Biocleaning: Cleaning and decontamination of surfaces

in cleanrooms and apparatus


Course outline

  • European GMP Regulations
    • “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 to eliminate:
    • Cross Contamination, Chemical residuals of ancillary products ((detergents, disinfectants, …)., Particles, Microorganisms.
  • The different steps of a Biocleaning program, :
    • Disposal of visible waste
    • Dusting (wet sweeping and wet wiping)
    • Detergency
    • Disposal of soiled solution
    • Disinfection
  • 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.


Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp
Share on email
Date & Time
December 14, 2020
- December 15, 2020
13.30-17.00 CET

1 050,00 950,00

No. persons
3 persons or more 15% if registered and invoiced together for the same course.

make an inquiry

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.

We take great care of your contact details. To learn more, read our Privacy Policy

Your Instructor(s)

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

Elodie Pastre

Pierre Devaux



For your best experience are we using cookies on this website.