Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
Document Number: ISO 8871-3:2003 File Size: 154 kB Language: English Provider: ANSI Shipping: Available for download - Link will be provided in My ComplianceOnline section
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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.
