• Micro-Reliance, LLC

    Kenneth H. Muhvich, Ph.D. is a globally-recognized consultant specializing in Microbiology and Regulatory Compliance. Based in Charlotte, NC, USA, Ken lives within a half hour drive from the Charlotte Douglas International Airport, the 6th busiest airport in the world. 


      • Investigations - guiding pharmaceutical firms needing investigations into sterility assurance failures
      • Environmental Monitoring - assistance in identifying negative trends in facility EM data and in performing EMPQ.
      • Filamentous Mold Investigations & Mitigation Activities
      • Audits of sterile manufacturing facilities and microbiology labs in preparation for FDA Mock Inspections
      • Assistance in developing 483 Response Strategies

      Affiliations: Jeff Yuen and Associates 

Aspergillus braziliensis
(former niger) colony on agar

Sterility Test Isolator

Mixed microbial flora including pink yeast (probably Rhodotorula species) and at least three (3) types of filamentous molds

Automatic aseptic syringe
filling machine