Decontamination Process and the new Draft of the EU GMP Annex 1


The course reviews the new requirements and main differences to decontaminate Isolators, RABS and General Surfaces in Cleanrooms described in the new Draft of Annex 1 published in February 2020.

Course description

This course begins by a short description of the content of this new draft GMPs Annex 1 and main hot topics. Following, the course focuses on a specific hot topic : Decontamination Process.

This Process is always difficult to manage and a clear vision of the new requirements described in this draft is particularly important. Indeed, although the general approach is always the same “to disinfect efficiency a surface, it’s essential to clean it before!”, the methods and the requirements to attain a low level of contaminants are different, depending the surfaces concerned!

The scope of this course is to focus about the Decontamination Process for the 4 chapters concerned :

  • Chapter 4 Premises
  • Chapter 5 Equipment,
  • Chapter 6 Utilities
  • Chapter 8 Production and specific technologies.

Some keywords are difficult to define and they must be clearified :
Washing/Cleaning/Detergent, Disinfection/Disinfecting Agent, Fumigation/Sporicidal Agent, Sterilization and Decontamination.

We will also explain the following Keypoints :
Decontamination of surfaces of equipment in contact with product versus General Surfaces in Cleanrooms, Decontmination of RABS and Isolator : Major Differences, Utilities : Decontamination of a storage system and a loop distribution of a purified or a WFI Water.

To finish, we’ll come back about the comparison between a Fumigation Process (e.g. vapour-phased Hydrogen Peroxide) and a sterilization process to manage the decontamination process of surfaces in contact direct with products and especially vibrating bowls of closure systems in an isolator.

Course content

  • Introduction New Draft Annex 1 February 2020
  • Decontamination Process : General Presentation of Chapters concerned in the Draft
    • Chapter 4 : Premises
    • Chapter 5 : Equipment
    • Chapter 6 : Utilities
    • Chapter 8 : Production and specific technologies
  • Glossary : Definition of key words often misunderstood
    • Washing/Cleaning/Detergent
    • Disinfection/Disinfecting Agent
    • Fumigation/Sporicidal Agent
    • Sterilization
    • Decontamination
  • Focus on the different Decontamination Processes and the new requirements of the Draft
    • Equipment in contact with product versus General Surfaces in Cleanrooms
    • RABS versus Isolator : Major Differences
    • Primary Container : Example of Glass Vials
    • Utilities : Storage System and Loop Distribution of a purified or a WFI Water
    • Fumigation (e.g. Vapour-phased Hydrogen Peroxide) versus Sterilization
  • Questions and Answers

Who should attend

  • Qualified Persons
  • Sterility Assurance Managers
  • Quality Directors
  • Qualification and validation Managers
  • Quality Control Managers
  • Production Managers
  • Teams responsible for Batch Release


LevelBasic, Intermediate

Pierre Devaux