Intended function

Reliability. The rehabiUty of a system is defined as the probabiUty that the system will perform its intended function satisfactorily for a specified interval of time when operating under stated environmental conditions. It has to be realized that supposedly identical products fail at different times, thus rehabihty can be quantified only as a probabiUty. For any product there is some underlying function that describes this success pattern. Typical reUabiUty functions are shown in Figure 1 for two different products. These products can be compared at the same rehabihty level R or the rehabihty levels can be compared for any selected time period, t. ... 

System Effectiveness. A system is designed to perform some intended function in a prescribed fashion. This overall capabihty is termed system effectiveness. Figure 2 illustrates the design trade-offs that constitute the components of system effectiveness. 

Erythrocyte Entrapment of Enzymes. Erythrocytes have been used as carriers for therapeutic enzymes in the treatment of inborn errors (249). Exogenous enzymes encapsulated in erythrocytes may be useful both for dehvery of a given enzyme to the site of its intended function and for the degradation of pathologically elevated, diffusible substances in the plasma. In the use of this approach, it is important to determine that the enzyme is completely internalized without adsorption to the erythrocyte membrane. Since exposed protein on the erythrocyte surface may ehcit an immune response following repeated sensitization with enzyme loaded erythrocytes, an immunologic assessment of each potential system in animal models is required prior to human trials (250). 

Equipment Reliability The probability that, when operating under stated environment conditions, process equipment will perform its intended function adequately for a specified exposure period. 

The reliability of a product is the measure of its ability to perform its intended function without failure for a specified time in a particular environment. Reliability engineering has developed into two principal areas part and system. Part reliability is concerned with the failure characteristics of the individual part to make inferences about the part population. This area is the focus of Chapter 4 of the book and dominates reliability analysis. System reliability is concerned with the failure characteristics of a group of typically different parts assembled as a system (Sadlon, 1993). 

The elements of a PM plan include periodic inspection, cleaning, and service as warranted, adjustment and calibration of control system components, maintenance equipment and replacement parts that are of good quality and properly selected for the intended function. Critical HVAC system components that require PM in order to maintain comfort and deliver adequate ventilation air include a outdoor air intake opening, damper controls, air filters, drip pans, cooling and heating coils, fan belts, humidification equipment and controls, distribution systems, exhaust fans. 

Performance of the corrective measure based on the effectiveness of the technology to perform its intended function and the length of time the level of effectiveness can be maintained. 

CER50.65, the Maintenance Rule requires nuclear plant licensees in the U. S. to monitor the condition of structures, systems, or components (SSC) against licensee goals to assure the SSC are fulfilling their intended function. 

Each jet must be designed for a specific function. A jet could easily transport or increase the capturing of contaminants, but could also very easily destroy the intended function of a local ventilation system. 

One of the most essential parameters for a jet is the direction. A small deviation in the outlet angle could easily change not only the direction of the jet but also its intended function, be it as a shield or for air transport. 

Flame Arrester A device fitted to the opening of an enclosure or to the connecting piping of a system of enclosures and whose intended function is to allow flow but prevent the transmission of flame from either a deflagration or detonation. 

No Less More Part of As well as Reverse Other tlian No part of intended function is accomplished Quantitative decrease in intended activity Quantitative increase in intended activity Tlie intention is acliieved to a certain percent Tlie intention is accomplished along with side effects Tlie opposite of the intention is achieved A different activity replaces tlie intended activity... 

Risk is defined as tlie product of two factors (1) tlie probability of an undesirable event and (2) tlie measured consequences of the undesirable event. Measured consequences may be stated in terms of financial loss, injuries, deatlis, or Ollier variables. Failure represents an inability to perform some required function. Reliability is the probability that a system or one of its components will perform its intended function mider certain conditions for a specified period. Tlie reliability of a system and its probability of failure are complementary in tlie sense tliat the sum of these two probabilities is unity. This cluipler considers basic concepts and llieorenis of probability tliat find application in tlie estimation of risk and reliability. 

