Sterilization Procedures, Technology, Equipment & Validation

This is a two-day basic course covering the microbial, scientific, technological, and statistical foundations of sterilization methods. The purpose of the course is to provide fundamental information on the application of sterilization methods in production processes for technicians, engineers, cleanroom designers, and supervisors of operations who may have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction.

The level of the material presented is geared for those without advanced level courses in microbiology, chemical or physical science, or sterilization engineering, and for those wishing for a review of present sterilization methods and future trends in their development and validation.

Learning Objectives

Upon completion of this course, you will:

• Understand the principles and practices of the basic microbiology of procaryotes and eukaryotes applied to their potential contamination of products
• Understand the principles and methods for microbial detection and identification
 Presently used methods
 Future trends
• Understand the role of humans in the potential contamination of products
• Know the detailed scientific and technological basis of all contemporary sterilization methods
 Physical and chemical methods
 Filtration
 Water sterilization and standards
 Emerging technologies
• Have an overview of regulatory mandates on sterilization of products
 Present regulations and guidances
 Introduction to risk analysis and process analytical techniques (PAT)
 Cleanroom standards
 Trends in regulatory thinking and practice
• Have a quantitative understanding of the statistical nature of sterility assurance and its validation

Course Description

The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. The content of the course emphasizes the practical application of present-day basic scientific knowledge to the destruction of microbials, to the manufacture of sterile products, and to validation of the sterilization procedures used. After you complete this course you will be able to understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different sterilization methods. You will also be presented with the trends in regulatory thinking applied to aseptic processes and in possible near-term future technological developments in sterilization methods and in microbial monitoring techniques.
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COURSE AGENDA

DAY ONE

Basic microbiology applied to sterilization

• What are sterile products and how is sterile production achieved?
• Physical properties, chemical compositions, and internal structures of bacteria, viruses and fungi
• The compositions, properties and practical importance of bacterial cell walls
• Exotoxins and Endotoxins: their properties and pathophysiologies
• The growth of bacteria in the environment and in the laboratory: requirements, mechanism and quantification
• Sporulation; formation of biofilms
• Viruses; their properties and propagation
• The properties, environmental presence, growth and importance of fungi

The working environment

• Microbial contamination of products; sources and interactions within the workplace
• Microbial detection and identification: traditional and emerging methods
• Introduction to aseptic techniques

Introduction to current standards and regulatory requirements

• Current Federal regulations and guidances
• Trends in regulatory directions applying to sterile products and production
• Compendial regulations

DAY TWO

Comprehensive basic science and technology of sterilization

• Disinfection and antisepsis in the laboratory and workplace
• The major sterilization methods: wet and dry heat, radiation, chemicals, filtration
• Theoretical, practical and quantitative aspects of heat sterilization methods
• Theoretical, practical and quantitative aspects of radiation sterilization methods
• The nature and practical applications of liquid and gaseous chemical sterilants
• Quantitative and practical aspects of gas and liquid filters and filtration
• Water standards and achieving them
• Discussion of emerging sterilization technologies

Quantitative aspects of sterility assurance

• Introduction to the statistics of sterility assurance
• The effects of bioburden on sterility assurance and estimation of bioburdens
• Introduction to the concepts and procedures for sterilization validation
• Example: sterility assurance in autoclave validation
• Sterilization testing: practical and regulatory aspects
• Sample sterility audit checklist

Monitoring

• Environmental microbial monitoring
• In-process microbial monitoring; risk analysis, trending, and investigations
• Examples of auditing and common citations