Scale productivity considerations

Product innovation absorbs considerable resources in the fine chemicals industry, in part because of the shorter life cycles of fine chemicals as compared to commodities. Consequently, research and development (R D) plays an important role. The main task of R D in fine chemicals is scaling-up lab processes, as described, eg, in the ORAC data bank or as provided by the customers, so that the processes can be transferred to pilot plants (see Pilot PLANTS AND microplants) and subsequently to industrial-scale production. Thus the R D department of a fine chemicals manufacturer typically is divided into a laboratory or process research section and a development section, the latter absorbing the Hon s share of the R D budget, which typically accounts for 5 to 10% of sales. Support functions include the analytical services, engineering, maintenance, and Hbrary. 

Since the first application of turbocompressors (Figure 4-1) in large-scale production of nitric acid as a raw material for fertilizers, explosives, plastics, and a variety of other chemical products, the requirements on processes as well as on rotating equipment have become increasingly demanding. Environmental as well as economic considerations have heavily influenced the development of such plants. 

At present moment, no generally feasible method exists for the large-scale production of optically pure products. Although for the separation of virtually every racemic mixture an analytical method is available (gas chromatography, liquid chromatography or capillary electrophoresis), this is not the case for the separation of racemic mixtures on an industrial scale. The most widely applied method for the separation of racemic mixtures is diastereomeric salt crystallization [1]. However, this usually requires many steps, making the process complicated and inducing considerable losses of valuable product. In order to avoid the problems associated with diastereomeric salt crystallization, membrane-based processes may be considered as a viable alternative. 

One of the most significant developments in phosphazene chemistry during the past year has been the reported application of alkoxycyclophos-phazenes, [NP(OR)2l3,4, as flame retardants in rayon. This development has, in turn, provided a stimulus for improvements to be made in the large-scale production of chlorocyclophosphazenes. Interest in the properties of the monophosphazenes has again increased considerably. 

As Britain is relatively poor in mineral deposits, this type of mining is less important here than in other countries of the world. The gold mines in South Africa, metal mines in the U.S.A., Canada and Sweden all use considerable amounts of explosive. In such mines the methods of working are often appreciably different from those described above and adapted to very large-scale production. 

Mehta, A. M., Scale-Up Considerations in the Fluid-Bed Process for Controlled Release Products, Pharm. Tech., 12 46-52(1988)... 

Vinyl chloride has been known for over a hundred years and its polymerization to polyvinyl chloride (PVC) was achieved in 1912. Industrial-scale production of this plastic began in 1927. PVC is still the most versatile plastic. One of the reasons for this is the numerous variations made possible by the method of manufacture of the polymer, namely by copolymerization with other monomers and their processing. Thus, PVC can be thermoformed on all conventional processing machines if the slight thermal damage is taken into consideration. Machining is easy and the material can be bonded, bent, welded, printed and thermoformed. 

The early days of Copper Phthalocyanine Green synthesis were dominated by two competitive routes. One method was the synthesis of tetraphenyl copper phthalocyanine (Bayer), while the second method involved chlorination of copper phthalocyanine in carbon tetrachloride to form copper tetradeca to hexadeca-chloro phthalocyanine (BASF). It was on the grounds of economical considerations that manufacturers began to prefer the chlorination technique in industrial scale production. 

Since that time an enormous number of surfactants covering a wide range of chemical and physicochemical properties have been developed for quite universal as well as specific tasks in domestic and industrial applications. The criteria for selection of a surfactant for industrial production is directly connected with the feasibility of large-scale production. This is determined by several factors including availability and costs of raw materials, cost of manufacture, and performance of the finished products. In addition to these aspects, environmental considerations likewise play an increasingly important role. 

It should be noted that different species of field crops possess different biomass yields. For example, for every hectare of pea crop grown, only a third of a hectare of tomato crop would be required to produce the same amount of protein, even though the yield of protein per unit biomass is lower in tomato than in pea. Thus, consideration of which crop species to use becomes of paramount importance in the design of large-scale production of a particular biopharmaceutical. The relative biomass yields for a number of crops currently used for the production of biopharmaceuticals are listed in Table 6.2. 

It is important to add heat transfer scale-up considerations to the scale-up approach for liquid parenteral solutions as heat transfer applications may play a considerable role in preparation of these products. For heat transfer applications, constant horsepower per unit volume is used to achieve approximately similar heat transfer coefficients for the same type of impeller. This approach is a close approximation since the effect of horsepower on the heat transfer coefficient (ho) is relatively small ... 

For purification, scale-up considerations are important even in the earliest phases of development. It is important to avoid the use of purification techniques of limited scale-up potential even for early clinical production because thorough justification of process changes and demonstration of biochemical comparability are necessary prior to product licensure. For successful scale-up, it is important to understand the critical parameters affecting the performance of each purification step at each scale. Conversely, it is important to verify that the scaled-down process is an accurate representation of the scaled-up process, so that process validation studies, such as viral clearance and column lifetime studies, can be performed at the laboratory scale. 

Scale-Up Considerations Product Moisture Content During... 

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