SIST EN ISO 13408-6:2011
(Main)Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005)
Der vorliegende Teil von ISO 13408 legt die Anforderungen an Isolatorensysteme fest, die bei der aseptischen Herstellung eingesetzt werden, und stellt einen Leitfaden zur Qualifizierung, Biodekontamination, Validierung, zum Betrieb und zur Kontrolle von Isolatorensystemen, die bei der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge eingesetzt werden, zur Verfügung.
Der vorliegende Teil von ISO 13408 ist auf die Anwendung von Isolatorensystemen zur Aufrechterhaltung aseptischer Bedingungen ausgerichtet; das kann die Anwendung gefährlicher Stoffe einschließen.
Der vorliegende Teil von ISO 13408 ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (en: Good Manufacturing Practices, GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen.
Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)
L'ISO 13408-6:2005 spécifie les exigences en matière de systèmes isolateurs utilisés pour le traitement aseptique et indique les lignes directrices relatives à la qualification, la biodécontamination, la validation, le fonctionnement et le contrôle des systèmes isolateurs utilisés pour le traitement aseptique des produits de santé.
L'ISO 13408-6:2005 se concentre sur l'utilisation des systèmes isolateurs afin de maintenir les conditions aseptiques. Cela peut inclure les applications pour les matières dangereuses.
L'ISO 13408-6:2005 n'a pas pour vocation de remplacer ou d'annuler 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 - 6. del: Sistemi izolatorjev (ISO 13408-6:2005)
Ta del ISO 13408 določa zahteve za sisteme izolatorjev, uporabljene za aseptično proizvodnjo, in ponuja smernice za kvalifikacijo, biodekontaminacijo, validacijo, delovanje in nadzor sistemov izolatorjev, uporabljenih za aseptično proizvodnjo izdelkov za zdravstveno nego. Ta del ISO 13408 je osredotočen na uporabo sistemov izolatorjev za vzdrževanje aseptičnih pogojev; to lahko vključuje uporabo nevarnih materialov. 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
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005)Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 13408-6:2011SIST EN ISO 13408-6:2011en01-oktober-2011SIST EN ISO 13408-6:2011SLOVENSKI
STANDARDSIST EN 13824:20051DGRPHãþD
SIST EN ISO 13408-6:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13408-6
June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005) 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 worldwide for CEN national Members. Ref. No. EN ISO 13408-6:2011: ESIST EN ISO 13408-6:2011
EN ISO 13408-6:2011 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices .5Annex ZC (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6 SIST EN ISO 13408-6:2011
EN ISO 13408-6:2011 (E) 3 Foreword The text of ISO 13408-6:2005 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 EN ISO 13408-6:2011 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat 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 13408-6:2005 has been approved by CEN as a EN ISO 13408-6:2011 without any modification. SIST EN ISO 13408-6:2011
EN ISO 13408-6:2011 (E) 4 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 Directive 90/385/EEC Qualifying remarks/Notes 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. SIST EN ISO 13408-6:2011
EN ISO 13408-6:2011 (E) 5 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 Directive 93/42/EEC Qualifying remarks/Notes 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. SIST EN ISO 13408-6:2011
EN ISO 13408-6:2011 (E) 6 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 Directive 98/79/EC Qualifying remarks/Notes 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.
