SIST EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 3: Gefriertrocknung (ISO 13408-3:2006)

Der vorliegende Teil von ISO 13408 legt die Anforderungen an Ausrüstung, Verfahren, Programme und Verfahrensweisen zur Kontrolle und Validierung der Gefriertrocknung als ein aseptisches Verfahren fest und stellt einen Leitfaden dafür zur Verfügung. Er behandelt nicht die physikalischen/chemischen Zielvorgaben eines Lyophilisierungsverfahrens.

Traitement aseptique des produits de santé - Partie 3: Lyophilisation (ISO 13408-3:2006)

L'ISO 13408-3:2006 spécifie les exigences et donne les lignes directrices relatives à l'équipement, processus, programmes et procédures de contrôle et de validation de la lyophilisation en tant que processus aseptique. Elle n'aborde pas les questions liées aux objectifs physiques/chimiques d'un processus de lyophilisation.

Aseptična proizvodnja izdelkov za zdravstveno nego - 3. del: Liofilizacija (ISO 13408-3:2006)

Ta del ISO 13408 določa zahteve in ponuja smernice za opremo, procese, programe in postopke za nadzor in validacijo liofilizacije kot aseptične proizvodnje. Ne obravnava fizikalnih/kemijskih ciljev liofilizacijskega procesa.

General Information

• Status: Published
• Public Enquiry End Date: 14-Apr-2011
• Publication Date: 15-Sep-2011
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 29-Jul-2011
• Due Date: 03-Oct-2011
• Completion Date: 16-Sep-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: EN ISO 13408-3:2011 - Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

Relations

• Replaces: SIST EN 13824:2005 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 01-Oct-2011
• Replaces: SIST EN 13824:2005 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-3:2011
01-oktober-2011
1DGRPHãþD
SIST EN 13824:2005
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO/LRILOL]DFLMD,62

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 3:
Gefriertrocknung (ISO 13408-3:2006)
Traitement aseptique des produits de santé - Partie 3: Lyophilisation (ISO 13408-3:2006)
Ta slovenski standard je istoveten z: EN ISO 13408-3:2011
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-3:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-3:2011

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SIST EN ISO 13408-3:2011


EUROPEAN STANDARD
EN ISO 13408-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2011
ICS 11.080.01 Supersedes EN 13824:2004
English Version
Aseptic processing of health care products - Part 3:
Lyophilization (ISO 13408-3:2006)
Traitement aseptique des produits de santé - Partie 3: Aseptische Herstellung von Produkten für die
Lyophilisation (ISO 13408-3:2006) Gesundheitsfürsorge - Teil 3: Gefriertrocknung (ISO 13408-
3:2006)
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 Ref. No. EN ISO 13408-3:2011: E
worldwide for CEN national Members.

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SIST EN ISO 13408-3:2011
EN ISO 13408-3:2011 (E)
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

2

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SIST EN ISO 13408-3:2011
EN ISO 13408-3:2011 (E)
Foreword
The text of ISO 13408-3:2006 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 13408-3:2011 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 13408-3:2006 has been approved by CEN as a EN ISO 13408-3:2011 without any
modification.
3

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SIST EN ISO 13408-3:2011
EN ISO 13408-3:2011 (E)
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 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.
4

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SIST EN ISO 13408-3:2011
EN ISO 13408-3:2011 (E)
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 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 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.
5

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SIST EN ISO 13408-3:2011
EN ISO 13408-3:2011 (E)
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 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 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.


