Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

ISO 8362-5:2016 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.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

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

Status
Published
Publication Date
15-Mar-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-Mar-2016
Completion Date
16-Mar-2016

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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

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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.
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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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