Decontamination process and validation

• Understanding the GMP Requirements about cleaning and disinfection in cleanrooms
• Integrate the requirements of the Draft Annex 1 2020
• Design a Biocleaning program adapted to premises and its activities

Course content

• European and American Regulations
  • European GMPs
    • “Part I Chapter 3 – Premise and Equipment”
    • “Part I Chapter 5 – Production”
    • “Annex 1 Manufacture of Sterile Medicinal Products”, New draft February 2020
  • American GMPs Regulations
    • FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic processing – Current Good Manufacturing Practice (September 2004)”
    • PDA “Technical Report No.70 Fundamentals of cleaning and Disinfection Programs for Aseptic Manufacturing Facilities”
• Contaminants concerned:
  • Cross Contamination, Chemical residuals of ancillary products ((detergents, disinfectants, …)., Particles, Microorganisms.
• The different steps of a Biocleaning program:
  • Practical details
• Good practices of Biocleaning:
  • Feedback on actual cases
• Characteristics of different tools and storage conditions in production:
  • Wipes, brooms,…
• Quality Assurance and Biocleaning:
  • The different documents needed and example of an audit tool
• Disinfection by air:
  • Hydrogen peroxide vapor techniques
• Fumigation or vapour disinfection (e.g. Vapour-phased Hydrogen Peroxide) of cleanrooms
• Practices after a shutdown
• Validation of Disinfection in according with the Annex 15:
  • Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner

Learning objectives

• Better understanding of the GMP context to clean and disinfect premises and non critical surfaces in classified areas and apparatus.
• Master the choice of methods to put in place and adapt them to GMP requirements.
• Design a Biocleaning program adapted to premises and its activities.
• Give innovative practices in order to put in place practical methods.

Who should attend

This training is intended to Managers and Operators in charge of Disinfection operations in cleanrooms : Quality Support, Production and Sterility Assurance Departments.

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