Manufacturing process layout

FIGURE 1 Typical solid dosage manufacturing process layout. 

There exists a set of administrative requirements specifically for imported finished products. A prominent example is the requirement of a detailed Certificate of Free Sale from the authorities in the country of origin, to be provided at the time of submission of the application. Package layout, package inserts and labeling should conform to local directives. All manufacturing sites involved in the manufacturing process have to be approved specifically with respect to GMP. For imported products, a GMP certificate of the relevant authorities and a plant meister file have to be provided. 

The applicant is required to state the pharmaceutical dosage forms to be manufactured and submit a layout of the factory and other important features. Sanitary facilities should also be indicated. A list of equipment for manufacturing, assembly and quality control should be submitted together with a summary of the manufacturing processes. 

The production studies will be the last step prior to the industrial production of this mask, which will then be distributed through selective commercial channels to the general public. The production engineering studies will consider the problems of mass production, quality control, detailed written descriptions of the manufacturing processes, specifications of special tools, and equipment inherent to mass production, and the whole process will be filmed. It will provide the manufacturers with specifications for machinery and tools, the prototype plant layout, and all the knowledge with respect to production that a potential producer will need. We feel sure that industry will cooperate. 

Assist in developing the manufacturing process, flow, and plant layout. 

Several methods of static control have been successful in different facets of decorating and assembly. In some parts of the manufacturing processes it is better to try to prevent dust attracting throughout the process than after the part has been contaminated. In others it is more logical to remove the dust inline because of the plant layout or potential for contamination throughout molding and secondary processes. 

Local exhaust ventilation (LEV) equipment is intended to control mechanically the emission of contaminants such as dust and fumes that are given off during a manufacturing process or in a chemical laboratory. Normally this is done as close to the point of emission as possible using a stream of air to remove the airborne particulate matter and transport it to where it can be safely collected for ultimate disposal. The physical layout and setting of LEV equipment is critical for it to work effectively, and comparatively minor alterations can affect its performance. It is, therefore, important that LEV equipment should be properly designed, manufactured, installed, operated and maintained. Fume cupboards in chemical laboratories are included in this type of equipment. 

Fig. 8. Process layout showing main components of solution SB block copolymer manufacturing process.

As noted previously, substrate (typically PCB) design has an effect not only on board/component layout, but also on the actual manufacturing process. Incorrect land design or layout can negatively affect the placement process, the solder process, the test process, or any combination of the three. Substrate design must take into account the mix of surface mount devices that are available for use in manufacturing. 

Functional importance—Functionally arranged displays may be used to monitor manufacturing processes. The display may be constructed to represent the flow of the product through the manufacturing process to supply information at each stage. This functional display may differ from the actual plant layout. 

Apart from improved forecasting of customer demands, a lot of risk mitigation potential resides in the design of products as well as in the layout of the manufacturing processes. Products can be modularized and components standardized so that the firm becomes more tolerant against the uncertainties on both supply and customer markets. In production and manufacturing, capacity buffers, stockpihng and flexibility are common measures. 

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