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