Vial: difference between revisions
Diff·revision 49 → 50·04:15, 12 Jul 2025
Difference between revision 49 and revision 50 of Vial. 3 lines changed; the page grew by 564 bytes.
| Revision 49 — 02:38, 2 Jul 2025 CouplingCillian (talk) expand §Dimensions and nominal capacity 21,712 bytes ±0 | Revision 50 — 04:15, 12 Jul 2025 ResinRhoswen (talk) add confidence interval 22,276 bytes +564 | ||
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| 138 | The mechanism is understood as a two-stage process. During forming, localised heating volatilises alkali and boron species from the glass surface, which redeposit as a layer of altered composition, chemically less durable than the bulk glass. In service, solution attacks that layer, and where attack is uneven the layer separates as flakes rather than dissolving. Risk factors identified in the advisory and in the literature include high pH, phosphate, citrate and tartrate buffers, terminal sterilisation, prolonged storage, and vials formed from tubing rather than moulded.{{r|fda2011,ennis2001}} | 138 | The mechanism is understood as a two-stage process. During forming, localised heating volatilises alkali and boron species from the glass surface, which redeposit as a layer of altered composition, chemically less durable than the bulk glass. In service, solution attacks that layer, and where attack is uneven the layer separates as flakes rather than dissolving. Risk factors identified in the advisory and in the literature include high pH, phosphate, citrate and tartrate buffers, terminal sterilisation, prolonged storage, and vials formed from tubing rather than moulded.{{r|fda2011,ennis2001}} |
| 139 | 139 | ||
| + | 140 | USP <1660> provides the compendial approach to evaluating inner-surface durability, combining accelerated attack under defined conditions with surface analysis and with examination for lamellae. Its purpose is prospective screening during development rather than release testing, because the phenomenon develops over storage and a release test cannot detect it.{{r|usp1660}} | |
| + | 141 | ||
| 140 | == References == | 142 | == References == |
| 141 | {{reflist}} | 143 | {{reflist}} |
| ⋮ | ⋮ | ||
| 147 | <ref name="usp1151">United States Pharmacopeia, General Chapter <1151>, "Pharmaceutical Dosage Forms" (informational), including recommended excess volumes for injections. USP–NF, current revision.</ref> | 149 | <ref name="usp1151">United States Pharmacopeia, General Chapter <1151>, "Pharmaceutical Dosage Forms" (informational), including recommended excess volumes for injections. USP–NF, current revision.</ref> |
| 148 | <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> | 150 | <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> |
| + | 151 | <ref name="usp1660">United States Pharmacopeia, General Chapter <1660>, "Evaluation of the Inner Surface Durability of Glass Containers" (informational). USP–NF, current revision.</ref> | |
| 149 | <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> | 152 | <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> |
| 150 | <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> | 153 | <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> |