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ISO 8362-5

Injection containers and accessories — Part 5: Freeze drying closures for injection vials

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Organization: ISO
Publication Date: 15 October 2008
Status: inactive
Page Count: 16
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO 8362 are intended for single use only.

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

Document History

ISO 8362-5
February 15, 2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which...
ISO 8362-5
October 15, 2008
Injection containers and accessories — Part 5: Freeze drying closures for injection vials
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which...
ISO 8362-5
January 1, 1995
Injection Containers for Injectables and Accessories - Part 5: Freeze Drying Closures for Injection Vials First Edition
A description is not available for this item.

References

This document references:
ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
Published by ISO on October 1, 2003
This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous...
This document references:
ISO 15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Published by ISO on September 1, 2017
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs...
This document references:
ISO 2230 - Rubber Products - Guidelines for Storage
Published by ISO on April 15, 2002
This International Standard gives guidelines for the inspection, recording procedures, packaging and storage of products, assemblies and components made from vulcanized or thermoplastic rubber prior...
This document references:
ISO 3302-1 - Rubber - Tolerances for products - Part 1: Dimensional tolerances
Published by ISO on July 15, 2014
This part of ISO 3302 specifies classes of dimensional tolerances and their values for moulded, extruded, and calendared solid rubber products. The relevant test methods necessary for the...
This document references:
ISO 3302-2 - Rubber — Tolerances for products — Part 2: Geometrical tolerances
Published by ISO on October 1, 2008
This part of ISO 3302 specifies the following geometrical tolerances for moulded and extruded solid rubber products, including those with metal inserts: — flatness tolerance; — parallelism tolerance;...
This document references:
ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
Published by ISO on October 1, 2003
This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous...
This document is referenced by:
BS EN ISO 22413 - Transfer sets for pharmaceutical preparations - Requirements and test methods
Published by BSI on June 30, 2021
A description is not available for this item.
This document is referenced by:
EN ISO 22413 - Transfer sets for pharmaceutical preparations - Requirements and test methods
Published by CEN on June 1, 2021
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
This document is referenced by:
SN EN ISO 22413 - Transfer sets for pharmaceutical preparations - Requirements and test methods
Published by SNV on August 1, 2021
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
This document is referenced by:
DIN EN ISO 8871-2 - Elastomere Teile fuer Parenteralia und fuer Geraete zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2020); Deutsche Fassung EN ISO 8871-2:2020
Published by DIN on September 1, 2020
A description is not available for this item.
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