Equipment and Processing Report, Sep 21, 2011 - Pharmaceutical Technology

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Equipment and Processing Report, Sep 21, 2011
Production Lines
Can Redundant Filtration Make Sterility Assurance Double Sure?
By Erik Greb
In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.
In the Mixer
Testing for Glass Flakes in Pharmaceutical Vials
By Kristie J. Diebold
Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.
Troubleshooting
Vial Stoppers That Won't Stop Clumping
In our manufacturing process, we are running into issues with our vial stoppers clumping in the feeder bowl. How can we ensure that the stoppers go through smoothly without clumping up?
Editor's Picks
September 2011 Editor's Picks: Products from Lechler and National Bulk Equipment
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Lechler and National Bulk Equipment.

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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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