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DIN EN ISO 8871-3:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003); German version EN ISO 8871-3:2004, text german and english

Elastomeric parts may be superficially contaminated with particles visible to the naked eye. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts, and detoriate the quality of such preparations. The method serves to evaluate contamination of this kind by collecting and counting the particles, detached from the elastomeric part by rinsing.

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Deutsches Institut für Normung [din]

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