About Ken H. Muhvich, Ph.D.

Ken has more than 35 years of experience as a microbiologist. He frequently conducts audits of sterile product manufacturing facilities, including their microbiology laboratories. He is often asked to provide advice regarding investigations into product sterility failures.

From 1992 to 1997, Ken was a Review Microbiologist at the U.S. Food & Drug Administration’s Office of Generic Drugs. While at the FDA, he performed more than six hundred sterility assurance reviews. While at FDA, Ken was awarded the FDA Commendable Service Award “for sustained superior performance in maintaining review consistency, quality, and productivity, and coordination of sterility assurance issues for the Office of Generic Drugs” and the FDA Scientific Achievement Award from the Office of Pharmaceutical Sciences for a Microbiologist – Excellence in Review Science “for exceptional contributions to review science as exemplified in the review of microbiological quality of drug products and the development of regulatory positions.” Ken is widely recognized as an expert in aseptic processing of sterile drug products.

Prior to working for FDA, he supervised the Clinical Microbiology Laboratory at Sinai Hospital in Baltimore, Maryland for ten years. He was Co-leader of the PDA Task Force that wrote Technical Report No. 77 “The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology”. Ken has been a JYA-Micro-Reliance LLC Expert Microbiologist Affiliate since 2002.

He holds a Bachelors degree in Health Science from the University of Delaware, a Masters degree in Medical Microbiology from West Virginia University, and a Doctor of Philosophy degree in Experimental Pathology from the University of Maryland.

Published Works

Muhvich, K. H., Ph.D. (2015). Successful Sterility Test Failure Investigations - A Practical Approach. American Pharmaceutical Review, 18(2), 10-17. PDF