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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

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.

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.

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

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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