for Risk Assessment and Aseptic Processing Manufacturing


  • Guenther Gapp, Syvlie Guyomard, Pascale Nabet, Jean Scouvart: Evaluation of the applications of a system for real- time microbial analysis of pharmaceutical water systems; Europ. Journal of Parenteral Sciences, Vol 4, 131 – 136, 2000

  • J.C. Gray, S. Morandell, G.Gapp, N.L.Goff, G. Neuhaus, A. Staerk: Identification of Microorganisms after Milliflex Rapid Detection- A Possibility to Identify Nonsterile Findings in the Milliflex Rapid Sterility Test, PDA J Pharm Sci Tech Jan/ Feb 2011, Vol 65, 42- 54

  • Guenther Gapp, Peter Holzknecht : Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach ; PDA J Pharm Sci and Tech 2011, , Vol 65, 217- 226 (NOTE: Award for Best Paper in the PDA Journal 2011)
    Link to the PDA AWARD 
    Link to the Best Paper in the PDA Journal 2011


  • Guenther Gapp: New Risk Assessment Tools for Sterile Products; Contamination Control in Healthcare Products Vol 2, 271- 317, March 2014 , DHI Publishing, LLC (PDA Bookstore /

  • European Pharmaceutical Review / Magazine Issue 3 2014

    Microbiology IN-DEPTH FOCUS,
    page 33- 36

    "How to deal with non-sterile results in aseptic processing"




Latest Publication:

European Pharmaceutical Review / Volume 20, Issue 2, 2015

(pages 35- 38)

"Reducing microbial contamination via sterile risk assessment"


 PDA Aseptic Processing Industry Survey , 2017