BS EN ISO 8362-2 Injection containers and accessories. Closures for injection vials

BS EN ISO 8362-2:2010

Injection containers and accessories. Closures for injection vials

Status : Revised, Superseded, Withdrawn   Published : September 2010 Replaced By : BS EN ISO 8362-2:2015

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BS EN ISO 8362-2:2010 Injection containers and accessories. Closures for injection vials

The purpose of this part of BS EN ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical use. Closures made from elastomeric materials are suitable primary packaging materials for parenteral preparations. In order to provide seal integrity of the container closure systems the dimensions of the elastomeric closures have to be compatible with the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.

Primary packaging components made of elastomeric materials are an integral part of medicinal products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these components.

Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the European Community and the United States of America.

BS EN ISO 8362-2 was drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

ISO 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

BS EN ISO 8362 consists of the following parts, under the general title Injection containers and accessories:

Part 1: Injection vials made of glass tubing
Part 2: Closures for injection vials
Part 3: Aluminium caps for injection vials
Part 4: Injection vials made of moulded glass
Part 5: Freeze drying closures for injection vials
Part 6: Caps made of aluminium-plastics combinations for injection vials
Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part

Part 2 of BS EN ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.

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

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

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




Standard NumberBS EN ISO 8362-2:2010
TitleInjection containers and accessories. Closures for injection vials
StatusRevised, Superseded, Withdrawn
Publication Date30 September 2010
Withdrawn Date31 October 2015
Normative References(Required to achieve compliance to this standard)ISO 8871-1, ISO 3302-1, ISO 3302-2, ISO 8871-5:2005, ISO 8871-4, ISO 48, ISO 7619-1
Informative References(Provided for Information)ISO 2230, ISO 15378
Replaced ByBS EN ISO 8362-2:2015
ReplacesBS EN 28362-2:1993, ISO 8362-2:1988
International RelationshipsEN ISO 8362-2 (ISO 8362-2:2008,ISO 8362-2:2008
DescriptorsNatural rubber, Ageing (materials), Elastomers, Seals, Designations, Synthetic rubber, Dimensions, Marking, Phials, Bottles, Hardness, Medical equipment, Caps (closures), Performance, Injection instruments, Containers, Glass
ICS11.040.20
Title in FrenchRécipients et accessoires pour produits injectables. Bouchons pour flacons
Title in GermanInjektionsbehältnisse und Zubehör. Stopfen für Injektionsflaschen
CommitteeCH/212
ISBN978 0 580 56904 3
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size351 KB
Price£110.00


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