Next to production monitoring, sterility tests are the crucial instrument for controlling the microbiological safety of sterile pharmaceuticals and medical devices. As one of the largest suppliers of sterility tests, we are capable of conducting tests in accordance with the requirements laid down in the common pharmacopoeias (Ph Eur 2.6.1, USP Chapter <71>, JP Chapter 4.06, ISO standards 11137-1/-2 (sterilization of health care products) and 11737-1/-2 (sterilization of medical devices) and other regulations on request).
In addition, we offer our customers a broad range of consulting and control services to support them.
- Clean room (class A in B)
- Four aseptic isolators, one isolator specifically designed for the testing of toxic substances such as cytotoxic agents
- Testing of the entire range of pharmaceuticals and medical devices
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