Lyophilisation: difference between revisions
Diff·revision 65 → 66·01:05, 10 Dec 2025
Difference between revision 65 and revision 66 of Lyophilisation. 2 lines changed; the page grew by 558 bytes.
| Revision 65 — 04:15, 2 Dec 2025 DMF_Dermot (talk) fix unit 28,121 bytes ±0 | Revision 66 — 01:05, 10 Dec 2025 ColdChainCleo (talk) add citation for the incidence figure 28,679 bytes +558 | ||
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| 168 | Quality-by-design approaches address this by constructing a design space in terms of the two variables that actually constrain the process — the maximum sublimation rate the equipment can support, and the shelf temperature at which the product would reach its critical temperature — and locating the operating point inside both boundaries. Presented graphically, this is conventionally called a design-space or primary-drying diagram, and it makes explicit that a cycle is equipment-specific.{{r|tang2004}} | 168 | Quality-by-design approaches address this by constructing a design space in terms of the two variables that actually constrain the process — the maximum sublimation rate the equipment can support, and the shelf temperature at which the product would reach its critical temperature — and locating the operating point inside both boundaries. Presented graphically, this is conventionally called a design-space or primary-drying diagram, and it makes explicit that a cycle is equipment-specific.{{r|tang2004}} |
| 169 | 169 | ||
| + | 170 | For an encyclopedia the transferable point is narrower: a statement that a product is lyophilised conveys almost nothing about how it was lyophilised, and two vials of nominally identical peptide from different suppliers may have experienced cycles differing by tens of degrees in product temperature and by a factor of three in duration. Where cake appearance, moisture and reconstitution behaviour differ visibly between lots of the same compound, process difference is a more parsimonious explanation than difference in the peptide itself.{{r|nail2002}} | |
| + | 171 | ||
| 170 | == References == | 172 | == References == |
| 171 | {{reflist}} | 173 | {{reflist}} |