Bioburden Testing

Alerting you to possible production problems,  which could lead to inadequate sterilization or possible product recall.

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 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 NameSample NeededTurn-Around Time
Bioburden Validation - Repetitive (Exhaustive) Recovery Method3-10 nonsterile units1 week
Bioburden Validation - Spore Inoculation3-10 nonsterile units1 week
Bioburden Testing10 samples with each quarterly audit, per AAMI Radiation
Sterilization guideline (AAMI/ANSI/ISO 11737)
1 week