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

Amended by

ISO 8871-3:2003/Amd 1:2018

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Published date

31-07-2003

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 8871-3 (08/2003) Together with ISO 8871-1, ISO 8871-2, ISO 8871-4 and ISO 8871-5, supersedes ISO 8871. (08/2005)
DocumentType	Standard
Pages	6
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 8871:1990 ISO 8871:1990/Amd 1:1995

Standards	Relationship
UNI EN ISO 8871-3 : 2019	Identical
BS EN ISO 8871-3:2004	Identical
EN ISO 8871-3:2004	Identical
DIN EN ISO 8871-3:2004-09	Identical
UNI EN ISO 8871-3 : 2004	Identical
PN EN ISO 8871-3 : 2005	Identical
UNE-EN ISO 8871-3:2004	Identical
I.S. EN ISO 8871-3:2004	Identical
NF EN ISO 8871-3:2004	Identical
SN EN ISO 8871-3 : 2004	Identical
NEN EN ISO 8871-3 : 2004	Identical
NS EN ISO 8871-3 : 1ED 2004	Identical
GOST R ISO 8871-3 : 2010	Identical
SS-EN ISO 8871-3:2005	Identical
NBN EN ISO 8871-3 : 2004	Identical
ONORM EN ISO 8871-3 : 2004	Identical
NF EN ISO 8871-3 : 2004 AMD 1 2018	Identical

BS EN ISO 8871-1:2004	Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
VDI 2083 Blatt 9.2:2017-01	Cleanroom technology - Consumables in the cleanroom
00/560909 DC : DRAFT MAR 2000	BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
ISO 8871-1:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
EN ISO 8871-1 : 2004	ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES

ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods

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ISO 8871-3:2003

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