BH GSO ISO 8871-3:2016
ISO 8871-3:2003
Bahraini Standard
Current Edition
·
Approved on
08 February 2016
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
BH GSO ISO 8871-3:2016 Files
English
6 Pages
Current Edition
Reference Language
BHD
19.93
BH GSO ISO 8871-3:2016 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.
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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