Berkshire Sterile Manufacturing (BSM), a fill-finish contract manufacturing organization (CMO) located in Lee, MA, has unveiled a new sterility testing isolator which 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.

“We have waited up to 3 months to receive sterility test results back when we outsourced to other laboratories. Now that we have a dedicated sterility isolator to perform these tests, we can have those same results back in three weeks or less,” said Lindsey Lungren, microbiology manager, BSM.

Bringing the capability in-house is expected to slash release timelines in half.

“Getting the sterility results is usually what slows the release of a drug product. It takes a while to receive them back, and they are critical to the lot release. It is a test that cannot be skipped,” said BSM’s vice president of quality control, Devin Wigington.