04/2011:20601 Biological Tests - Sterility

The sterility test is applied to substances, preparations or articles which, according to the Pharmacopoeia, must be sterile. However, microorganism was detected in the sample examined under test conditions.

Precautions Against Microbial Contamination

Sterility testing is performed under aseptic conditions. To achieve such conditions, the test environment must be adapted to the way sterility testing is performed. The precautions taken to prevent contamination are such that they do not affect the microorganisms that will appear in the test. The working conditions in which the test is carried out are regularly monitored by taking appropriate samples from the working area and making appropriate controls.

Sterility Test Method

Perform a test as described below as part of the seriality test of the product to be inspected using exactly the same methods, except for the following modifications.

After Membrane Filtration has transferred the contents of the container or containers to be tested to the membrane, add a small inoculum of viable microorganisms (not more than 100 CFU) to the last portion of the sterile diluent used to rinse the filter.

Direct Inoculation, add the inoculum of a small number of viable microorganisms (up to 100 CFU) after transferring the contents of the container or containers to be tested (for veterinary catgut and other surgical sutures: threads) to the culture medium. ) middle.

In both cases, use the same microorganisms as described above under the Growth promotion test of aerobes, anaerobes and fungi. Perform a growth promotion test as a positive control. Incubate all containers containing medium for up to 5 days.

Our organization, EUROLAB, provides testing services to businesses within the framework of laboratory testing services, by our professional engineer staff within the scope of 04/2011:20601 biological tests - sterility test standard.