Sterility testing is one of the central instruments for controlling the microbiological safety of sterile drugs and medical devices. This test demonstrates that a product is free of viable microorganisms. Labor LS has established customised test plans for classical pharmaceutical products, biologicals, medical devices, cell cultures and in-process samples that require sterility.
We conduct the sterility test for you in accordance with the respective current specifications of the common pharmacopoeias:
- Ph. Eur. 2.6.1
- USP Section <71>
- JP Section 4.06
- Various ISO standards, in particular pursuant to ISO 11137
- Other regulations on request (e.g. Russian Pharmacopoeia, Chinese Pharmacopoeia)