Understanding Bioburden Testing Services
The Bioburden test is carried out in order to determine the total number of viable microorganisms on a medical device. Bioburden tests are performed prior to sterilization after all in-process steps are completed. The dose used for effective radiation sterilization is determined by the resulting bioburden counts. Routine bioburden testing acts as a monitoring system which may alert possible production problems which could lead to inadequate sterilization or possible product recall.
Testing Capabilities
- Aerobic
- Anaerobic
- Aerobic & Anaerobic Yeast/Mold
- Total Bioburden (Aerobic, Anaerobic, Heat Shock, and Yeast / Mold)
- Bioburden Validation
Testing Categories and Specifications
| Test Name | Sample Needed | Turn-Around Time |
|---|---|---|
| Bioburden Validation - Repetitive (Exhaustive) Recovery Method | 3-10 nonsterile units | 1 week |
| Bioburden Validation - Spore Inoculation | 3-10 nonsterile units | 1 week |
| Bioburden Testing | 10 samples with each quarterly audit, per AAMI Radiation Sterilization guideline (AAMI/ANSI/ISO 11737) | 1 week |