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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.

 

Document History

  1. DANSK DSF/PREN 17141


    Cleanrooms and associated controlled environments – Biocontamination control

    • Historical Version
  2. DANSK DSF/FPREN 17141


    Cleanrooms and associated controlled environments – Biocontamination control

    • Historical Version
  3. DANSK DS/EN 17141

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    Cleanrooms and associated controlled environments – Biocontamination control

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