Vial: difference between revisions
Diff·revision 18 → 19·05:18, 16 Oct 2024
Difference between revision 18 and revision 19 of Vial. 18 lines changed; the page grew by 1,691 bytes.
| Revision 18 — 14:01, 9 Oct 2024 CounterfeitCato (talk) reorder sections to follow the class template 9,207 bytes ±0 | Revision 19 — 05:18, 16 Oct 2024 CouplingCillian (talk) attribute claim in-text 10,898 bytes +1,691 | ||
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| 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 |
| ⋮ | ⋮ | ||
| 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 | == Elastomeric closures == | |
| + | 65 | 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. | |
| + | 66 | ||
| + | 67 | |+ Closure elastomers in pharmaceutical use | |
| + | 68 | | !Elastomer | Gas and moisture permeability | Resealing | Typical role | | |
| + | 69 | |---|---|---|---| | |
| + | 70 | | Bromobutyl rubber | Low | Good | Standard for lyophilised and aqueous parenterals | | |
| + | 71 | | Chlorobutyl rubber | Low | Good | Standard alternative; different cure chemistry | | |
| + | 72 | | Natural rubber | High | Very good | Largely superseded; latex protein concerns | | |
| + | 73 | | Silicone | Very high | Good | Specialised, where extractables must be minimal | | |
| + | 74 | | Isoprene blends | Intermediate | Good | Occasional, in blends | | |
| + | 75 | ||
| + | 76 | 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}} | |
| + | 77 | ||
| 62 | == References == | 78 | == References == |
| 63 | {{reflist}} | 79 | {{reflist}} |
| ⋮ | ⋮ | ||
| 65 | <ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref> | 81 | <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> | 82 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> |
| + | 83 | <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> | 84 | <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> | 85 | <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]] | 94 | [[Category:Manufacturing and supply]] |
| 78 | [[Category:Compendial testing]] | 95 | [[Category:Compendial testing]] |
| + | 96 | [[Category:Traceability]] | |
| 79 | 97 |