<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>
Registration number (WIID)
92133
Scope
<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>
