Pharmaceutical Technology, May 1, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, May 1, 2012
Articles
Bioprocessing Trends: Annual Survey Results
By Amy Ritter
Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.
Rapid Microbial Testing
By Amy Ritter
In this technical forum, experts describe different methods of rapid microbial testing and their applications.
Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
By Tim Sandle , Madhu Raju Saghee
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.
Using Closed-Vial Technology in Aseptic Filling
By Benoit Verjans
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.
Biological Indicator Growout Times: The Impact on Establishing a Reduced Incubation Time Protocol
By Philip M. Schneider , John R. Gillis
The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.
Parametric Release and Real-Time Release Testing
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.
A More Rational Approach for Sterile Product Manufacturing
By James E. Akers , James P. Agalloco
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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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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