Laboratory requirements

For laboratories required to do a large number of heavy-element analyses, particularly those where interferences with the L spectra are present, the purchase of a 100-kv source may well be justified. Two examples to illustrate this are shown in Figure 9-3, furnished by M. L. Salmon. 

Planning and building a laboratory requires a cooperative effort involving administrators, designers, equipment supply houses, contractors, and the laboratory operator. A laboratory designed for efficient operation can be achieved only if all of them work together with mutual respect and the best possible communication. 

Figuring space for educational laboratories requires some dif-...

Successful use of modern liquid chromatography in the clinical laboratory requires an appreciation of the method s analytical characteristics. The quantitative reproducibility with respect to peak height or peak area is quite good. With a sample loop injector relative standard deviations better than 1% are to be expected. The variability of syringe injection (3-4% relative standard deviation) requires the use of an internal standard to reach the 1% level (2,27). 

At least eight laboratories must report results for each material. Only when it is impossible to obtain this number (expensive instrumentation specialized laboratories required) may the study be conducted with an absolute minimum of five... 

Inter-laboratory study Three laboratories required One independent Recommended but not... 

WASTE DISPOSAL, UTILITIES, SHIPPING AND LABORATORY REQUIREMENTS... 

The explosive growth in the availability of computer tools In the laboratory requires a new look at the concept of laboratory automation. Much larger gains in the efficiency and effectiveness of research can be realized by automating tasks rather than by simply automating instruments. Research is done by researchers, not by instruments. Instruments are Just one of many tools which can be used by the researcher. This paper will attempt to give an overview of instrument automation as the traditional view of laboratory automation, and extend this concept to the automation of the total task of research. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Materials purchased for the purpose of mixing with other materials in the preparation of pharmaceutical products are called raw materials. Pharmaceutical companies often purchase solid raw materials as powders in large drums. Quality assurance laboratories require samples of the material in the drums for the purpose of performing quality tests to see if the raw materials meet the specifications required for the company s products. 

A reasonably well established analytical laboratory requires a number of standard solutions for its routine as well as specific assays. Therefore, it necessitates to know the intricacies of preparing the standard solutions as detailed in the following steps ... 

The electrical electronics market dictates some specific regulations. Among them a typical example is the UL (Underwriters Laboratories) requirements related to the long-term service temperature and the fire rating. 

A CRM is an ideal test material for a PT scheme. Unfortunately their high cost and lack of availability of snitable CRMs in the qnantity and concentration range needed limit their nse. Very often a PT scheme has to deal with more or less nnstable samples to meet the laboratories requirements. In this case CRMs are very unlikely to be available. 

Figure 1.3 Fishbone diagram of ADME/Tox process elements. The scale up of the ADME/Tox screening laboratory requires careful consideration of all crucial elements involved in its process. The commonly accepted approach of route cause analysis has been applied to identify potential hurdles that should be reviewed when planning a...

An automated laboratory requires written SOPs to demonstrate adequate control over automated data collection systems. The minimum SOP topics are... 

The discipline of the regulated laboratory requires the equivalent of a notebook or log, physical or electronic, that will record problems. The recording by itself, however, is not sufficient evidence of control. The tracking and resolution of these problems both demonstrate that active measures are... 

In spite of the large amount of work over the past ten years, the ideal resist is yet to be developed. Most materials are deficient in one or more requirements so that resists have tended to be designed for specific applications such as mask making and usually for a specific set of exposure conditions dictated by machine design. For example, the electron beam mask maker EBES, designed at Bell Laboratories, requires resists with sensitivity better than 10-6 C/cm2 at 10 kV for maximum machine throughput. 

What does the laboratory require (Quality Control) ... 

Dynamic experiments underway in our laboratory require a higher value of T0, and it is possible that T0 depends on the magnitude of the strain. The strains used in the present investigation were of the order of 4%. Another possibility, suggested by R. G. Mancke, is that T0 might depend on the time scale of the measurements and would thus necessarily be different in dynamic and transient experiments. Work at present underway is expected to help clarify this issue. 

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