Software Personal Computer-. Review

This volume marks the return of the Physical Methods chapter last presented in 2001. Most notable is a very marked increase in theoretical and computational studies facilitated by the availability of increasingly more sophisticated and powerful personal computer software programs. These studies combined with experimental observations invariably give valuable evidence towards the understanding of the chemistry. There have been three excellent reviews on newer methods in combinatorial synthesis, asymmetric synthesis and green electrosynthesis that include a range of physical methods. 

If the review is conducted overseas, two main issues may arise. Firstly, the local language may be inconsistent with available specific safety review software or a consultant, if used, may not be available in the host country language. A translator is sometimes used in these instances. Secondly, if a portable personal computer is used, its power requirements may be different both in voltages and plug connections. In these circumstances it is best to plan ahead and bring power converters, adapters and multiple outlet busbars. 

All review sessions should be recorded using a personal computer (PC). Word processing software should be used for the report narrative write-up. A computer software spreadsheet, prepared for process safety reviews, should be used for all HAZOP and What-If reviews. It facilitates speed, ease of use and maintains exact consistency in format. 

A "PC projection panel" and overhead projection of the spreadsheet greatly eases viewing of the computer video output. The PC projection panel provides an overhead projection of the computer screen so that all review team members can easily and simultaneous observe and comment on the recorded information as it is being recorded. The PC projection panel consist of a liquid crystal display (LCD) panel that duplicates data, text or graphics, generated from the computer screen. When placed on an overhead projector the LCD image is projected onto a projector screen or a wall. Personal computer screens are viewable by only two or three personnel at a time. A typical review involves at least 5 personnel, so the PC projection pad enables all participants to view the software worksheet as it is prepared (note a "reflective" type of overhead projector will not operate with the PC projection panel, direct illumination from below the panel is required). Further details of a typical PC projection panel are provided in Appendix F. 

All costs are based on using a personal computer with standard HAZOP or What-If software support. Conducting a review without this similar support will lengthen its period. 

Spectroscopic methods can provide fast, non-destructive analytical measurements that can replace conventional analytical methods in many cases. The non-destructive nature of optical measurements makes them very attractive for stability testing. In the future, spectroscopic methods will be increasingly used for pharmaceutical stability analysis. This chapter will focus on quantitative analysis of pharmaceutical products. The second section of the chapter will provide an overview of basic vibrational spectroscopy and modern spectroscopic technology. The third section of this chapter is an introduction to multivariate analysis (MVA) and chemometrics. MVA is essential for the quantitative analysis of NIR and in many cases Raman spectral data. Growth in MVA has been aided by the availability of high quality software and powerful personal computers. Section 11.4 is a review of the qualification of NIR and Raman spectrometers. The criteria for NIR and Raman equipment qualification are described in USP chapters <1119> and < 1120>. The relevant highlights of the new USP chapter on analytical instrument qualification <1058> are also covered. Section 11.5 is a discussion of method validation for quantitative analytical methods based on multivariate statistics. Based on the USP chapter for NIR <1119>, the discussion of method validation for chemometric-based methods is also appropriate for Raman spectroscopy. The criteria for these MVA-based methods are the same as traditional analytical methods accuracy, precision, linearity, specificity, and robustness however, the ways they are described and evaluated can be different. 

M. Sadek and S. Munro, /. Comput.-Aided Mol. Design, 2, 81 (1988). Comparative Review of Molecular Modelling Software tor Personal Computers. 

User Interface. The object of software systems for risk assessment is to make the process of generating or reviewing risk assessments easier for system users. Software that is not easy to learn or use, or that requires constant reference to manuals or other support documents, will do little to help risk assessors faced with a demanding workload. Accordingly, a key emphasis in the development of Risk Assistant is that the software be usable by persons with little or no computer experience, without the need for training, and that the majority of a user s questions can be answered in the software, without the need to refer to manuals. The development of technical manuals is an important part of the Risk Assistant effort, but the user should not need to refer to these manuals frequently. 

Crucial to the success of the UAW-GM joint process was the inclusion of the hourly skilled trades and production personnel, who were extensively involved in the task-based risk assessments. This involvement was based on the premise that the person who does a job every day has intimate knowledge of it and can make meaningful contributions on how a job or process can be changed to make it safer. (The TABRA process has matured now, internally developed computer-based software is used in the safety design review process and for recordkeeping.)... 

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