Process safe time

Now with the help of Fig. IX/4.2.2-1, an attempt will be made to see how process safe time is determined. When an untoward incident occurs after a small gap of time, alarm appears with the help of sensor, alarm logic, and HMI. The small gap told here is sensor detection time and reaction time of alarm logic and HMI. After appearance of alarm in HMI there will be some time for operator s detection, diagnosis, and response as shown in Fig. IX/4.2.2-1. Now after operator responds actual thing to happen there will be reaction time, which comprises of process dead band and system reaction time. Sum total of operator action time and reaction time will be minimum necessary for any corrective action to happen. So, if hazardous event occurs after these time from T = 0, then system will be safe. Thus, process safe time wiU be as shown in Fig. IX/4.2.2-1. 

The development of a new drag for human use is a rather extensive process requiring time, workforce, and financial investments. The potential drag candidate must fulfill a series of rigorous requirements before it will receive its approval for marketing by the health authorities. This approval can only be obtained if the drag is effective, has a significant benefit for the patient, and, most important, is safe for the patient. 

The history of the FDA is a story of continuously stepping back. Is the product free of contaminants Then step back and consider the process of production. Is the product well organized and safe Examine next the hardware and software systems that control that manufacturing process. Every time one level of concern has achieved industr3rwide predominance it is possible to apply the energies used to achieve that awareness and compliance to yet another previous step. The process is, in effect, continuous quality improvement in action. 

In a eutectic system, the whole composition or just the excipient may be subject to crystallisation, but this process takes time to reach completion. It may be much longer than the time taken to freeze the product to the desired temperature (Tg). After primary drying (ice sublimation), only solid solutes remain. The mixture may then be carefully warmed to its final storage temperature. The residual solid will not necessarily be anhydrous and may, for example, contain water of crystallisation. In addition, as the temperature is raised, the crystalline product may undergo solid-solid transitions, i.e. over a period of time, a different polymorph may become the preferred crystal habit. In a completely crystalline preparation, the maximum safe storage temperature will be governed by the component with the lowest melting point. 

The objective of scale-up and process development in the pharmaceutical industry is ° "... designing to operate a process safely and cost effectively with predictable results at the scale of choice, by making best use of data and knowledge available at a certain time. ... 

To achieve this, the sum of the diagnostic test interval and the reaction time to achieve a safe state should be less than the process safety time . The process safety time is defined as the time period between a failure occurring in the process or the basic process control system (with the potential to give rise to a hazardous event) and the occurrence of the hazardous event if the safety instrumented function is not performed. 

SOLUTION The diagnostics operate rapidly and complete execution sixty times per expected demand period. The diagnostic test time plus the response time is within the process safety time. Therefore dangerous detected failures will be converted into safe failures. The remaining dangerous failure rate is 0.5 x 10 failures per hour. That meets the requirements for SIL2 per Figure 7-4. 

Is there a modifications man available who can provide expertise has the time to review changes and can promptly answer process safely questions ... 

Control valve as final element if -proof test and maintenance records demonstrate that it meets the shutoff closing speed needs -the fail safe action is defined correctly -it is not shared with another IPL for the same scenario -the interlock has to work direct on the actuator Acceptable if the valve is not the only IPL which reacts within the process safety time for this scenario (e.g. PSV or alarm but nonsafety related) Acceptable as second final element Acceptable second final element NOTE This architecture is not allowed for new or upgraded installations. 

When the demand frequency is more than twice the periodic proof-test frequency, the application should be considered a high-demand mode application. Therefore the equations and techniques that use test interval as a key variable are not valid. In effect, one cannot take credit for periodic inspection unless it is done very frequently. Credit may be taken for diagnostics that cause the device to fail to the safe state (i.e. automatic process shutdown on any detected dangerous failure) in the high-demand case, as long as the diagnostic time period plus the time necessary to safely return the process to a safe state is less than the available process safety time (the time period between initiation of a demand and the hazard). 

In this case, the process engineer determined that upon detection of a dangerous fault, the SIF should be initiated. A diagnostic alarm is displayed on the BPCS HMI to alarm when the SIF level signal falls below -5%, which indicates a failure of the SIF level transmitter. When the operator receives the alarm, the operator manually activates the SIF per the operating procedures to bring the system to a safe state. The hazard and risk analysis indicated that there was sufficient process safety time for the operator to respond effectively (refer to Annex B for more information on operator alarm with response). Alternatively, the SIF could be configured such that on detection of transmitter failure, the SIF is automatically initiated. 

The purpose of this annex is to provide guidance for establishing instrument setpoints for safety instrumented functions in the process industries. The scope of ANSI/ISA-84.00.01 is requirements for... a safety instrumented system, so that it can be confidently entrusted to place and/or maintain the process in a safe state." This annex provides guidance on instrument uncertainty calculations and setpoint determination for instruments used in an SIS to ensure that each SIF responds to achieve or maintain the safe state of the process within one-half of the process safety time with respect to a specific hazardous event. If measurement uncertainty is not considered in the determination of an SIS setpoint, the SIF may not detect the presence of a valid process demand. 

Information is required from process engineering to begin the setpoint determination process. For each SIF, those inputs are the Process Parameter Limit, Process Lag Time, and the Safe Upper and Lower Limits for the process. A suggested SIS setpoint or range would also be beneficial. 

Setpoints for SIFs should be selected such that actions can be taken to achieve or maintain the safe state of the process within the allocated process safety time. 

Response time requirements related to process safe state... 

With an estimate of the process settling time T, the important frequency region for parameter estimation is the low frequency region up to radians/time, where n can be safely selected within the remge of 11 to 19 for many processes. One approach would be to choose the input signal such that it contains a set of equally weighted frequencies 0,. .,... 

An SIF is a function that is safety-critical in process system and is monitored by a SIS. SIFs are determined and implemented in a SIS as part of an overall risk reduction strategy which is intended to reduce the likelihood of identified hazardous events involving a catastrophic release. The SIS safe state is a state of the process operation where a mishap cannot occur. The safe state should be achieved within one-half of the process safety time. Most SIFs are focused on preventing catastrophic mishaps. 

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