News about GMP/cGMP

18.09.2020

Now published: EN 17141:2020 Cleanrooms and associated controlled environments – biocontamination control

The new European standard EN 17141:2020 has been issued on 12 August 2020 and will replace the DIN EN ISO 14698 (Parts 1 and 2) of the year 2003, which no longer reflects the state of the art.

EN 17141 is based on a quality risk management approach and defines the modern principles and basic methodology of an operational system for the control of biocontamination in cleanrooms and all associated controlled areas. It specifies methods for a consistent assessment of the risk areas to be monitored and the application of control measures according to the existing level of risk. In addition, new ways of evaluating and verifying microbiological sampling equipment are identified. Users will be supported in standardizing their monitoring in order to compare the results from one facility with those of another.The practical annexes of the document containing checklists, flowcharts, tables on cleanliness levels and application examples, are to be highlighted.

EN 1741:2020 is addressed to everyone involved in contamination control, from engineering support to quality assurance. The standard is proposed  for inclusion in the group of ISO 14644 by the European work on biocontamination control (CEN/TC 243).


Source:

BSI

 



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