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BS ISO 11040-5:2012

BS ISO 11040-5:2012

Current

Current

The latest, up-to-date edition.

Prefilled syringes Plunger stoppers for injectables

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-02-2012

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Bibliography

Describes the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4.

Committee
CH/212
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Current

This part of ISO11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO11040-4.

Plunger stoppers specified in this part of ISO11040 are intended for single use only.

This part of ISO11040 is not applicable to barrier-coated plunger stoppers.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

Standards Relationship
ISO 11040-5:2012 Identical

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 11040-4:2015 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 9997:1999 Dental cartridge syringes
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
ISO 9001:2015 Quality management systems — Requirements
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods

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Hardcopy - English
PDF - English
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