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ISO 8871-3:2003

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
31 korr 2003

General information

90.92     27 maj 2025

ISO

ISO/TC 76

International Standard

11.040.20  

anglisht   frëngjisht   rusisht  

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Scope

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.
ISO 8871-3:2003 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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 8871:1990

WITHDRAWN
ISO 8871:1990/Amd 1:1995

NOW

PUBLISHED
ISO 8871-3:2003
90.92 Standard to be revised
27 maj 2025

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 8871-3:2003/Amd 1:2018

REVISED BY

IN_DEVELOPMENT
ISO/AWI 8871-3