Introduction to Fill Finish Operations

Course Descriptor

This three day 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.

Introduction to Fill Finish Operations

SKU: fill-finish-operations Category:

2,250.00

Clear
Dates:
  • 07/05/2019 - 09/05/2019

    Out of stock

  • 09/12/2019 - 11/12/2019

    Out of stock

  • 03/09/2019 - 05/09/2019

    Out of stock

Fee:
€2250
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

  • 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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