Vial: difference between revisions
Diff·revision 1 → 2·21:54, 23 Jul 2024
Difference between revision 1 and revision 2 of Vial. 9 lines changed; the page grew by 1,480 bytes.
| Revision 1 — 09:00, 23 Jul 2024 CounterfeitCato (talk) create article 1,793 bytes +1,793 | Revision 2 — 21:54, 23 Jul 2024 TSH_Tallulah (talk) remove weasel wording 3,273 bytes +1,480 | ||
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| 12 | The container has three simultaneous duties. It must contain the product without contributing to it, which constrains the chemistry of both glass and elastomer; it must exclude micro-organisms and, for many products, moisture and oxygen, which is a matter of seal integrity rather than of material; and it must permit withdrawal by needle without loss of that integrity, which is why the closure is a penetrable elastomer rather than a screw cap.{{r|usp381,usp1207}} | 12 | The container has three simultaneous duties. It must contain the product without contributing to it, which constrains the chemistry of both glass and elastomer; it must exclude micro-organisms and, for many products, moisture and oxygen, which is a matter of seal integrity rather than of material; and it must permit withdrawal by needle without loss of that integrity, which is why the closure is a penetrable elastomer rather than a screw cap.{{r|usp381,usp1207}} |
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| + | 14 | == Construction and materials == | |
| + | 15 | Pharmaceutical glass vials are produced by two routes with different characteristics. | |
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| + | 17 | '''Tubing-drawn vials''' are formed by softening a length of drawn borosilicate tubing and shaping the base and neck. Wall thickness is set by the tubing and is thin and uniform; dimensional tolerances are close; and the process is fast, which makes tubing the route for small vials produced in quantity. Because the neck and base are formed by localised heating, the inner surface at those points reaches higher temperatures than elsewhere and is chemically altered, which is the origin of the delamination susceptibility discussed below.{{r|ennis2001}} | |
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| + | 19 | '''Moulded vials''' are formed by pressing molten glass in a mould. Walls are thicker and less uniform, tolerances looser, and the vials heavier and more robust. Moulding dominates for larger containers and where mechanical strength matters more than dimensional precision.{{r|iso8362_1}} | |
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| 14 | == References == | 21 | == References == |
| 15 | {{reflist}} | 22 | {{reflist}} |
| 16 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> | 23 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> |
| 17 | <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> | 24 | <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> |
| + | 25 | <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> | |
| + | 26 | <ref name="ennis2001">Ennis RD, Pritchard R, Nakamura C, et al. "Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination." ''Pharmaceutical Development and Technology'' 6(3):393–405 (2001).</ref> | |
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| 19 | {{DEFAULTSORT:Vial}} | 28 | {{DEFAULTSORT:Vial}} |