Biocleaning: Cleaning and decontamination of surfaces

ONLINE

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
• American GMP 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 to eliminate:
  • Cross Contamination, Chemical residuals of ancillary products ((detergents, disinfectants, …)., Particles, Microorganisms.
• The different steps of a Biocleaning program, Practical details :
  • 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.

#5125