SIST EN ISO 13408-5:2011
(Main)Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 5: Sterilisation vor Ort (ISO 13408-5:2006)
1.1 Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an die Sterilisation vor Ort (SIP) fest, die auf die Produktkontaktflächen der Ausrüstung angewendet werden, die 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.
ANMERKUNG Die SIP kann unter Verwendung von Dampf oder anderen gasförmigen oder flüssigen Sterilisiermitteln erreicht werden. Ein spezieller Leitfaden für die Dampfsterilisation vor Ort, die das am häufigsten angewendete Verfahren ist, ist in Anhang A angeführt.
1.2 Der vorliegende Teil von ISO 13408 gilt für Verfahren, bei denen Sterilisiermittel auf die innenliegenden Oberflächen der Ausrüstung, die in Kontakt mit dem Produkt kommen können, aufgebracht werden.
1.3 Der vorliegende Teil von ISO 13408 gilt nicht für Verfahren, bei denen die Ausrüstung demontiert und in einen Sterilisator eingebracht wird.
1.4 Der vorliegende Teil von ISO 13408 ersetzt keine behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (en: Good Manufacturing Practices, GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen.
1.5 Der vorliegende Teil von ISO 13408 legt keine Anforderungen an die Entwicklung, Validierung und Routinekontrolle eines Verfahrens zur Inaktivierung der Erreger spongiformer Enzephalopathien, wie z. B. Scarpie, bovine spongiforme Enzephalopathie oder Creutzfeld Jakob Krankheit, fest. In einzelnen Ländern wurden spezielle Empfehlungen für die Verarbeitung von Materialien, die möglicherweise mit diesen Erregern kontaminiert sind, erarbeitet.
ANMERKUNG Siehe auch ISO 22442 1, ISO 22442 2 und ISO 22442 3.
Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)
L'ISO 13408-5:2006 spécifie les exigences générales relatives à la stérilisation sur place (SSP) appliquée aux surfaces de l'équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit, et ce 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 13408-5:2006 s'applique aux procédés au cours desquels des agents stérilisants sont administrés aux surfaces internes de l'équipement qui peuvent être en contact avec le produit.
Aseptična proizvodnja izdelkov za zdravstveno nego - 5. del: Sterilizacija na mestu proizvodnje (ISO 13408-5:2006)
Ta del ISO 13408 določa splošne zahteve za procese sterilizacije 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.
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 5: Sterilisation vor Ort (ISO 13408-5:2006)Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 13408-5:2011SIST EN ISO 13408-5:2011en01-oktober-2011SIST EN ISO 13408-5:2011SLOVENSKI
STANDARDSIST EN 13824:20051DGRPHãþD
SIST EN ISO 13408-5:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13408-5
June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version
Aseptic processing of health care products -Part 5: Sterilization in place (ISO 13408-5:2006)
Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 5: Sterilisation vor Ort (ISO 13408-5:2006) 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 13408-5:2011: ESIST EN ISO 13408-5:2011
EN ISO 13408-5:2011 (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 13408-5:2011
EN ISO 13408-5:2011 (E) 3 Foreword The text of ISO 13408-5:2006 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 13408-5:2011 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 13408-5:2006 has been approved by CEN as a EN ISO 13408-5:2011 without any modification. SIST EN ISO 13408-5:2011
EN ISO 13408-5:2011 (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 13408-5:2011
EN ISO 13408-5:2011 (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 13408-5:2011
EN ISO 13408-5:2011 (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 13408-5:2011
INTERNATIONALSTANDARDISO13408-5First edition2006-11-15Reference numberISO13408-5:2006(E)© ISO2006Aseptic processing of health care products—Part5:Sterilization in placeTraitement aseptique des produits de santé—Partie5: Stérilisation sur place
SIST EN ISO 13408-5:2011
ISO13408-5:2006(E)ii© ISO2006–All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shallnot be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. Indownloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariataccepts 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-creationparameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In theunlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.©ISO2006All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below orISO's member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel.+ 41 22 749 01 11Fax+ 41 22 749 09 47E-mailcopyright@iso.orgWebwww.iso.orgPublished in SwitzerlandSIST EN ISO 13408-5:2011
ISO13408-5:2006(E)© ISO2006–All rights reservediiiContents Page1Scope . 12Normative references . 13Terms and definitions . 24Quality system elements . 34.1General . 34.2Management responsibility . 34.3Design control . 34.4Measuring instruments and measuring systems . 35Process and equipment characterization . 45.1General concepts . 45.2Effectiveness of sterilization in place (SIP) . 45.3Equipment . 46Sterilizing agent characterization . 66.1Selection of sterilizing agent(s) . 66.2Quality of sterilizing agent(s) . 66.3Safety and the environment . 67SIP process . 67.1Process parameters . 67.2Cycle development . 78Validation . 78.1Validation protocol . 78.2Design qualification . 78.3Installation qualification . 78.4Operational qualification . 88.5Performance qualification . 88.6Review and approval of validation . 108.7Requalification . 109Routine monitoring and control . 109.1SIP process control . 109.2Procedures . 109.3SIP process records . 119.4Change control . 119.5Maintenance of equipment . 1110Personnel training . 11AnnexA(informative)Steam sterilization in place . 12Bibliography . 14SIST EN ISO 13408-5:2011
ISO13408-5:2006(E)iv© ISO2006–All rights reservedForewordISO (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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational 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 patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO13408-5 was prepared by Technical Committee ISO/TC198, Sterilization of health care products.ISO13408 consists of the following parts, under the general title Aseptic processing of health care products: —Part1:General requirements—Part2:Filtration—Part3:Lyophilization—Part4:Clean-in-place technologies—Part5:Sterilization in place—Part6:Isolator systemsSIST EN ISO 13408-5:2011
ISO13408-5:2006(E)© ISO2006–All rights reservedvIntroductionDuring the process of preparing ISO13408-1, several items, e.g. filtration, freeze drying and sterilization inplace, were found to be in need of supplementary information which was too voluminous to be given incorresponding annexes.This part of ISO13408 includes requirements and guidance that are to be observed during sterilization in place.The purpose of this part of ISO13408 is to achieve standardization in the field of validation and routine controlof sterilization in place processes used in the manufacture of health care products.Sterilization in place is, in most instances, preceded by cleaning in place which is described in ISO13408-4.While methods of cleaning in place and sterilization in place differ considerably in technology, the concept of insitu treatment is similar.The most important issue to consider in establishing sterilization-in-place technology is the design of thesystem(s) to ensure that they be able to successfully sterilize manufacturing equipment to the desired level ofsterility assurance.SIST EN ISO 13408-5:2011
SIST EN ISO 13408-5:2011
INTERNATIONAL STANDARDISO13408-5:2006(E)© ISO2006–All rights reserved1Aseptic processing of health care products—Part5:Sterilization in place1Scope1.1This part of ISO13408 specifies the general requirements for sterilization in place (SIP) applied to productcontact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processingand offers guidance on qualification, validation, operation and control.NOTESIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steamsterilization in place, which is the most common method used, is given in AnnexA.1.2This part of ISO13408 applies to processes where sterilizing agents are delivered to the internal surfacesof equipment that can come in contact with the product.1.3This part of ISO13408 does not apply to processes where equipment is dismantled and delivered to asterilizer.1.4This part of ISO13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regionaljurisdictions.1.5This part of ISO13408 does not specify requirements for development, validation and routine control of aprocess for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovinespongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced inparticular countries for the processing of materials potentially contaminated with these agents. NOTESee also ISO22442-1, ISO22442-2 and ISO22442-3.2Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO11138 (all parts), Sterilization of health care products — Biological indicatorsISO11140 (all parts), Sterilization of health care products — Chemical indicatorsISO13408-1, Aseptic processing of health care products— Part1: General requirementsISO13408-4, Aseptic processing of health care products— Part4: Clean-in-place technologiesISO14161, Sterilization of health care products— Biological indicators— Guidance for the selection, use andinterpretation of resultsISO14937, Sterilization of health care products— General requirements for characterization of a sterilizingagent and the development, validation and routine control of a sterilization process for medical devicesSIST EN ISO 13408-5:2011
ISO13408-5:2006(E)2© ISO2006–All rights reservedISO17665-1, Sterilization of health care products— Moist heat— Part1: Requirements for the development,validation and routine control of a sterilization process for medical devicesISO/IEC90003, Software engineering— Guidelines for the application of ISO 9001:2000 to computer software3Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO13408-1 and the following apply.3.1 dead leglocation which, by design, does not permit adequate accessibility of the sterilizing agent3.2 design qualificationverification that the proposed specification for the facility, equipment or system is suitable for the intended use[ISO/TS11139:2006, definition 2.12]3.3 material safety data sheetMSDSdocument specifying the properties of a substance, its potential hazardous effects for humans and theenvironment, and the precautions necessary to handle and dispose of the substance safely[ISO/TS11139:2006, definition 2.23]3.4 process parameterspecified value for a process variableNOTEThe specification for a sterilization process includes the process parameters and their tolerances.[ISO/TS11139:2006, definition 2.34]3.5 process variablecondition within a sterilization process, changes in which alter microbicidal effectivenessEXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.[ISO/TS11139:2006, definition 2.35]3.6 sterilization in placeSIPmethod of sterilization of the internal surfaces of parts of the equipment or an entire process system in situ,without disassembly, using appropriate sterilizing agentsNOTEThe term “Steam in place” is used in ISO13408-1, Clause19, and this term is sometimes abbreviated as SIP.However, in this part of ISO13408, “SIP” is used with a wider meaning and includes not only steam in place, but all kinds ofsterilization used for the sterilization “in place” or “in situ”. In this part of ISO13408, “Steam sterilization in place” is referredto as “Steam SIP”.SIST EN ISO 13408-5:2011
