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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.

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