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Sterility testing

Sterility testing

According to DIN EN ISO 11737-2, a product that has been sterilised can be accepted for sale if the test shows that no more than one out of ten products tested positive for contamination. The validation dose varies based on the microbial load and the resistance properties of the load. It is usually determined using the standard dilution method, which requires an SAL of 10-2 or less.

The procedure for validating sterility test methods is specified in DIN EN ISO 11737-2. The microbial load must be determined experimentally using a SAL of 10-6, the probability of finding one viable microorganism per million units of product. The SAL is then applied to a sample of 10 product units and the verification dose. In this way, the validity of the procedure is ensured.

The method for establishing the bioburden alert limit is defined in DIN EN ISO 11137-2. The method involves determining the mean of a product's bacterial count. The method is then based on the calculated mean and standard deviation for that group. The result is a bioburden alert limit. In addition to this, a sterility test can be validated by the number of colonies that develop after the first application.

DIN EN ISO 11737-2 is an important standard for sterility testing. It provides guidelines and testing procedures for a variety of microorganisms. These methods are important to make sure that medical products do not contain any harmful germs. However, these standards are not complete, and there is always room for improvement. The GfPS method addresses these issues by focusing on the microbiological characterisation of the bacterial load.

The method provides an extensive range of culture media and appropriate rinsing solutions. The GfPS method considers the needs of different microorganisms. Anaerobic bacteria cannot grow without atmospheric oxygen, whereas fast-growing fungi need a different culture media. In addition, it focuses on the microbiological characterisation of the bacterial load. Changes in the microflora of a product can influence the sterility validations.

Normally, the DIN EN ISO 11737-2 standard uses the membrane filtration method for liquid products. The media is incubated with a particular microbial population to determine its resistance to the substance. This method is not valid for non-sterile products. It is only valid if there is no microbial growth in the presence of the product. This is why periodic audits are essential.

There are two types of methods for sterility testing. The first one is the pharmacopoeia method, which uses two different media. The second method, the thioglycollate method, is a more sensitive version of the method and requires two media - tryptic soy broth and thioglycollate broth. After undergoing the test, the organisms must be tested in their presence.

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