Medical Product Steam Sterilization Validation

Medical Product Steam Sterilization Validation

This work is carried out as a proof that products that are introduced to the market as sterile or non-sterile are successfully sterilized before use.

We are carrying out steam sterilization validation work with the following steps,

  • Preparation of validation protocol,
  • Determination of the product bioload before starting the study,
  • Sterilization process with the same parameters in 3 different cycles to show repeatability,
  • Sterility analysis of biological indicators placed in the cabinet and product during cycles,
  • Sterility analysis of products that represent the difficult condition after cycles,
  • The preparation of the validation report tells the whole process along with the results.

Steam sterilization validation, Sterile of TS EN ISO 17665-1- Sterilization of health products – Moist heat – Part 1: Features related to the development, validity and routine control of sterilization for medical devices