Laboratory development program

De Van, J. H. and Jansen, D, H., Fuels and Materials Development Program Quart. Progr. Rept., Sept. 30 (1968) ORNL-4350, Oak Ridge National Laboratory, p91 Bonilla, C. F., in Reactor Handbook, Vol. IV (ed. S. McLain), Interscience, New York, 107 (1964)... 

Advances in materials and new container construction techniques are usually evaluated with one- or two-year test packs. The time required to prove performance of new materials or container constructions slows development programs. However, several laboratory techniques are available which provide a reasonable estimate of container performance. 

As the twentieth century came to a close, the job market for computational chemists had recovered from the 1992-1994 debacle. In fact, demand for computational chemists leaped to new highs each year in the second half of the 1990s [135]. Most of the new jobs were in industry, and most of these industrial jobs were at pharmaceutical or biopharmaceutical companies. As we noted at the beginning of this chapter, in 1960 there were essentially no computational chemists in industry. But 40 years later, perhaps well over half of all computational chemists were working in pharmaceutical laboratories. The outlook for computational chemistry is therefore very much linked to the health of the pharmaceutical industry itself. Forces that adversely affect pharmaceutical companies will have a negative effect on the scientists who work there as well as at auxiliary companies such as software vendors that develop programs and databases for use in drug discovery and development. 

In 1901, the U.S. National Bureau of Standards (NBS) - now the National Institute of Standards and Technology (NIST) - was founded because of the increasing demand for various kinds of standards in the rapidly developing engineering industries. The early history of the NBS reference material program started in 1905 with a cooperative effort within the iron and steel industry whereby industrial analysts helped characterize the individual reference materials. Cooperation with NBS was recognized as a mark of achievement for the laboratory, so this effort served a dual purpose. It both helped the laboratory develop its measurement skills and also helped NIST understand the meastuement problems associated with a given matrix. 

The use of reference samples for method calibration and development/validation occurred hand-in-hand with the development of all modern instrumental methods of analysis. In fact, the two developments are intimately linked with one another. As already noted, G-i and W-i (Fairbaim et al. 1951 Stevens i960) illustrate first instance of reference samples specifically developed for calibration purposes. Following that, the use of BCR-i as a reference sample throughout the lunar program (Science 1970) is a prime illustration of the quality assurance and method validation applications in large-scale inter-laboratory measurement programs. 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

This work was supported by the Laboratory Directed Research and Development Program at the Pacific Northwest National Laboratory (PNNL), a multiprogram national laboratory operated by Battelle for the U.S. Department of Energy under Contract DE-AC06-76RL01830. Part of the research described in this paper was performed at the Enviromnental Molecular Science Laboratory, a national scientific user facility located at PNNL. 

The Instrumentation and Laboratory Improvement (ILI) Program aids in the purchase of laboratory equipment for use in undergraduate laboratories at all levels. Annual funding has been 23 million for the past 5 years and is anticipated to remain at this level for the near future. Typically, 2300 proposals are received, resulting in approximately 600 awards per year. ILI has two components The major one accepts proposals for equipment only, the other, known as Leadership in Laboratory Development, seeks to support the development of exemplary national models for laboratory curricula by providing funds for personnel and supplies as well as for equipment. Five percent of the ILI budget is devoted to Leadership projects, and preliminary proposals are required. A 50% institutional match for equipment costs is necessary for all ILI proposals. The maximum allowable request from NSF is 100,000. In the 1992 competition, 60 proposals to initiate or improve materials science laboratories were received 15 were from departments of chemistry, the remainder from engineering units. 

If machine or detergent manufacturer s research laboratories develop new improved wash programs, these can very easily be transferred retrospectively to machines in situ using existing update technology. Fig. 3.13 shows how a service technician could use a special infrared interface. Other manufacturers achieve the same result using a conventional PC interface. 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

Work at Los Alamos National Laboratory (LANL) was supported by the DOE Office of Basic Energy Sciences and by the LANL Laboratory Directed Research and Development program. LANL is operated by Los Alamos National Security, LLC, for the National Nuclear Security Administration of the US DOE under Contract No. DE-AC52-06NA25396. Work at University of Toledo was supported by NSF grant DMR-0606307. 

In our laboratory between 1999 and 2010, the rat and rabbit were employed as the routine species for regulatory reproductive toxicity testing. The mouse was chosen as the rodent species in just two development programs out of 58 (Table 2). 

The support of the Director s Discretionary Research and Development Program of the National Renewable Energy Laboratory during the writing of this manuscript is gratefully acknowledged. 

Report to the Strategic Environmental Research and Development Program, Department of Defense, Pacific Northwest Laboratory, Richland, Washington. 

The work reported in this chapter was conducted in 1971, at the Engineering Physics Laboratory of E. I. du Pont de Nemours and Company. This research was performed as part of the ESCA instrument development program active at that time, and was presented by Jansson and Davies (1974). An example of a deconvolved polyester spectrum obtained in the early work appeared in the review article by Herglotz and Suchan (1975). 

In the past, the scale-up was carried out by selecting best guess process parameters. The recent trend is to employ the Factorial and Modified Factorial Designs and Search Methods. These statistically designed experimental plans can generate mathematical relationships between the independent variables, such as process factors, and dependent variables, such as product properties. This approach still requires an effective laboratory/pilot scale development program and an understanding of the variables that affect the product properties. 

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