Multi-dose vial: difference between revisions
Diff·revision 36 → 37·18:26, 28 Aug 2025
Difference between revision 36 and revision 37 of Multi-dose vial. 7 lines changed; the page grew by 1,348 bytes.
| Revision 36 — 16:20, 19 Aug 2025 SharpsSukhi (talk) expand §The period after initial puncture 18,736 bytes ±0 | Revision 37 — 18:26, 28 Aug 2025 StabilityStig (talk) fix unit 20,084 bytes +1,348 | ||
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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 | == Reconstituted peptides and multiple withdrawal == | |
| + | 111 | 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use are supplied as lyophilised solids and are reconstituted by the recipient, and the resulting solution is generally withdrawn from repeatedly.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. | |
| + | 112 | ||
| + | 113 | 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}} | |
| + | 114 | ||
| + | 115 | 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}} | |
| + | 116 | ||
| 110 | == References == | 117 | == References == |
| 111 | {{reflist}} | 118 | {{reflist}} |