BS EN 17141:2020 Cleanrooms and associated controlled environments. Biocontamination control

BS EN 17141:2020

Cleanrooms and associated controlled environments. Biocontamination control

Status : Current   Published : August 2020



What is BS EN 17141:2020 about?

This new European standard establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.

Who is BS EN 17141:2020 for?

Individuals associated with microbiological contamination control from:

  • Engineering and technical support
  • Production
  • Quality assurance and control
  • Regulatory authority compliance functions

Industries using clean controlled environments include:

  • Pharmaceutical
  • Biopharmaceutical
  • Medical devices and other life science industries
  • Healthcare and hospitals
  • Food

Why should you use BS EN 17141:2020?

Replacing BS EN ISO 14698-1:2003 and BS EN ISO 14698-2:2003, this new standard provides updated guidance and further information on best practice for establishing and demonstrating control of airborne and surface microbiological contamination in clean controlled environments.

The standard will help:

-        Increase the effectiveness of risk management associated with microbiological contamination

-        Improve efficiency

-        Develop the risk management expertise of individuals who engage with its principles

-        Where applicable, provide alignment with the regulatory authority’s expectations for continued compliance and process approvals

BS EN 17141:2020 describes requirements for microbiological contamination control, giving information on the qualification and verification of clean controlled environments. It includes considerations for medical devices and food applications.

Informative annexes give tables of cleanliness levels for monitoring of microbiological contamination in specific types of clean controlled environments and offer additional guidance on the choice of environmental monitoring sampling methods; the management and trending of collected data; and the role of alternative and real-time microbiological detection systems.

The standard retains and updates information relating to microbiological air sampler verification requirements that is included, and widely referenced, in BS EN ISO 14698–1:2003.  

BS EN 17141:2020 will provide users with the methodology and understanding to derive an effective formal system of microbiological control that identifies, controls and monitors microbiological contamination on an ongoing basis.

For regulated industries, the standard provides guidance which is consistent with the expectations of the regulatory authorities.

Standard NumberBS EN 17141:2020
TitleCleanrooms and associated controlled environments. Biocontamination control
Publication Date12 August 2020
Normative References(Required to achieve compliance to this standard)ISO 14644-1:2015, EN ISO 14644-1:2015
Informative References(Provided for Information)ISO 11290-2, 2004/23/EC, PDA TR 33:2013, ISO 13408-7, EN ISO 11290-2, EN ISO 13408-7, ISO 6579-1, IS0 13485, EN ISO 13485, EN ISO 11290-1, EN ISO 6579-1, ISO 11290-1, ISO 14971, ISO 15161, EN ISO 14644-3:2005, ISO 15214:1998 (R04), IEC 60812:2018, EN ISO 14644-5:2004, EN ISO 14644-4:2001, EN ISO 14644-1:2015, ISO 14644-2:2015, IEC 61025:2006, EN ISO 11139:2018, ISO 11139:2018, EN 61025:2007, EN ISO 18593:2018, ISO 14644-1:2015, EN ISO 14644-2:2015, EN ISO 14644-7:2004, IEC 31010:2019, ISO 18593:2018, ISO 17665-1:2006, ISO 14644-7:2004, ISO 14644-4:2001, EN ISO 17665-1:2006, ISO 14644-3:2005, ISO 14644-5:2004
ReplacesBS EN ISO 14698-1:2003, BS EN ISO 14698-2:2003
International RelationshipsEN 17141:2020
Draft Superseded By17/30329441 DC18/30383200 DC
DescriptorsContamination, Sterile areas, Microbiological analysis, Risk analysis, Biocontamination
Title in FrenchSalles propres et environnements maîtrisés apparentés. Maîtrise de la biocontamination
Title in GermanReinräume und zugehörige Reinraumbereiche. Biokontaminationskontrolle
ISBN978 0 580 91483 6
File Size1.208 MB

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