Wednesday, 1 November 2017

Biocontamination control for cleanrooms - prEN 17141:2017



A new European cleanroom standard is in the early stages development: “Cleanrooms and associated controlled environments - Biocontamination control” prEN 17141:2017.

The scope is: “This European Standard establishes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments. These principles are based on establishing control and then on demonstrating control. This standard specifies the methods required for assessing risk monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. It will also give guidance on the assessment and verification of microbiological sampling devices, with the aim of helping users standardize their monitoring so that results from one facility to another can be compared. Within this standard, only microbiological hazards are addressed. There is specific guidance given on common applications, including Food, Hospitals and Life Sciences (Pharma/Biopharma and Medical Devices).”

The standard is being considered by the German national committee NA 041-02-21 AA - Cleanroom technology (mirror committees are CEN/TC 243 and ISO/TC 209).

Posted by Dr. Tim Sandle