Projekta Nr.ISO/AWI 8871-3
Nosaukums<p>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.</p> <p>Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.</p> <p>ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.</p> <p>It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.</p>
Reģistrācijas numurs (WIID)92133
Darbības sfēra<p>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.</p> <p>Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.</p> <p>ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.</p> <p>It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.</p>
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