Multi-dose vial: difference between revisions

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1	{{Infobox concept	1	{{Infobox concept
2	\| name = Multi-dose vial	2	\| name = Multi-dose vial
+		3	\| image = vial.svg
+		4	\| caption = Repeated penetration of a single closure is the defining feature, and the source of both the preservative requirement and the coring risk.
3	\| Compendial term = Multiple-dose container	5	\| Compendial term = Multiple-dose container
4	\| Defining feature = Intended for more than one withdrawal	6	\| Defining feature = Intended for more than one withdrawal
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49	The phenolic preservatives illustrate that a preservative is not an inert additive. In insulin formulations, phenol and m-cresol bind at a specific site on the hexamer and shift the conformational equilibrium, and their presence is required for the physical stability of the formulation as well as for its preservation. Removing the preservative from such a product is therefore not merely a microbiological change.{{r\|brange1993}}	51	The phenolic preservatives illustrate that a preservative is not an inert additive. In insulin formulations, phenol and m-cresol bind at a specific site on the hexamer and shift the conformational equilibrium, and their presence is required for the physical stability of the formulation as well as for its preservation. Removing the preservative from such a product is therefore not merely a microbiological change.{{r\|brange1993}}
50		52
+		53	=== Preservative loss during use ===
+		54	Preservative concentration is not constant over a container's in-use life. Volatile preservatives such as chlorobutanol are lost to the headspace and through the closure; benzyl alcohol partitions into elastomer; and adsorption onto the stopper is documented for several preservatives. Compendial expectations accordingly include a preservative content specification at the end of shelf life, not only at release, and effectiveness testing is conventionally performed at the lower end of the specified range rather than at the target concentration.{{r\|usp51,usp1381mdv}}
+		55
+		56	Repeated withdrawal has an additional effect that is easy to overlook: as liquid is removed the headspace grows, increasing both the volume into which a volatile preservative can partition and the surface area of elastomer per unit of remaining liquid. A vial near the end of its contents therefore has a somewhat less favourable preservative situation than a full one, at exactly the point at which it has accumulated the most punctures.{{r\|usp1381mdv}}
+		57
+		58	== The period after initial puncture ==
+		59	USP <797>, the general chapter governing sterile compounding in the United States, sets the framework within which opened containers are dated. Its treatment distinguishes conventionally manufactured products from compounded preparations, and within manufactured products distinguishes single-dose from multiple-dose containers.
+		60
+		61	\|+ Dating of opened conventionally manufactured containers under USP <797>
+		62	\| !Container \| Environment when entered \| Permitted period after entry \|
+		63	\|---\|---\|---\|
+		64	\| Single-dose container \| ISO Class 5 air or better \| Up to 12 hours \|
+		65	\| Single-dose container \| Worse than ISO Class 5 air \| Up to 1 hour \|
+		66	\| Multiple-dose container \| Any, subject to aseptic technique \| 28 days, unless the manufacturer specifies otherwise \|
+		67	\| Pharmacy bulk package \| ISO Class 5 air \| As specified on the label \|
+		68
+		69	Periods are those tabulated in the 2023 revision of the chapter; the chapter is periodically revised and its earlier revisions differ in detail.{{r\|usp797}}
+		70
51	== References ==	71	== References ==
52	{{reflist}}	72	{{reflist}}
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54	<ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref>	74	<ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref>
55	<ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref>	75	<ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision.</ref>
+		76	<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>
56	<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>	77	<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>
57	<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>	78	<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>