Vial: difference between revisions
Diff·revision 10 → 11·18:02, 30 Aug 2024
Difference between revision 10 and revision 11 of Vial. 4 lines changed; the page grew by 618 bytes.
| Revision 10 — 14:46, 25 Aug 2024 CDMO_Caradoc (talk) cite the trial publication rather than the press release 6,141 bytes ±0 | Revision 11 — 18:02, 30 Aug 2024 FreightFenna (talk) convert list to prose 6,759 bytes +618 | ||
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| 31 | | NP | Soda-lime, general purpose | Powdered glass test | Non-parenteral only | | 31 | | NP | Soda-lime, general purpose | Powdered glass test | Non-parenteral only | |
| 32 | 32 | ||
| + | 33 | The classification is by measured hydrolytic resistance rather than by nominal composition, and the tests differ between types: powdered glass tests interrogate the bulk composition, whereas the water attack test interrogates the treated inner surface. The European Pharmacopoeia operates a closely comparable scheme through general chapter 3.2.1 and the ISO 719 and ISO 720 grain tests.{{r|usp660,pheur321}} | |
| + | 34 | ||
| 33 | === Depyrogenation === | 35 | === Depyrogenation === |
| 34 | 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}} | 36 | 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}} |
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| 42 | <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> | 44 | <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> |
| 43 | <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> | 45 | <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> |
| + | 46 | <ref name="pheur321">European Pharmacopoeia, general chapter 3.2.1, "Glass containers for pharmaceutical use", read with ISO 719 and ISO 720 hydrolytic resistance tests.</ref> | |
| 44 | <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> | 47 | <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> |
| 45 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | 48 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> |
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| 49 | [[Category:Preparation and handling]] | 52 | [[Category:Preparation and handling]] |
| 50 | [[Category:Manufacturing and supply]] | 53 | [[Category:Manufacturing and supply]] |
| + | 54 | [[Category:Compendial testing]] | |
| 51 | 55 |