Regulatory Requirements for Isolators for Aseptic Use
- Regulatory bodies
- US laws and regulations
- European laws and regulations
- Guidelines
- Basic Isolator definitions
Isolator Application / Projects: From the Conceptual Design to the Validated Equipment incl. Mock-Up Study
- Key decisions
- What do we need from our customers?
- From URS to engineering – technical details and solutions
- Process challenges and features
- FAT – Installation – Qualification
- Purpose of mock-up
- What is required before starting a mock-up
- How to document a mock-up
- What simulations need to be included in the mock-up
- Execution of the mock-up itself
- Examples for our mock-up to underline the points above
Annex 1 - Risk Analysis and Consideration of Transfer
- Material and Environmental Monitoring
- Contamination Control Strategy & Quality Risk
- Management Principles
- Environmental monitoring program
- Gloves/Sleeves management program
- Transfer materials & personnel interventions
- Aseptic processing validation management
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
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
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)
Isolator Technology and Challenges in Sterility Testing
Isolators Used in Aseptic Fill Finish Manufacturing
- Isolator technologies in a parenteral production
- Preparation of an isolator used for aseptic filling
- Implementation of a new isolator
- Design / Mock-up / From qualification to validation
Workshop Session
Workshop 1: Validation Planning for an Aseptic 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
Workshop 2: Development and Quantification of H2O 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
Workshop 3: Isolators according EU Annex 1
- Handling in isolators
- Personnel at isolators
- RTP system
- Environmental monitoring in isolators
- Frequency of decontaminations
- Problems in isolators from the point of view of a user
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.