Manufacturing operations computing equipment

Recent years have seen two important developments relating to the control and planning of manufacturing operations. One of these has been the emergence of new theoretical methods of problem analysis, most of which are predominantly mathematical in character. The second is the availability of automatic computing equipment capable of performing... 

A large part of accounting is concerned with providing control information for manufacturing operations. It is not within the scope of this chapter to discuss the many applications of computers in this work. There is, however, a part of accounting procedures which is of particular interest from a technical viewpoint. This is the subject of operations accounting, which is concerned with the current operations of process equipment. The subject is important in the planning of future operations as well as the control of current operations. It is worth while, if not indeed necessary, to know both what information is available and how it was obtained. 

The instructions embedded in computer program(s) either provide information on what the operators are supposed to do, or information on how the equipment or processes are intended to function. For example, for manufacturing operations, the batch production and control records may provide procedures, controls, instructions, specifications, and precautions to be followed when using computer systems. These programs may also contain control data for product formulation, batch size, yields, and automated in-process sampling/testing procedures. 

Pharmaceutical and healthcare companies must then, in turn, themselves validate all the computer systems used to fulfill operations governed by GxP regulations. Software and hardware must comply with GxP requirements for manufacturing records and equipment, respectively. 

A location that can provide partial capabilities with equipment, operation, storage, and computer equipment such as servers, mainframes, and network connectivity. The key concept to consider is the time reqnired to restore a level of service. The closer to real time this is, the hotter is the recovery site. However, this is rarely the case in manufacturing recovery activity. Warm sites are most typical. 

The AeroSizer, manufactured by Amherst Process Instmments Inc. (Hadley, Massachusetts), is equipped with a special device called the AeroDisperser for ensuring efficient dispersal of the powders to be inspected. The disperser and the measurement instmment are shown schematically in Figure 13. The aerosol particles to be characterized are sucked into the inspection zone which operates at a partial vacuum. As the air leaves the nozzle at near sonic velocities, the particles in the stream are accelerated across an inspection zone where they cross two laser beams. The time of flight between the two laser beams is used to deduce the size of the particles. The instmment is caUbrated with latex particles of known size. A stream of clean air confines the aerosol stream to the measurement zone. This technique is known as hydrodynamic focusing. A computer correlation estabUshes which peak in the second laser inspection matches the initiation of action from the first laser beam. The equipment can measure particles at a rate of 10,000/s. The output from the AeroSizer can either be displayed as a number count or a volume percentage count. 

However, the developments of microprocessor or computer-based instrumentation that can be used to monitor the operating condition of plant equipment, machinery and systems have provided the means to manage the maintenance operation. They have provided the means to reduce or eliminate unnecessary repairs, prevent catastrophic machine failures, and reduce the negative impact of the maintenance operation on the profitability of manufacturing and production plants. 

Perhaps you have just purchased a new electronic device, such as a personal computer, video camera, pager, or cell phone. The advanced circuitry in such devices can malfunction in humid environments. Moisture can reroute and even short circuit electric signals, impairing the operation of your new electronic equipment. Manufacturers recognize that moisture can adversely affect their products and... 

The respondents who showed the most interest in life prediction were cable manufacturers, electrical distribution authorities, gas distribution authorities, nuclear power station designers and operators, and the aircraft industry. Interest was less, but nevertheless increasing, among the manufacturers of small electronic and electrical equipment and computers, many of whom use polymers principally for housings and similar components. 

While validating a production process, several steps were listed as they pertained to each of the components of manufacturing equipment, process conditions, personnel, and so forth. These key elements multiply rapidly when it comes to analytical methods validation. Take, for example, HPLC — the most commonly used method of analysis. A typical analytical method would involve use of columns, pumps, heaters, detectors, controllers, samplers, sensors, recorders, computers, reagents, standards, and operators — put together as a system. Each of these components and systems needs independent validation, followed by a validation of the system. Note that when this equipment is used to manufacture a product such a therapeutic proteins wherein HPLC techniques are used for the purification purpose, then all additional requirements of a manufacturing system also apply, including, but not limited to, the requirement that the equipment be of a sanitary kind. This limits the choice for manufacturers, and these considerations should be taken into account in the first selection of equipment. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

This life-cycle phase will normally involve all parts of the computerized operation, not just the computer system. It is therefore essential that other equipment such as operating plant, utilities, and services that are part of or related to the manufacturing process have also been qualified or commissioned to the appropriate level prior to commencing PQ. 

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