Multi-dose vial: difference between revisions
Diff·revision 5 → 6·23:33, 8 Feb 2025
Difference between revision 5 and revision 6 of Multi-dose vial. 4 lines changed; the page grew by 784 bytes.
| Revision 5 — 22:49, 6 Feb 2025 RotationRosalind (talk) merge two short sections 2,077 bytes ±0 | Revision 6 — 23:33, 8 Feb 2025 PortalPolly (talk) restructure 2,861 bytes +784 | ||
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| 11 | Two requirements follow from repeated entry. Because each penetration of the closure is an opportunity for microbial ingress, and because the contents are held at or near room temperature for a period afterwards, a multiple-dose preparation must contain an antimicrobial preservative whose effectiveness has been demonstrated by the challenge testing described in USP <51>. And because the preservative controls but does not eliminate risk, the period during which the container may be used after its first puncture is limited, conventionally to 28 days unless the manufacturer specifies otherwise.{{r|usp51,usp797}} | 11 | Two requirements follow from repeated entry. Because each penetration of the closure is an opportunity for microbial ingress, and because the contents are held at or near room temperature for a period afterwards, a multiple-dose preparation must contain an antimicrobial preservative whose effectiveness has been demonstrated by the challenge testing described in USP <51>. And because the preservative controls but does not eliminate risk, the period during which the container may be used after its first puncture is limited, conventionally to 28 days unless the manufacturer specifies otherwise.{{r|usp51,usp797}} |
| 12 | 12 | ||
| + | 13 | The 28-day convention is frequently misread as a statement about chemical stability. It is not: it derives from the antimicrobial effectiveness of preserved formulations and from infection-control practice, and it is independent of whether the active substance remains within specification. A preparation may be chemically stable for a year and still be discarded at 28 days, and a preparation may lose potency well before 28 days despite its preservative performing perfectly.{{r|usp797,cdc_injection}} | |
| + | 14 | ||
| 13 | == References == | 15 | == References == |
| 14 | {{reflist}} | 16 | {{reflist}} |
| ⋮ | ⋮ | ||
| 16 | <ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref> | 18 | <ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref> |
| 17 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref> | 19 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref> |
| + | 20 | <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> | |
| 18 | 21 | ||
| 19 | {{DEFAULTSORT:Multi-dose vial}} | 22 | {{DEFAULTSORT:Multi-dose vial}} |
| 20 | [[Category:Preparation and handling]] | 23 | [[Category:Preparation and handling]] |
| 21 | [[Category:Fill and finish]] | 24 | [[Category:Fill and finish]] |
| + | 25 | [[Category:Injection technique]] | |
| 22 | 26 |