Our Sterility Testing Services

Sterility testing is carried out by our team of microbiological experts to verify the effectiveness of a sterilization process using ISO11137 or aseptic manufacture

STERIS Laboratories completes sterility testing to either USP or ISO 11737 using direct immersion, fluid pathway or membrane filtration techniques depending on product and Customer requirements.

Test for sterility

Sterility testing is performed for two reasons:
  • Confirm requirements for sterility of a product following exposure to a sterilization process or aseptic manufacture – USP/EP sterility testing methods required
  • Qualify the minimum irradiation dose needed to achieve a specified sterility assurance level (SAL)

STERIS Laboratories offers:

  • Sterility testing to USP/EP or ISO 11737
  • Isolated integrity maintained for individual Customer products within clean room suites
  • Custom method development and validations
  • Full protocols (provided upon request)
  • Bacteriostasis and Fungistasis (B/F) method performed
  • Antimicrobial activities assessed
  • Sterility testing on large or complex devices or products, for example products exceeding a capacity of 20 liters per sample

Sterility 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 Sterility Testing