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Aseptic Processes and Cleanroom Basics

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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