Sterility Testing

Accredited method

The Product Sterility – test is necessary for medical devices that claim to be sterile or free from viable microorganisms.

A Sterilization process should kill all microbiological contaminants on a medical device and thereby transform non-sterile products into sterile ones. Sterility testing is used to verify or assess the effectiveness of sterilization.

To safeguard Sterility Testing, all testing is carried out within an ISO 5 Laminar low cabinet which is in an ISO 6 Cleanroom. All of the cabinets are routinely monitored with particulate counts, active air sampling, contact plates and settle plates.  Our microbiologists are thoroughly trained in aseptic technique.

Test method validations, to include bacteriostasis/ fungistasis or sterility test method suitability, are also provided.

Standard:

  • ISO 11737-2

“Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process”

Method:

  • Direct immersion

Requirements:

  • Validation methods for each medical device
  • for validation 6 sterile devices
  • for routine analysis sterile devices acc. to customer requirements [exp. 3-10 devices]