The US Food and Drug Administration (FDA) defines bioburden as the total number of microorganisms associated with a particular product prior to sterilization. Another definition of bioburden is as follows: the level and type of microorganisms that can be found in raw materials, APIs and intermediates (for example, whether they are objectionable).
Bioburden is considered contamination unless levels are exceeded or identified as objectionable organisms.
The bioburden test is generally a test performed on a bulk solution for injection products that have either been produced aseptically or have been sterilized finally. Commonly used methods are membrane filtration or plate counting.
Producing safe products is the primary goal of all medical device manufacturers, and sterility assurance is an important component in achieving this goal. Many disposable medical devices are sterilized by radiation methods such as ethylene oxide, gamma or e-ray. FDA and other regulatory agencies require verification of the sterilization process, and these verifications typically require a bioburden and sterility test. As part of routine quality control, sterility testing and biological load testing are performed on devices.
The bioburden test determines the number of microbes in the medical device. Generally, a suitability test is performed before this test. This suitability test is a method validation and its purpose is to ensure that the bioburden test method is effective in recovering microorganisms present in the instrument and to demonstrate that the test method will allow the growth of instrument microorganisms.
After method validation is complete, the device is bioburden tested to determine its microbiological loads. The bioburden level is often used in sterilization verifications to calculate the verification or sterilization dose a device needs. Also, as part of quality control, quarterly bioload monitoring is performed to determine if the microbiological load on a device has changed.
These tests are carried out according to the ISO 11137 Sterilization of Healthcare Equipment - Radiation standard published by the International Standards Organization (ISO). In our country, this set of standards has been published by the Turkish Standards Institute (TSE) with the following titles:
Our organization also provides biological load testing services within the framework of national and international standards, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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