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  • Be Patient, Says Winkle: PAT Standards Development Will Take Time

    In her remarks to the ASTM Committee E55 Workshop on Application of PAT to the Pharmaceutical Industry, FDA's Helen Winkle, director of CDER's Office of Pharmaceuticals, noted that the Agency's cGMP Initiative for the 21st Century dictates the need for developing and supporting standards for PAT. However, she also said standards development may be a rocky road and realistically, once developed, standards will take time to implement.

    Helen Winkle, Director, Office of Pharmaceuticals, FDA/CDER
  • PAT in Perspective: Do We Need Final Release Tests with PAT?

    NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests…and concludes that they’re still essential as a reference method, and important in minimizing liability.

    Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
  • Servos Help Bottle Filler/Capper Provide Pharmaceutical Flexibility

    This article from our sister site,, spotlights a machine builder's monoblock servo bottle filler/capper motion control system that uses four servo axes and three variable-speed motors to control its motion accurately.

    Jim Montague, Executive Editor, Control Design
  • Improving Energy Efficiency in Pharmaceutical Manufacturing Operations — Part II: HVAC, Boilers and Cogeneration

    Significant potential exists for improving energy efficiency in the U.S. pharmaceutical industry, and a focused, strategic approach can allow any organization to identify opportunities and implement efficiency measures and practices. This article, the second in a two-part series, summarizes strategies for reducing pharmaceutical facility energy costs.

    Christina Galitsky, Ernst Worrell, Eric Masanet, and Sheng-chieh Chang, Lawrence Berkeley National Laboratory, Environmental Energy Technologies Division
  • Flooring System Meets Challenges at Vaccine Pilot Plant

    A critical consideration design and construction of a new Vaccine Pilot Plant recently developed by the National Institutes of Health, National Institutes for Allergy and Infectious Diseases, Vaccine Research Center, was the flooring system selected. As a major building component, the flooring system and its ability to perform under harsh conditions have a critical impact on day-to-day operations in the manufacture of pharmaceuticals or, in this case, vaccines.

    Doni Riddle, Vice President, Industrial & Marine Marketing, The Sherwin-Williams Co.
  • Inside GSK’s New RFID Pilot

    The initial benefits will be modest, but GSK’s new pilot goes beyond what other manufacturers have attempted to do with RFID data, says IBM’s Paul Chang.

    Paul Thomas, Managing Editor
  • Can Packaging Materials Foil RFID Success?

    Little research has been done on the impact that metals, glass and other drug packaging materials have on the effectiveness and read ranges of RFID. Even cardboard can affect RF signals if it has a certain moisture content, says Michigan State’s Robb Clarke.

    Paul Thomas, Managing Editor
  • Should RFID Certification Be Your Next Career Move?

    There’s a dearth of systems integrators and other workers skilled in the ways of RFID; a new certification program will address that need, and could provide a much-needed career boost to those who take part.

    Paul Thomas, Managing Editor
  • From the Editor: Lessons from Shingo

    Our survey on pharmaceutical operational excellence suggests that many drug companies still fail to take seriously two fundamental principles of manufacturing.

  • The Needle Gets Another Shot

    Manufacturers are ramping up liquid and lyophilization capabilities and adding specialized services.

  • Separations Anxieties

    Separations expert Tom Jupille assesses the evolutionary, revolutionary and mundane of today’s chromatography, for the QC lab and beyond.

  • What's New on Our Weblog

    A recap of ISPE Orlando; pricing controls and political change; AstraZeneca's Tony Zook and Mylan Labs CEO interviews; performance and peer review: what do they really mean?

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