Multi-dose vial: difference between revisions
Diff·revision 16 → 17·22:14, 2 Sep 2025
Difference between revision 16 and revision 17 of Multi-dose vial. 9 lines changed; the page grew by 1,753 bytes.
| Revision 16 — 19:43, 14 Aug 2025 A1c_Alder (talk) de-orphan 18,736 bytes +539 | Revision 17 — 22:14, 2 Sep 2025 TrialsTabitha (talk) clarify that the figure is per dose, not per vial 20,489 bytes +1,753 | ||
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| 108 | The best documented example is an outbreak of hepatitis C at an endoscopy clinic in Nevada, investigated in 2007 and 2008. Investigators concluded that reuse of syringes on individual patients, combined with the use of single-use propofol vials for multiple patients, transmitted hepatitis C virus; the investigation led to notification of thousands of former patients for testing. The event is cited in infection-control literature as the canonical demonstration that the syringe, not the vial, is the proximate vector.{{r|fischer2010}} | 108 | The best documented example is an outbreak of hepatitis C at an endoscopy clinic in Nevada, investigated in 2007 and 2008. Investigators concluded that reuse of syringes on individual patients, combined with the use of single-use propofol vials for multiple patients, transmitted hepatitis C virus; the investigation led to notification of thousands of former patients for testing. The event is cited in infection-control literature as the canonical demonstration that the syringe, not the vial, is the proximate vector.{{r|fischer2010}} |
| 109 | 109 | ||
| + | 110 | Similar events have been reported in outpatient clinics, pain-management practices and alternative-medicine settings, and reviews of outpatient infection-control breaches identify unsafe injection practices involving shared vials as a recurring category. The Centers for Disease Control and Prevention's public campaign on injection safety was established in response to that pattern.{{r|cdc_injection}} | |
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| + | 112 | == Reconstituted peptides and multiple withdrawal == | |
| + | 113 | Peptides distributed for research use are supplied as lyophilised solids and are reconstituted by the recipient, and the resulting solution is generally withdrawn from repeatedly. The compendial position on such a preparation is unambiguous and worth stating precisely. | |
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| + | 115 | A vial reconstituted with [[Sterile water for injection|sterile water for injection]] or with sodium chloride injection contains no preservative. In compendial terms it is a single-dose preparation, and the framework in §The period after initial puncture assigns it a period measured in hours rather than days.{{r|usp797}} | |
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| + | 117 | A vial reconstituted with [[Bacteriostatic water|bacteriostatic water for injection]] contains benzyl alcohol, conventionally at 0.9% w/v. It therefore has the composition of a preserved preparation, but not the demonstration that the preservative is effective ''in that formulation'' — the antimicrobial effectiveness test in USP <51> is performed on a specific finished formulation, and adding a preserved diluent to an arbitrary lyophilised solid does not transfer the demonstration. Whether the resulting solution meets the criteria depends on its pH, on excipients present, on the concentration achieved after dilution by the solid, and on any interaction with the peptide.{{r|usp51,ppmdv}} | |
| + | 118 | ||
| 110 | == References == | 119 | == References == |
| 111 | {{reflist}} | 120 | {{reflist}} |