查看更多>>摘要：I notice that there are a lot of different job titles these days that in some way connote a connection to a field of scientific study. Today, people with all kinds of titles such as researcher, professor, analyst, technician, vice president, and others, all like to think of themselves as scientists. I, however, am not as liberal with the attribution. Let me be clear: I am not a scientist. However, I am a student of science and I have a document attesting to that fact. My document attests to nothing more than this, however, and certainly says nothing about my absolute belief in the scientific method and my great appreciation for the practicing scientists who instilled in me the critical importance of upholding this belief above all else in any scientific endeavor. You see, "to be termed scientific, a method of inquiry must be based on gathering observable, empirical and measurable evidence subject to specific principles of reasoning. And, a scientific method consists of the collection of data through observation and experimentation, and the formulation and testing of hypotheses."
查看更多>>摘要：One visit to Peanut Corp. of America's (PCA) facilities would have raised red flags for any food manufacturer who is even modestly aware of food safety. The Chicago Tribune cited former workers at the Blakely, GA peanut-processing plant who'd witnessed leaking roofs and mice crawling in the peanuts, and a recent FDA inspection report that noted the presence of roaches, mold, and dirty utensils used in food preparation.
查看更多>>摘要：This isn't the best of times for chipmakers, and even the biggest names are feeling the effects. Intel (Santa Clara, CA) announced early this year a halt to production at five older factories, one of which was the company's last major manufacturing facility left in Silicon Valley. Given that, some might question the timing of the late January launch of the new Environment, Safety & Health (ESH) Technology Center by the International SEMATECH Manufacturing Consortium (ISMI; Austin, TX).
查看更多>>摘要：BioMerieux, a developer of in vitro diagnostics, has entered into an exclusive referral agreement with ICNet Systems, Inc., an international provider of health-care associated infection (HAI) case management and surveillance software. ICNet is a web-enabled application that reportedly helps hospitals reduce medication costs through quicker and appropriate use of real-time microbiology diagnostic data management, surveillance, and reporting, which uses timelier root-cause analysis to decrease the risk of spreading preventable infections.
查看更多>>摘要：The CleanRooms Europe 2009 conference program will be structured around the highly relevant and timely theme "Improving Productivity and Lowering Life-Cycle Costs." Productivity is the number one issue for all manufacturers and service providers-whether the product is something tangible like a drug or semiconductor, or something immeasurable like the confidence that conies from knowing your hospital operating or treatment room is free of non-patient-derived infection sources.
查看更多>>摘要：AFPRO Filters manufactures all kinds of filters such as HEPA filters, prefilters, and fine filters according to the latest regulations such as EN779:2002, EN1822, and others. With offices and factories in Germany, the Netherlands, China, and Belgium, and dealers in many other countries, AFPRO Filters can be found all over the world. All products are designed by the company's engineers according to the latest requirements from the market. At CleanRooms Europe, the company will exhibit products that show low-pressure drops in order to reduce energy costs. It will also exhibit its latest range of chemical filters that are designed to reduce the amount of chemicals in cleanrooms.
查看更多>>摘要：Experts in the pharmaceutical and biotechnology industries are the first to admit that they are not trendsetters when it comes to implementing new technologies. While electronics and semiconductor manufacturers are constantly shrinking geometries and implementing smaller, more cost-effective tools to improve their yields, pharmaceutical experts embrace caution when it comes to innovation.
查看更多>>摘要：Even though his manufacturing operation is in the United States, Aaron Gordon, director of sterile operations for DSM Pharmaceuticals in Greenville, NC, is spending a tot of time thinking about EU regulations for aseptic filling and packaging. "We manufacture products for a worldwide market," he points out. "Even though our base guidance body is the FDA, we need to comply with all markets."
查看更多>>摘要：Pharmaceutical manufacturers face various restrictions when it comes to automating the sterilization process, notes Josh Epstein, director of marketing for Advanced Electron Beams (AEB), a maker of compact electron-beam emitters for sterilization of products and packaging, based in Wilmington, MA. 'Terminal sterilization is the surest way to kill bugs, but most injectable drugs can't withstand the radiation or heat."
查看更多>>摘要：That completes a general overview of the types of tests and monitoring activities associated with the formulation and F/F of purified bulk drug substance to final drug product. Although the overall process is fairly straightforward, it can be easy to over-test, especially during formulation activities. Keep in mind these key points: Test only when necessary to reduce interventions; test using methods that give data as quickly as fittingly possible to condense processing times; and utilize a client's knowledge of the product and the contractor's knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.
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