Alexandra Stärk
Novartis Pharma Stein
Referierende
Theresa Ladwig
SKAN
Katharina Schlereth
Labor LS
Yves Scholler
SKAN
Ruben Rizzo
SKAN
Jordi Ruano
Hipra
Dr Tarik Cheema
F. Hoffmann-La Roche
Participate in all four workshops at SKAN AG
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.
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
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 4 workshops at the manufacturing site of Skan in Allschwil
Each participant takes part in all 4 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.
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 current EU GMP Annex 1 from 2022 also deals with isolators in great detail.
Programm
Regulatory Requirements for Isolators for Aseptic Use
- Regulatory bodies
- US laws and regulations
- European laws and regulations
- Guidelines
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
From Concept to Inspection: Implementation and Validation of HIPRA’s Aseptic Filling Isolator Line under EU GMP Annex
- End-to-end implementation of HIPRA’s first aseptic filling isolator line aligned with EU GMP Annex 1 and successfully inspected and approved. Project, installation, mock-up, smoke studies and VHP process studies.
- Robust VHP decontamination and aseptic process Validation
- Risk-based contamination control strategy integrating glove integrity testing before and after each batch/campaign, mock-up studies, airflow validation, and worst-case media fills.
- Strong operational performance: environmental control results
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
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
Troubleshooting in Isolator Technology
- Annex 1 – What changed and why
- The role of isolators
- Key Annex 1 Challenges in Aseptic Isolator Manufacturing
- Navigating the Challenges
- Key Takeaways
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 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
Weitere Informationen
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members EUR 1,990
APIC Members EUR 2,090
Non-ECA Members EUR 2,190
EU GMP Inspectorates EUR 1,095
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event
On 10 November 2026 you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies and the speakers in a relaxed atmosphere.
On 10 November 2026 you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies and the speakers in a relaxed atmosphere.
Workshops on 11 November 2026 at SKAN AG
The four 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.
Presentations/Certificate
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.
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.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-40, mangel@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka +49 6221 84 44-22, schopka@concept-heidelberg.de
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-40, mangel@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka +49 6221 84 44-22, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 10 Nov 2026
(Registration and coffee 08:30-09:00 h)
09:00-18:00 h
Wed, 11 Nov 2026, 08:00-16:05 h
After the workshops on 11 November 2026 at appr. 16:05 h, a bus shuttle service will bring the participants to the airport, the train stations or the hotel.
(Registration and coffee 08:30-09:00 h)
09:00-18:00 h
Wed, 11 Nov 2026, 08:00-16:05 h
After the workshops on 11 November 2026 at appr. 16:05 h, a bus shuttle service will bring the participants to the airport, the train stations or the hotel.
All times mentioned are CET.
Teilnahmegebühr
| 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
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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