Acceptance zone

Let us first segregate the two sources forming the feed to the incinerator. As can be seen from the source-sink mapping diagram (Fig. 9.20), the gaseous emission from the ammonium nitrate process (R2) is within the acceptable zone for the incinerator. Therefore, it should not be mixed with R] then separated. Instead, the ammonia content of Ri should be reduced to 0.10 wt% then mixed with R2 to provide an acceptable feed to the incinerator as shown by Fig. 9.20. The task of removing ammonia from Rj to from 1.10 wt% to 0.10 wt% is identical to the case study solved in Section 9.3. Hence, the solution presented in Fig. 9.18 can be used. 

Sites D and E operate with the highest TSE, approximately four times that of site A, very clearly also out of any acceptance zone. 

We have to formulate decision rules in such a way that we define acceptance zones (where the product is declared comphant) and rejection zones (where the product is declared non-comphant). 

If the measurement lies in the acceptance zone the product is declared compliant... 

If we use the decision rule from the example (slide 57) the acceptance zone increases the upper limit. That means that we have a high confidence of correct rejection. If we transform this to the sale of a commercial product, the purchaser takes the risk of a wrong decision. 

It is noticeable that an increase of the osmotic pressure of the wash solution that is used can lower the time required to restore the pH to a physiologically acceptable zone. Therefore, it shortens the required washing time (the gap is due to osmolarity) (Fig. 3.86) ... 

Note 2 Acceptable zone diameter is greater than or equal to control disc... 

Note 1 Kirby-Bauer Test - acceptable zone diameter (of inhibition) is greater than the control disk of 6 mm... 

If the risk finked to a scenario falls into the non-acceptable zone, it must be reduced by appropriate risk-reducing measures. These are usually classified following two viewpoints, the action level and the action mode. The action level can... 

One possible approach is to select the most important response, the one that should be optimized, such as the yield of pellets. For the remaining responses, we can choose acceptable upper and lower limits. Response surfaces are plotted with only these limits, with unacceptable values shaded. The unshaded area is the acceptable zone. Within that acceptable zone, we may either select the center for maximum ruggedness of formulation or process or look for a maximum (or minimum or target value) of the key response. 

Let the desired penetration rate be between 0.5 and 1 mg.h , the lag time be less than 0.75 h, and the highest acceptable irritation score be 10. Figure 6.2b shows these limits superimposed, revealing a small acceptable zone around the point 1% d-limonene and 45% ethanol. In the original paper, the authors used a multi-objective optimization method. 

Figure 6.4 Acceptable zones in formulation of an oral solution.

For illustration purposes, we assume that the following requirements must be met crushing strength greater than 100 N, disintegration time less than 60 s, and price less than 400 cts/kg. An acceptable zone may be defined (figure 9.5b). 

According to the traffic light system there is a green zone / area if the AGW is not exceeded. Additional measures to reduce the exposure to the substance via inhalation are not required (the so-called acceptable zone / area). No relevant risks to human health can be expected. 

The severity of substances X and Y during eight technological modality 2 designs x 2 food types x 2 storage conditions is plotted in Figure 13.12(b). The acceptable zone corresponds to a severity lower than 100 (migration lower than the... 

Length and direction of risk reduction vector depends on safety measures apphed, in particular the protection layers (BPCS, AS/human operator and SIS). The safety-related measures proposed should enable to reduce risk to tolerable or acceptable zone. When it will be assumed that the measures will not reduce consequences (C = const) then the risk reduction vector will be directed vertically to the button. In such case reducing the frequency is expressed as follows (LOPA 2001)... 

Figure 2.28 By comparison with Figure 2.27, special lubricants contained in the modified anaerobic adhesive lift the torque/tension relationship back into the accepted zone, even when used on degreased bolts.

FIGURE 10.121 Asimplified version ofthe CBEMA curve. Voltage levels outside the acceptable zone results in potential system shutdown and hardware and software loss. (From [2]. Used with permission.)... 

The scale of risk evaluation provides for the definition of an ALARP zone. For a risk to be ALARP, it must be possible to demonstrate that the risk is not able to be eliminated, but that it can be managed in some technical or procedural way. This is one of the requirements of ISO 14971 however, the ALARP management approach does not permit to stop the search by the manufacturer of solutions that can eliminate or reduce the risk to an acceptable zone. 

The table is used to state the need of a mitigation, and the risk zone after the mitigation is applied. The goal is to have all the risks in the acceptable zone when the identifieation of a mitigation is diffieult or expansive, when it can lead to additional risks or when the proteetion does not move the risk in the acceptable zone, the residual risk is evaluated against the elinical benefits of the functionality. 

Risk is so small, it can be neglected instead of spending resources or effort to reduce (i.e., acceptable zone in ALARP principle Fig. 1/4.3-1). 

The top part in the figure is the unacceptable region and detailed QRA, and suitable additional control measures are necessary to reduce risk. The mid portion is the tolerable region and suitable control measures are necessary after semiquantified analysis to bring them to SFARP. Even for the acceptable zone risk analysis is necessary but qualitative will do. Adapted control measures must be shown to collectively eliminate or reduce to ALARP, with details in the safety document. Additional control measures (Clause 4.5) may be adapted for ... 

On this purely physical aspect, water and DIPHOTERINE solution have the same effect. DIPHOTERINE solution improves the washing effect of water by restoring the pH toward the physiologically acceptable zone while water maintains a corrosive pH (Fig. 4.8). For the latter sulfuric acid, the fundamental elanent of aggressiveness is the persistence of pH valnes out of the physiological range. 

Thus, for acceptable zone, it should meet the equation (23) deriving from equation (21). In the similar way, for ALARP zone, it should meet the equation (24) deriving from equation (22). 

Fig. 3 Accelerated in vivo ESC test. At the top is a tubing specimen stretched over a 0.5-inch-long dumbbell mandrel, with the strain fixed at each end by polyester ligatures. Samples are tied together in strings, identified with a colored glass bead, and implanted in the subcutis of rabbits as shown above. After explant, observations made in the accept zone are accepted. Observations in the reject zone, where the strain is uncontrolled, are rejected. A coating of medical adhesive in heptane can be applied to the ends of the samples to cover the knots, etc., isolating the tissue exposure to the center portion of the specimens where the strain is ideally controlled. Samples may then be analyzed by FUR, HPLC molecular weight, SEM, and other suitable techniques...

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