Equipment and Processing Report, Jul 20, 2011 - Pharmaceutical Technology

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Equipment and Processing Report, Jul 20, 2011
Production Lines
A Hybrid Approach to Combination Products
By Erik Greb
Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.
In the Mixer
Basic Equipment-Design Concepts to Enable Cleaning in Place: Part II
By Elizabeth Rivera
The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.
Troubleshooting
Erratic Recovery-Test Results
We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?
Editor's Picks
July 2011 Editor's Picks: Products from BETE Fog Nozzle and Continental Disc
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2011 edition from BETE Fog Nozzle and Continental Disc.

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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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