Process Design Report

Process design is the initial stage of process development where an outline of the clinical trial and commercial manufacturing processes are identified on paper, including the intended scale(s) of manufacture. This should be documented in a Process Design Report. 

The Process Design Report should include all the factors that need to be considered for the design of the process, including the facilities and environment, equipment, manufacturing variables and any material handling requirements. A list of factors to consider is given in Table 8.5. 

A process design report identifies the key assumptions in the design and their potential impact on the performance of the process and its anticipated profitability. This is particularly important for designs completed by undergraduate students at universities, where facilities and time are rarely available for laboratory work or pilot-plant testing. 

The remaining sections are essentially identical to Sections 15-18 of the process design report... 

Wi.N TF.RS, C. E. et al., Homogeneous Reactor Preliminary Process Design Report, US.VEC Reports. VECD-3980 and ORNL-527(Del.), Oak Ridge National Laboratory, Dec. 28, 1949. 

G. A. Siletti and G. Stephanopoulous, M Computer Programfor SynthesifingDoivnstream Process Designs, technical report no. LISPE-88-043, Laboratory... 

The HAZOP team consisted of a HAZOP leader, scribe, process engineer, senior operator, and afety engineer. Previously, the HAZOP leader collected information on the process design (e.g P lDs, operating procedures, emergency procedures and incident reports) for distribution to each team men The leader sectioned the process and identified process deviations prior to the HAZOP. 

U.S. EPA, Process Design Manual for Sludge Treatment and Disposal, Report EPA 6251-174-006, U.S. EPA, National Technical Information Service, Springfield, VA, 1974. 

In this book, we report on the state of the art of methods for catalyst separation recovery and recycling, not just describing the chemistry, but also discussing the process design that would be required to put the processes into practice. 

NREL (National Renewable Energy Laboratory). Lignocellulosic biomass to ethanol process design and economics utilizing co-current dilute add prehydrolysis and enzymatic hydrolysis for com stover. Golden, CO US (2002). Report available on web http //www.mel.gov/ docs/ fy02osti/32438.pdf... 

For this report, the committee concentrated on evaluating the following critical components of the GATS process design that had been identified as potential concerns in earlier NRC reports ... 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

There should be an oral presentation towards the end of the semester to the management (which is your classmates, the professor, and the invitees) on your business plan for a proposed new product on the innovative product idea, on market and technology analysis, on the financial and environmental analysis, and on your recommended action. Be prepared to answer searching questions from your management, and to hear constructive comments intended to improve your research, your analysis, your recommendation, and your presentation skills. If time permits, it would be useful to take all the comments and constructive suggestions into consideration, and make a second oral presentation. The product design project concludes with the submission of a written report, which would be in parallel with the traditional process design project. 

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