Bioburden enumeration is the quantification of the total number of viable microorganisms on a raw material, container, product component, process water or finished medical device. Bioburden enumeration is performed to establish the effective dose for radiation sterilization as well as a process monitoring tool during quarterly dose audits. Manufacturers are recommended to conduct regular and random bioburden enumeration on the materials, components and finished product to alert themselves to any process control deviations or problems which may ultimately affect the sterility of the final product.
Typically, aerobic bacteria and fungi bioburden are evaluated. Charles River Singapore offers a combination of various bioburden tests to meet your requirements.
| Test Code | Description |
| BIO-E |
Routine bioburden enumeration (Membrane filtration method) - Total bioburden panel (Aerobic bacteria, aerobic spores, anaerobic bacteria, anaerobic spores, fungi) - Aerobic bacteria alone - Aerobic bacteria + fungi - Total aerobic panel (aerobic bacteria + aerobic spores + fungi) - Aerobic spores - Total anaerobic bacteria |
Charles River Singapore also offers customized bioburden tests.