Elastomeric parts for parenterals and for devices for pharmaceutical use Determination of released-particle count

Amendment of

BS EN ISO 8871-3:2004

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-04-2019

Publisher

British Standards Institution

The British Standards InstitutionElastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.

Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.

This part of ISO8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.

It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Committee	CH/212
DocumentType	Amendment
Pages	14
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 8871:1997