SIST EN ISO 13408-6:2011
Reference numberISO 13408-6:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO13408-6First edition2005-06-15Aseptic processing of health care products — Part 6: Isolator systems Traitement aseptique des produits de santé — Partie 6: Systèmes isolateurs
SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) © ISO 2005 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Quality system elements.3 4.1 General.3 4.2 Management responsibility.3 4.3 Design control.3 4.4 Measuring instruments and measuring systems.3 5 Design of isolator systems.4 5.1 General.4 5.2 Types of isolators.4 5.3 Materials of construction.4 5.4 Air-handling system.4 5.5 Operator interface.5 5.6 Ancillary equipment.6 6 Facility requirements.6 6.1 Surrounding room classification.6 6.2 Process utilities.7 7 User requirements.7 7.1 Product/process application.7 7.2 Ergonomics.7 7.3 Cleaning.7 7.4 Bio-decontamination.8 8 Validation.10 8.1 General.10 8.2 Design qualification.11 8.3 Installation qualification.11 8.4 Operational qualification.12 8.5 Performance qualification.13 8.6 Review and approval of validation.14 8.7 Requalification.14 9 Routine monitoring and control.14 9.1 Procedures.14 9.2 System integrity.14 9.3 Bio-decontamination process monitoring.15 9.4 Environmental monitoring.15 9.5 Change control.15 9.6 Maintenance and calibration.15 10 Personnel training.15 Bibliography.17
SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) iv © ISO 2005 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13408-6 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) © ISO 2005 – All rights reserved vIntroduction Health care products that are labelled “sterile” are prepared by using appropriate and validated methods. When a health care product is intended to be sterile and cannot be terminally sterilized, aseptic processing provides an alternative. This applies to the aseptic preparation and filling of solutions, suspensions, emulsions, and solids, as well as to the aseptic handling, transfer and filling of those products which cannot be terminally sterilized. Aseptic processing is an exacting and demanding discipline. It is essential that manufacturers make use of qualified/validated systems, adequately trained personnel, controlled environments and well-documented systematic processes to assure a sterile finished product.
SIST EN ISO 13408-6:2011
SIST EN ISO 13408-6:2011
INTERNATIONAL STANDARD ISO 13408-6:2005(E) © ISO 2005 – All rights reserved 1Aseptic processing of health care products — Part 6: Isolator systems 1 Scope This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13408-1:1998, Aseptic processing of health care products — Part 1: General requirements ISO 13408-4:—1), Aseptic processing of health care products — Part 4: Clean-in-place technologies ISO 13408-5:—1), Aseptic processing of health care products — Part 5: Sterilization in place ISO 14644-7:2004, Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) ISO/IEC 90003, Software engineering
Guidelines for the application of ISO 9001:2000 to computer software 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13408-1:1998 and the following apply. 3.1 bio-decontamination removal of microbiological contamination or its reduction to an acceptable level
1) To be published. SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) 2 © ISO 2005 – All rights reserved 3.2 design qualification documented verification that the proposed design of the facilities, equipment or system is suitable for the intended use 3.3 isolator sealed enclosure capable of preventing ingress of contaminants by means of total physical interior/exterior separation, and capable of being subject to reproducible interior bio-decontamination NOTE 1 An isolator can range in size from a small box to a large room. NOTE 2 Physical separation can be achieved by an absolute solid wall completely surrounding the entire interior, where any discontinuities in such wall are equipped to physically prevent ingress of contaminants. Examples of such physical protection include pass-through air locks for sterile or bio-decontaminated goods, (HEPA)-filtered (high efficiency particulate air-filter) or sterilized inflow air, and high flow rate of outflow air through a minimal-sized orifice. Operators always remain totally separated from the interior of an isolator by means of an absolute physical barrier. 3.4 isolator system isolator with transfer system(s) and ancillary equipment used for aseptic processing 3.5 leak test physical test to identify a quantifiable leakage rate under repeatable test conditions 3.6 material safety data sheet document specifying the properties of a material, its potential hazardous effects for humans and the environment, and the precautions necessary to handle and dispose of the material safely 3.7 risk assessment overall process comprising a risk analysis and a risk evaluation [ISO 14971:2000, 2.15] 3.8 separative device equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume
