Bioburden Testing Services

Does your manufacturing process meet your microbial quality and sterilization requirements?

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

Bioburden can be introduced from the raw materials used in the manufacturing process, or be introduced via the workforce or manufacturing environment. 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 to:

  • Demonstrate microbial quality control of the manufacturing process through routine monitoring and trending (ISO 11737)
  • Determine radiation dose for terminally sterilized product (ISO 11137)
  • Investigate root cause of contamination excursions from routine production (Alert and Action levels)
  • Test raw and finished product materials for microbiological examination of non-sterile products (USP<61>)
  • 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. (USP<62>, USP<60>)

STERIS 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
  • Human Tissue
  • Animal Tissue
  • Cosmetics
Contact our team of experts to find out more about our Global Contract Sterilization Services