Standard

ISO 8871-3:2003

Jul 2003 Current

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Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count — Amendment 1 Current ISO 8871-3:2003/Amd 1:2018 Amendment from Publication date: Jan 2018 Pages: 1 Language: English, French Services: Online, Online + Pdf

Abstract

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.

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Standard from ISO
Published: July 31 2003
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.20
International TC: ISO/TC 76

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Adopted by: NF EN ISO 8871-3:2004
Adopted by: SN EN ISO 8871-3:2004
Revises: ISO 8871:1990

ISO 8871-3:2003

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ISO 8871-3:2003

ISO 8871:1990/Amd 1:1995

ISO 8871:1990

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Version history Related Corrigenda and Amendments (1)

ISO 8871-3:2003/Amd 1:2018

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ISO 8871-3:2003

ISO 8871:1990/Amd 1:1995

ISO 8871:1990

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Products specifications

Product Relations

Product life cycle