Design reliability improvement measures

Since reliability and the related measures are essentially design parameters, improvements are most easily and economically accomplished early in the design cycle. Useful techniques for design reUabiUty improvement are described below. 

NMR measurements can be made while drilling with the tool placed behind the drill bit and information transmitted to the surface [3, 4]. Measurements of Tj are more reliable because it is less sensitive to motion, but improved tool design has made measurements of T2 possible [4]. 

In evaluating drugs in man, there also have been improvements in methodology, particularly in the design of better controlled experiments and the use of statistical techniques to interpret the data. This has been more significant in disease conditions in which subjective factors may obscure the interpretation of results. However, in some major diseases, as for example atherosclerosis, osteoporosis, and connective tissue degenerations, the absence of reliable qualitative measures for early identification of the disease state and quantitative measures for comparing improvements or deteriorations have become a much more serious limitation than they were 10 years ago. The requirement for proof of efficacy of a... 

A recent design of the maximum bubble pressure instrument for measurement of dynamic surface tension allows resolution in the millisecond time frame [119, 120]. This was accomplished by increasing the system volume relative to that of the bubble and by using electric and acoustic sensors to track the bubble formation frequency. Miller and co-workers also assessed the hydrodynamic effects arising at short bubble formation times with experiments on very viscous liquids [121]. They proposed a correction procedure to improve reliability at short times. This technique is applicable to the study of surfactant and polymer adsorption from solution [101, 120]. 

A failure modes and effects analysis is a systematic analytical technique for identifying potential failures in a design or a process, assessing the probability of occurrence and likely effect, and determining the measures needed to eliminate, contain, or control the effects. Action taken on the basis of an FMEA will improve safety, performance, reliability, maintainability and reduce costs. The outputs are essential to balanced and effective quality plans for both development and production as it will help focus the controls upon those products, processes, and characteristics that are at risk. It is not the intention here to give a full appreciation of the FMEA technique and readers are advised to consult other texts. 

The improved methods introduced in the years 1940 to 1945 created new possibilities in this field. The Van Slyke method for quantitative determination of amino acids, based on the measurement of the volume of carbon dioxide evolved in the course of the reaction between amino acids and ninhydrin (V2), was much more reliable than the older methods. At the same time the microbiological methods designed for amino acid determinations (D3, S6) made possible the detection of very small concentrations of these compounds. The application of these... 

A device described by Sawyer and Dixon [13] was used for the determination of alcohol and acid in beer and stout. Attempts to improve the reliability of this method and to improve the signaTto-noise characteristics of the measurements prompted a critical design described by Lidzey et al. [14]. This unit overcomes many of the fluctuations in results observed with use of the first unit in this a number of possible sources of surging were indicated and these were not controlled owing to the varying conditions in the coil. In addition, the separation of the waste involatile material from the volatile phase took place outside the heated flask distillation unit. Air bubbles present in the segmented stream were also responsible for considerable surging. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

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