NF EN ISO 8871-3

NF EN ISO 8871-3

December 2004
Standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3 : determination of released-particule count

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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Main informations

Collections

National standards and national normative documents

Publication date

December 2004

Number of pages

16 p.

Reference

NF EN ISO 8871-3

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
83.140.99   Other rubber and plastics products

Classification index

S93-102-3

Print number

1 - 21/12/2004

International kinship

ISO 8871-3:2003

European kinship

EN ISO 8871-3:2004
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3 : determination of released-particule count

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.

Replaced standards (2)
NF EN ISO 8871
December 1997
Standard Cancelled
Elastomeric parts for aqueous parenteral preparations.

NF EN ISO 8871/A1
December 1999
Standard Cancelled
Elastomeric parts for aqueous parenteral preparations

Table of contents
View the extract
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Détermination des particules visibles à l'oeil nu
    1
  • 4 Détermination des particules non visibles à l'oeil nu
    3
  • Bibliographie
    6
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