Assessment of Process Component Design

Assessment of Process Component Design, 113 Disassembly of Munitions (Steps 1, 3, 4, 6), 114 Hydrolysis of Energetic Materials (Steps 5, 7, and 15), 114... 

Based on previously cited EDP documentation and EDS II testing results of the AEA SILVER II process, as well as the committee s consideration of test results obtained during Demo II, the following assessment of process component design and operation has been prepared (NRC, 2001b). 

Simulation data on mixture adsorption can be used to screen zeolites as adsorbents, but experimental data are necessary to validate the simulations and to accurately design the separation process. The first step of the process design is to obtain such data. However, the experimental assessment of multi-component adsorption equilibria and kinetics is not straightforward and is highly time-consuming. As a result, some theories have been developed that predict adsorption behaviour for a mixture based on the pure component equilibria [1,3]. The isotherm data have to be correlated before their use in a design model... 

As a result of the contact of blood with none-ndothelial surfaces, several humoral and cellular systems can be activated. Exposure of blood proteins and cells to blood contacting medical devices can activate plasma proteolytic systems (coagulation (blood clotting system), fibrinolysis (process by which clot is broken down), complement cascade (a system of soluble proteins involved in microbiocidal activity and the release of inflammatory components), Kallekrein-kinin and contact systems) and at least three cellular elements (leukocytes, endothelial cells, and platelets). Contrary to the normal situations whereby these mechanisms are localized and intended to promote wound healing, activation of these systems by medical devices can result in nonlocalized systemic reactions. The preclinical and clinical assessments of hemocompatibility are designed to minimize modification of these systems. 

Typical events that are considered are fire, explosion, ship collision, and the failure of pressurized storage vessels for which historical data established the failure frequencies. Assessment of consequences was based partly on conservative treatment of past experience. For example ilic assessment of the number of casualties from the release of a toxic material was based on past histoiy conditioned by knowledge of the toxicology and the prevailing weather conditions. An altemati. e used fault trees to estimate probabilities and identify the consequences. Credit is taken in this process for preventative measures in design, operation, and maintenance procedures. Historical data provide reliability expected from plant components and humans. 

The high level of safety and reliability required of nuclear power stations has meant that systematic estimates of polymer lifetime have been performed more widely here than in any other industry. The approach is described in Section 5.3. Many applications of polymers are in locations that cannot be monitored by regular inspection. The practice has been to subject polymers in these regions to independent assessment or environmental qualification , a process in which their potential degradation mechanisms are identified within a worst case environment of 40 °C and high humidity. If the predicted lifetime of a component is less than the design life of 40 years a schedule is laid down for its replacement. 

A hazard is anything that will produce an adverse effect on human health and the environment. In environmental risk assessment, the hazard component generally refers to toxicity. Exposure is the quantitative or qualitative assessment of contact to the skin or orifices of the body by a chemical. Traditional pollution prevention techniques focus on reducing waste as much as possible however, risk assessment methods used in pollution prevention can help quantify the degree of environmental impact for individual chemicals. This approach provides a powerful tool that enables engineers to better design processes and products by focusing on the most beneficial methods to minimize all aspects of risk. 

All GxP functions, processes, components, and devices identified within the GxP assessment should be challenged as part of the Design Review. Consideration may also be given to occupational health matters such as the potential effects of the computer system and associated equipment on the personnel who may use or contact the system. GxP functionality includes the use of electronic records and signatures. Hybrid systems must be dehned and subject to a verification process to determine whether or not they are robust. It is often nsefnl for processes to be mapped, showing critical points in the process and how varions compnter systems support these critical process points. 

Where a change is reqnired to the LIMS hardware due to the failure of a component, there are two possible scenarios. The first is that the failed component is no longer available and a new design mnst be installed. In this case a Design Review process will be reqnired to assess the effect on the rest of LDVtS, followed by the normal testing approach. The second is that the component is a standard offering from the supplier and is therefore a like for like replacement. In this case simple testing of the fnnctionality of the replaced component is all that is reqnired. 

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