Qualification of components

This section should describe the design bases for qualification of components to resist such environmental factors as vibration, thermal expansion, radiation, corrosion, dynamic effects, mechanical loadings and high pressure, high temperature, humidity, water, steam, chemicals, low temperature or vacuum. Qualification tests and analyses that have (or will be) performed should be described. 

This section shall provide the conclusion that the facility is designed to meet the overall safety objective and underlying safety objectives, and that appropriate external events, codes, standards and design methods have been considered in the design of the facility, including qualification of components. 

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This section should provide information concerning the seismic and tectonic characteristics of the site and of the region surrounding the site. The evaluation of seismic hazards should be based on a suitable geotectonic model substantiated by appropriate evidence and data. The results of this analysis, to be used further in other sections of the SAR in which structural design, seismic qualification of components and safety analysis are considered, should be described in detail. Further discussion on matters to be covered in this section of the SAR is provided in Refe [16,17]. 

The usability of for example components describes the qualification of components in safety applications. 

After many decades of application, industry has completely accepted standard NDT as an inevitable but invaluable part of production and maintenance of components. Its application has been well-regulated, acceptance criteria for weld defects exist, good schemes for personnel qualification are in place and equipment has evolved to a standard of nearperfection. NDT has become a commodity. Pioneering years are over. 

NDT has a very important formal status. Requirements for performanee of NDT, acceptance criteria and requirements for personnel qualification are implemented in codes and standards. The NDT procedure is part of the contract. During the many years that NDT methods have been used in industry a well-established situation has evolved, enabling the use of NDT for the evaluation of welds against Good Workmanship Criteria on a routine basis, thus maintaining workmanship standards and minimising the risks of component failure. 

The National system of accreditation gives much attention to the training and qualification of NDT personnel. Significant subjective component, such as training and qualification of personnel, is present in NDT implementation and assessment of its results, thus all specialists carrying out NDT must be certified in compliance with CTBEH 473. 

KSC increases the failure rates of components from causes such as earthquake, fiic. flooding, tornado, erroneous maintenance or inis-sp>ecifying the operating cnvironmcni. [ nvironmental qualification (EQ) of equipment, specified by Regulatory Guide 1.97, as.surcs ihc operation of instruments in an accident environment. Similar qualification is required for a tiesi uu-basis earthquake. 

During operation qualification, all components of the instrument are tested individually along with integral parts of the overall instrumentation. In this section, results of some of the most common performance parameters are presented with a brief description of the methods used for evaluation. 

The testing methods shall apply to the construction of pipe components and qualification of welding and brazing procedures in accordance with the requirements of ASME BPV Code Section IX, Parts IP and PL, and the engineering design as follows ... 

Qualification of a capillary electrophoresis instrument is performed using failure mode, effects, and criticality analysis as the risk analysis tool. The instrument is broken down into its component modules and the potential failures of those components identified. The potential effect of those failures is defined and the risk characterized. Any current evaluation of those failures is identified and any recommended actions to mitigate the risk defined. 

The installation qualification of automatic control systems shall consist of a logical panoply of tests. The tests are carried out step-by-step on each component. The structure of the installation qualihcation shall be standardized for all installation qualihcations of computerized pharmaceutical systems as follows. 

Section Val. 1900 includes four aseptic processes associated with monitoring and qualification programs covering determination of components bioburden before sterilization sterility test failure investigation, bacterial endotoxin determination in WFI, in-process finished product, and monitoring the bioburden, spore bioburden, and endotoxin present on stoppers and unprocessed vials. 

Suitability refers to the tests and studies used and accepted for the initial qualification of a component, or a container closure system, for its intended use. Quality control refers to the tests typically used and accepted to establish that, after the application is approved, the components and the container closure system continue to possess the characteristics established in the suitability stud-... 

The medical devices for category 3 in Table 1 are constituted (assembled) at the user site. Method verification for constitution should be one of the key factors, as well as qualification and validation in the manufacture of components (parts). Nuclear magnetic resonance spectroscopy (NMR) is included in this category. 

Leachables in orally inhaled and nasal drug products (OINDP) are compounds which are present in the drug product due to leaching from container closure system components. Extractables are compounds that can be extracted from OINDP device components, or surfaces of the OINDP container closure system when in presence of an appropriate solvent(s) and/or condition(s). Leachables are often a subset of, or are derived directly or indirectly from, extractables. Extractables may, therefore, be considered as potential leachables in OINDPs. Some leachables may affect product quality and/or present potential safety risks, therefore regulatory guidance has provided some recommendations regarding the analysis and toxicological safety assessment (i.e., qualification) of such compounds. 

Performance Qualification of Infrastructure is not conducted in the traditional sense. Rather, an ongoing monitoring program should be established in order to ensure that the network and associated components provide adequate performance and data security. Ongoing monitoring should include ... 

There is considerable interest in the chemical composition and properties of citrus oils and essences as well as the role they play in food and nonfood industries. Citrus peel oils and essences possess a pleasant aroma, with oxygenated compounds being the major constituents that account for their characteristic odor. Terpenes, the most abundant components in cold-pressed citms peel oil, are removed in concentrated oil production, usually by use of adsorbant and supercritical carbon dioxide, to increase the concentration of oxygenated compounds and to enhance the qualification of the oil. Meanwhile, citms seed oils are composed largely of triacylglycerols and are rich in oleic and linoleic acids. 

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