SN EN 17141:2021
Cleanrooms and associated controlled environments - Biocontamination control
This document 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. This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination. There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.
- Originator
- INB
- Published
- 2021-01-01
- ICS
- 13.040.35
SN EN 17141:2021
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle
Cleanrooms and associated controlled environments - Biocontamination control
This document 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. This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination. There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.
Content pages for this standard
guide
Overview of SN EN 17141:2021 - Cleanrooms and Biocontamination Control
Explore SN EN 17141:2021, a standard for microbiological contamination control in cleanrooms and associated environments.
Understanding SN EN 17141:2021 Compliance Requirements
Explore SN EN 17141:2021 compliance requirements for biocontamination control in cleanrooms and related environments.