Product manufacture chapter

In this chapter, we focus on strategies, tools and metrics that help chemical choosers to green their chemical product inventories and to benchmark progress. The term chemical chooser applies to those who purchase chemicals for use in the development of formulated products or those who purchase formulated chemical products for use in their use in activities such as maintenance, repair and operations. Most product manufacturers are chemical and material choosers in contrast to chemical or raw material manufacturers who process, synthesize and supply chemicals as raw materials. 

It is indeed humbling to compose this introductory chapter as there is already a vast array of introductory literature on process analysis. " It is worthwhile, however, to expand upon these works as the field continues to advance. This chapter is written from a PA experience base spanning three disparate sectors (chemical, pharmaceutical and surveillance) and various real-time analytical problems. The experience includes disparate products (fine chemical, polymer, pharmaceutical materials during product manufacture, etc.) and material physical states as well as PA solutions. 

Nowsuppose that price discrimination is perfect. In this case, manufacturers can offer deep discounts to the poorest patients with no effect on patent revenues. In fact, profit-maximizing manufacturers will automatically offer such discounts until prices reach their marginal cost of production (Reinhardt, Chapter 2). This means that sponsors should subsidize production only if the desired access price is below marginal cost. 

Historically, and even today, emphasis on the validation of sterile products is placed mainly on the sterilization processes. No manufacturing operation can be considered under complete control without qualification of every system that can potentially affect product quality, however. The following discussion will touch upon other systems and processes involved in sterile product manufacturing expected to be validated. Much of this section relies on the following literature sources [Refs. 43,73-80], Also refer to other chapters in this book that discuss certain topics in much greater detail. 

A major issue for biomass as a raw material for industrial product manufacture is variability. Questions of standardisation and specifications will therefore need to be addressed as new biofuels, biomaterials and bioproducts are introduced onto the market. Another major challenge associated with the use of biomass is yield. One approach to improve/modify the properties and/or yield of biomass is to use selective breeding and genetic engineering to develop plant strains that produce greater amounts of desirable feedstocks, chemicals or even compounds that the plant does not naturally produce (Fernando et al., 2006). This essentially transfers part of the biorefining to the plant (see Chapter 2 for some example of oils with modified fatty acid content). 

Alternatively, 3-picoline is produced by vapor phase cyclization of 2-methyl-pentane-1,5-diamine (Fig. 2.25) over, for example, H-ZSM-5 followed by palladium-catalyzed dehydrogenation [78]. This diamine is a by-product of the manufacture of hexamethylenediamine, the raw material for nylon 6,6, and these two reactions are key steps in the Lonza process for nicotinamide production (see Chapter 1) [79]. 

At the gin, baled cotton is sampled so that grade and other quality parameters can be determined and the cotton is classed at the U.S. Department of Agriculture (USDA) classing offices. Classification is a way of measuring the fiber quality and physical attributes of this natural product that affect the manufacturing efficiency and quality of the finished product (see Chapter 8). Cotton bales are usually stored in warehouses prior to going to the textile mill [42]. 

The complex composition of toxaphene also creates nomenclature problems. Initially, toxaphene was the trademark of the product manufactured by the Hercules Inc. However, due to the non-restricted use of the trademark, toxaphene has become a general term for this pesticide. Further frequently applied terms were camphechlor , polychlorinated bornanes , camphenes , and ter-penes , as well as chlorobornanes . The expression toxaphene is not the same as the trademark Toxaphene , since residues in the environment may also originate from other technical products (see Table 2). Toxaphene is the reaction product of the chlorination of technical camphene is a suitable definition of the expression used in the scientific language [27]. Owing to the problems with abbreviations as described below, toxaphene will be used in the following chapters as a synonym for the compounds of technical toxaphene. 

Early on in product development, the potential for the successful development of a solid oral dosage form is assessed, based on the physicochemical properties of the API (1). Prior to solid dosage form development, it is necessary to anticipate the physicochemical properties that can have a major influence on product manufacture and performance. The early development (preformulation and early formulation development) studies should focus on these properties so as to avoid problems at later stages of development. While the molecular properties dictate the intrinsic solubility and the chemical stability of the compound, by controlling the physical form of the compound and by modifying physical properties (e.g., particle size), the dissolution rate can be enhanced with the potential for improving bioavailability. This chapter will focus on physical properties including particle characteristics, and most importantly, the physical form (i.e., solid state) of the API. 

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