Bioburden Testing Services

Do your bioburden levels meet your sterilization requirements?

Bioburden testing, or total viable count testing, is the measure of microbial contamination levels on or in a product.

Bioburden testing can derive from the raw materials used in the manufacturing process, or be introduced via the workforce or manufacturing operation. With numerous sources of contamination, the bioburden of a product can fluctuate between batches, so regular, routine testing is advisable.

Bioburden testing (total viable count)

Bioburden test results may be used in one of three ways:
  • Control, reduction or elimination of contamination in the manufacturing process
  • When testing is conducted at predefined intervals, results are trended over time to provide information on contamination in the manufacturing process
  • When testing is conducted on batches for low bioburden products or raw materials, results can be used to release individual batches

Bioburden speciation or absence testing

Methods for the absence of specified or objectionable microorganisms can be developed. These methods not only give total viable counts, but also identify the presence or absence of specified microorganisms, providing complete, robust test results.

STERIS Laboratories offers:

  • A bioburden testing method developed and validated for each individual product/device type, ensuring best accuracy and repeatability in bioburden testing
  • Controlled testing documentation issued to Customers for every bioburden method developed, ensuring consistency in testing throughout product/device life span
  • Bioburden method designed to suit each Customer’s need – Speciation in bioburden testing
  • Product warning and/or alert limits included in individual bioburden methods

Bioburden testing is used for:

  • Medical devices
  • Pharmaceuticals
  • Packaging
  • Raw materials
Available services vary between laboratories. Contact us to learn more about the services offered at each of our locations

Contact our team of experts to find out more about Bioburden Testing