Multi-dose vial: difference between revisions
Diff·revision 22 → 23·20:58, 12 May 2025
Difference between revision 22 and revision 23 of Multi-dose vial. 14 lines changed; the page grew by 2,139 bytes.
| Revision 22 — 15:17, 6 May 2025 GramsNotUnitsGil (talk) cite the trial publication rather than the press release 12,830 bytes +341 | Revision 23 — 20:58, 12 May 2025 FreightFenna (talk) British spelling per PP:MOS 14,969 bytes +2,139 | ||
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| 14 | | Methylparaben with propylparaben = approximately 0.18% with 0.02% w/v | 14 | | Methylparaben with propylparaben = approximately 0.18% with 0.02% w/v |
| 15 | | Thimerosal = 0.003–0.01% w/v; largely withdrawn | 15 | | Thimerosal = 0.003–0.01% w/v; largely withdrawn |
| + | 16 | <!-- Governing chapters --> | |
| + | 17 | | Container definitions = USP <659> | |
| + | 18 | | Antimicrobial effectiveness = USP <51> | |
| + | 19 | | Sterile compounding = USP <797> | |
| + | 20 | | Closure self-sealing and fragmentation = USP <381> | |
| 16 | }} | 21 | }} |
| 17 | {{hatnote|For the container itself and its materials, see [[Vial]]. For the dating of an opened container, see [[Beyond-use date]].}} | 22 | {{hatnote|For the container itself and its materials, see [[Vial]]. For the dating of an opened container, see [[Beyond-use date]].}} |
| ⋮ | ⋮ | ||
| 79 | Three features of this framework are consequential. The single-dose periods depend on the air quality of the environment in which the container was entered, which is a recognition that the risk being managed is airborne and personnel-borne contamination during the entry itself. The multiple-dose period does not depend on air quality, because the preservative is doing that work. And the phrase ''unless the manufacturer specifies otherwise'' is not decorative: several products carry shorter in-use periods on their labels, and those govern.{{r|usp797}} | 84 | Three features of this framework are consequential. The single-dose periods depend on the air quality of the environment in which the container was entered, which is a recognition that the risk being managed is airborne and personnel-borne contamination during the entry itself. The multiple-dose period does not depend on air quality, because the preservative is doing that work. And the phrase ''unless the manufacturer specifies otherwise'' is not decorative: several products carry shorter in-use periods on their labels, and those govern.{{r|usp797}} |
| 80 | 85 | ||
| + | 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 | ||
| + | 88 | == 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}} | |
| + | 90 | ||
| + | 91 | Resealing is not unconditional. Its reliability falls with the diameter of the needle used, with repeated penetration through the same point, and with damage to the elastomer surface. A closure penetrated twenty times with a 30-gauge needle at varied points is in a different condition from one penetrated twenty times with a 21-gauge needle at one point, and the compendial test — performed with a specified needle and technique — characterises the closure rather than any particular pattern of use.{{r|usp381mdv}} | |
| + | 92 | ||
| 81 | == References == | 93 | == References == |
| 82 | {{reflist}} | 94 | {{reflist}} |
| ⋮ | ⋮ | ||
| 84 | <ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref> | 96 | <ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref> |
| 85 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref> | 97 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref> |
| + | 98 | <ref name="usp381mdv">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections", including self-sealing and fragmentation tests. USP–NF, current revision.</ref> | |
| 86 | <ref name="usp1381mdv">United States Pharmacopeia, General Chapter <1381>, "Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems" (informational). USP–NF, current revision.</ref> | 99 | <ref name="usp1381mdv">United States Pharmacopeia, General Chapter <1381>, "Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems" (informational). USP–NF, current revision.</ref> |
| + | 100 | <ref name="pheur329mdv">European Pharmacopoeia, general chapter 3.2.9, "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders", including the fragmentation test.</ref> | |
| 87 | <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> | 101 | <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> |
| 88 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> | 102 | <ref name="fischer2010">Fischer GE, Schaefer MK, Labus BJ, et al. "Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008." ''Clinical Infectious Diseases'' 51(3):267–273 (2010).</ref> |