Name: EN ISO 8362-5:2016
Brand: CEN

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

Published date

16-03-2016

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Annex A (informative) - Determination of moisture
Bibliography

ISO 8362-5:2016 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.

Committee	CEN/TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
NF EN ISO 8362-5 : 2016	Identical
DIN EN ISO 8362-5 E : 2016	Identical
I.S. EN ISO 8362-5:2016	Identical
BS EN ISO 8362-5:2016	Identical
SN EN ISO 8362-5:2016	Identical
NS EN ISO 8362-5 : 2016	Identical
UNE-EN ISO 8362-5:2016	Identical
UNI EN ISO 8362-5 : 2016	Identical
NBN EN ISO 8362-5 : 2016	Identical
ISO 8362-5:2016	Identical
DIN EN ISO 8362-5:2016-07	Identical
NEN EN ISO 8362-5 : 2016	Identical
PN EN ISO 8362-5 : 2016	Identical

ISO 8871-1:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
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 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 3302-2:2008	Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 554:1976	Standard atmospheres for conditioning and/or testing — Specifications
ISO 8871-5:2016	Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
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