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Bioprocessing Trends: Annual Survey Results
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Amy Ritter
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Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.
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Rapid Microbial Testing
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Amy Ritter
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In this technical forum, experts describe different methods of rapid microbial testing and their applications.
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Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
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Tim Sandle
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Madhu Raju Saghee
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This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements.
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Using Closed-Vial Technology in Aseptic Filling
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Benoit Verjans
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Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.
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Biological Indicator Growout Times: The Impact on Establishing a Reduced Incubation Time Protocol
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Philip M. Schneider
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John R. Gillis
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The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.
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Parametric Release and Real-Time Release Testing
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Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.
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A More Rational Approach for Sterile Product Manufacturing
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James E. Akers
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James P. Agalloco
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The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.
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