Course Description -
Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Attendees from the sterile medical device industry have also benefited from this training.
Although, this aseptic training course emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals, these subjects are presented in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking.
Please be aware that this course is designed to address aseptic filling common to biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes.
Who Should Attend
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. This aseptic training course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.
Learning Objectives
During and upon completion of this course, you will:
- Understand fundamental aseptic facility design principles
- Appreciate what the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
- Better understand aseptic container-closure systems and leak testing
- Know how to properly check equipment and systems in preparation for processing via process simulations - media fills
- Learn the difference between aseptic processing and terminal sterilization
- Learn about the importance of an environmental monitoring program
- 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 the difference between isolators and barriers
- Know more about lesser-used techniques in aseptic processing
- Understand autoclave cycles and microbiological lethality
- Know about dry heat sterilization and depyrogenation
- Understand gamma and beta radiation sterilization
- Learn about ethylene oxide sterilization
- Know the basics of lyophilization - freeze drying
- Learn where cleaning validation fits in
- Learn about the various types of pharmaceutical water, including water for injection; pure steam generators
- Understand how validation concepts are inter-woven
- Receive practical tips on how to manage your aseptic operations
Frequently Asked Questions
What level of complexity is this course?
This course is designed for people working in sterile aseptic processing in the pharmaceutical, biological and, very often, medical device industries. Attendees at the supervisory, management, and director levels find the most benefit because the underlying risks and reasons for the way things are done are explained.
Is it all lecture, all "hands on," or a mixture?
It is classroom lecture style, not "hands on," although there are frequent breakout sessions for groups to work on case studies such as aseptic deviation investigations and risk-based approaches.
How much microbiology do I need to know? Are there any other prerequisites?
Attendees need not know any microbiology but need to have an interest in learning at least the basics since such knowledge is needed to understand aseptic processes. Attendees should also come with a good understanding of pharmaceutical GMP as that will be taken for granted. You should also be aware of the major aseptic processes and which ones are used in your company such as steam, water, dry heat, ethylene oxide, radiation, lyophilization, filtration, and/or disinfection.
Will this deal with FDA requirements?
Since most attendees are from companies that export, the course deals with GLOBAL aseptic requirements including FDA, Europe, and Canada, which are each more rigorous than the others in specific matters.
