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The objective of determination of bioburden is to determine the population of viable microorganisms (bacteria and fungi) on or in a product or its packaging.
The determination of this number is an important step in the validation of a sterilization process and in process-related quality tests when manufacturing and/or cleaning a medical product.
For this purpose, the product is placed in a culture medium, or it is rinsed in a sterile solution, the rinsing medium is filte-red through a sterile membrane and the membrane is applied to several culture media. The culture media are incubated for several days and the microorganism colonies formed in the process are counted. The number of colonies grown is then equal to the number of colony-forming units (CFUs, individual microorganisms or groups of microorganisms adhering to each other) which were originally on the product. By using various culture media and incubation conditions, it is initially possible to roughly differentiate between bacteria and fungi. By using additional selective media, a further specification of the microorganisms found can subsequently be carried out primarily for the bacteria. This can then be used to localize the origin of contamination during the manufacturing and/or cleaning process of the product.
Validation of test method
The material and the geometry of a medical producthave a major influence on the efficiency of the test method. Therefore, a one-time validation of the test method should be carried out for each product.
For this purpose, the product is inoculated with a known number of a known test organism and then tested with clearly defined parameters. At the end of the test, the CFUs found are counted and compared with the number applied. This ratio is the recovery rate. This is then used to calculate a correction factor which is calculated into all subsequently conducted bioburden determinations on this product. In accordance with the DIN EN ISO 11737-1standard, the recovery rate should be at least 50 %, otherwise the parameters of the test method must be changed and tested again. If the recovery rate has reached a satisfactory value, all bioburden determinations on this product must be carried out with exactly the same parameters as during validation.
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CleanControlling Medical GmbH & Co. KG
Gehrenstraße 11a
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