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This work is carried out as proof of successful sterilization of products that are placed on the market as sterile or placed on the market as non-sterile and sterilized before use.

We are performing a steam sterilization validation study with the following steps,

  • Preparing the validation protocol,
  • Determining the product bioburden before starting work,
  • Performing the sterilization process with the same parameters in 3 different cycles to prove repeatability,
  • Analysis of the sterility of biological indicators placed in the cabinet and in the product during the cycles,
  • After the cycles, sterility analysis of the products representing the difficult condition,
  • Preperation of the validation report describing the whole process with the results.

Steam sterilization validation, TS EN ISO 17665-1- Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices