Archive for the ‘Regulatory Compliance’ Category

Advancing Innovation in Pharmaceutical and Biologics Manufacturing

Posted in Life Sciences, Regulatory Compliance on Monday, August 13th, 2018. No comments yet
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In a U.S. Food and Drug Administration’s FDA Voice blog post, FDA Budget Matters: Investing in Advanced Domestic Manufacturing, FDA Commissioner Dr. Scott Gottlieb opened noting: Advanced manufacturing, which includes various technologies, such as continuous manufacturing and 3D printing, holds great promise for improving the American market for drugs and biologicals. Emerson’s Ron Rossbach shared […]

Data Integrity for Pharmaceutical and Biotech Manufacturers

Posted in Life Sciences, Regulatory Compliance on Tuesday, March 13th, 2018. No comments yet
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Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity […]

Fugitive Emissions Compliant Ball Valves

Posted in Final Control Element, Regulatory Compliance on Wednesday, December 6th, 2017. No comments yet
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In 2007, the U.S. Environmental Protection Agency (EPA) published Leak Detection and Repair, A Best Practices Guide. Here is how the EPA describes this guide. Leaking equipment, such as valves, pumps, and connectors, are a large source of emissions of volatile organic compounds (VOCs) and volatile hazardous air pollutants (VHAPs) The Leak Detection and Repair: […]

Ways to Reduce Greenhouse Gas Emissions and Energy Use

Posted in Emerson Exchange, Energy, Regulatory Compliance on Tuesday, October 13th, 2015. No comments yet
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Emerson’s Dr. Douglas White presented, Reducing Process Plant Greenhouse Gas Emissions and Energy Use Through Automation. His abstract: Even with the recent reduction in energy prices, energy remains the largest cost after feedstocks for most process plants. Reducing fuel usage is also the preferred way to reduce emission as required by the steadily more stringent […]

Regulations and Coal-Fired Power Plants

Posted in Power, Regulatory Compliance on Friday, July 17th, 2015. No comments yet
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Author: Dennis Tkacs At the end of 2011, the U.S. Environmental Protection Agency (EPA) proposed a rule to regulate mercury and other pollutants from coal and oil fired power plants. Last month, this Mercury and Air Toxics Standard or MATS was dealt a setback by a Supreme Court ruling. The Supreme Court ruled that the […]