Bioburden and sterility tests performed in medical devices are carried out under different reproduction conditions for the growth of microorganisms.
In both bioburden and sterility tests, it is recommended that our laboratory examine the presence of microorganisms that grow under aerobic and anaerobic conditions. In this way, both aerobic and facultative aerobic microorganisms and anaerobic and facultative anaerobic microorganisms are examined.
The ISO 11737-2 standard (Article A.6.7) states that the use of a single culture condition is not appropriate considering the possibility of survival of microorganisms exposed to sterilizing agents. Therefore, it is not recommended to perform the test in an aerobic environment.
The nature of the product, the production method, potential sources of microbiological contamination, and the types of microorganisms that are likely to be encountered should be selected and the culture conditions to be selected.
The information obtained from the identification of the bioburden observed in the guidance of ISO 11737-1 on the variety of microorganisms may help in the selection of culture conditions.
As a result, it is recommended to determine the culture conditions by considering the type and risks of the product for which a single reproductive culture is not suitable for sterility testing. As Saniter, we recommend that the sterility test should be performed in both aerobic and anaerobic conditions.
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