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.
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 :
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.
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