Development phase

Resoles. Like the novolak processes, a typical resole process consists of reaction, dehydration, and finishing. Phenol and formaldehyde solution are added all at once to the reactor at a molar ratio of formaldehyde to phenol of 1.2—3.0 1. Catalyst is added and the pH is checked and adjusted if necessary. The catalyst concentration can range from 1—5% for NaOH, 3—6% for Ba(OH)2, and 6—12% for hexa. A reaction temperature of 80—95°C is used with vacuum-reflux control. The high concentration of water and lower enthalpy compared to novolaks allows better exotherm control. In the reaction phase, the temperature is held at 80—90°C and vacuum-refluxing lasts from 1—3 h as determined in the development phase. SoHd resins and certain hquid resins are dehydrated as quickly as possible to prevent overreacting or gelation. The end point is found by manual determination of a specific hot-plate gel time, which decreases as the polymerization advances. Automation includes on-line viscosity measurement, gc, and gpc. 

A portion of the effluent is recirculated, ia order to smooth out flow, keep the food concentration constant, lower film thickness and control psychoda flies, and reseed the appHed sewage with acclimatized organisms. The psychoda, or filter fly is a very small iasect that breeds ia thick trickling-filter slimes. It does not bite, but can be a nuisance. Its radius of flight is small, but it can be carried great distances by the wiad. The fly can be controlled ia the development phase by occasional flooding of the filter or chlorination of the appHed sewage. 

In the development phase of catalyst research, testing of the catalyst s chemical and physical properties and evaluation of the catalyst s performance ate two essential tasks. In the manufacturing process, many of the same analyses and evaluations are used for quaHty assurance. A number of the testing procedures outlined eadier for catalyst supports can also be appHed to catalysts (32). 

There is a need for verification techniques in DFQ that can be used in the early and critical product development phases, where the quality is determined, i.e. can be applied on abstract and incomplete product models (Morup, 1993). The CA methodology is largely a verification technique that aims to achieve this. 

Before setting about the task of developing such a model, the product development process requires definition along with an indication of its key stages, this is so the appropriate tools and techniques can be applied (Booker et al., 1997). In the approach presented here in Figure 5.11, the product development phases are activities generally defined in the automotive industry (Clark and Fujimoto, 1991). QFD Phase 1 is used to understand and quantify the importance of customer needs and requirements, and to support the definition of product and process requirements. The FMEA process is used to explore any potential failure modes, their likely Occurrence, Severity and Detectability. DFA/DFM techniques are used to minimize part count, facilitate ease of assembly and project component manufacturing and assembly costs, and are primarily aimed at cost reduction. 

Three types of control plan are required. During the product design and development phase, a prototype control plan is required to be produced. During the process design and development phase, a pre-launch or pilot production control plan is required, and during the product and process validation phase, the production control plan is to be issued. 

Definition of the stages in the development phase at which verification can most economically be carried out. 

The program plans for the five areas addressed during the program strategy development phase are implemented at this stage. 

The involvement of the final users in the conceptual design phase and during the whole development phase is crucial [40]. Users are often not able to specify all their expectations and requirements during the first stages of the system development, but periodic and continuous revisions of evolved prototypes allow them to evaluate and contribute to the improvement... 

During the development phase a series of laboratory or pilot-scale batches will be subjected to this stability program. As soon as the process is scaled up to production-size batches, the first few, and at least one per year thereafter will also go on stability. Submission is only possible if the product completes a minimal combination of tests, e.g., one full-size batch for 12 months and two reduced-size batches for 6 months... 

Product specification documents and analytical test methods—In preclinical development, these are important documents and they evolve along with the development phases. Drug substances and products for clinical trials are tested based on these documents, and so are the stability samples. It is critical to ensure that the analyst will perform the right tests against the right specifications with the correct version of the test method. Therefore a mechanism must be in place to control these documents. This can be done manually or with TIMS. A manually controlled system would require the analyst to sign out hard copies of the documents from a central location. After the testing is done, the analyst would have to return these controlled documents to the... 

Cmcial documentation needed in the development phase includes end-user manuals, a unit test summary report, a user acceptance test plan, results of the database design, results and methods employed in the source code evaluations, and a trace-ability analysis. A source code traceability analysis verifies that all code is linked to established specifications and established test procedures. 

Although the polymer industry is often considered a bulk industry, the development and production of the different types, grades and compounds requires advanced technology and an appreciable amount of R D. In support of the industrial development phase, production control and quality management, the polymer industry needs to determine more than 60 elements in polymeric materials, in concentrations ranging from per cent down to ppt levels. 

A side benefit of this designed type of experimentation is its potential usefulness in product and process validation. The subject of validation is of great interest to those in the operations area, but if approached rationally, validation must begin in the product development phase. The designs usually... 

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