Definition of Process

GmeraHy, the solids are not structurally homogeneous, but the solid and liquid neveithel will be called phases and leaching will be treated as a two-phase, mass transfer process. The solid consists of a matrix of insoluble solids, the marc, and the occluded solution. It may also contain undissolved striute and a nonextractable secondary phase, for example, coffee oil in water-soaked coffee grounds. This secondary phase is treated as part of the marc. Dimensionless parameters that can affect solute transfer include the soittte equilibrium distribution coefficients, nr and M the Fkk number, r, the sttqiping factor, et the ffiot number, Bi and the Pedet number, Pe. These parameters ate defined mote precisely in the Notation section. 

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Definition of process objectives Generation of separation core structure Selection of separation sequence and unit operations Addition of further units to the process structure Selection of crystallizer type... 

Stankiewicz and Moulijn extend the definition of process intensification from size reduction of apparatus to dramatic improvements in key features of chemical processing [25]. Substantial decreases in the following process-engineering properties are listed ... 

Phillips of the BHR Group, UK, provides a compact definition of process intensification, saying it is ... a design philosophy whereby the fluid dynamics in a process are matched to its chemical, biological and/or physical requirements,. .. [27]. In this way, significant benefits are gained, those listed above. 

Process. USEPA has basically adopted OSHA s definition of process USEPA decided to coordinate interpretations of the definition of process with OSHA to ensure that the rule is applied consistently. 

A broadly accepted definition of process analytics is difficult to capture as the scope of the methodology has increased significantly over the course of its development. What was once a subcategory of analytical chemistry or measurement science has developed into a much broader system for process understanding and control. Historically, a general definition of process analytics could have been ... 

This wider definition can be summarized as the analysis of the process and had been developing in the pharmaceutical industry since around 2004-2006 to encourage better use of the information content of classical process analytical methods for the improvement of process development and connol. Particularly in the pharmaceutical industry, the acronym PAT for Process Analytical Technology was often being used to describe this newer definition of process analytics. 

With the onset of the QbD initiative (see Section 2.3.4), first codified in the ICH Q8 document in 2006, the above-mentioned broader definition of process analytical technology has somewhat evolved into parts of the key elements of the broad definition of QbD, resulting in a partial retraction of the term PAT back... 

Definition of process output Potency, yield, physical parameters... 

Objective Type of validation Type of process Definition of process... 

Definition of process output Definition of test methods... 

One approach that QA would use to assure itself that a given process (step) is under control is the effort associated with the concept of process capability. Ekvall and Juran [15] defined the concept as the measured inherent reproducibility of the product turned out by the process. The statistical definition of process capability is that all the measured values fall within a 6-sigma range (i.e., range of the minimum to maximum limits). The information is used to show that the process is under control over a period of time as well as determine whether there is any drifting or abnormal behavior from time to time. Process validation is a QA tool in this case because its data will be used as the origin for the data curve developed for the process capability concept. 

Definition of Process and Systems Process R D - Installation Qualification Operational Qualification Prospective Performance Qualification i IMb Commercial Production... 

The validation era brought with it the need for humans involved to communicate with new terminology. The purpose of this chapter has been to identify and explain the key terminology needed to understand nonaseptic process validation. A currently popular, lucid, and accurate definition of process validation itself is well-organised, well-documented common sense. 

A risk analysis is not an objective by itself, but is one of the elements of the design of a technically and economically efficient chemical process [1]. In fact, risk analysis reveals the process inherent weaknesses and provides means to correct them. Thus, risk analysis should not be considered as a police action, in the sense that, at the last minute, one wants to ensure that the process will work as intended. Risk analysis rather plays an important role during process design. Therefore, it is a key element in process development, especially in the definition of process control strategies to be implemented. A well-driven risk analysis not only leads to a safe process, but also to an economic process, since the process will be more reliable and give rise to less productivity loss. 

Process intensification can be considered to be the use of measures to increase the volume-specific rates of reaction, heat transfer, and mass transfer and thus to enable the chemical system or catalyst to realize its full potential (2). Catalysis itself is an example of process intensification in its broadest sense. The use of special reaction media, such as ionic liquids or supercritical fluids, high-density energy sources, such as microwaves or ultrasonics, the exploitation of centrifugal fields, the use of microstructured reactors with very high specific surface areas, and the periodic reactor operation all fall under this definition of process intensification, and the list given is by no means exhaustive. 

Premises Expression system defined Process scalability Primary definition of process No validation Refinement of operational control parameters Development of scale-down process models for validation Process out-of-limit definition Finalization of process control parameters Fixed and defined process and products Pivotal process validation and characterization studies Validated production process Well-characterized product Robust process ... 

Each incident is unique. One working definition of Process Safety Incidents is incidents which—in the judgment of responsible, informed, in-plant administrators (such as the shift superintendent or any second-level supervisor)—could reasonably have resulted or actually had resulted in a catastrophic release of highly hazardous chemicals. A catastrophic release for these purposes is a major uncontrolled emission, fire, or explosion, involving one or more highly hazardous chemicals, that presents serious danger to employees in the workplace. 

A more formal definition of process synthesis is possible. 

To complement the equations obtained from the application of the conservation principles, it is required to use some equations based on physical, chemical, or electrochemical laws, that model the primary mechanisms by which changes within the process are assumed to occur (rates of the processes, calculation of properties, etc.). These equations are called constitutive equations and include four main categories of equations definition of process variables in terms of physical properties, transport rate, chemical and electrochemical kinetics, and thermodynamic equations. 

The considerations and the experimental evidence just described suggest that the reactor design as well as the definition of process conditions need a tool, able to provide reliable predictions for the on-set of fluidization worsening and bed defluidization. Mastellone and Arena [37] proposed a predictive defluidization model valid for low-temperature pyrolysis... 

Lagging Metrics—process safety incidents that meet the threshold of severity and shouid be reported as part of the process safety metric Near-Miss Incidents—incidents that did not meet the definition of process safety incident metric... 

The ultimate goal of the process safety system is to prevent process safety incidents. The Center for Chemical Process Safety s Process Safety Leading and Lagging Metrics Report (CCPS, 2007b) defines a consensus from several chemical and allied processing industries for definitions of process safety incidents and process safety near misses. If an organization adopts these definitions, a... 

There is much confusion regarding the definition of process validation and what constitutes process validation documentation. The term validation is used here generically to cover the entire spectrum of current GMP concerns, essential most of which are facility, equipment, component, method, and process qualification. Based upon the FDA process validation guidelines, the specific term should be reserved for the final stage(s) of the product and process development sequence. The essential or key steps or stages of a successfully completed development program are shown in Table 1. 

Definition of Process Technology for the Optimal Route (Route D) 343... 

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