Isolator Technology Workshop
Im Auftrag der ECA Academy

Programm

Regulatory Requirements for Isolators for Aseptic Use

• Regulatory bodies
• US laws and regulations
• European laws and regulations
• Guidelines

Isolator and associated technologies

• Isolator technology in GSK Bio
• Applications for bulk
• Applications for formulation
• Applications for filling processes
• Sterility testing

Isolator Application / Projects: From the Conceptual Design to the Validated Equipment (Supplier)

• Key decisions
• What do we need from our customers?
• From URS to engineering – technical details and solutions
• Process challenges and features
• FAT – Installation – Qualification

Isolator Application / Projects: Mock-up study

• 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

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)

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 while understanding

• 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

Microbiology in Filling and Sterility Isolators

• Environmental monitoring
• Media Fills
• Sterility tests
• Integrity of gloves and sleeves
• Validation studies
• OOS results in isolators

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 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

Workshop 3:
Isolators in Routine

• 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.