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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. ​