Validation of moist and dry heat sterilization

Course Details

Module length  
From 1 DAY and a half to 2 Days 
Learning tools  
Presentations, Lectures, Case Studies, Discussion, Question & Answers session


Target audience  
Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance


Regulatory aspect from International Agencies (e.g. EMA/EDQM, USA-FDA/USP, ANVISA, ISPE, WHO)
Technical Background from cGEP (Good Engineering Procedures) (e.g. ASME BPE, ISPE Baseline)
EU-Annex 1 revision contents
Validation Life Cycle
  • Design Qualification
  • Installation Qualification
  • Instruments Calibration
  • Operational Qualification
  • Performance Qualification
Operational and Maintenance Aspects
Inspection points to consider from DOC experience
Case Studies from DOC experience
Case Studies from DOC experience

Regulatory & technical references

  • EU GMP Annex 1: “Manufacture of sterile medicinal products”
  • 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)

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