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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

This is a comprehensive, practical and hands-on course based on current aseptic techniques related to working in a clean room and isolator environment. The course includes microbiological monitoring, sampling, testing, validation, identification methods and techniques.

  • Definition and scope of aseptic processing
  • Facility design, velocity and airflow studies
  • Aseptic process simulations (media fills)
  • Gowning and personnel qualification and good aseptic technique
  • Basic microbiology, environmental monitoring and control systems
  • Sanitisation techniques and sterilisation qualification
  • Filtration and liquid filter integrity testing
  • Glove integrity testing.
  • Reading and evaluating media fills
  • Good documentation practices
  • Sterility testing and final product testing
  • Use of isolator and barrier technology.
  • Environmental data trending and excursion analysis
  • Formulation development
  • Process Development
  • Analytical Development
  • Quality control
  • Process and analytical validation
  • Manager, supervisors and Trainers involved in Freeze Drying
  • Demonstrate an increased proficiency of techniques and skills relating to aseptic processing
  • Evaluate and improve current aseptic processing procedures at your facility
  • Evaluate your environmental monitoring program to collect appropriate data, identify and interpret trends
  • Incorporate proper gowning principles
  • Describe the importance of filter integrity testing when filtering water, gases or proteinaceous solutions
  • Develop robust media fill protocols including appropriate interventions, observation and documentation procedures
  • Discuss finished product testing requirements
  • Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
  • Integrate industry-approved sanitisation techniques and disinfectant evaluation into a comprehensive contamination control program
  • Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

Assessment
A competency based assessment will be undertaken at the end of the course. This will certify proficiency in both the theory and in the practical skills.

Section 1
Final Quiz