6

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SIST EN ISO 13408-3:2011


INTERNATIONAL ISO
STANDARD 13408-3
First edition
2006-09-15

Aseptic processing of health care
products —
Part 3:
Lyophilization
Traitement aseptique des produits de santé —
Partie 3: Lyophilisation




Reference number
ISO 13408-3:2006(E)
©
ISO 2006

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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
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©  ISO 2006
All 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 or
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ii © ISO 2006 – All rights reserved

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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Quality system elements. 1
4.1 General. 1
4.2 Management responsibility . 2
4.3 Design control. 2
4.4 Measuring instruments and/or measuring systems . 2
5 Product definition . 2
6 Process definitions. 2
7 User requirements . 3
7.1 General. 3
7.2 Equipment characterization. 3
7.3 Product handling . 4
7.4 Microbiological and particulate environmental monitoring . 4
7.5 Cleaning and sterilization . 4
7.6 Vent filter system. 5
7.7 Lyophilizer leak test. 5
8 Validation. 5
8.1 General. 5
8.2 Design qualification. 6
8.3 Installation qualification. 6
8.4 Operational qualification. 6
8.5 Performance qualification. 8
8.6 Process validation . 8
8.7 Review and approval of validation. 9
9 Routine monitoring and control . 9
9.1 General. 9
9.2 Operator training. 9
9.3 Standard operating procedures . 9
9.4 Requalification . 10
9.5 Maintenance of equipment . 10
9.6 Change control. 10
Bibliography . 11

© ISO 2006 – All rights reserved iii

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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
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 13408-3 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
iv © ISO 2006 – All rights reserved

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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
Introduction
This part of ISO 13408 deals with lyophilization, which is a physical-chemical drying process designed to
remove solvents from both aqueous and non-aqueous systems, primarily to achieve product or material
stability. Lyophilization is synonymous to the term freeze-drying. Lyophilization involves freezing an aqueous
system and removing the solvent, first by sublimation (primary drying) and then by desorption (secondary
drying), to a level that no longer supports chemical reactions or biological growth. The result is a stable, well-
formed product meant to rapidly disperse or solubilize while retaining biological or other activity. Because it is
often the final step in an aseptic process with direct impact on the safety, quality, identity, potency and purity
of a product, lyophilization is a critical processing step.
Where the finished lyophilized product is intended to be sterile, the product to be dried is an aqueous system
that has already been sterilized. Therefore, all activities that can affect the sterility of the product or material
need to be regarded as extensions of the aseptic processing of that sterilized product or material. In general,
the predominant challenge in ensuring product or material sterility during lyophilization is to prevent
microbiological and particulate contamination between the filling operation and completion of the lyophilization
process. Of special, equipment-related concern is the protection of the product or material from
microbiological contamination within the chamber.
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SIST EN ISO 13408-3:2011

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SIST EN ISO 13408-3:2011
INTERNATIONAL STANDARD ISO 13408-3:2006(E)

Aseptic processing of health care products —
Part 3:
Lyophilization
1 Scope
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes,
programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not
address the physical/chemical objectives of a lyophilization process.
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 9001, Quality management systems — Requirements
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
ISO 13408-4, Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 13408-5, Aseptic processing of health care products — Part 5: Sterilization in place
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13408-1 and the following apply.
3.1
lyophilization
physical-chemical drying process designed to remove solvents from both aqueous and non-aqueous systems,
by sublimation and desorption
3.2
leak test
physical test for the capability to provide a quantifiable leakage rate under repeatable test conditions
4 Quality system elements
4.1 General
4.1.1 The requirements of ISO 13408-1 shall apply.
4.1.2 Documented procedures for each phase of the development, validation, routine monitoring, control
and maintenance of the lyophilizer shall be prepared and implemented.
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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
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 responsibility 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 the lyophilizer shall be undertaken in accordance with a documented plan. At defined stages,
design reviews shall be planned, conducted and documented. Software used to control and/or to monitor shall
be prepared in accordance with a quality system that provides documented evidence that the software meets
its design specification.
4.4 Measuring instruments and/or measuring systems
4.4.1 A documented system shall be specified for the calibration of all measuring instruments and/or
measuring systems.
4.4.2 Procedures shall be specified for control of all measuring instruments and/or measuring systems
designated as non-conforming, and for corrective action.
5 Product definition
5.1 The product to be lyophilized shall be defined and documented. The specification of the product shall
include but not be limited to:
a) its chemical, physical and pharmaceutical properties as appropriate;
b) container and closure configuration.
5.2 Following application of the specified lyophilization process it shall be demonstrated that the product
meets its specified requirements for safety, quality and performance.
6 Process definitions
6.1 A specification for the lyophilization process shall be documented.
6.2 The lyophilization process applicable for a defined product shall be established. Process development
shall be performed to determine critical process parameters.
6.3 The process parameters, together with their tolerances, shall be established and documented. These
shall include, but not be limited to:
a) the range of temperatures and pressures;
b) the rates of freezing;
c) the time at a given temperature and pressure.
2 © ISO 2006 – All rights reserved

