Alexandra Stärk
Novartis Pharma Stein
Referent:innen
Andreas Kerschbaumer
Novartis
Dr. Timo Krebsbach
SKAN
Theresa Ladwig
SKAN
Katharina Schlereth
Labor LS
Yves Scholler
SKAN
Ruben Rizzo
SKAN
Dr. Jonathan Gerber
Lonza
Zielsetzung
Why should you attend this event?
- You get an update on isolators for aseptic manufacture and for sterility testing
- 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 both in sterility testing and in the production of sterile medicinal products, particularly in aseptic manufacture. 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“. The new EU GMP Annex 1 from 2022 also deals with isolators in great detail.
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“. The new EU GMP Annex 1 from 2022 also deals with isolators in great detail.
Zielgruppe
This GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers for aseptic (toxic) manufacture and for sterility testing involved in the engineering, validation and operation of these systems, 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 companies can register their employees for this event.
Please understand that, for competitive reasons, not all companies can register their employees for this event.
Date / Venue / Presentations / Certificate
Date
Tuesday, 11 November 2025, 09.00 h – 18.00 h CET
(Registration and coffee 08.30 h – 09.00 h CET)
Wednesday, 12 November 2025, 08.00 h – 16.05 h CET
After the workshops on 12 November 2025 at appr. 16.05 h, a bus shuttle service will bring the participants to the airport, the train stations or the hotel.
Venue
Pullman Basel Europe
Clarastrasse 43
4058 Basel, Switzerland
Phone +41(0)61 6908 080
Fax +41(0)61 6908 880
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
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)
Isolators for CDMO Business
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
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 VR Mockup
- Isolator Design engineering using Virtual Reality (VR)
- Use of real-world objects for physical feedback and position validation (XR experience)
- Ergonomic assessment and future manipulation simulation
Workshop 4: Plant tour incl. E-Beam
- Design of an Isolator
- Construction details
You will take part in all workshops!
The workshops will take place at SKAN AG in Allschwil. After the workshops, at appr. 16.05 h, a bus shuttle service will bring the participants to the airport (appr. 16.25 h), the Swiss train station (appr. 16.55 h), the German train station (appr. 17.10 h), or to the hotel.
The workshops will take place at SKAN AG in Allschwil. After the workshops, at appr. 16.05 h, a bus shuttle service will bring the participants to the airport (appr. 16.25 h), the Swiss train station (appr. 16.55 h), the German train station (appr. 17.10 h), or to the hotel.
| ECA-Member*: | € 1990,- |
| Non ECA Member*: | € 2190,- |
| EU/GMP Inspectorates*: | € 1095,- |
| APIC Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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