Reference number
ISO 8871-3:2003
© ISO 2024
International Standard
ISO 8871-3:2003
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
Edition 1
2003-08
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Published (Edition 1, 2003)
This publication was last reviewed and confirmed in 2019. Therefore this version remains current.
This standard has 1 amendment.

ISO 8871-3:2003

Language
Format
CHF 42
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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.

General information

  • Status
     : Published
    Publication date
     : 2003-08
    Stage
    : International Standard under systematic review [90.20]
  • Edition
     : 1
    Number of pages
     : 6
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.20 
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 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2018

Language
Format
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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