Cleanroomsandassociatedcontrolled environments-Biocontaminationcontrol
bsi.
Nationalforeword
supersedes BS EN ISO 14698-1:2003 and BS EN ISO 14698-2:2003 which This British Standard is the UK implementation of EN 17141:2020. Itare withdrawn.
Committee LBi/30 Cleanroom technology. The UK participation in its preparation was entrusted to Technical
A list of organizations represented on this mittee can be obtained onrequest to its mittee manager.
This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.
The British Standards Institution 2020Published by BSI Standards Limited 2020
ISBN 978 0 580 91483 6
ICS 13.040.35
Compliance with a British Standard cannot confer immunity from legal obligations.
This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2020.
Amendments/corrigenda issued since publication
Date Text affected
EN17141
English Version
Cleanroomsandassociatedcontrolledenvironments- Biocontaminationcontrol
Salles propres et environnements maitrises apparentes - Maitrise de la biocontamination
Reinraume und zugehorige Reinraumbereiche - Biokontaminationskontrolle
This European Standard was approved by CEN on 4 November 2019.
CEN members are bound to ply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical referencesmember. concerning such nationa standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
q pe ene ao ue u uosa y (ua a ) ssaa eo a u sisxa peps uadng stranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre has the same status as the official versions.
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Contents
Page
European foreword. 5Introduction... ..6.1 Scope. ..82 Normative references..... ...83 Terms and definitions.4 Establishment of microbiological control. 114.2 4.1 General.. Establishing a formal system for microbiological control. 11 114.3 Microbiological contamination control system quality attributes 124.4 4.4.1 Identification of all potential sources and routes of microbiological contamination. Genera... 12 124.4.2 Sourcesof microbiological contamination... 134.5 4.4.3 Routes of transfer of microbiological contamination.. Risk assessment. 14 134.6 Establishment of microbiological environmental monitoring plan. 144.6.1 4.6.2 Monitoring locations. General. 14 144.6.3 Monitoring frequencies. 144.7 4.8 Establishment of documentation system.. Establishment of alert and action limits. 15 154.9 Personnel education and training 155 5.1 Trending Demonstration of microbiological control 16 165.2 Verification of the formal microbiological control system. 165.2.1 5.2.2 Out of specification (oos) investigation... General. 16 165.2.3 Records.. 165.2.4 5.2.5 Sample tracking.. Integrity of result.. 17 175.2.6 Data recording- Data evaluation. 175.2.7 5.2.8 Trend analysis. 17 18Microbiological measurement methods. 186.1 6.2 Choice of sampling method. General. 18 186.3 Volumetric air samplers. 196.4 6.5 Culture media and incubation... Incubators... 19 19Annex A (informative) Guidance for life science pharmaceutical and biopharmaceuticalapplications. 20A.2 A.1 Introduction. Risk/impact assessment.. 20 21A.3 Demonstrating control..... 21Annex B (informative) Guidance for life science medical device applications. 22
B.2 B.1 Introduction. Risk assessment 22 22B.2.1 Example 1: Sterile -terminal sterilisation is possible from a packaged product General. 22B.2.2 B.2.3 Example 2: Sterile No terminal sterilisation is possible due to product properties. ..25 .24B.2.4 Example 3: Non-sterile products.... 25B.3.1 B.3 Establishing Microbiological Control. Microbiological contamination limits ..26 ..26B.4 B.3.2 Additional microbiological control considerations. Demonstrating microbiological control. ..27B.4.1 Enumeration as part of measurement methods (Clause 6). ..27 ..27B.4.2 B.4.3 Microbiological Environmental Monitoring(EM)plan. Methods for sampling...... ...27 .27B.5 Other informative annexes for Medical Device applications.. ...29Annex C (informative) Guidance for healthcare/hospital applications. ..30C.1 C.2 Establishing control in a healthcare/hospital application. Introduction. ...30 .30C.3 Risk assessment for operating room hospital applications.. ...30Annex D (informative) Guidance for food applications D.1 31D.2 Introduction. Establishment of microbiological control ...31 31D.3 D.4 Microbiological cleanliness levels for monitoring Demonstration of microbiological control. 32 33D.5 Example for food manufacture. ...33Annex E (informative) Guidance on culture based microbiological measurement methodsE.1 and sampler verification. General ...35 35E.2 Air sampling. 35E.2.2 E.2.1 Volumetric air samplers.. Settle plates. ..35 37E.3 Surface sampling. ...7E.3.1 E.3.2 Contact plates and strips.. General ..37 37E.3.3 E.4 Swabs and sponges.... Microbiological growth media. ...38 ...38E.4.1 General.. .38E.4.2 E.4.3 Media dehydration.. ...38 .39E.4.4 Media disinfectant inhibition... ..39E.4.5 E.5 Plate incubation. Validation of air samplers.... ...39 39E.5.1 General 39E.5.2 E.5.3 Physical collection efficiency. Biological collection efficiency. ..39 ..40E.6 Experimental method. 40E.6.1 E.6.2 Simplified laboratory method.. Aerosol chamber method ..40 ..42E.6.3 Incubation. 43E.6.4 E.6.5A Collection efficiency calculations from testing results. Air sampler revalidation... 43 44