ISO13408-5:2006(E)© ISO2006–All rights reserved33.7 sterility assurance levelSALprobability of a single viable microorganism occurring on an item after sterilizationNOTE1The term SAL takes a quantitative value, generally or . When applying this quantitative value toassurance of sterility, an SAL of
provides a greater assurance of sterility than an SAL of .[ISO/TS11139:2006, definition 2.46]NOTE2For the purposes of this part of ISO13408, the product is considered to be product contact surfaces subject to SIP.3.8 sterilization processseries of actions or operations needed to achieve the specified requirements for sterility[ISO/TS11139:2006, definition 2.49]3.9 sterilizing agentphysical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve sterilityunder defined conditions[ISO/TS11139:2006, definition 2.50]4Quality system elements4.1General4.1.1The requirements of ISO13408-1 shall apply.4.1.2Documented procedures for each phase of the development, validation, routine monitoring and control ofthe SIP process shall be prepared and implemented.4.1.3Documents required by this part of ISO13408 shall be reviewed and approved by designated personnel.4.1.4Records of development, validation, routine control and monitoring shall be maintained to provideevidence of conformity to the requirements of this part of ISO13408.4.2Management responsibility4.2.1The responsibilities and authority for implementing and performing the procedures described in this partof ISO13408 shall be specified.4.2.2If the requirements of this part of ISO13408 are undertaken by organizations with separate qualitymanagement systems, the responsibilities and authority of each party shall be specified.4.3Design controlCharacterization of the sterilizing agent, sterilization process, equipment to deliver SIP and equipment to besubject to SIP shall be undertaken in accordance with a documented plan. At defined stages, design reviewsshall be planned, conducted and documented.4.4Measuring instruments and measuring systems4.4.1A documented system shall be specified for the calibration of all measuring instruments or measuringsystems.10−610−310−610−3SIST EN ISO 13408-5:2011
ISO13408-5:2006(E)4© ISO2006–All rights reserved4.4.2The accuracy and tolerance of the measuring instrument shall be adequate to the process to bemeasured.5Process and equipment characterization5.1General concepts5.1.1Specifications for the SIP process shall include, but not be limited to:a)compatibility of the equipment with the sterilizing agent(s) and processing conditions;b)pre-requisite cleaning procedure, where necessary;c)introduction, homogeneity, distribution and contact time with the sterilizing agent;d)physical and/or chemical characteristics of sterilizing agent(s);e)demonstration of the efficacy of the process;f)sterilizing agent residuals or degradation products;g)drying of product contact surfaces, where necessary;h)maintenance of sterility after the completion of the process;i)acceptable tolerances for any potential residues from the process in the product to be made in theequipment;j)physical integrity testing and establishing limits.5.1.2Process parameters and their tolerances shall be specified, documented and reviewed.5.1.3During production processes, the sterilizing conditions achieved shall be monitored, maintained withinspecified tolerances, and documented throughout the duration of the sterilization process.5.1.4Although the entire processing system can be sterilized as a single entity in SIP, it can be advantageousto divide the system into several parts in order to simplify the sterilization procedures. When a large system issterilized by dividing it into several segments, the segments should overlap to ensure that all portions of thesystem are adequately and effectively sterilized.5.1.5Complex sequences of opening and shutting of valves in the pipes of a system could be required. Wherethis is controlled manually, detailed documentation of individual steps is required. Where automation is used,electronic automation systems should be carefully designed and validated.5.2Effectiveness of sterilization in place (SIP)The sterility assurance level of the process shall be established and documented. Justification of the processparameters shall be included in the documentation.5.3Equipment5.3.1Equipment to be subjected to SIP5.3.1.1The equipment shall be designed and manufactured to facilitate SIP and to ensure that the sterilizingagent(s) can enter all internal product contact parts of the equipment to be sterilized (such as filter housings,pipe branches, and valves).Design considerations shall include, but not be limited to:a)smoothness of inner surface of equipment;b)accessibility of the sterilizing agent to all relevant surfaces;SIST EN ISO 13408-5:2011
ISO13408-5:2006(E)© ISO2006–All rights reserved5c)correct placement of ports to admit the sterilizing agent(s) and, where applicable, to allow bleeding tofacilitate sterilizing agent distribution;d)absence of dead legs in piping systems;e)drainability of the system (e.g. slope of piping to ensure the complete removal of remaining liquid in thesystem);f)correct placement of ports to permit inclusion of process monitoring devices;g)where applicable, exhaust port for safe removal of gaseous sterilizing agent;h)where applicable, resistance of the equipment to pressure, vacuum and heat;i)compatibility of materials of construction (e.g. pipes, tanks, valves, nozzles, filters, gaskets, sensors) withthe sterilizing agent, over the anticipated number of sterilization cycles;j)provisions for maintenance of sterility during and after completion of SIP (e.g. by elevated pressure).Materials made of resin, such as gaskets, require particular attention.Inner corners or shoulders of the tank and/or vessel of the system should be designed so that they do not entrapair and thereby cause incomplete sterilization in the resulting air pocket.Valves, connection
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