Equipment and Processing Report, Nov 16, 2011 - Pharmaceutical Technology

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Equipment and Processing Report, Nov 16, 2011
Production Lines
Is Three Still the Magic Number for Process Validation?
By Erik Greb
Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.
In the Mixer
Pharmaceutical Manufacturers Seek to Eliminate Waste
By Mel Panko , Dave Carson
Implementing a zero-waste strategy is not merely an option, it can be seen as a crucial business imperative.
Troubleshooting
Collapsed Cakes
We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?
Editor's Picks
November 2011 Editor's Picks: Products from Sartorius Stedim Biotech and Thermo Fisher Scientific
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2011 edition from Sartorius Stedim Biotech and Thermo Fisher Scientific.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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