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Bioburden

 

The term bioburden is commonly used to describe the population of viable microorganisms present on a material or product prior to sterilisation. Conducting bioburden testing allows the manufacturer to determine if there are any problems within their processes and will allow them to take the relevant steps to ensure complete sterilisation of the product.

Any sterilisation process can kill only a finite number of microorganisms. Monitoring of the bioburden provides useful information on the microbiological challenge presented to the sterilisation process and maintains assurance of the sterilisation efficiency. Bioburden testing may also be employed as part of the quality system to assess the efficacy of a cleaning process in removing microorganisms, for process monitoring for products which are supplied non-sterile but for which the microbiological cleanliness is specified, and for the monitoring of raw materials, components or packaging.

Before any test product can be analysed validation studies are first required. This involves selecting the most appropriate technique to be used based upon the nature of the test product followed by validating the chosen method to determine the recovery efficiency. From this a correction factor is thus established for the product which is then used to estimate bioburden in the test samples.

bioburden

SMTL offer a comprehensive bioburden testing service to manufacturers of medical devices. SMTL also provide bioburden testing of reusable surgical instruments for hospital sterile services departments, in both the NHS and private sector, wishing to demonstrate that their decontamination processes are working effectively.

SMTL are UKAS accredited for the testing of reusable surgical instruments as well as surgical gowns and drapes.

If you have a product you wish to have tested or have any questions, please contact smtl.info@wales.nhs.uk

 

Relevant Standards

  • BS EN ISO 11737-1 - Sterilisation of Medical Devices - Microbiological Methods - Part 1: Determination of a population of microorganisms on products.