Manufacturing process starting design

Designers and processors to produce products at the lowest cost have unconsciously used the basic concept of the FALLO approach. This approach makes one aware that many steps are involved to be successful, all of which must be coordinated and interrelated. It starts with the design that involves specifying the plastic, and specifying the manufacturing process. The specific process (injection, extrusion, blow molding, thermoforming, and so forth) is an important part of the overall scheme and should not be problematic. 

Information on manufacturing processes, equipment parameters, materials of construction, costs and the physical properties of process materials are needed at all stages of design from the initial screening of possible processes, to the plant start-up and production. 

When designing a new manufacturing process it is essential to understand the entry point and fate of all potential impurities on the process these include impurities in the registered starting materials, those generated by side reactions, and many causes that would be insignificant in most related industries ... 

The cocoa and chocolate consumed by the American market are produced by a relatively small number of American and Dutch manufacturers who start with the dried, fermented beans. Current manufacturing practice uses improved machine design and extended automatic control in accord with modern principles of chemical engineering, but it is based solidly on the traditional process, little modified during the last century. 

On the basis of this development afforded by Eastman and Halcon, in 1983 the Eastman Chemical Company (Kingsport, TN) started the commercial process for the manufacture of acetic anhydride (Figure 5). Methyl acetate, the feedstock for the carbonylation reaction, was produced in a separate esterification step from acetic acid and methanol. The process was designed to produce 225 000 tons of acetic anhydride and 75 000 tons of acetic acid/year. The overall yield of acetic anhydride based on methanol is approximately 96 % [2, 47]. 

Development usually starts with the discovery synthesis, a process designed to produce only small quantities, and often involving chemicals and procedures not amenable to a manufacturing process. Early development converts the discovery route to a synthetic route that does not have chemical, safety, environmental, or operational issues that would prevent it from being commercially viable. This must be done before the drug substance solid form and impurity profile become set by formulation development and toxicological studies. 

In general, a development process starts with an analysis of system requirements, followed by design on system level. Subsequently, the system is decomposed into its components and the components are designed and developed. At this stage, manufacturing of first samples of the components is started. If the components pass funcrtion tests, the parts are assembled and the complete system is tested. After a subsequent acceptance test, this process leads to the final product. 

The manufacture of starting materials or drugs of biological origin which are obtained by processes of this nature, designed for the manufacture of pharmaceutical products containing them, can only be performed in specially equipped facilities or in special and independent sections of a production facility and these must in ail cases have been authorized by the institute. 

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