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Pharmaceutical manufacturing mass transfer

Mass transfer phenomena exist everywhere in nature and are important in the pharmaceutical sciences. We may think of drug synthesis preformulation studies dosage form design and manufacture and drug absorption, distribution, metabolism, and excretion. Mass transfer plays a significant role in each. Mass transfer is referred to as the movement of molecules caused not only by diffusion but also by convection [1],... [Pg.40]

Pharmaceutical manufacturing can be divided into a number of unit process on the basis of a few fundamental principles. The following monograph describes briefly fluid flow and heat and mass transfer. [Pg.3862]

All phases of analytical development are ideally supported by chemical separation techniques such as HPLC, TLC, GC, SFC, and CE. HPLC continues to be the primary method of analysis throughout the pharmaceutical development process. Although HPLC is limited in its ability to separate more than 15-20 components in a single analysis, and variations in columns and instrumentation manufacturer to manufacturer complicate transfer of methods, HPLC can readily be implemented to meet ICH requirements for method performance. For early-phase methods, HPLC can be coupled dynamically to mass and nuclear magnetic resonance spectrometers to facilitate the identification of unknown impurities. In later phases, HPLC can be implemented in a fully automated format as a high-throughput method for release and stability testing. [Pg.383]

While continuous processing is standard for most products manufactured on a large scale, batch production tends to be the norm in the fine chemical and pharmaceutical industries. Although batch manufacture may be superficially flexible, it runs counter to the whole intensification ethos. This is because the heat and mass transfer duty for the entire batch is concentrated in a restricted period and the heat/ mass transfer equipment must be sized to accept the peak batch load. If this is not done, then reactor runaway can ensue, with disastrous consequences. On the other hand, with continuous production, the respective steady state heat and mass transfer rates are much less and automatically involve smaller equipment. [Pg.362]

Immobilization is the method of cultivation of microorganisms that allows a repeated use of biocatalysts (be it enzyme or whole cells), creating prerequisites for the production of valuable products in an automated continuous mode. The most considerable problem in using biocatalysts is related to mass transfer. In aerobic systems, low solubility of oxygen in carriers, especially in some gels and polymers, can decrease the effectiveness of biocatalyst action. In this respect, propionic acid bacteria, which do not require aeration, show certain advantages over aerobic cultures. At present, about eight different processes that use immobilized enzymes and cells have found industrial applications. These are mainly one-or two-step processes used in the manufacture of foods and pharmaceutical preparations (Vorobjeva et al, 1978). An essential characteristic of a biocatalyst is productivity. [Pg.196]

Another recent trend in fermentation is the use of disposable bioreactors instead of stainless steel reactors for process development, especially in pharmaceutical manufacturing (Hanson et al., 2(X)9). Disposable bioreactors are typically plastic devices, such as microtiter plates, T-flasks, shake flasks and wave reactors, with different sizes. Disposable bioreactors can be used as a seed fermentor or as a production fermentor for products on a small scale (Mikola et al, 2007). The main advantages of disposable reactors include more flexibility in operation and use for different products, elimination of CTOss-contamination, less time needed to set up because the reactor is ready to use, low cost and less labor needed. However, disposable reactor sizes do not exceed 2,000L because of physical limitations, stabihty issues and heat and mass transfer limitations, as these reactors do not have impellers for mixing. In addition, disposable plastic reactors may leach chemical components into the media that could negatively impact the quahty of the final product (Hanson et al, 2009). [Pg.201]


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See also in sourсe #XX -- [ Pg.3862 ]




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