PURPOSE
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.
EUROPEAN PHARMACOPOEIA:
Chapter 2.6.1 on so-called sterile substances, preparations or products.
Standard 11737-2
Sterilization of Health Products – Microbiological Methods – Part 2: Sterility controls performed during the definition, validation and maintenance of a sterilization process
METHODS
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
For products whose physico-chemical nature is not compatible with membrane filtration, the sample is analyzed by direct plating.
This means that a defined amount of product will be placed directly into the culture medium which is then incubated under conditions that allow the growth of any contaminants.
STATE-OF-THE-ART EQUIPMENT
Previous slide
Next slide
