SS-EN-ISO-8871-3 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

SS-EN-ISO-8871-3 - 2005 EDITION - CURRENT


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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 ISO 8871 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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Designation Name

SS-EN ISO 8871-3:2005

Revision Level

2005 EDITION

Status

Current

Publication Date

April 1, 2005

Language(s)

English

Page Count

11

International Equivalent

ISO 8871-3:2003(IDT); EN ISO 8871-3:2004(IDT)