ISO 8871-3:2003
Current
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
Hardcopy , PDF
07-31-2003
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.
| Committee |
ISO/TC 76
|
| 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 |
| Standards | Relationship |
| BS EN ISO 8871-3:2004 | Identical |
| EN ISO 8871-3:2004 | Identical |
| DIN EN ISO 8871-3:2004-09 | Identical |
| PN EN ISO 8871-3 : 2005 | Identical |
| I.S. EN ISO 8871-3:2004 | Identical |
| NF 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 |
| UNE-EN ISO 8871-3:2004 | Identical |
| NF EN ISO 8871-3 : 2004 AMD 1 2018 | Identical |
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