ISO 11418-7:2016

Containers and accessories for pharmaceutical preparations - Part 7: Screw-neck vials made of glass tubing for liquid dosage forms

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 — Partie 7: Flacons avec bague à vis en verre étiré pour diagnostics forme liquide

General Information

• Status: Published
• Publication Date: 12-Jun-2016
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
• Current Stage: 9093 - International Standard confirmed
• Start Date: 07-Sep-2021
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 11418-7:1998 - Containers and accessories for pharmaceutical preparations - Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
• Effective Date: 31-May-2014

Overview

ISO 11418-7:2016 - Containers and accessories for pharmaceutical preparations - Part 7 specifies the design, dimensions, materials and performance requirements for screw-neck vials made from glass tubing intended for liquid dosage forms. It applies to colourless (cl) and amber (br) vials produced from borosilicate or soda‑lime‑silica glass used as primary packs in direct contact with pharmaceutical products. The standard covers form, nominal capacities, thread finish, marking and packaging, and defines test methods for chemical and physical performance.

Key topics and technical requirements

• Design & dimensions: Thread profile, neck finish and nominal capacities are defined (see Table 1 in the standard). Specific dimensional tolerances and nominal tubing sizes are provided for consistent interchangeability with closures.
• Material classes: Vials may be borosilicate or soda‑lime‑silica glass and must meet designated hydrolytic resistance grain classes (ISO 719/720 references).
• Hydrolytic resistance: Internal surface hydrolytic resistance is verified per ISO 4802‑1 or ISO 4802‑2 and classified as container class HC 1, HC 2 or HC 3.
• Annealing quality: Residual stress is controlled - optical retardation must not exceed 40 nm per mm of glass thickness when inspected in a strain viewer.
• Physical characteristics: Vials must be free from seeds and bubbles that interfere with visual inspection and must provide a sealing surface compatible with closures.
• Marking & packaging: Packages must show quantity, designation and manufacturer identification; packaging sizes and formats are agreed between supplier and customer.
• Designation example: Vial ISO 11418-7 – Glt 10 – br – 1 (glass tubing size 10, amber, hydrolytic class 1).

Practical applications and users

ISO 11418-7:2016 is intended for:

• Pharmaceutical packaging engineers and designers selecting primary containers for liquid drugs and diagnostics.
• Vial manufacturers and glass suppliers establishing production tolerances and material specifications.
• Quality assurance and regulatory teams validating container compatibility (potency, purity, stability).
• Suppliers of closures, filling lines and contract packagers who require consistent neck finish and thread dimensions.
• Procurement teams comparing compliant vial specifications across vendors.

Typical applications include packaging, storage and transport of injectable solutions, diagnostics, and liquid formulations where primary-pack performance affects drug stability.

Related standards

• ISO 11418 series (Parts 1–5, 7) - related container types
• ISO 4802-1 / ISO 4802-2 - hydrolytic resistance of interior surfaces of glass containers
• ISO 719 / ISO 720 - hydrolytic resistance test methods for glass grains
• Relevant pharmacopoeias (European Pharmacopoeia, USP) for light‑resistance and additional test methods

Keywords: ISO 11418-7:2016, screw-neck vials, glass tubing, borosilicate, soda‑lime‑silica, hydrolytic resistance, vial dimensions, pharmaceutical packaging, primary pack.

Standards Content (Sample)

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 2016
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

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
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

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

ISO/DIS 11418-7:2014(E)
© 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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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/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

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
...