Bioburdene Test

Bioburden, or bioburden test, is done to determine the number of bacteria living on an unsterilized surface. Bioburden is the total number of microorganisms associated with a particular product prior to sterilization.

Whether the production processes of the enterprises meet the microbial quality and sterilization requirements is determined only by this test. The bioburden test or total live count test is a measure of the level of microbial contamination in a product.

Bioburden usually originates from the raw materials used in the production process or from the workforce or production environment. With so many sources of contamination, a product's bioload can fluctuate between batches. Therefore, regular, routine bioburden tests are required.

In general, test results from bioburden are used in the following areas:

• To perform microbial quality control of the manufacturing process through routine monitoring and trending
• Finally, to determine the radiation dose of the sterilized product
• To understand the root cause of contamination deviations from routine production
• For testing raw material and finished product materials for the purpose of microbiological examination of non-sterile products

Methods for the absence of specified or objectionable microorganisms are being developed. These methods not only give total viable bacterial counts, but also determine the presence or absence of specified microorganisms, providing reliable test results.

Bioburdene tests are mainly carried out in the following areas: medical devices, pharmaceuticals, packaging, raw ingredients, human tissue, animal tissue and cosmetics.

The standard referenced in these tests is the ISO 11137 standard published by the International Standards Organization (ISO). In our country, this series of standards has been published by the Turkish Standards Institute (TSE) with the following titles:

• TS EN ISO 11137-1 Sterilization of healthcare equipment - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices
• TS EN ISO 11137-2 Sterilization of healthcare equipment - Radiation - Part 2: Determination of sterilization dose
• TS EN ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on the development, validation and routine control of the dosimetric direction

Our organization also provides bioburden test 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.