Multi-dose vial: difference between revisions
Diff·revision 25 → 26·15:50, 3 Jun 2025
Difference between revision 25 and revision 26 of Multi-dose vial. 2 lines changed; the page grew by 225 bytes.
| Revision 25 — 17:47, 27 May 2025 EscalationEira (talk) clarify whether figure is gross or net mass 15,615 bytes ±0 | Revision 26 — 15:50, 3 Jun 2025 PBM_Perrin (talk) convert list to prose 15,840 bytes +225 | ||
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| 86 | Infection-control guidance from the Centers for Disease Control and Prevention adds a practice dimension that the compendial rule does not address. Its recommendations are that a multiple-dose vial be dedicated to a single patient wherever possible; that vials be entered with a new sterile needle and syringe on every occasion; that a vial be discarded if sterility is compromised or questionable regardless of its date; and that vials entered in an immediate patient-treatment area be discarded at the end of the procedure rather than retained.{{r|cdc_injection}} | 86 | Infection-control guidance from the Centers for Disease Control and Prevention adds a practice dimension that the compendial rule does not address. Its recommendations are that a multiple-dose vial be dedicated to a single patient wherever possible; that vials be entered with a new sterile needle and syringe on every occasion; that a vial be discarded if sterility is compromised or questionable regardless of its date; and that vials entered in an immediate patient-treatment area be discarded at the end of the procedure rather than retained.{{r|cdc_injection}} |
| 87 | 87 | ||
| + | 88 | The last of these is the rule most often surprising, and its rationale is that proximity to a patient introduces contamination risks that the preservative and the 28-day period were not intended to cover.{{r|cdc_injection}} | |
| + | 89 | ||
| 88 | == Repeated entry: coring and closure integrity == | 90 | == Repeated entry: coring and closure integrity == |
| 89 | Each penetration of an elastomeric closure creates a channel that reseals by elastic recovery. The closure's ability to do so repeatedly is a specified property, tested compendially by the self-sealing test in USP <381> and the corresponding European Pharmacopoeia chapter: a defined number of penetrations is made and the container is then examined for leakage.{{r|usp381mdv,pheur329mdv}} | 91 | Each penetration of an elastomeric closure creates a channel that reseals by elastic recovery. The closure's ability to do so repeatedly is a specified property, tested compendially by the self-sealing test in USP <381> and the corresponding European Pharmacopoeia chapter: a defined number of penetrations is made and the container is then examined for leakage.{{r|usp381mdv,pheur329mdv}} |