range of critical assessment services for manufacturers of sterile products. This complete biopharmaceutical testing package also includes microscopy to reduce the risks of particulate contamination, as well as endotoxin to analyse potential pyrogen contamination.
