Sterilization Validation

Sterilization Validation

The sterilization process is a key part of the aseptic product. Leon Biotech has many years of experience in assisting customers with complete sterilization planning, and is constantly updating the latest global regulatory services and meeting the technical requirements of the review authority, including EO sterilization foundry. With the effective planning, the moist heat sterilization confirmed the ISO 17665, and the sterilization parameters of the reusable device products were confirmed.

  • ISO 11137 (Gamma Radiation)
  • ISO 11135 (EO sterlization )
    • Sterilization process design and consulting
    • Bioburden/BIs validation method
    • Overkill method
    • ISO 10993-7 (EO、ECH residue analysis)
  • Moisture steam sterilization validation
    • ISO 17665 non Sterile device sterlization validation
    • Reusable device sterilization validation (AAMI ST79)

服務內容

  1. 中國 醫療器械質量管理體系諮詢輔導
  2. 美國 QSR/ISO 13485系統輔導諮詢
  3. 歐盟 MDD-MDR 系統轉版輔導
  4. 台灣 GMP 系統輔導