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Operator Certification for Tangential
Flow Filtration Module Maintenance

Two-Day Course

Course Description

Using a combination of theory and hands-on instruction, you will learn the key tangential flow filtration (TFF) procedures to increase process efficiency, quality and consistency as well as to ensure reproducible TFF separation. This two-day course covers the central elements of TFF maintenance including installation, sanitization and integrity testing. Post-TFF procedures such as cleaning, cleaning assessments and storage are also highlighted.

Course ID: TRTFF02
Course Content
  • Ensuring reproducible performance of TFF modules
  • Avoiding yield losses and increasing production efficiency
  • Maintaining module longevity
  • Maintaining microbial control of modules during storage

Hands-on practical section:

  • Perform manual and automatic integrity testing of tangential flow filtration modules
  • Perform standard cleaning procedures
  • Measure normalized water permeability (NWP)
  • Troubleshoot, using real case studies
Learning Goals
  • Explain the steps required to maintain TFF modules using industry best practices
  • Evaluate filter-flushing effectiveness
  • Conduct integrity testing to evaluate the integrity of the TFF system
  • Take manual normalized water permeability (NWP) measurements to determine cleaning effectiveness
  • Choose and implement a cleaning protocol based on the type of TFF membrane module and sample composition
  • Identify TFF module replacement criteria
  • Collect essential data and calculate important TFF module maintenance performance criteria
  • Apply troubleshooting guidelines
Who should attend?
  • The course is designed primarily for production quality or validation personnel who are responsible for TFF processes in pharmaceutical and biopharmaceutical production operations.
What will you receive?
  • A copy of the course materials
  • A certificate of successful completion. The assessment comes from the results of the workshop and a practical quiz.
Course Schedule and Program
Day 1: 08.30 – 17.30
  • Welcome and course introduction
  • Introduction to TFF
  • Basic TFF operation
  • Practical session - installing and flushing modules
  • Integrity-testing TFF modules
  • Cleaning TFF modules and practical applications
  • Method to determine cleaning effectiveness
  • Practical session - measuring integrity and NWP
Day 2: 08.30 – 15.45
  • Practical session - cleaning and NWP troubleshooting exercise
  • Practical certification for integrity and NWP measurements
  • Demonstration - automatic integrity test
  • Integrity-testing troubleshooting exercises
  • Certification and conclusion
Enrollment Limited to 10 Participants
Due to the hands-on nature of this course, enrollment is limited to 10. We recommend early booking to ensure a place.
Price
Please contact your local representative or email ilearn@merckgroup.com for a quote.