- Datum:
-
- Seminar
Isolator Technology Workshop
- Veranstaltungsort:
- Basel
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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
Isolators in Aseptic Manufacturing
- Basics of isolator technology
- including material transfer systems
- Qualification concept
- VHP cycle development
- Qualification of isolator combined with e-beam:
VHP cycle; dosimetry; smoke study
Case Study on Management of Indirect Products Contact Parts in an Isolator
- Definition of indirect product contact part
- Regulation’s requirement
- Example of implementation along the all lifecycle of indirect product contact parts
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
Initial Validation by Media Fill of a Syringe Isolator Filling Line
- General Media Fill Design
- Line-specific Media Fill Design
- Media Fill Failure with Root Cause
- Inspection Feedback to Media Fill Design
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)
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!
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
