This paper describes an approach and technical process for developing and implementing a Control Strategy, which is a planned set of controls, derived from current product and process understanding that assures process performance and product quality. Development of a Control Strategy requires a structured process, involving a multidisciplinary team of experts, linking pharmaceutical development to the manufacturing process, and engineering controls of process equipment. The PQLI Control Strategy Team has proposed a Control Strategy Model that facilitates understanding and that may be used a cross-functional communication tool. This paper concentrates on the techniques and principles involved in developing the early Control Strategy rather than the operational implementation of the strategy.
The requirements of the MACT Standards for Emissions from Leaking Equipment and the requirements of the amended Clean Air Act will change how environmental control programs are administered within plants. No longer will the programs be the responsibility solely of the separate environmental function. The programs will need to be administered via a team of personnel that involves maintenance, computer systems, environmental, emissions measurement specialists, and planning personnel as well as management. Compliance with the rules will be based on an inspection ofpaper records and computer databases. The enforcement penalties will not be trivial, The ability of the plant togrow and be modfied will need to be balanced against the potential benefits from early reduction programs, which will allow for delayed implementation of some programs. EPA RECENTLY COMPLETED a negotiation process that resulted in rules which defme National Emission Standards for Hazardous Air Pollutants (NESHAP) emissions from leaking equipment. These rules apply to emissions from valves, pumps, flanges, compressors, relief valves, agitators, sampling systems, and openended lines. These new rules will be a template for the establishment of Maximum Achievable Control Technology (MACT) requirements under the Clean Air Act Amendments for emissions from leaking equipment. The new fugitive emission rules and the new Clean Air Act requirements are summarized and the implications for plant operations are discussed in this article.The plant performance data summarized below indicate that a quality approach is needed to reduce emissions from leaking equipment. This quality approach is summarized and explained. The approach must involve all aspects that affect emissions from leaking equipment. That is, all the systems affecting equipment emissions must be brought into control to achieve low emission performance. These systems include purchasing, specification, inspection, vendor quality assurance, owner quality assurance, operations, maintenance, and leak detection and repair programs.
This paper reports the results of a study conducted to measure the effects of the introduction of a pre-eurrieular computer course for certain prospective Computer Technology students at IPFW.The paper discusses certain screening techniques used to allow admission to the regular computer curriculum.The paper also compares the grades in the first computer course prior to administering the selected placement criteria and after the placement criteria was established.Finally, the paper discusses the effect on prospective CIS majors who where placed into this pre-curricular course prior to beginning the regular CIS curriculum.The results show a significant increase in the average grades for students placing into the regular curriculum versus students who were placed into the pre-curricular computer course and who then enrolled in the regular computer curriculum.The results also show that a large number of students who declared Computer Technology as their major and who failed to place into the regular computer curriculum did not continue in the Computer Technology curriculum after completing the precurricular computer course.
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