Any decontamination or sterilization process can only kill a finite number of organisms. Bioburden testing is the enumeration and microbial characterization of the population of viable microorganisms that are present on or in a medical device, component, raw material or sterile barrier packaging. Bioburden tests estimate the total viable aerobic microorganisms on any surface of the item tested.
This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
Bioburden results are reported on individual samples showing total aerobic count with a breakdown of bacteria and fungi.
Anaerobic bioburden and heat-shocking methods for enumeration of spores are also available upon request.
- ISO 11737-1
“Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products.”
- Membrane filtration
- Plate-count (pour-plate method)
- Validation methods for each medical device
- for validation 11 sterile devices
- for routine analysis not sterile devices acc. to customer requirements [exp. 3-10 devices]