Product-based design overview

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

This section provides an introductory overview of some of the concepts and ideas that underlie the development of sustainable design approaches. This overview is followed by a discussion of cradle-to-cradle design, a lifecycle-based approach to material assessment and product design, and a brief discourse on the emerging principles of sustainable engineering. These correspond to some of the emerging... 

This chapter presents an overview of performance plastic polymers in commercial planar and 3-dimensional circuit board products, and describes in detail one approach (two-shot molding) developed as an integrated 3-D circuit manufacturing technology. The distinctions between conventional planar (2-dimensional) circuitry, based on thermoset laminates and "subtractive etching processes, and the enhanced design flexibility afforded by expanded interconnection capacity in three axes are discussed. Specific examples of 3-dimensional interconnect protoypes and products are described and pictured. 

Baculovirus-based protein expression in insect ceU culture represents today a ripened method for the rapid production of proteins up to pilot scale. Recent advances on all levels of the production process such as optimized expression vectors, chemically defined media, optimized nutritional and kinetic parameters as well as the design of novel cultivation systems contribute to drastically increased protein yields with concomitant reduction of process time and costs. This chapter provides a comprehensive overview on recent research and achievements on the successive steps in a protein expression process, with a focus on how to integrate these findings for achieving overall optimized performance. A case study on the production of a secreted protein illustrates the impact of the different optimization steps on the overall process yields. 

This chapter covers many of the steps under the blocks of Process Creation and Development of Base Case in Figure 1.2, which provides an overview of the steps in designing new chemical products and processes. These are two of the major blocks on which design teams concentrate much of their effort. 

The design of bionanoreactors is based on encapsulation/insertion of active compounds (proteins, enzymes, mimics) inside polymeric supramolecular assemblies, such as dendrimers, capsules, and vesicles, in which they can act in situ while being protected from proteolytic attack [3,6]. These supramolecular assemblies should allow the passage of products or substrates to the inner spaces where the active compounds are located in order to support reactions confined within their structures. Various approaches to providing accessibility to the inner reaction space of the polymer assemblies are presented, even though not all have been used in the design of nanoreactors, in order to give an overview of the variety of solutions that can be expected to advance this field of science. 

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