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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
6.4 During all processes the conditions achieved shall be monitored, maintained within specified tolerances,
and recorded.
6.5 Where conditioning of the product is required prior to the lyophilization process it shall be defined and
documented as part of the lyophilization process.
6.6 The following stages of the lyophilization process shall be evaluated to determine the relevance of
maximum hold or wait times:
a) between the start of filling and the start of the lyophilization cycle;
b) between the end of the lyophilization cycle and the start of unloading (where stoppers are not seated into
the product containers within the equipment prior to the opening of the lyophilizer chamber);
c) between sterilization of the lyophilizer and the start of the lyophilization cycle;
d) between sterilization and use of utensils (such as trays, bags, placing devices, tweezers etc).
6.7 Specifications for the Cleaning-in-Place (CIP) and Sterilization in Place (SIP) processes shall be
documented. ISO 13408-4 and ISO 13408-5 shall apply.
7 User requirements
7.1 General
7.1.1 Documentation shall define clearly and precisely the equipment functionality and performance
required but without regard as to how that functionality shall be designed or implemented. It shall be reviewed
and approved by the user.
7.1.2 The product/process application shall be developed before designing the lyophilizer. The process
conditions/parameters, together with their tolerances, shall be defined so that the use of the lyophilizer and the
ancillary equipment will produce a reliable and safe product.
7.2 Equipment characterization
7.2.1 Design specifications for equipment to deliver the required processes within defined tolerances shall
be established and documented.
7.2.2 The equipment shall be designed, built and located so as to facilitate aseptic processing, cleaning,
sterilization and lyophilization. For CIP and SIP, ISO 13408-4 and ISO 13408-5 shall apply.
7.2.3 The design shall address such issues as the internal surfaces and the surrounding environment from
the prior processing step through to loading and unloading, with special attention to the position of equipment,
personnel and critical processing zones.
7.2.4 The design of the lyophilizer shall permit effective cleaning and sterilization of chamber and
condenser.
7.2.5 Blocks, cassettes, frames, shelves, trays etc. required for the lyophilization process shall be defined
and documented as part of the process.
NOTE Flat shelves are desirable for even product contact for both reasons of temperature uniformity and the
distribution of mechanical pressure (e.g. during stoppering in the case of vials with stoppers) and for the prevention of
condensate retention.
7.2.6 The maximum permitted leakage of air into the lyophilizer shall be specified.
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SIST EN ISO 13408-3:2011
ISO 13408-3:2006(E)
7.2.7 If compressed air, nitrogen or any other gas is admitted into the lyophilizer, its purity and rate of
admission shall not impair the integrity of the product.
7.2.8 Equipment controls in the critical processing zone shall be minimized.
7.2.9 The specification for the location in which the equipment and its components are to be installed shall
be established and documented and include (but not be limited to):
a) the services that are required for the lyophilizer and for the area in which it is installed;
b) the materials of construction for the parts that transport the utilities to and from the lyophilizer.
7.3 Product handling
7.3.1 Transport to, and loading of, the lyophilizer
7.3.1.1 A procedure for loading the lyophilizer, including the loading pattern within the chamber, shall be
specified and documented.
7.3.1.2 Transport to the lyophilizer and loading of the filled product, utensils or other equipment into the
lyophilizer shall take place in a critical processing zone. Where auxiliary equipment or containers are used for
transport, the validated conditions maintained therein shall be equivalent to the critical processing zone.
7.3.1.3 Airflow patterns resulting from transport devices and venting of the loading zone w
...