Bioburden and Sterility

SFA ARGE
Bioburden and Sterility

Bioburden Test The detection of microorganism load is performed on medical device and medical product samples according to the "TS EN ISO 11737-1" standard. Microorganisms can be collected from the product using membrane filtration, homogenization or swabbing methods.

Sterility Test This is a test conducted to verify the sterility of a sterilized product using different methods. The test is performed according to the European Pharmacopeia (E.P) 2.6.1-Sterility standard.