Multi-dose vial: difference between revisions
Diff·revision 23 → 24·04:59, 20 May 2025
Difference between revision 23 and revision 24 of Multi-dose vial. 9 lines changed; the page grew by 646 bytes.
| Revision 23 — 20:58, 12 May 2025 FreightFenna (talk) British spelling per PP:MOS 14,969 bytes +2,139 | Revision 24 — 04:59, 20 May 2025 PatientPanelPru (talk) expand §Labelling and records 15,615 bytes +646 | ||
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| 91 | Resealing is not unconditional. Its reliability falls with the diameter of the needle used, with repeated penetration through the same point, and with damage to the elastomer surface. A closure penetrated twenty times with a 30-gauge needle at varied points is in a different condition from one penetrated twenty times with a 21-gauge needle at one point, and the compendial test — performed with a specified needle and technique — characterises the closure rather than any particular pattern of use.{{r|usp381mdv}} | 91 | Resealing is not unconditional. Its reliability falls with the diameter of the needle used, with repeated penetration through the same point, and with damage to the elastomer surface. A closure penetrated twenty times with a 30-gauge needle at varied points is in a different condition from one penetrated twenty times with a 21-gauge needle at one point, and the compendial test — performed with a specified needle and technique — characterises the closure rather than any particular pattern of use.{{r|usp381mdv}} |
| 92 | 92 | ||
| + | 93 | ''Coring'' is the excision of a fragment of elastomer by the needle, treated in detail at [[Vial|vial]]. Its relevance to multiple-dose use is that its likelihood accumulates: the probability of at least one coring event over twenty entries is substantially higher than over one, and the resulting channel persists. Reports of elastomer particles recovered from withdrawn liquid are the direct evidence, and the compendial fragmentation limit exists to bound it.{{r|usp381mdv,pheur329mdv}} | |
| + | 94 | ||
| 93 | == References == | 95 | == References == |
| 94 | {{reflist}} | 96 | {{reflist}} |
| ⋮ | ⋮ | ||
| 104 | <ref name="manning2010mdv">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010).</ref> | 106 | <ref name="manning2010mdv">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010).</ref> |
| 105 | <ref name="ppmdv">PeptidePedia community reconstitution-practice tally, 2026 (self-reported; no sterility or preservative-effectiveness data; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> | 107 | <ref name="ppmdv">PeptidePedia community reconstitution-practice tally, 2026 (self-reported; no sterility or preservative-effectiveness data; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> |
| + | 108 | ||
| + | 109 | == See also == | |
| + | 110 | * [[Vial]] | |
| + | 111 | * [[Beyond-use date]] | |
| + | 112 | * [[Bacteriostatic water]] | |
| + | 113 | * [[Reconstitution of lyophilised peptides]] | |
| + | 114 | * [[Sterile water for injection]] | |
| 106 | 115 | ||
| 107 | {{DEFAULTSORT:Multi-dose vial}} | 116 | {{DEFAULTSORT:Multi-dose vial}} |