Aseptic Processes and Cleanroom Basics
This eLearning module focuses on concepts of contamination, basic design of cleanrooms, their monitoring and manufacturing of aseptic products.
Types of sterile drug products- Aseptic & terminally sterilized
Cleanroom and facility design and how it impacts the product
Proper environmental monitoring practices and systems
Aspects of good environmental monitoring program
Types, sources and control of contamination
FDA warning letters related to aseptic operations
Why it matters
Proper aseptic technique is critical for the successful manufacture of safe and sterile therapeutics. Aseptic operations are also highly dependent on operator performance and techniques.
Understanding the fundamentals of aseptic operation could help individuals and organizations improve their aseptic operations and manage cleanrooms in the ideal state.
Who is it for
This course benefits aseptic operators, aseptic sample handlers, QC Microbiology staff and line QA staff supporting cleanroom operations.