36. New Tools for Microbiological Risk Assessment, Risk Management, and Process Validation Methodology

  1. Howard Q. Zhang5,
  2. Gustavo V. Barbosa-Cánovas6,
  3. V.M. Balasubramaniam7,8,
  4. C. Patrick Dunne9,
  5. Daniel F. Farkas10 and
  6. James T.C. Yuan11
  1. Cynthia M. Stewart1,
  2. Martin B. Cole2,
  3. Dallas G. Hoover3 and
  4. Larry Keener4

Published Online: 20 APR 2011

DOI: 10.1002/9780470958360.ch36

Nonthermal Processing Technologies for Food

Nonthermal Processing Technologies for Food

How to Cite

Stewart, C. M., Cole, M. B., Hoover, D. G. and Keener, L. (2010) New Tools for Microbiological Risk Assessment, Risk Management, and Process Validation Methodology, in Nonthermal Processing Technologies for Food (eds H. Q. Zhang, G. V. Barbosa-Cánovas, V.M. Balasubramaniam, C. P. Dunne, D. F. Farkas and J. T.C. Yuan), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9780470958360.ch36

Editor Information

  1. 5

    USDA Western Regional Research Center, 800 Buchanan St., Albany, CA 94710, USA

  2. 6

    Center for Nonthermal Processing of Food, Washington State University, Pullman, WA 99164-6120, USA

  3. 7

    Department of Food Science and Technology, USA

  4. 8

    Department of Food Agricultural and Biological Engineering, The Ohio State University, 333 Parker Food Science and Technology Building, 2015 Fyffe Court, Columbus, OH 43210-1007, USA

  5. 9

    Science, Technology and Applied Research Directorate, U.S Army Natick Soldier R, D & E Center, 15 Kansas Street, Natick, MA 01760, USA

  6. 10

    Department of Food Science and Technology, Oregon State University, Corvallis, OR 97331-6602, USA

  7. 11

    Pepsico Beverages & Foods, 100 Stevens Avenue, Valhalla, NY 10595, USA

Author Information

  1. 1

    Silliker, Inc., 160 Armory Drive, South Holland, IL 60473, USA

  2. 2

    CSIRO Food and Nutritional Sciences, Riverside Corporate Park, 11 Julius Avenue, North Ryde, NSW 2113, Australia

  3. 3

    Department of Animal & Food Sciences, University of Delaware, 17 Townsend Hall, Newark, DE 19716-2150, USA

  4. 4

    International Product Safety Consultants, 4021 W Bertona St, Seattle, WA 98199, USA

Publication History

  1. Published Online: 20 APR 2011
  2. Published Print: 31 DEC 2010

ISBN Information

Print ISBN: 9780813816685

Online ISBN: 9780470958360



  • new tools for microbiological risk assessment - risk management and process validation methodology;
  • novel processing technologies, offering alternatives - to traditional heat processing as a food safety control measure;
  • International Commission on Microbiological Specifications for Foods (ICMSF) - scheme for management of microbial hazards for foods;
  • ICMSF, reducing and/or preventing - these illness types, a major goal of societies;
  • concept of Hazard Analysis Critical Control Point (HACCP) - addressing shortcomings;
  • food safety umbrella, elements of integrated food safety management system - with improvements in performance objectives and food safety as outcomes;
  • model food chain, indicating position of food safety objective - and derived performance objectives;
  • designing and controlling food operations - considering pathogen contamination, methods of destruction, and factors governing microbial growth, survival and recontamination;
  • process validation decision tree;
  • process validation methods, ensuring safety, quality, and effectiveness - designed and built into the product produced by process


This chapter contains sections titled:

  • Introduction

  • New Tools for Microbiological Risk Assessment and Risk Management

  • Good Manufacturing Practices, HACCP, and Integrated Food Safety Management Systems

  • Performance, Process, and Product Criteria

  • Process Validation Methodology

  • Process Validation Methods

  • Approach to Process Validation

  • Variation and Validation

  • Summary

  • References