Bioburden and Sterility Test

Bioburden Test is performed for the determination of microorganism load in medical device and medical product samples according to ‘TS EN ISO 11737-1’ standard. Microorganisms can be taken from the product by Membrane Filtration, Homogenisation or swab method. Sterility Test It is a test performed to check the sterility of a product sterilised using different methods. The test is performed according to the European Pharmacopeia (E.P) 2.6.1-Sterility standard. Bacterial Endotoxin (LAL) Test A bacterial endotoxin test such as Limulus amebocyte lysate (LAL) is an in vitro test method used to detect bacterial endotoxins.