ISO 11418-2:2005

Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups

ISO 11418-2:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-2:2005 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

Récipients et accessoires pour préparations pharmaceutiques — Partie 2: Flacons en verre à bouchon à vis pour sirops

General Information

• Status: Withdrawn
• Publication Date: 06-Feb-2005
• Withdrawal Date: 06-Feb-2005
• 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: 9599 - Withdrawal of International Standard
• Completion Date: 14-Nov-2016

Relations

• Revised: ISO 11418-2:2016 - Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck glass bottles for syrups
• Effective Date: 15-Mar-2014
• Revises: ISO 11418-2:1996 - Containers and accessories for pharmaceutical preparations — Part 2: Screw-neck bottles for syrups
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11418-2
Second edition
2005-02-01

Containers and accessories for
pharmaceutical preparations —
Part 2:
Screw-neck glass bottles for syrups
Récipients et accessoires pour préparations pharmaceutiques —
Partie 2: Flacons en verre à bouchon à vis pour sirops




Reference number
ISO 11418-2:2005(E)
©
ISO 2005

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ISO 11418-2:2005(E)
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ISO 11418-2:2005(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 11418-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 11418-2:1996), which has been technically
revised.
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

© ISO 2005 – All rights reserved iii

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INTERNATIONAL STANDARD ISO 11418-2:2005(E)

Containers and accessories for pharmaceutical preparations —
Part 2:
Screw-neck glass bottles for syrups
1 Scope
This part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck glass
bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to
primary packs used in direct contact with a drug.
This part of ISO 11418 is applicable to screw-neck glass bottles used in pharmacy. Together with the
corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not
intended for parenteral use.
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.
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, th
...