SIST EN ISO 8362-5:2016
(Main)Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
This part of EN ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single use only.
Injektionsbehältnisse und Zubehör - Teil 5: Gefriertrocknungsstopfen für Injektionsflaschen (ISO 8362-5:2016)
Dieser Teil von ISO 8362 legt die Form, Maße, Werkstoffe, Leistungsanforderungen und Kennzeichnung für eine Stopfenart für Injektionsflaschen nach ISO 8362-1 und ISO 8362-4 fest, die in Verbindung mit der Gefriertrocknung (oder Lyophilisierung) von Arzneimitteln und biologischen Präparaten verwendet wird.
Die maßlichen Anforderungen sind nicht auf beschichtete Stopfen anwendbar.
Die in diesem Teil von ISO 8362 beschriebenen Stopfen sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Récipients et accessoires pour produits injectables - Partie 5: Bouchons à lyophilisation pour flacons d'injection (ISO 8362-5:2016)
L'ISO 8362-5:2016 fixe la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons pour flacons d'injection, tels que décrits dans l'ISO 8632‑1 et l'ISO 8362‑4, utilisés pour les médicaments et les produits biologiques à lyophiliser.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet de la présente partie de l'ISO 8362-5:2016 sont à usage unique seulement.
NOTE La nature et les performances de l'emballage primaire peuvent influer considérablement sur l'efficacité, la pureté, la stabilité et la sécurité d'un produit pharmaceutique au cours de sa fabrication et de son stockage.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 5. del: Pokrovčki za liofiziranje za injekcijske viale (ISO 8362-5:2016)
Ta del standarda EN ISO 8362 določa obliko, dimenzije, material, zahteve za delovanje in označevanje za vrsto pokrovčka za injekcijske viale, kot je opisano v standardih ISO 8362-1 in ISO 8362-4, ki se uporablja v zvezi s sušenjem z zamrzovanjem (ali liofilizacija) zdravil in bioloških materialov. Zahteve glede dimenzij ne veljajo za pokrovčke s pregrado. Pokrovčki, ki jih določa ta del standarda ISO 8362, so namenjeni le enkratni uporabi.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8362-5:2016
01-maj-2016
9VHEQLNL]DSDUHQWHUDOQHIDUPDFHYWVNHREOLNHLQGRGDWQDRSUHPDGHO
3RNURYþNL]DOLRIL]LUDQMH]DLQMHNFLMVNHYLDOH ,62
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
(ISO 8362-5:2016)
Injektionsbehältnisse und Zubehör - Teil 5: Gefriertrocknungsstopfen für
Injektionsflaschen (ISO 8362-5:2016)
Récipients et accessoires pour produits injectables - Partie 5: Bouchons à lyophilisation
pour flacons d'injection (ISO 8362-5:2016)
Ta slovenski standard je istoveten z: EN ISO 8362-5:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-5:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8362-5:2016
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SIST EN ISO 8362-5:2016
EN ISO 8362-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Injection containers and accessories - Part 5: Freeze drying
closures for injection vials (ISO 8362-5:2016)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 5:
Partie 5: Bouchons à lyophilisation pour flacons Gefriertrocknungsstopfen für Injektionsflaschen (ISO
d'injection (ISO 8362-5:2016) 8362-5:2016)
This European Standard was approved by CEN on 2 January 2016.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-5:2016 E
worldwide for CEN national Members.
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SIST EN ISO 8362-5:2016
EN ISO 8362-5:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8362-5:2016
EN ISO 8362-5:2016 (E)
European foreword
This document (EN ISO 8362-5:2016) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
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 September 2016, and conflicting national standards
shall be withdrawn at the latest by September 2016.
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.
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, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8362-5:2016 has been approved by CEN as EN ISO 8362-5:2016 without any
modification.
3
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SIST EN ISO 8362-5:2016
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SIST EN ISO 8362-5:2016
INTERNATIONAL ISO
STANDARD 8362-5
Third edition
2016-02-15
Injection containers and
accessories —
Part 5:
Freeze drying closures for injection
vials
Récipients et accessoires pour produits injectables —
Partie 5: Bouchons à lyophilisation pour flacons d’injection
Reference number
ISO 8362-5:2016(E)
©
ISO 2016
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SIST EN ISO 8362-5:2016
ISO 8362-5:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 8362-5:2016
ISO 8362-5:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Shape and dimensions . 2
5 Designation . 4
6 Material . 4
7 Performance requirements . 4
7.1 General . 4
7.2 Physical requirements . 4
7.2.1 Hardness . 4
7.2.2 Penetrability . 4
7.2.3 Fragmentation . 4
7.2.4 Self-sealing and aqueous solution tightness . 5
7.2.5 Aqueous solution tightness . 5
7.2.6 Resistance to ageing . 5
7.2.7 Residual moisture . 5
7.3 Chemical requirements. 5
7.4 Biological requirements . 5
7.5 Particulate contamination requirements . 5
8 Labelling . 5
Annex A (informative) Determination of moisture . 6
Bibliography . 9
© ISO 2016 – All rights reserved iii
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SIST EN ISO 8362-5:2016
ISO 8362-5:2016(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8362-5:2008), which has been technically
revised to include a new 7.5.
ISO 8362 consists of the following parts, under the general title Injection containers and accessories:
— Part 1: Injection vials made of glass tubing
— Part 2: Closures for injection vials
— Part 3: Aluminium caps for injection vials
— Part 4: Injection vials made of moulded glass
— Part 5: Freeze drying closures for injection vials
— Part 6: Caps made of aluminium-plastics combinations for injection vials
— Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
iv © ISO 2016 – All rights reserved
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SIST EN ISO 8362-5:2016
ISO 8362-5:2016(E)
Introduction
Freeze drying closures are put on the top of a glass container after filling, leaving sufficient openings
for the sublimation process and vacuum. At the end of the drying process, they are fully inserted into
the glass container by hydraulic or mechanical means in the vacuum chamber.
Freeze drying closures can pick up water during shipping, storage, washing and steam sterilization
cycles, which is difficult to remove in a subsequent drying cycle. As a consequence, the freeze drying
closures are usually loaded with residual moisture. Depending upon the mass of the freeze-dried
product and the degree of its sensitivity to water, the residual moisture in the rubber material can spoil
the freeze-dried preparation during storage.
These specific process requirements have been addressed in this part of ISO 8362 by specifying relevant
requirements for freeze drying closures, including a test method for determining residual moisture.
Primary packaging components made of elastomeric materials are an integral part of medicinal
products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the
manufacturing of these components.
Pri
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