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Norm
ÖNORM EN ISO 8871-3
Issue date: 2019 08 15
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003 + Amd 1:2018) (consolidated version)
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.
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Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German
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ICS
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 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.
ÖNORM EN ISO 8871-3
2019 08 15
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of ...
Norm
↖
ÖNORM EN ISO 8871-3
2004 08 01
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of...
Norm
ÖNORM EN ISO 8871/A1
1999 09 01
Elastomeric parts for aqueous parenteral preparations (ISO 8871:1997/AM1:1999) (Amendment)
Norm
ÖNORM EN ISO 8871
1998 06 01
Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
Norm
ÖNORM EN 28871
1994 02 01
Elastomeric parts for aqueous parenteral preparations (ISO 8871:1988)
Norm
Norm
ISO 8871-3:2003
Issue date :
2003 07 31
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
Norm
ISO 3696:1987
Issue date :
1987 04 09
Water for analytical laboratory use — Specification and test methods