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

[中文适用范围]： 弹性封闭件的表面可能被可见和不可见的颗粒污染，并且当封闭件被针刺穿时也可能产生碎片。 此类颗粒可能会转移至与弹性体部分接触的药物制剂中并影响此类制剂的质量。 ISO 8871 的这一部分规定了通过漂洗从弹性部件上分离的可见颗粒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。 [外文原描述]： 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.