Multi-dose vial: difference between revisions
Diff·revision 17 → 18·23:41, 26 Sep 2025
Difference between revision 17 and revision 18 of Multi-dose vial. 7 lines changed; the page grew by 996 bytes.
| Revision 17 — 22:14, 2 Sep 2025 TrialsTabitha (talk) clarify that the figure is per dose, not per vial 20,489 bytes +1,753 | Revision 18 — 23:41, 26 Sep 2025 RepackRadek (talk) rm the individualised advice — the article describes, it does not instruct 21,485 bytes +996 | ||
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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}} | 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 | 118 | ||
| + | 119 | Two further considerations arise specifically in this context. The diluent volume chosen determines the final benzyl alcohol concentration only if the solid contributes negligible volume, which is the usual case for a few milligrams of peptide but not for a formulated product with a bulking agent. And the number of withdrawals is typically far higher than for a manufactured multiple-dose product — a vial divided into ten or twenty doses is common — which multiplies both the coring probability and the number of disinfection and technique opportunities.{{r|ppmdv}} | |
| + | 120 | ||
| 119 | == References == | 121 | == References == |
| 120 | {{reflist}} | 122 | {{reflist}} |
| ⋮ | ⋮ | ||
| 133 | <ref name="ppmdv">PeptidePedia community reconstitution-practice tally, 2026 (self-reported; no sterility or preservative-effectiveness data; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> | 135 | <ref name="ppmdv">PeptidePedia community reconstitution-practice tally, 2026 (self-reported; no sterility or preservative-effectiveness data; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> |
| 134 | 136 | ||
| + | 137 | == Further reading == | |
| + | 138 | * Dolan SA, Felizardo G, Barnes S, et al. "APIC position paper: safe injection, infusion, and medication vial practices in health care." ''American Journal of Infection Control'' 38(3):167–172 (2010). | |
| + | 139 | * Meyer BK, Ni A, Hu B, Shi L. "Antimicrobial preservative use in parenteral products: past and present." ''Journal of Pharmaceutical Sciences'' 96(12):3155–3167 (2007). | |
| + | 140 | ||
| 135 | == See also == | 141 | == See also == |
| 136 | * [[Vial]] | 142 | * [[Vial]] |
| ⋮ | ⋮ | ||
| 140 | * [[Sterile water for injection]] | 146 | * [[Sterile water for injection]] |
| 141 | * [[Sharps disposal]] | 147 | * [[Sharps disposal]] |
| + | 148 | * [[Sterility testing]] | |
| 142 | 149 | ||
| 143 | {{DEFAULTSORT:Multi-dose vial}} | 150 | {{DEFAULTSORT:Multi-dose vial}} |