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, ISO11135 or aseptic manufacture

STERIS completes sterility testing to either USP/EP or ISO 11737 using membrane filtration, direct immersion (inoculation) or removal of microorganisms from the product. These techniques can be applied on the total product part of the product or of the fluid pathway. The necessary techniques depend on product characteristics and Customer requirements.

Sterility testing

Sterility testing is performed for three reasons:

  • Test for sterility (USP/EP)- Confirm requirements for sterility of a product following exposure to a sterilization process or aseptic manufacture
  • Test of sterility (ISO11737-2)- Qualify the minimum irradiation dose needed to achieve a specified sterility assurance level (SAL)
  • Test for Sterility of Sub-lethal EO validation samples (ISO11135) to establish and prove the relationship between the BI and the natural product bioburden.

STERIS offers:

  • Sterility testing to USP/EP or ISO 11737
  • Range of Class IIV and Class IIV cleanroom suites available to offer focused and high quality testing.
  • Custom method selection and design
  • Full product specific protocols (provided upon request)
  • Method suitability test (Bacteriostasis and Fungistasis (B/F))
  • Minimization of inhibiting effects in test (Neutralizing Antimicrobial activity))
  • 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 with a sterility claim
  • Pharmaceuticals
  • Drug products
  • Raw materials
  • Packaging (for food/medical/pharmaceutical industry)
  • Raw materials
Contact our team of experts to find out more about our Global Contract Sterilization Services