SIST EN 17141:2020

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.

Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle

Dieses Dokument legt die Anforderungen, Empfehlungen und Methodiken für die mikrobiologische Kontaminationskontrolle in auf Sauberkeit kontrollierten Bereichen fest. Darüber hinaus legt dieses Dokument die Anforderungen an die Erstellung und den Nachweis der mikrobiologischen Kontrolle in auf Sauberkeit kontrollierten Bereichen fest.
Dieses Dokument beschränkt sich auf lebensfähige mikrobiologische Kontamination und schließt alle Betrachtungen endotoxiner, proteinös-infektiöser und viraler Kontamination aus.
Es bestehen spezifische Leitfäden zu gemeinsamen Anwendungen, einschließlich Pharma/Biopharma, Medizinprodukte, Krankenhäuser und Lebensmittel.

Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination

Le présent document établit les exigences, les recommandations et la méthodologie relatives à la maîtrise de la contamination microbiologique en environnement propre maîtrisé. Il définit également les exigences à mettre en œuvre pour établir et démontrer la maîtrise microbiologique en environnement propre maîtrisé.
Le présent document se limite à la contamination microbiologique viable et exclut toute considération quant à la contamination par endotoxine, par prion et par virus.
Il fournit des recommandations spécifiques concernant certains domaines d‘activités courants, comme les secteurs pharmaceutiques et biopharmaceutiques, les dispositifs médicaux, les hôpitaux et l’agro alimentaire.

Čiste sobe in podobna nadzorovana okolja - Kontrola biokontaminacije

General Information

• Status: Published
• Public Enquiry End Date: 28-Nov-2018
• Publication Date: 02-Sep-2020
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 24-Aug-2020
• Due Date: 29-Oct-2020
• Completion Date: 03-Sep-2020
• Ref Project: EN 17141:2020 - Cleanrooms and associated controlled environments - Biocontamination control

Relations

• Replaces: SIST EN ISO 14698-2:2004 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2020
Nadomešča:
SIST EN ISO 14698-1:2004
SIST EN ISO 14698-2:2004
SIST EN ISO 14698-2:2004/AC:2007
Čiste sobe in podobna nadzorovana okolja - Kontrola biokontaminacije
Cleanrooms and associated controlled environments - Biocontamination control
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle
Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination
Ta slovenski standard je istoveten z: EN 17141:2020
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 17141
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2020
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments -
Biocontamination control
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche -
- Maîtrise de la biocontamination Biokontaminationskontrolle
This European Standard was approved by CEN on 4 November 2019.

CEN members are bound to comply 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 references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17141:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 5
Introduction . 6
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Establishment of microbiological control . 11
4.1 General . 11
4.2 Establishing a formal system for microbiological control . 11
4.3 Microbiological contamination control system quality attributes . 12
4.4 Identification of all potential sources and routes of microbiological contamination . 12
4.4.1 General . 12
4.4.2 Sources of microbiological contamination . 13
4.4.3 Routes of transfer of microbiological contamination . 13
4.5 Risk assessment . 14
4.6 Establishment of microbiological environmental monitoring plan . 14
4.6.1 General . 14
4.6.2 Monitoring locations . 14
4.6.3 Monitoring frequencies . 14
4.7 Establishment of alert and action limits . 15
4.8 Establishment of documentation system . 15
4.9 Personnel education and training . 15
5 Demonstration of microbiological control . 16
5.1 Trending . 16
5.2 Verification of the formal microbiological control system . 16
5.2.1 General . 16
5.2.2 Out of specification (OOS) investigation . 16
5.2.3 Records . 16
5.2.4 Sample tracking . 17
5.2.5 Integrity of results . 17
5.2.6 Data recording . 17
5.2.7 Data evaluation . 17
5.2.8 Trend analysis . 18
6 Microbiological measurement methods . 18
6.1 General . 18
6.2 Choice of sampling method. 18
6.3 Volumetric air samplers . 19
6.4 Culture media and incubation . 19
6.5 Incubators . 19
Annex A (informative) Guidance for life science pharmaceutical and biopharmaceutical
applications . 20
A.1 Introduction . 20
A.2 Risk/impact assessment . 21
A.3 Demonstrating control . 21
Annex B (informative) Guidance for life science medical device applications . 22
B.1 Introduction . 22
B.2 Risk assessment . 22
B.2.1 General . 22
B.2.2 Example 1: Sterile - terminal sterilisation is possible from a packaged product . 24
B.2.3 Example 2: Sterile – No terminal sterilisation is possible due to product properties . 25
B.2.4 Example 3: Non-sterile products . 25
B.3 Establishing Microbiological Control . 26
B.3.1 Microbiological contamination limits . 26
B.3.2 Additional microbiological control considerations . 27
B.4 Demonstrating microbiological control . 27
B.4.1 Enumeration as part of measurement methods (Clause 6) . 27
B.4.2 Methods for sampling . 27
B.4.3 Microbiological Environmental Monitoring (EM) plan . 27
B.5 Other informative annexes for Medical Device applications . 29
Annex C (informative) Guidance for healthcare/hospital applications . 30
C.1 Introduction . 30
C.2 Establishing control in a healthcare/hospital application . 30
C.3 Risk assessment for operating room hospital applications . 30
Annex D (informative) Guidance for food applications . 31
D.1 Introduction . 31
D.2 Establishment of microbiological control . 31
D.3 Microbiological cleanliness levels for monitoring . 32
D.4 Demonstration of microbiological control . 33
D.5 Example for food manufacture . 33
Annex E (informative) Guidance on culture based microbiological measurement methods
and sampler verification . 35
E.1 General . 35
E.2 Air sampling . 35
E.2.1 Volumetric air samplers. 35
E.2.2 Settle plates. 37
E.3 Surface sampling . 37
E.3.1 General . 37
E.3.2 Contact plates and strips . 37
E.3.3 Swabs and sponges . 38
E.4 Microbiological growth media . 38
E.4.1 General . 38
E.4.2
...