Vial: difference between revisions
Diff·revision 22 → 23·14:42, 15 Jul 2025
Difference between revision 22 and revision 23 of Vial. 6 lines changed; the page grew by 732 bytes.
| Revision 22 — 08:09, 24 Jun 2025 NPOV_Nadia (talk) state that a phase-change pack and a gel pack behave differently 21,712 bytes +1,439 | Revision 23 — 14:42, 15 Jul 2025 SPPS_Sorrel (talk) rm the vendor-specific packaging detail; not general enough for the article 22,444 bytes +732 | ||
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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> |
| ⋮ | ⋮ | ||
| 158 | * Sacha GA, Saffell-Clemmer W, Abram K, Akers MJ. "Practical fundamentals of glass, rubber, and plastic sterile packaging systems." ''Pharmaceutical Development and Technology'' 15(1):6–34 (2010). | 161 | * Sacha GA, Saffell-Clemmer W, Abram K, Akers MJ. "Practical fundamentals of glass, rubber, and plastic sterile packaging systems." ''Pharmaceutical Development and Technology'' 15(1):6–34 (2010). |
| 159 | * Guazzo DM. "Container closure integrity testing" in ''Sterile Product Development'', Springer (2013). | 162 | * Guazzo DM. "Container closure integrity testing" in ''Sterile Product Development'', Springer (2013). |
| + | 163 | ||
| + | 164 | == External links == | |
| + | 165 | * [https://www.usp.org/ USP General Chapters index] — Chapters <660>, <381>, <697>, <1207> and <1660> are the relevant ones; text is paywalled. | |
| 160 | 166 | ||
| 161 | == See also == | 167 | == See also == |