Pharmaceutical Technology, May 1, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, May 1, 2009
Articles
Trend Analysis for Sterile Manufacturing
By Patricia Van Arnum
A Pharmaceutical Technology survey examines capacity expansions, outsourcing practices, innovation levels, and the role of quality by design in sterile manufacturing and aseptic processing.
Disposable Components in Aseptic Processing
By Maik W. Jornitz , Jean-Marc Cappia , Theodore H. Meltzer
The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.
USP <1211>: The Compendial Informational Chapter on Sterility Assurance
By Scott Sutton
The author provides a history of the information chapter USP ‹1211› "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.
FDA's Draft Guidance for Process Validation: Can It Be Applied Universally?
By James P. Agalloco
The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.
Applying Quality by Design to Sterile Manufacturing Processes
By Warren Charlton
The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.
The Impact of Automation on Aseptic Processing
By Yoshi Izumi , James E. Akers
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
Identification of Fungi Using Ribosomal Internal Transcribed Space DNA Sequences
By Michael Waddington
Identification of fungi, especially filamentous fungi, has been a very difficult task. Because of the amount of experience required to accurately identify filamentous fungi to the species level, it has become acceptable to either identify these organisms to the genus level or, in some cases, simply identify them as "molds."

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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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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