What is Bioburden?
The term bioburden refers to the number of germs present on the surface of a product before sterilization (total germ count). Since such germ contamination can easily occur in the manufacturing process, manufacturers of sterile medical devices are obligated through the GMP (Good Manufacturing Practice) to perform germ counts on their products.
How is it tested?
The test piece is rinsed in an eluant (e.g. buffered peptone water) to rinse germs (bacteria, yeasts, molds) of the surface. The extract is now plated on a nutrient agar with a defined volume and filtered through a membrane filter. This membrane filter is also plated and incubated at 37 ° C. After 24 hours the colony forming units (CFU) are counted and the germ load per mL is calculated. By selective agar, a first determination of the germs can take place already during the determination of the total germ count. For a precise identification of the germs, the following methods are also available:
- PCR (polymerase chain reaction)
- PEP (Primer extension preamplification)
- DNA sequencing
Why choose us?
We are a certified laboratory with many years of experience in the testing of medical devices and are happy to perform the required bioburden tests and microbial determinations on your medical devices for you. We test all types of sterile and non-sterile components (e.g. plastic or metal) with regard to the germ load according to DIN EN ISO 11737. Through Germany-wide interlaboratory tests, we have already been able to prove our correct method of operation several times.