Information Regarding the Microbiology and Engineering of Sterilization Processes Course

2. Description of the Intensive 3-Day M&E Lecture-Problem Course

Objective:

To develop an understanding of the basic principles of both the microbiology and the engineering aspects of sterilization processes in an intensive three-day lecture-problem course.  The course is directed toward heat sterilization, but the principles are applicable to other sterilization systems, for example, ethylene oxide, radiation, hydrogen peroxide.

Audience:

Degreed scientists and technical managers involved in microbial control in the research, development and manufacture of food, medical devices and pharmaceutical products.

Instructional Materials:

• Syllabus-Problem Book containing the course outline, problems, worksheets and supplementary material.

• Textbook entitled, Microbiology and Engineering of Sterilization Processes, Eleventh Edition, 2003, prepared by I. J. Pflug; contains 22 chapters, including a Glossary and Index.  Both  basic principles and applications of microbiology and technology of microbial-control processes are treated.

• Selected Papers on the Microbiology and Engineering of Sterilization Processes, Sixth Edition, 2003, Edited by I. J. Pflug.  This is a collection of thirty-seven published and unpublished reports in the areas of (1) heat resistance of microorganisms, (2) analytical evaluation of sterilization processes, (3) measurement of heating rates, (4) monitoring of sterilization processes, and  5) other important supporting reports.

Course Outline:

First Day:  Major Topic:  Microbiology - The Survivor Curve

• Introduction

• Definition of Terms

• Introduction to Environmental Microbiology

• Science and Engineering of Killing Microorganisms

• Basis for the Engineering Technology, Microbial-Control Unit Operation

• Statistics and Sterilization Processes

• Test Methods for Gathering Microbial Destruction Data

• Analyzing Microbial-Destruction Data; Calculating DT-Values

Second Day:  Major Topic:  Microbiology - Technology

• Review of Day 1 Topics, the Survivor Curve

• Temperature Coefficients, z-Values, Thermal Resistance and Thermal-Death-Time Curves

• The General Method of Process Calculation

• Principles of Temperature Measurement

• Analysis of Heating and Cooling Data

• Biological Qualification

• Applications Problem:  Validation of a Steam Sterilization Process, Physical Methods

Third Day:  Major Topic:  Application

• Review of Microbial Survival Characteristics

• Review of Day 1 and 2 Topics

• Designing a Food Sterilization Process

• Mathematical Method of Process Calculation

• Designing Microbial-Control Processes for Pharmaceutical & Medical Devices

• Applications Problem:   Biological Validation of a Sterilization Process

• Completion of the Environmental Microbiology Project

• Ethylene Oxide and Hydrogen Peroxide

• Using a Barrier Isolator for Microbial Control

• General Discussion

Recent Course Instructors

• Kristen D. Evans, Biomedical Engineer

• John R. Gillis, Ph.D., SGM Biotech, Inc.

• Margarita Gomez, Ph.D., VPCI, Inc., W. Bloomfield, MI

• Ann Nicholas, Consultant and Certified Auditor, Lovingston, VA

• Irving J. Pflug, Ph.D., Professor of Food Science, University of Minnesota, St. Paul, MN