It is carried out to determine whether products or content that need to be sterile are sterile or not.
Sterility Test is carried out in accordance with EP 9.8 <2.6.1> and USP 43-NF 38 <71> standards unless otherwise specified in any standard.
Since the sterility test analyses performed in our laboratory are carried out in an isolator, the personnel and environmental errors that may occur in the analysis results are minimized.
Sterility Testing and Method Validation
The sterility test of the product, which must be sterile, covers the studies carried out to determine the analysis method.
Within the scope of the validation study, the operating method of a sterile product is determined by “Producibility Tests, Negative Controls, Positive Controls and Statis Test” applications.