ISO 8871-3:2003 制药使用设备和不经肠道注射物的弹性部分-第3部分：释放颗粒测定

标准编号：ISO 8871-3:2003

中文名称：制药使用设备和不经肠道注射物的弹性部分-第3部分：释放颗粒测定

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

发布日期：2003-08

标准范围

弹性体封盖表面可能被可见和亚可见颗粒污染，当封盖被针刺穿时，也可能产生碎片。此类颗粒可转移到与弹性体部件接触的药物制剂中，并影响此类制剂的质量。ISO 8871-3:2003规定了通过冲洗从弹性体零件上分离的可见和亚可见颗粒数量的测定方法。它没有规定颗粒污染限值。这些必须在制造商和用户之间达成一致。

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.

标准预览图