QUALIFICATION BY ANALYSIS

The dynamic input motions used to qualify items are conservatively but realistically defined by either time histories or response spectra. In the case of response spectra, the spectrum shape, the peak ground acceleration and the duration of the motion should be derived consistently with the hazard 

It is common practice to apply the horizontal and vertical components of the seismic input simultaneously to the numerical model. In this case the components should be statistically independent. When the input components are applied individually, the corresponding structural responses should be suitably combined to account for the statistical independence of the two components of the input. 

Nuclear power plants can be modelled in many different ways according to their structural characteristics (e.g. lumped mass models, one dimensional models, axisymmetric models, two or three dimensional finite element models). The most suitable and reliable numerical technique should be used in order to minimize the contribution of the modelling techniques used to the uncertainties in the results. The continuing increase in the speed of computation and the progress in the graphical display of results have enabled the use of greatly refined structural and material models. 

In some States, a constant acceleration inpnt is used for a preliminary design or a simplified design, especially for items of lesser importance, and this is also used for the vertical direction. 

6x6 Stiffness matrix Kq. Rotational spring stiffness M Lumped masses 

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Seismic qualification by analysis alone, or by a combination of analysis and testing, may be used when justified. The analysis program can be justified... 

Large items (such as a large turbine), or if the functionality is ensured by the sole integrity of the component, can gain qualification by analysis. It is possible to combine experimental tests and analyses. The analysis has to demonstrate that the relative displacements of the structural elements which form the particular piece of equipment, are not such to prevent their movement. 

Environmental Qualification SSC classification dependent Testing or NDE for SCSSC. Analysis for SSSSC. Review for environmental qualification by analysis only. Backfit only if risk/cost effective. 

Section 2 discusses the safety implications of the design process and the relevant acceptance criteria required for different safety classes. In Section 3 the design principles for the achievement of the protection objective are recommended and the concept of periodic safety review is discussed in relation to the design issues. Guidance on an appropriate selection of methods for seismic qualification is provided in Section 4, recommendations for qualification by analysis are provided in Section 5, and qualification by test and... 

Seismic qualification by analysis should be used for items without a functional safety requirement that are unique and that are of a size or scale to preclude their qualification by testing. Civil engineering structures, tanks, distribution systems and large items of equipment are usually qualified by analytical methods after the modelling requirements discussed above have been fulfilled. 

In general the quality and detail of the information used to qualify individual items directly on the basis of data from experience should not be less than are required for direct qualification by analysis or testing. As is the case for direct qualification by analysis or testing, earthquake experience may be used as a basis for qualification by the indirect method also. 

Qualification by analysis use of code based stress and strength analysis (A in Table 9) ... 

For equipment, a systematic evaluation of the possible modes of failure related to earthquakes should be carried out with reference to the acceptance criteria assigned by the safety classification. This should be carried out by means of specific tests. However, as sophisticated techniques of analysis by computer simulation are improving, even the performance of active equipment (e.g. pumps, valves and diesel generator sets) under earthquake conditions may be predicted with some confidence by means of analysis. The operability of active components may be qualified by analysis only when their potential failure modes can be identified and described in terms of stress, deformation (including clearances) or loads. Otherwise, testing or earthquake experience should be used for the qualification of active components. 

Seismic qualification by means of analysis is treated in Section 5. The other three means form the subject matter for Section 6. 

Test qualification of items in seismic categories 1 and 3 should be carried out when failure modes cannot be identified or defined by means of analysis or earthquake experience. Direct qualification by testing makes use of type approval and acceptance tests. Low impedance (dynamic characteristic) tests should be limited to identify similarity or to verify analytical models. Code verification tests should be used for the generic verification of analytical procedures, which typically use computer codes. The methods of testing depend on the required input, weight, size, configuration and operational characteristics of the item, plus the characteristics of the available test fadlify. 

Qualification by special investigation when A, T or E are not applicable ( S in Table 9), special analysis (beyond the conventionally used standard based stress/strength analyses) and/or special testing (beyond the conventionally used test procedures). 

It is not necessary that participating laboratories be formally recognized, accredited or certified. Measurement of the property of interest should be completed by, or under the supervision of a technically competent manager qualified either in terms of suitable academic qualifications or relevant work experience. The participating laboratory should consider the analysis as a very special one, to be performed with special attention and all possible care, and not have it performed as part of its regular routine. 

Due to the nature of the test method, quality by design is an important qualification aspect for in vitro disolution test equipment. The suitability of the apparatus for the dissolu-tion/drug-release testing depends on both the physical and chemical calibrations which qualifies the equipment for further analysis. Besides the geometrical and dimensional accuracy and precision, as described in USP 27 and Ph.Eur., any irregularities such as vibration or undesired agitation by mechanical imperfection are to be avoided. Temperature of the test medium, rotation speed/flow rate, volume, sampling probes, and procedures need to be monitored periodically. 

Because the FCV algorithms are basically a non-statistlcal approach to cluster analysis it was not possible to attach estimates of mlsclasslfication error for step 2a). Similarly, the amount of data which could be collected for the investigation was not considered sufficient for use in defining confidence levels for the absolute values of plant emissions determined by step 2b). These qualifications need to be taken into consideration when interpreting the results of the investigation. 

Qualification of the laboratory. Qualification of the laboratory includes qualifying analysts initially by demonstrating their proficiency at preparing the necessary reagents, standards, and controls. Analyst qualification is necessary for each type of bacterial endotoxin analysis test prior to performance of any testing on actual samples. 

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. 

Since in-house facilities for handling a large volume of samples for routine analysis were not available, the analytical work was contracted out to three commercial laboratories. We will refer to them as Laboratories A, B, and C. The contractors were selected on the basis of qualification tests which were intended to serve also for interlaboratory calibration. The results were reported to NRDL as d.p.m. or equivalent 285U thermal-neutron fissions at detonation time. All of the radiochemical data obtained from the laboratories are reported in Ref. 5. These values were punched on cards and converted by computer to equivalent fissions of the device, based on mass-chain yield values supplied by the weapons laboratories. At the same time, the calibration factors derived from qualification-test analyses were applied. Values of the ratios, 95, were formed. All of the ratios for a given nuclide i were then selected along with the corresponding values of r89t95, and the data points were fitted... 

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