Robustness, technical requirements

The USP definition of robustness is equal to that of the ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use), which is given below. 

Step 2 Technical requirements Determine the specific technical requirements for the new method or analyzer that will ensure that it captures the previously determined business value. This is also done jointly by the customer and the project manager. Avoid would be nice ifs and focus on what is necessary. Technical requirements may include accuracy, precision, specificity, turnaround time, response time, robustness, maintenance needs, etc. They should be focused on what the analyzer needs to do (e.g. determine the concentration of component X with 1.5% relative precision, once a minute, in a corrosive process stream at 80°C), not how it will do it. (Issues that need to be considered in setting technical requirements are discussed in Section 11.2.3.)... 

The robustness of an analytical method can be described as the ability to reproduce the method in different laboratories or under different circumstances without the occurrence of unexpected differences in the obtained results. The term ruggedness is considered here as a synonym for robustness. The robustness of a method is tested in a robustness test. The most frequently u.sed definition for robustness in this area is due to the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) [79,80. It defines robustness as follows. The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage."... 

Laser resonators should have appropriate laser transition, good control of out-coupUng, high quality factor to ensure the desired temporal regime of emission, control of the mode stiucture and beam size, control of the thermal field (dissipation of heat, external cooling). Technical requirements include mechanical robustness, volumetric compact, lowest maintenance, and simple replacement of parts/ comjMjnents. 

Firstly, there are technical reasons concerning catalyst and reactor requirements. In the chemical industry, catalyst performance is critical. Compared to conventional catalysts, they are relatively expensive and catalyst production and standardization lag behind. In practice, a robust, proven catalyst is needed. For a specific application, an extended catalyst and washcoat development program is unavoidable, and in particular, for the fine chemistry in-house development is a burden. For coated systems, catalyst loading is low, making them unsuited for reactions occurring in the kinetic regime, which is particularly important for bulk chemistry and refineries. In that case, incorporated monolithic catalysts are the logical choice. Catalyst stability is crucial. It determines the amount of catalyst required for a batch process, the number of times the catalyst can be reused, and for a continuous process, the run time. 

Catalysis Issues in SOFC Catalytic processes play in important role in the operation of in particular, the SOFC anode and cathode, and the major challenges for the further development of SOFC towards a commercial project are largely related to improving catalytic activity and robustness. The critical technical issues for SOFC are reliability and lifetime, while economic requirements impose low manufacturing and materials costs. 

In order to use the sensor on an industrial scale, an appropriate housing is needed in which the required electrodes and temperature sensor are positioned in the scientifically and technically most considered and logical way. Additional requirements imply that the system should be robust and offer good protection against blows and/or other possible causes of defects. The system should be easy to handle, electrodes and other components should be straightforward to replace, the calibration of the electrodes should be accomplishable in a quick and particularly simple way, and the system must... 

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