Berkshire Sterile Manufacturing (BSM), a fill finish CMO located in Lee, MA, is proud to announce their sterility testing isolator is ready to perform onsite sterility testing for its GMP batches. The new service is expected to shorten the release for most, if not all the company’s clients.
BSM offers sterile filling of injectable medicines – most of which are in clinical trials or require a small commercial need. Sterility testing confirms the filled drug product is free of microbes that could cause patients to become sick administered with the medicine. It is a required test performed on every batch of drug product produced at BSM, but the test demands at least two weeks of incubation to receive results back.
BSM first announced the expansion of its facility in June of 2020, which included the expansion of its microbiology testing. BSM purchased a FCTS sterility test with a hydrogen peroxide vaporizer from Fedegari and a Steritest Symbio ISL pump kit from Millipore. Installation for the isolator took place in November of 2021 and was followed by extensive training and validation work. The isolator and sterility tester are now available to begin onsite sterility testing for drug product lots produced at BSM.
Prior to the addition of this capability, BSM outsourced all sterility testing. Nearly all clients paid costly fees to have their testing expedited, but they would still receive their results over a month after samples were shipped.
Bringing the capability in-house is expected to slash release timelines in half.
BSM has already scheduled testing, and the company is celebrating the opening of its new sterility isolator line with an informal ribbon cutting ceremony in early July.
About Berkshire Sterile Manufacturing
Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer which specializes in sterile filling of syringes, vials and cartridges for the biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, lyophilization of vials, dual chamber liquid/liquid and liquid/lyo all within an isolator. Lyophilization development, formulation development, and method development are also offered. For more information, visit https://berkshiresterilemanufacturing.com/.