Multi-dose vial: difference between revisions
Diff·revision 12 → 13·14:26, 23 Jun 2025
Difference between revision 12 and revision 13 of Multi-dose vial. 4 lines changed; the page grew by 721 bytes.
| Revision 12 — 06:01, 5 Jun 2025 HedgeHedda (talk) correct the unit conversion — U-100 not U-40 15,840 bytes +225 | Revision 13 — 14:26, 23 Jun 2025 SemaglutideSasha (talk) state the assumption that the whole vial is reconstituted at once 16,561 bytes +721 | ||
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| 95 | ''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 Reports of elastomer particles recovered from withdrawn liquid are the direct evidence, and the compendial fragmentation limit exists to bound it.{{r|usp381mdv,pheur329mdv}} | 95 | ''Coring'' is the excision of a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 Reports of elastomer particles recovered from withdrawn liquid are the direct evidence, and the compendial fragmentation limit exists to bound it.{{r|usp381mdv,pheur329mdv}} |
| 96 | 96 | ||
| + | 97 | Surface disinfection before each entry is the practice measure addressed at the other end of the problem. Once a flip-off button is removed, the exposed face of the closure is a surface like any other, and guidance expects it to be disinfected with an appropriate agent and allowed to dry before each penetration. Studies of contamination of vial closures in clinical use have found organisms recoverable from a proportion of them, which is the empirical basis for the practice.{{r|mattner2004,cdc_injection}} | |
| + | 98 | ||
| 97 | == References == | 99 | == References == |
| 98 | {{reflist}} | 100 | {{reflist}} |
| ⋮ | ⋮ | ||
| 105 | <ref name="cdc_injection">Centers for Disease Control and Prevention. ''Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care'', and associated injection-safety questions and answers on multi-dose vials.</ref> | 107 | <ref name="cdc_injection">Centers for Disease Control and Prevention. ''Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care'', and associated injection-safety questions and answers on multi-dose vials.</ref> |
| 106 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> | 108 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> |
| + | 109 | <ref name="mattner2004">Mattner F, Gastmeier P. "Bacterial contamination of multiple-dose vials: a prevalence study." ''American Journal of Infection Control'' 32(1):12–16 (2004).</ref> | |
| 107 | <ref name="brange1993">Brange J, Langkjaer L. "Insulin structure and stability." ''Pharmaceutical Biotechnology'' 5:315–350 (1993).</ref> | 110 | <ref name="brange1993">Brange J, Langkjaer L. "Insulin structure and stability." ''Pharmaceutical Biotechnology'' 5:315–350 (1993).</ref> |
| 108 | <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> | 111 | <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> |
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| 115 | * [[Reconstitution of lyophilised peptides]] | 118 | * [[Reconstitution of lyophilised peptides]] |
| 116 | * [[Sterile water for injection]] | 119 | * [[Sterile water for injection]] |
| + | 120 | * [[Sharps disposal]] | |
| 117 | 121 | ||
| 118 | {{DEFAULTSORT:Multi-dose vial}} | 122 | {{DEFAULTSORT:Multi-dose vial}} |