Critical process parameter

Fig. 12. Critical process parameters as a function of gas enthalpy where A is yield, B is concentration, and C is the specific energy requirement (SER).

Monitoring by Electromechanical Instrumentation. According to basic engineering principles, no process can be conducted safely and effectively unless instantaneous information is available about its conditions. AH sterilizers are equipped with gauges, sensors (qv), and timers for the measurement of the various critical process parameters. More and more sterilizers are equipped with computerized control to eliminate the possibiUty of human error. However, electromechanical instmmentation is subject to random breakdowns or drifts from caUbrated settings and requires regular preventive maintenance procedures. 

The assessor should also find out whether an effective testing program is in place to help ensure the serviceability of process measurement equipment. The successful toller should have an established calibration program to address the accuracy of critical measurement equipment. Safety critical process parameters should be monitored and critical process equipment should automatically interlock when monitoring instrumentation detects safety critical deviations. Interlocks should either facilitate a remedy to the critical deviation or bring the process to the zero energy state. These instruments and interlocking devices should be routinely tested to ensure operational reliability. 

Checks of critical process parameters and warnings about hazardous conditions that can cause injury or equipment damage are important factors which determine the occurrence and recovery of human error. The purpose of these checks is to emphasize critical process information. Because of the critical nature of this information, checks and warning should be highlighted in a way that distinguishes them from other notes, and should be located where process workers will not overlook them. 

Confirm Measurement System > Baseline In-Process Product Parameters (Control, Capability) > Identify/Prioritize Process Steps > Identify Critical Process Parameters... 

In order to illustrate the critical process parameters of SMB process validation, we will consider the separation of the racemic drug as described in Process design. The study represents the effect of the influence of feed concentration, number of plates and retention factor on the second eluting enantiomer. The simulation of the process for different values of feed concentration is performed and the variations of the extract and raffinate purities are shown in Fig. 10.10. 

Extensive studies have been reported with cisplatin in the field of chemoembolization (59,98). Microspheres prepared by a solvent evaporation procedure were characterized in vitro and critical processing parameters in regard to drug release kinetics were identified. 

Currently the main application of interest for parametric release is to replace the sterility test as a control method in appropriate cases (given the limited value of that test to predict sterility assurance due to statistical considerations, although it is also pointed out that a sterility test provides a final opportunity to identify a major failure, although other means should provide a more reliable way of detecting such failures). The concept is applicable to well-founded methods of sterilization where the product stability is known and development data have identified the critical process parameters. The measured parameters should be such as to ensure that correct processing of the batch provides sufficient assurance that the sterility assurance level intended has been achieved. 

QA, quality attributes SPC/MSPC, statistical process control/multivariate statistical process control CPPs, critical process parameters. 

The use of chemically informative online analysers in the early stages of route development enable identification of critical processing parameters. 

The variables used to build the necessary models need only to be sensitive to the critical processing parameters, in other words they can be surrogates of the actual variables (impurities, pH, etc.) being controlled. 

The choice of the method depends on the type of process. With electron beams the critical process parameters are beam energy, beam current, scanning factors and uniformity, beam pulse characteristics, and the configuration of the product being processed. 

Discussion of the influence possibilities on critical process parameters... 

Cooling zone. In the cooling zone, an additional HEPA-hltered laminar how unit cools down the sterilized containers. When leaving the tunnel, the container temperature is about 10 to 20°C above room temperature. The laminar how unit and exhaust fan of the cooling zone are adjusted so that the tunnel remains pressurized, thus preventing any unsterilized air from entering. All critical process parameters are fully controlled by a... 

The following case study illustrates how a product is scaled-up from 15 to 150 kg in equipment supplied by Niro pharma systems once one understands the critical process parameters used when scaling-up. 

Pilot phase development allows the formulator to evaluate critical process parameters of compression essential for trouble-free production. Typically, DOE are used to evaluate the effects of process variation on the resulting tablet... 

By identifying critical process parameters early on in the development process, a robust formulation was developed and successfully scaled-up... 

Critical process parameters Critical steps studied... 

The agglomeration process is a batch process, and accurate repeatable control of aU critical process parameters is necessary for a robust system. Earlier designs of... 

All critical process parameters can be identified in a way that removes personal bias. 

---