James Akers, Ph.D.

Aligning Environmental Monitoring Expectations with Scientific Realities
Tuesday, October 20, 2026
Considering the advances in aseptic processing and their effectiveness in eliminating the primary sources of contamination (i.e., human activity), it is not our intent to entirely disparage the value of monitoring. ... read more
Clinical Evidence for the Suitability of Current Bacterial Endotoxin Testing
Wednesday, October 23, 2019
Over the last three decades, the sciences of immunology and cell biology have been revolutionized by discovery of complex networks of cell receptors and signals. There is now a rich literature describing interaction between ... read more
Clean Rooms, RABS and Isolators: Validation and Monitoring in the Diverse World of Aseptic Processing
Sunday, May 01, 2011
Aseptic processing has become a diverse manufacturing technology, which is to say that there are at least three major means of accomplishing an acceptable outcome. read more
Risk and Scientific Considerations in the Environmental Monitoring of Isolators in Aseptic Processing
Friday, January 01, 2010
Isolator technology for aseptic manufacturing was introduced in Europe over 20 years ago. Since that introduction, isolators have become a widely accepted environmental control system for aseptic processing. Certainly, ... read more

Articles by James Akers, Ph.D.