Decontamination process – Barrier Technology and Premises

• 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
– Eudralex – EU Guidelines for GMP – Vol 4 – Part 1 – GMP Basic Requirements for Medicinal Products
– Eudralex – EU Guidelines for GMP – Vol 4 – Annex 1 – Manufacture of Sterile Medicinal Products
– Eudralex – EU Guidelines for GMP for Medicinal Products for Humans and Veterinary Use – Vol 4 – Annex 15 – Production and Validation

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:
– Particles, Microorganisms
– Chemical residuals of ancillary products (detergents, disinfectants,…)

The different steps of Decontamination process:
– Cleaning
– Disinfection and Bio-Decontamination

Good practices of cleaning and desinfection:
– Feedback on actual cases

Characteristics of different tools and storage conditions in production:
– Wipes, brooms, nebulizates or vaporization

Decontamination Validation
Practices after a shutdown
Specific case applicable for Barrier Technology
Validation of disinfectant:
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