After the successful qualification, BioChem Labor für biologische und chemische Analytik GmbH has put two more isolators into operation for sterility testing in accordance with the pharmacopoeia. Thus, a total of four isolators, built by the laboratory technology specialist Ehret, are now available to meet the strongly increased demand for sterility testing using either membrane filter or direct inoculation method according to Ph. Eur. 2.6.1 and USP <71>.

As a GMP-certified contract laboratory, we can now offer our clients an expanded capacitiy for timely, reproducible and reliable sterility test results for the release of their product batches. With up to four test cycles per isolator per day, we ensure that results for these time-critical samples are available as quickly as possible, depending on the incubation time required.

Isolators provide a safe and compliant environment for sterility testing, both from a regulatory and laboratory perspective. The test procedure is always specifically adapted to the respective product by our specially trained laboratory team in accordance with the test regulations.

The products we can test range from parenteral preparations in various dosage forms to medical devices for human or animal use.

Thanks to BioChem’s 25 years of experience in isolator technology, we can constantly offer our clients security regarding the sterility testresults of their products and thus safety for their patients. With these two additional isolators, BioChem has not only doubled its testing capacity, but also expanded its internal back-up system for sterility testing.

Please contact us if you are interested in our analyses. The experts of our microbiological department will be pleased to provide you with further information.