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EVS-EN ISO 8871-3:2004

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

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Kehtiv alates 12.10.2004
Alusdokumendid
ISO 8871-3:2003; EN ISO 8871-3:2004
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
15.04.2019
Muudatus
12.10.2004
Põhitekst
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. This part of ISO 8871 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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