Sep 20, 2021 · Approved in 2020, the cleanroom compliance standard EN 17141 is a refinement of the ISO 14698 series, combining the series into one document and bringing guidance more in line with current ideas on risk management.

Apr 21, 2021 · The new European standard EN 17141:2020 was issued on 12 August 2020 and supersedes EN ISO 14698-1:2003 and EN ISO 14698-2:2003. It is valid in Europe with the existing standard (14698) applicable elsewhere. The standard covers clean controlled environments and is relevant to cleanrooms, clean zones, controlled zones, clean areas, and …

Oct 14, 2021 · EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August of 2020, is the new European standard that replaces EN ISO 14698-1:2003 and EN ISO 14698-2:2003.

Dec 21, 2022 · How Do EN ISO 14698-1 & -2:2003 and EN 17141:2020 Differ? EN 17141 drives major changes in the focus of the standard. It places the emphasis on quality risk management through a contamination control strategy, similar to GMP Annex 1.

Jan 22, 2020 · BS EN 17141 replaces this method of validation with a d50 value that is based on a calculated fluid dynamics equation; AND an experimental method using a particle counter (Yao, 2006). The d50 is the particle size at which 50% of particles are recovered, and 50% remain in the air stream and are lost.

A new standard for cleanrooms has arrived; BS EN 17141:2020 replaces both ISO 14698-1:2003 and 14698-2:2003, and looks to establish the requirements, recommendations and methodology for microbiological contamination control in cleanrooms and how this control is demonstrated.

Feb 21, 2021 · Biocontamination control is generally concerned with microorganisms, viruses, microbial toxins, and particulates. A new standard has been produced to examine aspects of this – EN 17141. The...

Jul 21, 2021 · The new European standard EN 17141:2020 was issued on 12 August 2020 and supersedes EN ISO 14698-1:2003 and EN ISO 14698-2:2003. It is valid in Europe with the existing standard (14698) applicable elsewhere. The standard covers clean controlled environments and is relevant to cleanrooms, clean zones, controlled zones, clean areas, and …

Dec 14, 2022 · But how does EN 17141 differ from EN ISO 14698? How does it provide customized support to different industries? We’ll answer those questions (and more) in our next blog!