ISO 8871-3:2003
2003-08
Abstract
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.
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2018
Life cycle
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Previously
WithdrawnISO 8871:1990
WithdrawnISO 8871:1990/Amd 1:1995
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
-
95
Withdrawal
Amendments
Provide additional content; Available for purchase; Not included in the text of the existing standard.PublishedISO 8871-3:2003/Amd 1:2018
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00
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