Course Descriptor

This programme is designed to provide an introduction to current aseptic techniques related to working in an aseptic filling environment. This blended programme provides both a theoretical introduction to contamination control, environmental monitoring, filter integrity testing and filling systems, while also allowing trainees hands-on interaction with both isolator and RABs units while conducting glove integrity tests, media fills and troubleshooting. An introduction to Grade B gowning will also be included in the programme.

Course delivery method: Blended online and onsite training

  • Two mornings online theory
  • Two Days NIBRT Practicals

Course Costs:

  • Two mornings online theory only: €880
  • Full course of Two mornings online theory and 2 days NIBRT Practicals: €2640

 

 

Introduction to Fill Finish Operations

SKU: fill-finish-operations Category:

880.002,640.00

Clear
Dates:
  • 19/09/2022 - 22/09/2022

    4 Places Remaining

  • 12/12/2022 - 15/12/2022

    8 Places Remaining

  • 19/09/2022 - 20/09/2022

    4 Places Remaining

  • 12/12/2022 - 13/12/2022

    4 Places Remaining

Fee:
€880
Suitable for:

  • Manufacturing
  • QA/QC
  • Engineering Technicians
  • Specialists
  • Operators

Who should attend

  • Manufacturing
  • QA/QC
  • Engineering Technicians
  • Specialists
  • Operators

Key topics covered

  • 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

Learning outcomes

Upon completion of this course the trainee will be able to:

  • Demonstrate an increased proficiency of techniques and skills relating to aseptic processing
  • Evaluate environmental monitoring programmes 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

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.

 

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