Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

Senior management and regulatory affairs specialists will particularly benefit from the sessions devoted to validation, risk management and troubleshooting.

Learning Objectives:

During and upon completion of this course, you will:

• Understand the importance of sanitary design principles in aseptic processing
• Approach cleaning validation as a quantitative science
• Know how to properly sterilize equipment in preparation for processing
• Learn the difference between aseptic processing and terminal sterilization
• Appreciate what the Food and Drug Administration (FDA) expects in the operation of an aseptic filling operation
• Learn how to structure and execute challenge tests of your aseptic processing operations
• Understand the technical fundamentals behind filter sterilization
• Begin to apply risk management strategies to aseptic operations
• Be in a better position to manage your clean room operations
• Appreciate current FDA thinking on the use of isolators
• Know more about lesser used techniques in aseptic processing
• Learn the concept of validation as defined and practiced by FDA
• Understand how validation fits within the broader requirements of Good Manufacturing Practice
• Be able to properly manage third party validation exercises
• Understand how validation criteria are determined
• Solve a variety of practical problems related to aseptic processing operations
• Receive practical tips on how to troubleshoot your aseptic operations
• Learn how to use the case study approach to effectively solve contamination problems

Course Description

This course presents the technical fundamentals that govern aseptic processing operations and provides sufficient practical advice for attendees to effectively troubleshoot and manage their own operations. In class exercises and problems underscore the important points and help attendees practice what they have learned.

Although the course emphasizes industrial microbiology and engineering fundamentals, these fundamentals are presented in the context of regulatory compliance, Good Manufacturing Practice and FDA current thinking. To further put the technical fundamentals to good use, the course addresses and presents validation and troubleshooting as separate topics with special emphasis on the management of these two important activities.

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COURSE AGENDA

DAY ONE

Introduction and Course Overview

• Brief overview of the course and logistics
• The continuum of biological cleanliness
• Spectrum of products that require aseptic processing
• Aseptic Processing vs. Terminal Sterilization
• Managing Aseptic Operations

Sanitary Design Principles

• The importance of sanitary design in aseptic processing
• Principles of sanitary design
• Cleaning tutorial and cleaning validation
• Engineering and maintenance of sanitary systems
• In-class exercises with sanitary design principles

Preparing and Operating Aseptic Process Equipment

• The mechanics of steam sterilization
• Compendium of standard practices and tricks of the trade
• Monitoring operations to ensure sterility
• In-class problems related to steam sterilization

Packaging Aseptically Processed Materials

• Risk analysis and the decision to aseptically process through to final packaging
• Systems and equipment used in aseptic packaging
 Clean room design and operation
 The fallacy of laminar flow
 Environmental air systems
 Gowning techniques and clean room protocols
• Media fills and challenge testing
• In-class problems related to aseptic packaging/processing

DAY TWO

Terminal Sterilization for other Processed Materials

 Sterile filtration of liquids – types, mechanisms and systems
 Filter integrity testing
 Common problems in sterile filtration
 Autoclaving to achieve terminal sterilization
 In-class exercise with terminal sterilization

Other Means of Sterilization and Aseptic Processing

 The use of isolators – examples and FDA view
 Blow-fill operations and equipment
 Chemical sterilization (e.g., ethylene oxide, hydrogen peroxide, ozone)
 Sterilization using dry heat and radiation
 In-class problems related to chemical and dry heat sterilization

Validation of Aseptic Processing Operations

 Validation and Good Manufacturing Practice -- definitions and examples
 Establishing validation criteria
 Documenting your approach to validation
 The validation industry and how to use it
 In-class review of validated systems

Troubleshooting Aseptic Processing Operations

 The importance of preventative audits and maintenance
 The troubleshooting mindset and approach to risk management
 Using the case study approach to maximum advantage
 In-class examples and problems with aseptic processing operations