Fluid Bed Drier

To describe the procedure for validation of the fluid bed drier to ensure that it meets installation, operation, and performance qualification requirements 

It is the responsibility of the production manager and technical services manager to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

Instruments for measuring temperature, humidity, time, air volume and pressure, as well as recording devices for these variables, should be calibrated. 

Place several thermocouples at different locations in an empty fluid bed drier, e.g.  

Measure the temperatures, letting in air of a constant temperature (e.g., 60°C). 1.3 Inlet air installation 

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Polyethers such as monensin, lasalocid, salinomycin, and narasin are sold in many countries in crystalline or highly purified forms for incorporation into feeds or sustained-release bolus devices (see Controlled-RELEASE technology). There are also mycelial or biomass products, especially in the United States. The mycelial products are generally prepared by separation of the mycelium and then drying by azeotropic evaporation, fluid-bed driers, continuous tray driers, flash driers, and other types of commercial driers (163). In countries allowing biomass products, crystalline polyethers may be added to increase the potency of the product. 

The heat required to evaporate moisture may be obtained by eonveetion from the gas stream, by eonduetion e.g. on heated trays, in pneumatie risers, fluidized beds, spray towers, or by radiation. A typieal fluidized bed drier is depieted in Figure 4.28. The hydrodynamie prineiples of fluidization were summarized in Chapter 2. Within a fluid bed drier, heated air, or other hot... 

Fluidized-bed driers are also widely used due to their large heat- and mass-transfer coefficients. However, materials of even moderate adherence and cohesiveness cannot be dried in a fluid bed. The same applies to materials that are sensitive to oxygen, especially at elevated temperatures. Vacuum drying is often necessary for oxygen sensitive materials and this is not easy to realize in fluid-bed driers, although there are systems to deal with this problem. Fluid-bed driers are not as easy to clean as shelf driers or rotary driers. 

Borax decahydrate is produced from borate ores, primarily colemanite and also from dry lake brines. When produced from its ore, the ore is crushed and then blended with B2O3. The blend is mixed with hot recycle liquor in a dissolving plant. Rock and clay particles from the liquor are removed over vibrating screens. The hquor is then fed to thickeners for settling of insolubles after which the underflow mud is washed with water. The strong liquor of borax hydrates is then pumped into continuous vacuum crystallizers for the separation of the pentahydrate first and then the decahydrate. The products are dried in rotary or fluid bed driers. 

Via HVAC systems, fluid bed driers, film-coaters, vacuum systems, and product containers... 

Bruker Optics. Near IR Analysis of Powder Moisture in a Fluid Bed Drier, AF 506E. www.brukeroptics.com. 

More recently driers based on the fluid-bed principle were introduced. Figures 160 and 161 give diagrammatic presentations of sodium nitrate and woodmeal fluid-bed driers. 

F1g. 160. Sodium nitrate fluid-bed drier (Courtesy H. Orth G.m.b.H.( Ludwigshafen-Oggersheim, G.F.R.) 1—filter tube, 2— mill, 3—lift, 4—feeder, 5—outlet cyclone, 6— filter tube, 7— end-mill, 8—discharge funnel, 9—ventilator, 10—calorifuge, 11—fluid-bed... 

More modern fluid bed driers are now much in use. A diagrammatic presentation of such a drier is given in Fig. 164 and the general view in Fig. 165. 

The selection of the extruder design is based on the principal requirements of the extrudate and the nature of further processing. For the production of uniform granules to be dried in a fluid-bed drier, a low-compaction system, such as that provided by the various types of screen extruders may be suitable. Cylinder or gear-type extruders may be more appropriate when aiming for a densified extrudate, such as that required for spheronization. Ram-extrusion systems, which allow precision control of extrudate density, size, and shape, are ideal for the extrusion and forming of pharmaceutical polymers of the type used for sub-dermal implants. 

Exhaust air discharge points on pharmaceutical equipment and facilities, such as from fluid bed driers and tablet-coating equipment, and exhaust air from dust extraction systems, carry heavy dust loads and should be provided with adequate filtration to prevent contamination of the ambient air. 

Filter bags fitted to fluid bed driers should not be used for different products, without being washed between use. 

Requirements for solvent recovery systems are lower for single-pot processors compared with fluid-bed driers. Single-pot processors outfitted with vacuum are attractive for evaporating events that are explosive or for containing drug substances... 

Figure 4 An integrated pharmaceutical manufacturing facility (high-shear granulator-conical screening mill-fluid bed drier).

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