By Felix Franks

This e-book describes the know-how of freeze-drying with specific emphasis at the houses of the fabric to be processed, pre-freezing (formulation) and post-drying (stability and shelf life). it's the first single-author e-book, targeted customarily at the houses of the fabrics to be processed, kept and advertised. The ebook goals to remove the mystique that is nonetheless surrounding the expertise and issues tips to "Stability by way of Design".

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Extra resources for Freeze-Drying of Pharmaceuticals and Biopharmaceuticals: Principles and Practice

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For any 35 Essential Physics of Low Temperature and Freezing temperature below Tm, ice is the stable phase, so that DGco0. Opposing the growth of the cluster are the forces due to surface tension (s) between the liquid and the cluster surface. e. the cluster size for spontaneous crystal growth, is obtained as r* by differentiation of Equation (2): r* ¼ À2s/DGc and DG*l-s ¼ 16pr/3(DGc)2 (3) The nucleation relationships for water at 233 K (À401C) are shown in Figure 6. The number of critical nuclei in a given volume of water, n(r*), +4 +3 4πr2σ +2 ∆G(10−18J) +1 0 2 3 4 Drop radius (nm) −1 ∆Gls −2 −3 4 3 πr3∆Gv −4 Figure 6 The volume free energy of homogeneous nucleation of undercooled water at À401C as a function of the cluster radius at À401C (see Equation (2)).

Yet two further aspects associated with ice growth in a freezing solution deserve mention. For the sake of simplicity, we consider the advance of a planar ice front during controlled cooling, shown in Figure 14 for a 2% w/w solution of NaMnO4. A thin film is held between two thin glass plates set 10 mm apart and is seeded with an ice crystal and cooled inwards from 46 Chapter 4 Figure 13 TTT curves for the crystallisation of water and glycerol. 28 Initially, a planar ice front is maintained. As the front moves into the body of solution, a concentration gradient is established, because diffusion of the salt away from the freezing interface cannot keep up with the rate of advance of the ice front.

166 Neither preparation showed signs of deterioration. Similar success was achieved (Mathias & Franks, unpublished results) with tobacco embryos, grown in tissue culture, and stored at À201C. They were successfully grown into healthy plants. e. at Th. The ratios of the signal amplitudes corresponded exactly to the concentration ratios of intracellular water to empty water droplets. The undercooling technique can be considerably refined and is thus a useful means of storing live material or clinical fluid specimens for prolonged periods.

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