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Selected AbstractsPathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE® BayerHAEMOPHILIA, Issue 2002D. C. Lee Summary., Manufacturers of human therapeutic proteins derived from biological sources continuously strive to improve the pathogen safety profiles of these products. Efforts to improve pathogen safety margins for these biological products are directed towards several areas within the manufacturing processes including: (a) sourcing and screening of raw materials (b) determining the potential for manufacturing processes to reduce pathogen titres, and (c) incorporating methods designed specifically to remove or inactivate contaminating pathogens. Methods that could potentially reduce pathogen titres are a major focus for many manufacturers. In general, these methods are grouped into two categories, pathogen clearance and pathogen inactivation. Assessments are performed on small-scale, laboratory simulations of the manufacturing process of interest that are spiked with a known amount of a selected pathogen. These studies provide estimates of the potential for a process step to remove or inactivate a particular pathogen. There are several pathogen clearance/inactivation methods that are inherent in manufacturing processes, however, some methods are intentionally incorporated into manufacturing for the sole purpose of reducing putative pathogen titres. Not only are well-known pathogens such as viruses targeted, but also suspected pathogens such as those associated with the transmissible spongiform encephalopathies (TSEs). The production processes for the isolation of several biological products, including recombinant KOGENATE® Bayer (Kogenate®FS), have been evaluated for the ability to reduce pathogen titres and/or have been designed to incorporate methods for reducing potential pathogen safety risks. Several processing steps with the potential to reduce pathogen titres have been identified. [source] Temporary Employment and Strategic Staffing in the Manufacturing SectorINDUSTRIAL RELATIONS, Issue 1 2009MATT VIDAL While prior research has identified different ways of using temporary workers to achieve numerical flexibility, quantitative analysis of temporary employment has been limited to a few key empirical indicators of demand variability that may confound important differences. Our analysis provides evidence that many manufacturers use temporary workers to achieve what we call planned and systematic numerical flexibility rather than simply in a reactive manner to deal with unexpected problems. Although temporary work may provide many benefits for employers, a key function appears to be the provision of numerical flexibility not to buffer core workers but to externalize certain jobs. [source] GUIDELINES FOR IMPLEMENTING PREDICTIVE MAINTENANCE*PRODUCTION AND OPERATIONS MANAGEMENT, Issue 2 2002KATHLEEN E. MCKONE Recent advances in predictive maintenance technologies have led many manufacturers to abandon traditional periodic maintenance policies and replace them with predictive maintenance policies. The models in this paper explicitly evaluate the decision to utilize both predictive and periodic maintenance when the objective is to minimize expected maintenance costs per unit time. Renewal theory is used to obtain optimal policies as unique solutions of integral equations that depend on the failure distribution and prediction capabilities. Based on this research, we recommend that practitioners do not abandon the traditional maintenance methods but follow our guidelines for utilizing periodic maintenance in conjunction with the new technologies. [source] Features of Kansei Engineering Characterizing its Use in Two Studies: Men's Everyday Footwear and Historic FootwearQUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, Issue 6 2006Carolyn van Lottum Abstract The consumer goods sector is increasingly competitive with many manufacturers now operating in a global market. The growing numbers of on-line stores and product review Web sites have given the consumer new ways to compare and contrast product features before making a choice. The need for manufacturers to understand and interpret the wishes of their target consumer has led to the development of a number of techniques aimed at bringing the ,voice of the customer' into the design process. These have been successfully used by European manufacturers to identify quality and functional features critical to their customer base. However, an approach called Kansei engineering developed in the Far East uses the voice of the customer in a different way, identifying subjective emotional requirements as opposed to quality/functional requirements. Using Kansei engineering, it is possible to incorporate consumer emotion into the product design process, creating products that appeal to customers on a subjective level. This paper outlines the results of two field studies carried out as part of KENSYS, a Fifth Framework European project examining the use of Kansei engineering and product semantics as a suitable tool for European small and medium sized enterprises (SMEs). Copyright © 2006 John Wiley & Sons, Ltd. [source] |