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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

Jul 31, 2003

General information

90.92     May 27, 2025

ISO

ISO/TC 76

International Standard

11.040.20  

English   French   Russian  

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Published

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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WITHDRAWN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WITHDRAWN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
May 27, 2025

CORRIGENDA / AMENDMENTS

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

REVISED BY

PROJECT
ISO/AWI 8871-3

National adoptions

SRPS EN ISO 8871-3:2010  
ISS

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

60.60   Standard published

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