Regulatory Requirements for Sterility Test Isolators
- Regulatory bodies
- US laws and regulations
- European laws and regulations
- Guidelines
- Basic Isolator definitions
Sterility Test Isolators: Standard Process under Control
- Key decisions: sterility testing in isolator vs. cleanroom
- Cost comparison
- From URS to isolator
- Technical details and solutions
- Airflow and decontamination system
Bioindicators / Process Development of Isolator Decontamination
- Overview of current regulations and standards
- Basis and selection of suitable biological indicators as sensor for the inactivation effect
- Development and quantification of decontamination cycles
- Influence of H2O2 to routine processes
Isolators Used for Sterility Testing
- Requirements for the isolator
- Background of the isolator
- Performance Qualification
- Qualification of operators
- Test for gas-tightness of primary packaging materials
- Handling in isolator
- Capacity
- Testing the tightness of gloves
- Microbiological Monitoring
- Sample plan
- Contamination level
- Contamination source
- OOS/CAPA (example)
Troubleshooting in Isolator Technology
- The place of the isolator in a pharmaceutical process
- The influence of critical parameters on the decontamination process
- The reliability and reproducibility of biological indicators
- The expectations of regulators
Gone with the Wind – How Are we Doing with a SkanFog® Sterility Test Isolator?
- From clean room to isolators
- Why SkanFog® for sterility test isolators?
- Our 3 isolators and a bit technology
- Performance Qualification
- The new lab building @ Bayer Berlin
- Double challenge: New lab building and new technology
- Lessons learned
Alternative Sterility Testing Methods: Experience Feedback and Outlook
- Experience feedback regarding alternative method
- Outlook
- Challenges
- Impact on Sterility Test Isolators
Workshop Session
Workshop 1:
Validation Planning for an Sterility Test Isolator
- Test master plan (IQ/OQ)
- IQ / OQ test protocols
- Operational qualification - procedures
- Handling of deviations
Performance of Selected Qualification Tests
- Basic SOP for testing
- Execution of tests
- Generate test records
- Drawing up the test report
- Glove testing
Glove Integrity Testing
- Regulatory Background
- Physical methods for glove integrity tests and their boundaries
- Microbiological contamination risk
- Routine program for glove integrity testing
Alain Ribstein
Workshop 2:
Development and Quantification of H2O2 Decontamination Cycles
- Establish the requirements of a decontamination cycle
- Design a qualification strategy
- Work out the necessary physical and microbiological tests and their chronology
- Interpretation of test results and reaction on deviations
- Write a transparent qualification Report
- Workshop including a real isolator system
Theresa Ladwig
Workshop 3:
Sterility Test Isolators in Routine
- Handling in isolators
- Personnel at isolators
- RTP / airlock system
- Parametric release
- Frequency of decontaminations
- Point of view of a user
- Point of view of regulatory
Christian Doriath
You will take part in all workshops!
The workshops will take place at SKAN AG in Allschwil.
After the workshops, at appr. 16.15 h, a bus shuttle service will bring the participants to the airport (appr. 16.35 h), the German train station (appr. 16.50 h), the Swiss train station (appr. 17.15 h) or the hotel.