Articles by Russell E. Madsen Jr. - Pharmaceutical Technology

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Articles by Russell E. Madsen Jr.

Validation by Numbers

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.
May 2, 2010
By: Russell E. Madsen Jr.

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

The Relationship among Pore-Size Ratings, Bubble Points, and Porosity

Jan 2, 2007
By: Maik W. Jornitz, Russell E. Madsen Jr., Theodore H. Meltzer

Pore-size ratings are so unrelated to actual dimensions and so subject to anomalous interpretations as to make substantial dependency upon their values an unwise choice. Moreover, the means of measuring them are questionable. The pore-size rating system at best provides a qualitative differentiation.

The Use of Model Organisms in Sterilizing Filtration

May 1, 2006
By: Russell E. Madsen Jr., James E. Akers, Maik W. Jornitz, Theodore H. Meltzer

Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration.

Minimizing Risk Through Technology

May 1, 2005
By: Russell E. Madsen Jr.

New technologies and improvements to existing ones can reduce contamination risk in aseptic processing.

The Future of Aseptic Processing?An Update

May 1, 2004
By: Russell E. Madsen Jr.

In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.

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