Decontamination process and validation

Cleaning and desinfection in cleanrooms


  • 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
      • 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:
  • 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.


Date & Time

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Elodie Pastre



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