Sprecher
Dr Patricia Desmaris, Merck Group
Christian Doriath, SKAN
Theresa Ladwig, SKAN
Benoît Ramond, Sanofi
Ruben Rizzo, SKAN
Yves Scholler, SKAN
Alexandra Stärk, Novartis Pharma Stein
Patrick Vanhecke, GSK Vaccines
Christian Doriath, SKAN
Theresa Ladwig, SKAN
Benoît Ramond, Sanofi
Ruben Rizzo, SKAN
Yves Scholler, SKAN
Alexandra Stärk, Novartis Pharma Stein
Patrick Vanhecke, GSK Vaccines
Zielsetzung
Why should you attend this Event?
- You get an technological update on isolators for aseptic manufacture
- You get to know the results of recent studies on the validation of isolators
- You have the opportunity to discuss your individual questions personally with experts
- You can translate the theory directly into practice during 3 workshops at the manufacturing site of Skan in Allschwil
Each participant takes part in all 3 workshops. The workshops are held at the plant of SKAN AG, partly including operational isolators. This brings the participants as close to daily practice as possible.
Hintergrund
The use of isolators is increasing in the manufacturing of sterile medicinal products, particularly in aseptic manufacture, and in the handling of toxic / high potent APIs. It ensures a greater microbiological safety of the products, but at the same time requires increased inputs as regards the qualification of these systems and the validation of the production processes.
In 2004, Appendix 1 to the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“ defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 „Isolators used for Aseptic Processing and Sterility Testing“ and the expected revision of EU GMP Annex 1.
In 2004, Appendix 1 to the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“ defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 „Isolators used for Aseptic Processing and Sterility Testing“ and the expected revision of EU GMP Annex 1.
Zielgruppe
This GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers / Contract organisations involved in the engineering, validation and operation of Aseptic (toxic) Manufacturing Isolators, especially from the Areas Engineering / Production, Quality Assurance, Qualification/ Validation, Microbiology. The number of participants is limited.
Please understand that, for competitive reasons, not all firms can register their employees for this event.
Please understand that, for competitive reasons, not all firms can register their employees for this event.
Programm
Regulatory Requirements for Isolators for Aseptic Use
- Regulatory bodies
- US laws and regulations
- European laws and regulations
- Guidelines
- Basic Isolator definitions
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
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
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
Isolator and Associated Technologies
- Isolator technology in GSK Bio
- Applications for bulk
- Applications for formulation
- Applications for filling processes
- Sterility testing
Case Study Merck: New Aseptic Filling Building:
A Quality by Design Approach
A Quality by Design Approach
- Presentation of the project
- Business case construction
- Compliance requirements
- QBD approach and implementation
- Product Tech Transfer strategy
- ASTME2500 qualification and validation strategy
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
Aseptic Filling Isolators from a Microbiological Point of View
- Environmental monitoring
- Media Fills
- Sterility tests
- Integrity of gloves and sleeves
- Validation studies
- OOS results in isolators
Workshop Session
Workshop 1:
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 according to EU Annex 1
- Handling in isolators
- Personnel at isolators
- RTP system
- Environmental monitoring in isolators
- Frequency of decontaminations
- Problems in isolators from a users‘ point of view
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. (appr. 17.15 h) or the Hotel.
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. (appr. 17.15 h) or the Hotel.
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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