For a criterion of failure, life tests should measure the time required for a material to deteriorate to a condition where it is no longer capable of performing its intended function. Careful analysis and testing are required to determine the most important condition or property at the time of failure or the point when a material becomes inadequate to its intended function. 

Define all of the environmental stresses that the product will be exposed to in its intended function. 

With respect to development pharmaceutics data, the requirements stated in Directive 75/318/EEC (as amended) are included in the Annex to that document at Part 2 A 4 (page 20 of the Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use). With respect to the general requirement for pharmaceutical products this states 4.1 An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated. This, then, is the legal requirement. Needless to say, there is a... 

The choice of the excipients, their intended function, and their concentration will need to be considered in relation to those characteristics that may affect product performance. 

The cost of passive gas control systems is low. The passive concept has virtually no operating or maintenance costs. However, it is recommended that periodic inspections be made and that the surface gas be periodically monitored in the area being protected to ensure that the systems are performing their intended functions. 

The design of cover systems is site-specific and depends on the intended function of the final cover—components can range from a single-layer system to a complex multilayer system. To minimize percolation, conventional cover systems use low-permeability barrier layers. These barrier layers are often constructed of compacted clay, geomembranes, geosynthetic clay liners, or combinations of these materials. 

While the construction cost for an ET cover is expected to be less than that for a conventional cover, uncertainty exists about the costs for O M after construction. Several factors affecting the O M cost include frequency and level of maintenance (e.g., irrigation and nutrient addition), and activities needed to address erosion and biointrusion. In addition, when comparing the costs for ET and conventional covers, it is important to consider the types of components for each cover and their intended function. For example, it would generally not be appropriate to compare the costs for a conventional cover with a gas collection layer to an ET cover with no such layer. Additional information about the costs for specific ET cover systems is provided in project profiles, discussed in Section 25.9. 

The MCI is created by detonating or igniting a test round(s), or item(s) with all items in the operational configuration in the shield, including the equipment or reasonable simulation thereof, that performs the intended function on the munitions. If the shield is intended to be used for a variety of rounds, the one(s) having the most severe effects for overpressure, fragmentation, thermal emissions and shape charge effects is to be tested. 

Hopefully this discussion has provided food for thought in developing your own automated dissolution capabilities. The following section relating to testing and qualifications will help the user assure that the intended functionality is indeed delivered. 

PQ is defined as documented verification that the system performs its intended function in accordance with the system specification while operating in its normal environment. 

Drugs are administered by various means from oral to intravenous to topical. The oral route is a relatively slow process where a drug must be absorbed across the GI tract and then passed through the liver and metabolized before it becomes available to bind to receptors and perform its intended function. On the other hand, intravenous application is quick but has the potential of fast systemic reaction if adverse reactions occur. In the case of topical administration, the effects of the drug are localized. 

The design of a functional protease mimic thus has to be considered to be too difficult a problem for the time being. In contrast, the successful design strategies to date are based on relatively simple concepts that do not require several residues to be in the correct conformations simultaneously and where the chemistries and template structures are compatible with the intended functions. 

In order to circumvent this sensitivity limitation, the San Jose researchers sought to design resist materials that incorporate chemical amplification of the sort that characterizes the silver halide photographic emulsion system. In these systems a single photo event initiates a cascade of subsequent chemical reactions that ultimately result in the intended function. 

Although they obtained patents on the use of MDA for these applications (and also as a weight-loss product), they never developed commercial products from the compound. The problem, which appeared during human trials, was that the psychic effects on subjects were too severe to permit use of MDA for its intended functions. The compound caused overstimulation of the CNS, which sometimes resulted in panic attacks among subjects. This drawback did not, however, prevent the spread of MDA in the illicit drug market, where it eventually became one of the most popular substances used in the 1960s, when it was widely known as "the love drug. ... 

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