Operator Certification for Automatic Filter
Integrity Testing

Two-day Course

Course Description

Using a combination of theory and hands-on instruction, you will learn the key procedures of filter integrity testing, how to read printouts from automatic filter-integrity testers and troubleshoot filter-integrity test processes. This two-day course covers all current filter integrity tests, including bubble point, diffusive flow and water-flow integrity testing that apply to all liquid and gas membrane filtration applications.

Ordering Information: TRAU0PCER
Course Content
  • Understanding the filter-integrity test principles
  • Signing an automatic filter-integrity test print-out without understanding the content
  • Releasing or rejecting a sterile batch with a wrong filter-integrity test result
  • Uncertainty on how to retest a filter
  • Lost production time and deviations due to retesting filters
Learning Goals
  • Explain the basic science of manual and automated integrity testing
  • Describe the principles of automatic integrity testers
  • Setup a manual integrity-test system and an automatic integrity tester
  • Perform manual and automatic integrity testing
  • Interpret the outcome of manual and automatic integrity tests
  • Decide when a filter integrity test fails
  • Apply troubleshooting guidelines
Who should attend?

The course is primarily designed for operators and engineers who are responsible for automatic integrity testing of sterilizing filters in the pharmaceutical and biopharmaceutical industry.

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: 8:30 - 16:30
  • Welcome and course introduction
  • Introduction to sterilizing filtration
  • Bubble point and diffusion theory and manual test methods
  • Practical session - diffusion and bubble point
  • Automatic integrity testing method
  • Practical session - automatic integrity testing
Day 2: 8.30 - 15:00
  • Hydrophobic filter integrity testing method
  • Practical session - hydrophobic filter integrity testing
  • Certification test
  • Establishing and troubleshooting filter integrity testing processes
  • Conclusion
Hands-on practical section
The practical element of this course covers how to:
  • Perform manual and automatic bubble-point testing
  • Perform manual and automatic diffusive-flow testing
  • Perform manual and automatic water-flow integrity testing
  • Troubleshoot integrity-testing procedures
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.