Sterility Test

 

It is carried out in order to check whether the products or contents that need to be sterile are sterile. In order for the test to be valid, samples must not contain contaminated microorganisms. Regulations state that sterile products must be manufactured and sterilized by a suitable and valid method. Sterility test is performed by direct inoculation method in accordance with EU and USP pharmacopoeias. TS EN ISO 11737-2 standard requirements are met.