NOTE Some industry-specific examples of separative devices are clean air hoods, containment enclosures, glove boxes, isolators and mini-environments [ISO 14644-7:2004, 3.17] EXAMPLES For the aseptic processing industry: mouse-hole and cooling zone. 3.9 surrounding environment specific, characterized and controlled area in which an isolator system has been qualified and is operated 3.10 transfer device mechanism to effect movement of material into or out of separative devices while minimizing ingress or egress of unwanted matter [ISO 14644-7:2004, 3.18] EXAMPLES Transfer isolator, transfer container, and transfer system. SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) © ISO 2005 – All rights reserved 33.11 transfer port interface between the interiors of an isolator and a transfer device that can be attached to and detached from this equipment without any ingress or egress of unwanted matter 3.12 transfer system system allowing ingress and/or egress of material to an isolator without compromising the environmental quality of the critical processing zone EXAMPLES Autoclave, oven, depyrogenation tunnel, freeze dryer. 3.13 worst-case conditions set of conditions which represent the highest challenge to product integrity and safety which will be accepted during validation and routine production 4 Quality system elements 4.1 General 4.1.1 The requirements of ISO 13408-1:1998 shall apply. 4.1.2 Documented procedures for each phase of the development, validation, routine monitoring and control of isolator systems shall be prepared and implemented. 4.1.3 Documents required by this part of ISO 13408 shall be reviewed and approved by designated personnel. 4.1.4 Records of development, validation, routine control and monitoring shall be maintained to provide evidence of conformity to the requirements of this part of ISO 13408. 4.2 Management responsibility 4.2.1 The responsibilities and authority for implementing and performing the procedures described in this part of ISO 13408 shall be specified. 4.2.2 If the requirements of this part of ISO 13408 are undertaken by organizations with separate quality management systems, the responsibilities and authority of each party shall be specified. 4.3 Design control The design of isolator systems shall be undertaken in accordance with a documented plan. At defined stages design reviews shall be planned, conducted and documented. 4.4 Measuring instruments and measuring systems 4.4.1 A documented system shall be specified for the calibration of all measuring instruments or measuring systems. 4.4.2 Procedures for control of all measuring instruments or measuring systems designated as non-conforming and for corrective action shall be specified. 4.4.3 The accuracy and tolerance of the measuring instrument shall be justified for the process to be measured. SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) 4 © ISO 2005 – All rights reserved 5 Design of isolator systems 5.1 General 5.1.1 For the design of isolator systems, ISO 14644-7 shall apply. For design principles of containment enclosures, see ISO 10648-1. 5.1.2 The design of isolator systems shall be justified and documented to establish important operational parameters or key specifications. This shall include a risk assessment to identify critical steps. NOTE 1 Equipment and material transfer is one of the greatest challenges to the isolator processes. NOTE 2 In applications which require both aseptic conditions and protection of the operator, such as the manufacture of bio-hazard, cytotoxic or radioactive products, the design of the isolator system will address pressure (negative or positive) and location and integrity of the isolator system. The design, based on risk assessment, typically considers safety-specific requirements for location and surrounding environment. 5.2 Types of isolators 5.2.1 Closed Closed isolators are operated to exclude exterior contamination from air or other sources. Air from the room shall first pass through a filter, usually a HEPA, before entering the isolator. All materials used in the isolator shall be decontaminated or sterilized. The operator is located exterior to the isolator and works indirectly with material located on the interior of the isolator. Closed isolators shall remain closed during the ingress/egress of materials during operation. 5.2.2 Open Open isolators are similar to closed isolators, except that they shall allow for the continuous or semi-continuous ingress/egress of materials during operation. Design considerations shall include protective measures for the integrity of the isolator’s interior environment. Openings shall be protected by unidirectional air flow and/or air over-pressure. 5.3 Materials of construction 5.3.1 Materials used in the construction, including gasket materials, fans, ventilation systems, piping, viewing windows, and associated fittings shall be chemically and mechanically compatible with the intended processes, process materials, and application. The materials shall be compatible with the cleaning and bio-decontaminating agents and be cleanable. Construction materials shall be considered for protection against corrosion, degradation, and heat/fire resistance, where appropriate. Where appropriate, materials used shall be checked for thermal characteristics, sorption and out-gassing properties. Viewing window (panel) materials shall remain transparent and resistant to degradation and shall allow for proper interior lighting. 5.3.2 Flexible walls should be thick enough to resist puncture and flexible enough to allow the operator to work safely and efficiently. 5.4 Air-handling system 5.4.1 Air change rate The rate of air change shall be appropriate for the specific application. The rate shall be sufficient to ventilate the isolator to avoid the build-up of particulates, contaminants and heat. NOTE An increased rate of air changes is typically used to aid in the removal of the bio-decontaminating agent in a timely manner. SIST EN ISO 13408-6:2011
ISO 13408-6:2005(E) © ISO 2005 – All rights reserved 55.4.2 Air flow pattern The air flow
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