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pH Sensor Improves Product, Process, and Profits
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Автор:  san [ 20 серпня 2014, 23:22 ]
Тема повідомлення:  pH Sensor Improves Product, Process, and Profits

pH Sensor Improves Product, Process, and Profits
http://www.controleng.com/search/search ... f2afa.html
http://e-ditionsbyfry.com/Olive/ODE/CTL ... w=document
Inconsistencies had to stop. Not to mention the need to replace three failed $600 sensors per batch and adding anywhere from 20 to 40 trips to the lab with samples. Gilead Sciences Inc., is an international biopharmaceutical company that discovers, develops and commercializes innovative therapeutics to fill areas of unmet medical need. Headquartered in Foster City, CA, the company is faced with developing and scaling a wide range of chemistries and products, and ultimately delivering these on a commercial basis. “The compounds we produce are used in various human applications from cancer treatments to anti-virals,” says Rob Pastushak, senior manufacturing specialist, technical operations, at its facility in Alberta, Canada. “Processes have to be controlled tightly to ensure quality and consistent high yields. While our products are generally high value, it is a competitive industry so delivering high yield to the customer is a must.”
“Batches typically range from 300 to 900 kg. (660 to 1980 lb), and even the slightest variation in our process has a significant impact on costs. Over time, this could add up to substantial losses in production and profitability,” says Pastushak.
Another critical and ongoing challenge facing Gilead is demonstrating to the U.S. FDA (Food and Drug Administration), that it has complete control over its production process. The Gilead, Alberta, facility is CGMP (current good manufacturing practices) certified, which builds quality and repeatability into a production process. All of the company's production equipment must be tested and certified, which involves a strict qualification process for regulatory compliance and ongoing regular audits by the FDA. Gilead must document its processes to verify it can deliver quality ingredients consistently and in the high volumes required. “The majority of our business involves exports to the United States. If we don't receive FDA approval, we will go out of business,” says Pastushak.

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