There are 18 current BS EN ISO cleanroom standards in the ISO 14644 series. They all have a role to play, but which ones to choose and when can be confusing.
Gordon Farquharson, Chartered Engineer, President Contamination Control Network, Chair of BSI LBI/030, Chair of CEN TC 243 and UK delegate to ISO TC209 will present a “Route Map” using the structure of the soon to be published revised BS EN ISO DIS 14644-4:2021 (Design, Construction & Start-up).
The journey starts with the selection of competent and appropriate designers, and ends with commissioning and handover. The presentation will identify where the 18 standards play a part, and also show how and where industry regulations, such as Pharma GMPs should be integrated. This is very important because the cleanroom standards are generic and not application specific.
The importance of ‘Subject Matter Expertise’ (SME) and ‘Good Engineering Practice’ (GEP) will be emphasised because the cleanroom standards specify what needs to be achieved, not precisely how to get there.
The BS EN ISO family of International Cleanroom Standards
Ensuring my standards up to date
The links to Pharma/Life Sciences industry sector Guidance & Regulations
The links to other trade and profession best practices such as commissioning of engineering systems
The ‘Route Map’ to choosing the relevant standards