Containers and accessories for pharmaceutical preparations

ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug. It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Récipients et accessoires pour préparations pharmaceutiques

General Information

Status
Published
Publication Date
12-Jun-2016
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2021
Ref Project

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INTERNATIONAL ISO
STANDARD 11418-7
Second edition
2016-06-15
Containers and accessories for
pharmaceutical preparations —
Part 7:
Screw-neck vials made of glass tubing
for liquid dosage forms
Récipients et accessoires pour préparations pharmaceutiques —
Partie 7: Flacons avec bague à vis en verre étiré pour diagnostics
forme liquide
Reference number
ISO 11418-7:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
ISO 11418-7:2016(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
---------------------- Page: 2 ----------------------
ISO 11418-7:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Dimensions and designation ................................................................................................................................................................... 1

3.1 Dimensions ................................................................................................................................................................................................. 1

3.2 Designation ................................................................................................................................................................................................ 1

4 Material .......................................................................................................................................................................................................................... 2

5 Characteristics ........................................................................................................................................................................................................ 3

6 Requirements .......................................................................................................................................................................................................... 3

6.1 Hydrolytic resistance ......................................................................................................................................................................... 3

6.2 Annealing quality .................................................................................................................................................................................. 3

6.3 Light resistance ...................................................................................................................................................................................... 3

7 Marking .......................................................................................................................................................................................................................... 3

8 Packaging ..................................................................................................................................................................................................................... 3

© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 11418-7:2016(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 World Trade Organization (WTO) principles in the

Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood

processing equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 11418-7:1998), which has been technically

revised by
— amending the mass of screw-neck vials in Table 1, and
— editorially revising this part of ISO 11418.

ISO 11418 consists of the following parts, under the general title Containers and accessories for

pharmaceutical preparations:
— Part 1: Drop-dispensing glass bottles
— Part 2: Screw-neck glass bottles for syrups
— Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
— Part 4: Tablet glass bottles
— Part 5: Dropper assemblies
— Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 11418-7:2016(E)
Introduction

The purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements

of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing

are considered to be suitable for the packaging and storage of pharmaceutical preparations until they

are administered for medicinal purposes. Such vials may be made of different types of glass which can

affect chemical resistance properties. For example, those made from borosilicate glass will have a very

high level of chemical resistance where others made from soda-lime-silica glass will have a lower but

adequate chemical resistance for the
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 11418-7
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2015-01-12 2015-04-12
Containers and accessories for pharmaceutical
preparations —
Part 7:
Screw-neck vials made of glass tubing for liquid dosage forms
Récipients et accessoires pour préparations pharmaceutiques —
Partie 7: Flacons avec bague à vis en verre étiré pour diagnostics forme liquide
ICS: 11.120.99; 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11418-7:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
---------------------- Page: 1 ----------------------
ISO/DIS 11418-7:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 11418-7:2014(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Dimensions and designation ................................................................................................................................................................... 1

3.1 Dimensions ................................................................................................................................................................................................. 1

3.2 Designation ................................................................................................................................................................................................ 1

4 Material .......................................................................................................................................................................................................................... 3

5 Characteristics ........................................................................................................................................................................................................ 3

6 Requirements .......................................................................................................................................................................................................... 3

6.1 Hydrolytic resistance ......................................................................................................................................................................... 3

6.2 Annealing quality .................................................................................................................................................................................. 3

6.3 Light resistance ...................................................................................................................................................................................... 3

7 Marking .......................................................................................................................................................................................................................... 3

8 Packaging ..................................................................................................................................................................................................................... 3

© ISO 2014 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 11418-7:2014(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 11418-7 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and

blood processing equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 114118-7:1998) that has been

technically revised by
— amending the mass of screw-neck vials in Table 1, and
— editorially revising this standard.

ISO 11418 consists of the following parts, under the general title Containers and accessories for

pharmaceutical preparations:
— Part 1: Drop-dispensing glass bottles
— Part 2: Screw-neck glass bottles for syrups
— Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
— Part 4: Tablet glass bottles
— Part 5: Dropper assemblies
— Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
iv © ISO 2014 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 11418-7:2014(E)
Introduction

The purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements

of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing

are considered to be suitable for the packaging and storage of pharmaceutical preparations until they

are administered for medicinal purposes. Such vials may be made of different types of glass which can

affect chemical resistance properties. For example, those made from borosilicate glass will have a very

high level of chemical resistance where others made from soda-lime-silica glass will have a lower

...

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