Moist and Dry Heat Sterilization

Module Lenght

from 1 day and a half to 2 days

Agenda

  • Regulatory aspect from International Agencies
  • Technical Background from cGEP (Good Engineering Procedures)
  • Moist sterilization
  • Dry Heat sterilization
  • Validation Life Cycle
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Calibration
    • Performance Qualification
  • Operational and Maintenance Aspects

Target audience

  • Manufacturing
  • Quality Assurance
  • Quality Control
  • Validation
  • Engineering
  • Maintenance

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • CFPP 01-01C “Choice Framework for local Policy and Procedures 01-01 – Management and decontamination of surgical instruments (medical devices) used in acute care. Part C: Steam sterilization”
  • USP: <85>Bacterial Endotoxins Test, <1211> Sterilization and Sterility Assurance of Compendial Articles,  Endotoxin Indicator for Depyrogenation
  • “EP European Pharmacopoeia
  • 5.1.1 Methods of preparation of sterile products
  • 5.1.2 Biological indicators of sterilization
  • 5.1.5 Application of the F0 concept to steam sterilization
  • 2.6.14 Bacterial Endotoxins”
  • PDA TR1  “Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control “
  • PDA TR3 “Validation of Dry Heat Processes Used For Sterilization And Depyrogenation “
  • PDA TR7 “Depyrogenation”
  • PDA TR48 “Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance”
  • PDA TR61 “Steam In Place”
  • ISO 20857 “Sterilization of health care products – Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices”
  • ISO 17665-1 “Sterilization of health care products — Moist heat”
  • “Validation of Pharmaceutical Processes – Sterile Products” (F.J. Carleton – J.P. Agalloco)

Number of trainers

One

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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