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Lyophilisation: difference between revisions

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Revision 9 — 10:14, 16 Nov 2024
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1{{Infobox method1{{Infobox method
2| name = Lyophilisation2| name = Lyophilisation
+3| image = vial.svg
+4| caption = A lyophilised cake occupies approximately the volume of the original fill. Cake structure is a recorded quality attribute.
3| Also known as = Freeze-drying5| Also known as = Freeze-drying
4| Class = Dehydration by sublimation6| Class = Dehydration by sublimation
61| Sodium chloride | Eutectic ≈ −21.1 °C | Crystallises |63| Sodium chloride | Eutectic ≈ −21.1 °C | Crystallises |
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+65== Primary drying ==
+66Primary drying removes the ice, which for a typical aqueous fill is 90–98% of the water present. Its duration is set by the sublimation rate, which in the simplest treatment follows from an energy balance across the vial base: the mass flow equals the heat flow divided by the enthalpy of sublimation.
+67
+68A worked estimate for a single 6R vial illustrates the magnitudes involved. Taking a vial cross-sectional area of 3.14 cm², a vial heat transfer coefficient of 20 W·m⁻²·K⁻¹, a shelf temperature of −10 °C and a product temperature of −30 °C, the heat flow is
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+70{{math|Q = 20 W m^{-2} K^{-1} × 3.14 × 10^{-4} m^{2} × 20 K = 0.126 W}}
+71
+72and the sublimation rate is
+73
63== References ==74== References ==
64{{reflist}}75{{reflist}}
79[[Category:Preparation and handling]]90[[Category:Preparation and handling]]
80[[Category:Cold chain and stability]]91[[Category:Cold chain and stability]]
+92[[Category:Manufacturing and supply]]
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