DIN EN ISO 8871-3:2019

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003 + Amd 1:2018); German version EN ISO 8871-3:2004 + A1:2019

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. The amendment A1 contains additional information on shaking machines, see 3.3.1.