Vial: difference between revisions
Diff·revision 5 → 6·22:56, 4 Aug 2024
Difference between revision 5 and revision 6 of Vial. 4 lines changed; the page grew by 988 bytes.
| Revision 5 — 04:37, 3 Aug 2024 BPC_Bramwell (talk) expand §Construction and materials 3,923 bytes ±0 | Revision 6 — 22:56, 4 Aug 2024 RepackRadek (talk) fix hyphenation per PP:MOS 4,911 bytes +988 | ||
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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}} |
| 13 | 13 | ||
| + | 14 | Failures of each duty are documented and distinct. Leaching of glass constituents alters solution pH and can catalyse degradation; inner-surface delamination sheds glass flakes and was the subject of regulatory advisories and recalls in 2010 and 2011; incomplete sealing permits microbial ingress and moisture gain, the latter raising the residual moisture of a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} | |
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| 14 | == Construction and materials == | 16 | == Construction and materials == |
| 15 | Pharmaceutical glass vials are produced by two routes with different characteristics. | 17 | Pharmaceutical glass vials are produced by two routes with different characteristics. |
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| 27 | <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> | 29 | <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> |
| 28 | <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> | 30 | <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> |
| + | 31 | <ref name="iso8362_5">ISO 8362-5:2016, ''Injection containers and accessories — Part 5: Freeze drying closures for injection vials'', read with ISO 8362-6:2010, ''Part 6: Caps made of aluminium-plastics combinations for injection vials''. International Organization for Standardization.</ref> | |
| 29 | <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> | 32 | <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> |
| + | 33 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | |
| 30 | 34 | ||
| 31 | {{DEFAULTSORT:Vial}} | 35 | {{DEFAULTSORT:Vial}} |