EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.
ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.
ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 4: Reinigung vor Ort (ISO 13408-4:2005)

Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an die Verfahren zur Reinigung vor
Ort (CIP-Verfahren) fest, die auf die Produktkontaktflächen der Ausrüstung angewendet werden, welche bei
der Herstellung steriler Produkte für die Gesundheitsfürsorge durch aseptische Herstellung eingesetzt wird,
und stellt einen Leitfaden zur Qualifizierung, Validierung, zum Arbeitsablauf und zur Kontrolle zur Verfügung.
Der vorliegende Teil von ISO 13408 ist anwendbar auf Verfahren, bei denen Reinigungsmittel auf die
innenliegenden Oberflächen der für das CIP-Verfahren ausgelegten Ausrüstung, die in Kontakt mit dem
Produkt kommen können, aufgebracht werden.
Der vorliegende Teil von ISO 13408 ist nicht anwendbar auf Verfahren, bei denen die Ausrüstung demontiert
und in einer Waschanlage gereinigt wird.
Der vorliegende Teil von ISO 13408 ersetzt keine behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken
(GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale
Zuständigkeiten betreffen.

Traitement aseptique des produits de santé - Partie 4: Technologies de nettoyage sur place (ISO 13408-4:2005)

L'ISO 13408-4:2005 spécifie les exigences générales relatives au nettoyage sur place (NSP) appliqué aux surfaces de l'équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit en procédant à un traitement aseptique. Elle propose également des directives relatives à la qualification, à la validation, à l'exploitation et au contrôle.
L'ISO 13408-4:2005 s'applique aux processus dans lesquels des agents nettoyants sont appliqués sur les surfaces internes de l'équipement qui peuvent être nettoyées sur place, et qui peuvent entrer en contact avec le produit.
L'ISO 13408-4:2005 ne s'applique pas aux processus dans lesquels l'équipement est démonté et nettoyé dans une laveuse.
L'ISO 13408-4:2005 ne emplace pas ni n'annule des exigences réglementaires nationales, telles que les bonnes pratiques de fabrication (BPF) et/ou les exigences officielles, qui relèvent des juridictions nationales ou régionales particulières.

Aseptična proizvodnja izdelkov za zdravstveno nego - 4. del: Tehnologija čiščenja na mestu proizvodnje (ISO 13408-4:2005)

Ta del ISO 13408 določa splošne zahteve za procese čiščenja na mestu proizvodnje, uporabljene za površine opreme, ki je v stiku s proizvodi, uporabljanimi v proizvodnji sterilnih izdelkov za zdravstveno nego z aseptično proizvodnjo, in ponuja smernice za kvalifikacijo, validacijo, delovanje in nadzor. Ta del ISO 13408 velja za procese, kjer se čistilna sredstva nanašajo na notranje površine opreme, skladne s CIP, ki lahko pride v stik s proizvodom. Ta del ISO 13408 ne velja za procese, kjer se oprema razstavi in opere v pralnem stroju. Ta del ISO 13408 ne nadomešča ali zamenjuje nacionalnih regulatornih zahtev, kot so dobre prakse proizvodnje (GMP) in/ali strnjene zahteve, ki se nanašajo na nekatere državne ali regijske pristojnosti.

General Information

• Status: Published
• Publication Date: 28-Jun-2011
• Withdrawal Date: 30-Dec-2011
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Jun-2011
• Due Date: 16-Apr-2012
• Completion Date: 29-Jun-2011
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 13408-4:2011 - Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

Relations

• Replaces: EN 13824:2004 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
1DGRPHãþD
SIST EN 13824:2005
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO7HKQRORJLMDþLãþHQMD
QDPHVWXSURL]YRGQMH,62
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO
13408-4:2005)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 4: Reinigung
vor Ort (ISO 13408-4:2005)
Traitement aseptique des produits de santé - Partie 4: Technologies de nettoyage sur
place (ISO 13408-4:2005)
Ta slovenski standard je istoveten z: EN ISO 13408-4:2011
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 13408-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 11.080.01 Supersedes EN 13824:2004
English Version
Aseptic processing of health care products - Part 4: Clean-in-
place technologies (ISO 13408-4:2005)
Traitement aseptique des produits de santé - Partie 4: Aseptische Herstellung von Produkten für die
Technologies de nettoyage sur place (ISO 13408-4:2005) Gesundheitsfürsorge - Teil 4: Reinigung vor Ort (ISO
13408-4:2005)
This European Standard was approved by CEN on 10 June 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-4:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

Foreword
The text of ISO 13408-4:2005 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as
of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13824:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 13408-4:2005 has been approved by CEN as a EN ISO 13408-4:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10 7 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
4,5,6,7,8,9,10 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC on in vitro diagnostic medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10 B.2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

INTERNATIONAL ISO
STANDARD 13408-4
First edition
2005-11-01
Aseptic processing of health care
products —
Part 4:
Clean-in-place technologies
Traitement aseptique des produits de santé —
Partie 4: Technologies de nettoyage sur place

Reference number
ISO 13408-4:2005(E)
©
ISO 2005
ISO 13408-4:2005(E)
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ISO 13408-4:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Quality system elements. 2
4.1 General. 2
4.2 Management responsibility . 2
4.3 Design control. 2
4.4 Measuring instruments and measuring systems . 2
5 Process and equipment characterization .3
5.1 General concepts. 3
5.2 Effectiveness of CIP . 3
5.3 Equipment . 4
6 Cleaning agent characterization . 5
6.1 Selection of cleaning agent(s). 5
6.2 Quality of cleaning agent(s). 5
6.3 Safety and the environment.
...