To ensure that no contaminating microorganisms are present in the sterile sample being tested.
To ensure the feasibility of the test on the test product, HeX performs an applicability test before the sterility test is performed.
Chapter 2.6.1 on so-called sterile substances, preparations or products.
Sterilization of Health Products – Microbiological Methods – Part 2: Sterility controls performed during the definition, validation and maintenance of a sterilization process
Method 1: Membrane filtration via Steritest
Membrane filtration is carried out by means of a filtration apparatus of the Steritest type.
To do this, the sample to be analyzed is filtered on a membrane with 0.45µm diameter pores, which is deposited on culture media and placed in incubation under conditions allowing the growth of microorganisms.
Method 2: Direct plating
Symbio Flex pump in a closed system