Cycle development testing equipment

The sterilization of components and equipment will be validated for each load configuration using the cGMP autoclave. Cycle Development Testing and Performance Qualification Testing will qualify each sterilization process. A separate Performance Qualification and Cycle Development Testing Report will be written for each load configuration. The process will be considered validated when the acceptance criteria is met for three (3) successful consecutive runs. 

The general equipment used can range from very simple columns and test tubes to elaborate pumps, columns, detectors, and fraction collectors automatically controlled by a computer with an appropriate human interface. Minimal equipment is sufficient for exploratory work or one-time development cycles more sophisticated equipment is beneficial for laboratories engaged in more intensive development. A modest set of useful equipment includes 1) peristaltic pump 2) end-over-end tube rotator 3) fraction collector and 4) spectrophotometer (UV visible). 

Critical processes other than the actual product manufacturing process — such as sterilization, component washing, and equipment cleaning — require prevalidation cycle development work. This may include establishment of appropriate sterilization cycle types, cleaning agents, etc. This test work is performed during or after Operational Qualification. 

Record the range of all process or equipment parameters (set points, flow rates, timing sequences, concentrations, etc.) verified during cycle Development and Performance Qualifications testing. 

The basic building blocks of a system are depicted in Figure 2—the system, its related productfs), the life cycle processes required to support the products, and the subsystems that make up the produces). Each life cycle process—development, manufacturing, test, distribution, operation, support, training, or disposal— is itself hke a system in that products should be developed to fulfill the purpose of the life cycle process. For example, a product should be manufactured. Manufacturing is a life cycle process. The products associated with the manufacturing life cycle process include special equipment, tools, fadUties, and production processes and procedures. The products that make up life cycle processes may also require Ufe cycle sustainment in that they may be required to be developed, tested, manufactured, distributed, operated, supported, trained, and disposed of. 

Even if individual and collective protection gear functions perfectly as designed, there may be individuals who increase their risk of exposure due to behavioral factors (e.g., claustrophobia, extreme irritability due to discomfort, etc.). It is important for CBDP to learn as early as possible in the design, development, and test cycle whether new equipment has any characteristics that may increase the likelihood of such behaviors. A thorough understanding of behavioral factors may also provide useful design requirements. 

Although the state-of-the-art equipment shown in Figures 4.18 and 4.19 represents the limits of what can be achieved with readily available technology, such apparatus are yet to be used widely for the acquisition of filter cycle data it is noted that sophisticated filtration apparatus is becoming more widespread in universities (Andersen et al, 2004 de Kretser et al, 2001 Johansson and Theliander, 2003 Teoh et al, 2001) and within some companies (Townsend, 2002). Such test equipment does offer the potential and basis to develop standard methods for filter cycle testing, however, their greater cost and potential accuracy must be justified in relation to the more conventional techniques described in Sections 4.1.1 and 4.5.1. 

Equipment—client may not have the equipment required to manufacture a specific product. It may be that available capital and installation time are limited such that they simply can not design, acquire, install and test the process equipment to reach the desired capacity within the available budget and time. If a product is in the early stages of its life cycle, the capital required may be hard to justify. This could be based upon the low initial volume anticipated while developing the market or the need to take advantage of a time-sensitive business opportunity. Tolling can provide a means to safely produce introductoiy, short-term, or small volume products that would otherwise be uneconomic. 

The double promoter process involves the successive application of liquid promoter solutions of vinyltrichlorosilane (VTS) and 3-chloropropyltrimethoxy-silane followed by successive cure cycles in dry N2 at 90°C after each application and before photoresist application. The double promoter process evolved because it was felt that the silane reaction with the SiOH surface groups of low temperature oxides was incomplete for a single promoter application, and because vapor silane equipment did not exist at that time. Interestingly, a double HMDS liquid promoter process failed to yield adequate adhesion as well. Later in time, the successful but somewhat complex double promoter process was replaced by the vapor phase HMDS process in the Star 1000 (or 2000) then superior resist image adhesion was obtained on all four oxide substrates with all the photoresists tested. Before the advent of the HMDS vapor priming in standalone or wafer track equipment module chambers, liquid priming solutions were widely used, especially in development areas. 

Each item would generally require a detailed specihcation and installation documentation. The standards and documentation detailed in the appropriate sections above should be applied to this equipment. In addition, if the equipment involves the use of a computerized system, the system (application software and hardware) should be developed and tested using a formal, life-cycle methodology. ... 

The number of candidate processes to be evaluated in the component and systems development phase should be narrowed to not more than two or three. During this phase equipment for cold and hot (remote) processing should be designed, installed, and tested. At this time, planning and design studies may be initiated for the construction of a WO metric ton/year dedicated reprocessing facility based on modification to the EBR-II Fuel Cycle Facility. 

The 2" phase (2006-2009) R D activities undertake a SI process optimization and the performance tests of various chemical reactors selected for the SI cycle. The 2" phase research covers a dynamic code development for the SI process, a construction of a lab. scale( l 000 NL/h) SI process, and integrated operations of the process at prototypical pressures. On the other hand, conceptual and basic designs of a pilot scale( 100 Nm /li) SI process and its equipment will also be carried out according to the optimized process established from the theoretical evaluation using a commercial-base computer code and the experiences of the lab. scale construction and operations. Preliminary performance tests of the equipment, mechanical devices, and accessories for the pilot scale SI process should be carried out to obtain the design basis. Not only the several catalysts based on non-noble metals required for section II in the SI cycle but also a membrane for the separation of the hydrogen required for section III will be developed during the 2" phase research period. 

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