Non-sterile products

Bioburden determination

Numerous medical devices, single-use devices or primary packaging materials in the pharmaceutical industry are subjected to sterilisation due to their intended use. For the sterilisation process to be successful, only a certain number of germs may be present on the surface of the product or the packaging. The term bioburden refers to the number of germs on the surface of a product prior to sterilisation.

Testing for bioburden is regulated in DIN ISO 11737-1 is binding for the manufacturers of medical devices.

Your contacts on this topic

We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts:


Dr. Ina Buchholz

Microb. testing of non-sterile products
+49 9708 9100-709

Elke Meinken

Microb. testing of non-sterile products
+49 9708 9100-873

Routine testing

Suitability testing

Christian Lomb

Microb. testing of non-sterilenproducts
+49 9708 9100-319

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