Publications

The following copyrighted publications are available for view.  

To obtain a free reprint, click here: Publications Request

Sterilization: General

    Sterility Assurance Level (SAL) - The term and its definition continues to cause confusion in the industry.  Gregg Mosley.  Pharm Micro Forum Newsletter, Volume 14, Number 5,  2008.  [Click for Link to Article]

    Using High Temperature Formaldehyde Sterilization as a Model for Studying Gaseous Sterilization.   Gregg A. Mosley.  Biomedical Instrumentation and Technology, May/June, 2008.  [Coming Soon]

    Overcoming the Complexities of Instrument Sterilization.  Gregg A. Mosley.  Materials Management in Healthcare.  Nov 2005. [Click for PDF]

    Microbial Lethality: when it is log-linear and when it is not! Gregg A. Mosley Biomedical Instrumentation and Technology, Vol. 37, No.6, Nov/Dec 2003. [Request Reprint]

Sterilization: Biological Indicators

   Operating Precision of Steam BIER vessels and the Interactive Effects of varying Z Values on the Reproducibility of Listed D Values.  PDA Journal of Pharmaceutical Science and Technology.  Gregg A. Mosley and John R. Gillis.  Nov.-Dec. 2002. [Request Reprint]

    Estimating the Effects of EtO BIER Vessel Operating Precision on D-Value Calculations.  Gregg A. Mosley, MD&DI, April 2002. [Click for PDF]

Sterilization: EtO Sterilization

    Validation of Ethylene Oxide Sterilization Processes.  John R. Gillis and Gregg A. Mosley.  Validation of Aseptic Pharmaceutical Processes, 3rd edition, eds. Carleton, F.J.; Agallaco, J.P.  New York: Marcel Dekker, Inc.,  2007. 

   Interpreting and Understanding Microbial Data in Validation of Ethylene Oxide Sterilization Process.  Gregg A. Mosley and Clark W. Houghtling.  Biomedical Instrumentation and Technology.  Vol. 39 No. 6, 2005 [Request Reprint]

      Evaluating the Formulae for Integrated Lethality in Ethylene Oxide Sterilization Using Six Different Endospore Forming Strains of Bacteria, and Comparisons of Integrated Lethality for Ethylene Oxide and Steam Systems. PDA Journal of Pharmaceutical Science and Technology.  Gregg A. Mosley, John R. Gillis, and Garrett Krushefski.  January-February 2005. [Request Reprint]

     Factors Affecting Tailing in Ethylene Oxide Sterilization, Part 1: When Tailing is an Artifact...and Scientific Deficiencies in ISO 11135 and EN 550.  PDA Journal of Pharmaceutical Science and Technology.  Gregg A. Mosley and John R. Gillis.  March/April 2004. [Request Reprint]

     Formulae for Calculations of Integrated Lethality for EtO Sterilization Processes.  Refining the Concepts and Exploring the Applications.  Gregg A. Mosley, John R. Gillis and James E. Whitbourne.  Pharmaceutical Technology.  Oct. 2002. [Request Reprint]

     Calculating Equivalent Time for Use in Determining the Lethality of EtO Sterilization Processes.  Gregg A. Mosley, John R. Gillis and James W. Whitbourne.  MD&DI, February 2002. [Click for PDF]

Process Validation

   The Ever-Changing Landscape of ISO and IEST Cleanroom Standards.  Mosley, G.A. and R. Burrows.  CleanRooms Magazine, February 2008. [Click for PDF]

    Cleanroom manufacturing practices and voluntary compliance.  Gregg A. Mosley.  CleanRooms Magazine,  October 2007.  [Click for PDF]

     Managing Product and Environmental Microorganisms in Your Facility.  Gregg A. Mosley.  Controlled Environments, Vol. 9, No 6,  June 2006. [Click for PDF]

    Reasons to Comply with "Voluntary" Standards, such as the ISO 14644 Series, Are Often Misunderstood.  Gregg A. Mosley, Rosalyn Polloway, Kurt Fleschner, and Beth Jacques.  Controlled Environments, Vol. 9, No 3,  March 2006. [Click for PDF]

      Microbial Monitoring of Controlled Environments and Alert and Action Limits.  Gregg A. Mosley and Matthew A. Hansen.  A2C2, Vol. 7, No 6, pp. 9-11 June 2004. [Request Reprint]

      Contamination Control: LAL-Rapid, Sensitive and Precise.  Gregg A. Mosley and Wendy A. Mach.  Pharm. Formulation & Quality, Oct. 2004. [Request Reprint]

      Letter to the Editor: Monitoring Temperature Control Claims.  Pharmaceutical and Medical Packaging News.  Letter to the Editor.  Gregg A. Mosley.  Sept. 2002. [Request Reprint]