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ISO 8871-3:2003

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

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

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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.

SDO ISO: International Organization for Standardization
Document Number ISO 8871
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 76
Publish Date Document Id Type View
Not Available ISO 8871-3:2003 Revision