Troubleshooting

Aug 17, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?
Jul 20, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
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?
Jun 15, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
Our company is getting low and unpredictable cycle life out of our diaphragm valves. This problem has caused us to implement standard operating procedures for frequent replacement of the diaphragms, which is costly and time consuming. What could be happening, and what are our options?
May 18, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
How do you assign a minimum sample weight for a US Pharmacopeia <41> balance application when the tested repeatability gives a standard deviation of zero?
Apr 20, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?
Mar 16, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
We are making an emulsion using a high-shear in-line mixer. It?s a 60-gal batch, and it?s taking nearly an hour to get the results we?re looking for. We have tried changing the in-line mixer?s workheads to a two-stage configuration, but it doesn?t affect the mixing time. Where are we going wrong?
Feb 16, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?
Jan 19, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
An industry expert answers a reader's question about using a volumetric dry-material feeder and jet mill to create a finished product.
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