ISO 8871-3:2003
International Standard
Current Edition
·
Approved on
31 July 2003
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
ISO 8871-3:2003 Files
English
6 Pages
Current Edition
19.67 BHD
ISO 8871-3:2003 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.
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