Presenter: Kelly Thomas
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.
This is a 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 management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.
Areas Covered in the Session:
Lecture 1: Basic Micro Review
– The role of environmental monitoring
– Types & sources of microorganisms
– The impact of microorganisms on product and patient health and safety
Lecture 2: Review Aseptic Processing Basics
– Cleanliness classifications
– Process differences between aseptically produced and terminally sterilized product
– Relation of manufacturing and handling procedures to sources of product contamination
– The differences between and the purposes of cleaning, disinfection and sanitization
– Proper cleaning techniques
– The role of isolator technology
Lecture 3: Review Clean Area Behaviors
– Personnel gowning requirements
– Good clean area behaviors/practices
– Practices to avoid – and why
– Review site-specific EM/aseptic behavior observations/risks
Lecture 4: Aseptic Validation
– The purpose of media fills, and elements critical to their success
Who Should Attend: