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Sterility test


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.

Standard 11737-2

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

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.


Grade A Pharmaceutical Environment under monitoring
Temperature, pressure, flow rate and video of the trials
H2O2 decontamination system
Validated in "Overkill" 6 log
Incubator with controlled and monitored temperature
Symbio Flex pump in a closed system
Adaptable to all types of (single-dose solutions, liquids in ampoules, flexible bags, solutions in small vials, elution of medical devices, etc.)
Culture media
TSA / Thioglycolate medium
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