Articles by Russell E. Madsen - Pharmaceutical Technology

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Articles by Russell E. Madsen

Required Reading for Regulatory-Affairs Personnel

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.
Dec 2, 2007
By: Russell E. Madsen

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.

The Importance of Pre-Use Integrity Testing in Sterilizing Filtration

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.
May 1, 2007
By: Russell E. Madsen, Maik W. Jornitz, Theodore H. Meltzer

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.

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