Vial: difference between revisions
Diff·revision 13 → 14·16:05, 15 Sep 2024
Difference between revision 13 and revision 14 of Vial. 2 lines changed; the page grew by 397 bytes.
| Revision 13 — 06:25, 10 Sep 2024 FiveOhThreeB (talk) undo good-faith edit: the source does not say this 6,759 bytes ±0 | Revision 14 — 16:05, 15 Sep 2024 SupplyWatchSuri (talk) replace primary source with the review 7,156 bytes +397 | ||
|---|---|---|---|
| 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}} | 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 | 34 | ||
| + | 35 | Type I borosilicate is specified for essentially all injectable products. Its low alkali content limits pH shift on storage, and its linear expansion coefficient of roughly 32–33 × 10⁻⁷ K⁻¹ — about a third that of soda-lime glass — gives the thermal shock resistance required for depyrogenation at 250 °C or above and for the thermal cycling of a lyophilisation cycle.{{r|usp660}} | |
| + | 36 | ||
| 35 | === Depyrogenation === | 37 | === Depyrogenation === |
| 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}} | 38 | 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}} |