Vial: difference between revisions

Diff·revision 8 → 9·12:44, 14 Oct 2024

Difference between revision 8 and revision 9 of Vial. 20 lines changed; the page grew by 1,970 bytes.

Revision 8 — 11:29, 3 Oct 2024 ResinRhoswen (talk) expand §Delamination and glass defects 9,207 bytes +1,409	Revision 9 — 12:44, 14 Oct 2024 StubSorterBot (talk) bot: update parent category chain 11,177 bytes +1,970
1	{{Infobox concept	1	{{Infobox concept
2	\| name = Vial	2	\| name = Vial
+		3	\| image = vial.svg
+		4	\| caption = A tubing-drawn vial with an elastomeric closure and crimped aluminium ferrule. The three components together constitute the container closure system.
3	\| Function = Primary container for injectable and lyophilised products	5	\| Function = Primary container for injectable and lyophilised products
4	\| Usual material = Type I borosilicate glass	6	\| Usual material = Type I borosilicate glass
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60	Dimensions are nominal and subject to the tolerances in the standard.{{r\|iso8362_1}} Two consequences follow for reading a label. A vial described as a 2 mL vial holds about 4 mL brimful, so a 2R vial containing 1 mL of liquid looks nearly empty and a 2R vial containing a 5 mg lyophilised cake may appear to contain nothing at all. And the neck finish, not the nominal capacity, determines which closure fits — 13 mm and 20 mm are not interchangeable, and a 20 mm stopper on a 13 mm vial cannot be sealed.	62	Dimensions are nominal and subject to the tolerances in the standard.{{r\|iso8362_1}} Two consequences follow for reading a label. A vial described as a 2 mL vial holds about 4 mL brimful, so a 2R vial containing 1 mL of liquid looks nearly empty and a 2R vial containing a 5 mg lyophilised cake may appear to contain nothing at all. And the neck finish, not the nominal capacity, determines which closure fits — 13 mm and 20 mm are not interchangeable, and a 20 mm stopper on a 13 mm vial cannot be sealed.
61		63
+		64	The label declaration for an injectable is the volume or mass withdrawable, and vials are therefore filled with a small excess. USP <697> requires that the volume obtainable be not less than the labelled volume, and USP <1151> gives recommended excess volumes for that purpose.
+		65
+		66	== Elastomeric closures ==
+		67	The stopper performs three functions: it seals, it is penetrable by a needle and reseals afterwards, and it must not contribute leachables to the product. No single elastomer optimises all three, and formulation is a compromise.
+		68
+		69	\|+ Closure elastomers in pharmaceutical use
+		70	\| !Elastomer \| Gas and moisture permeability \| Resealing \| Typical role \|
+		71	\|---\|---\|---\|---\|
+		72	\| Bromobutyl rubber \| Low \| Good \| Standard for lyophilised and aqueous parenterals \|
+		73	\| Chlorobutyl rubber \| Low \| Good \| Standard alternative; different cure chemistry \|
+		74	\| Natural rubber \| High \| Very good \| Largely superseded; latex protein concerns \|
+		75	\| Silicone \| Very high \| Good \| Specialised, where extractables must be minimal \|
+		76	\| Isoprene blends \| Intermediate \| Good \| Occasional, in blends \|
+		77
+		78	Butyl elastomers dominate because their low permeability protects a lyophilised cake from moisture ingress and an oxygen-sensitive product from oxidation over a multi-year shelf life. A closure formulation is a mixture of elastomer, filler, curing system, pigment and lubricant, and the components other than the elastomer are frequently the source of the extractables that make a closure unsuitable for a particular product.{{r\|usp381,usp1381}}
+		79
62	== References ==	80	== References ==
63	{{reflist}}	81	{{reflist}}
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65	<ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref>	83	<ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref>
66	<ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref>	84	<ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref>
+		85	<ref name="usp1381">United States Pharmacopeia, General Chapter <1381>, "Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems" (informational). USP–NF, current revision.</ref>
67	<ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, "Package Integrity Evaluation — Sterile Products" (informational), with subchapters <1207.1> to <1207.3>. USP–NF, current revision.</ref>	86	<ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, "Package Integrity Evaluation — Sterile Products" (informational), with subchapters <1207.1> to <1207.3>. USP–NF, current revision.</ref>
68	<ref name="iso8362_1">ISO 8362-1:2018, ''Injection containers and accessories — Part 1: Injection vials made of glass tubing'', read with ISO 8362-4:2011, ''Part 4: Injection vials made of moulded glass''. International Organization for Standardization.</ref>	87	<ref name="iso8362_1">ISO 8362-1:2018, ''Injection containers and accessories — Part 1: Injection vials made of glass tubing'', read with ISO 8362-4:2011, ''Part 4: Injection vials made of moulded glass''. International Organization for Standardization.</ref>
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77	[[Category:Manufacturing and supply]]	96	[[Category:Manufacturing and supply]]
78	[[Category:Compendial testing]]	97	[[Category:Compendial testing]]
+		98	[[Category:Traceability]]
79		99