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SRPS EN ISO 8871-3:2010

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

Nov 29, 2010

General information

60.60     Nov 29, 2010

ISS

Z076

European Norm

11.040.20  

English  

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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

NOW

PUBLISHED
SRPS EN ISO 8871-3:2010
60.60 Standard published
Nov 29, 2010

Related project

Adopted from EN ISO 8871-3:2004

Adopted from ISO 8871-3:2003 IDENTICAL