ISO-8871-3 › Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count

ISO-8871-3 - 1ST EDITION - CURRENT


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 1ST EDITION - Aug. 1, 2003
 FOR 1ST EDITION AMENDMENT 1 SEE - Feb. 1, 2018

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.

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11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Document Number

ISO 8871-3:2003

Revision Level

1ST EDITION

Status

Current

Publication Date

Aug. 1, 2003

Committee Number

ISO/TC 76