Resumen
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.
Preview
Previsualice esta norma en nuestra Plataforma de navegación en línea (OBP)
Informaciones generales
Ciclo de vida
-
Anteriormente
RetiradaISO 8871:1990
RetiradaISO 8871:1990/Amd 1:1995
-
Ahora
-
00
Preliminar
-
10
Propuesta
-
20
Preparación
-
30
Comité
-
40
Consulta
-
50
Aprobación
-
60
Publicación
-
90
Revisión
-
95
Retirada
Correcciones / Modificaciones
PublicadoISO 8871-3:2003/Amd 1:2018
-
00
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)