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