ISO 8871-3:2003

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

Publication date: Jul 31, 2003

General information

Current stage: 90.93 Effective date: Dec 4, 2019

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.20

Languages: English French Russian

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Status: 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

Revises
ISO 8871:1990

Revises
ISO 8871:1990/Amd 1:1995

NOW

PUBLISHED
ISO 8871-3:2003
90.93 Standard confirmed
Dec 4, 2019

CORRIGENDA / AMENDMENTS

Amended by
ISO 8871-3:2003/Amd 1:2018

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