Elastomeric parts for parenterals and for devices for pharmaceutical use - Determination of released-particle count Ingestion-build-83346 Additional information for heat meters

Additional information for heat meters

Appearance and surface condition e

Inspection and insurance companies

then the organization needs to consider employing a third-party certification body accredited by a competent body

For each technique family it lists relevant existing standards

Elastomeric parts for parenterals and for devices for pharmaceutical use - Determination of released-particle count Ingestion-build-83346 Additional information for heat metersWhat is this standard about? 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