Vial: difference between revisions
Diff·revision 2 → 3·22:26, 6 Aug 2024
Difference between revision 2 and revision 3 of Vial. 8 lines changed; the page grew by 1,739 bytes.
| Revision 2 — 21:35, 25 Jul 2024 TSH_Tallulah (talk) ce, tighten prose 3,923 bytes +650 | Revision 3 — 22:26, 6 Aug 2024 CDMO_Caradoc (talk) correct the freezer temperature range given for long-term storage 5,662 bytes +1,739 | ||
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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a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} | |
| + | 15 | ||
| 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. |
| ⋮ | ⋮ | ||
| 21 | Polymer vials of cyclic olefin polymer or copolymer are established for products incompatible with glass or requiring extreme resistance to breakage. They eliminate delamination and alkali leaching, and they permit lower moisture-vapour barrier performance and different extractable profiles — trade-offs rather than improvements. Requirements for plastic packaging systems are set out in USP <661> and its subsidiary chapters.{{r|usp661}} | 23 | Polymer vials of cyclic olefin polymer or copolymer are established for products incompatible with glass or requiring extreme resistance to breakage. They eliminate delamination and alkali leaching, and they permit lower moisture-vapour barrier performance and different extractable profiles — trade-offs rather than improvements. Requirements for plastic packaging systems are set out in USP <661> and its subsidiary chapters.{{r|usp661}} |
| 22 | 24 | ||
| + | 25 | === Depyrogenation === | |
| + | 26 | Glass vials are rendered free of endotoxin by dry heat, conventionally at 250 °C or above for a validated period, with the requirement expressed as a demonstrated reduction of at least three logarithms in a challenge of bacterial endotoxin rather than as a time and temperature alone. The process is destructive to endotoxin rather than merely sterilising, which is why it is specified separately from sterilisation and why autoclaving does not substitute for it. Verification of the result is by the [[Bacterial endotoxin test|bacterial endotoxin test]] described in USP <85>.{{r|usp660,usp1207}} | |
| + | 27 | ||
| 23 | == References == | 28 | == References == |
| 24 | {{reflist}} | 29 | {{reflist}} |
| + | 30 | <ref name="usp660">United States Pharmacopeia, General Chapter <660>, "Containers — Glass". USP–NF, current revision.</ref> | |
| 25 | <ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref> | 31 | <ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref> |
| 26 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> | 32 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> |
| 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> | 33 | <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> | 34 | <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> |
| + | 35 | <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> | 36 | <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> |
| + | 37 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | |
| 30 | 38 | ||
| 31 | {{DEFAULTSORT:Vial}} | 39 | {{DEFAULTSORT:Vial}} |