ISO 8871-3-2003 非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定

标准号：ISO 8871-3-2003
中文标准名称：非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定
英文标准名称：Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
标准类型：C36
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C36
国际标准分类号：11.040.20
适用范围：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.