Dr Simone Biel
Merck
Referierende
Dr Daniel Müller
GMP Inspector
Prof Dr Regine Eibl-Schindler
Zürcher University of Applied Science
Nicola Rutigliani
Merck
- Available SU Technology: Possibilities and Limitations
- GMP Requirements for the Use of SU Equipment
- Design and Evaluation of an Extractables/Leachables Study
- Case Study (Merck): Single-Use Technology in Aseptic Drug Product Manufacturing
- GMP Requirements for the Use of SU Equipment
- Design and Evaluation of an Extractables/Leachables Study
- Case Study (Merck): Single-Use Technology in Aseptic Drug Product Manufacturing
Zielgruppe
The course is directed at staff from the pharmaceutical industry and suppliers from
- Production
- Engineering
- Research & Development
- Quality Assurance
who want to learn how Single-Use Equipment can be implemented in biotech and sterile operations in a GMP-compliant way.
Zielsetzung
This online training course provides an overview of available single-use technologies (SUT) and how they can be implemented in a GMP manufacturing environment.
Participants will gain a structured understanding of typical drivers for the increasing use of SUT in biotechnological processes and sterile filling, such as avoiding cleaning and cleaning validation, reducing time to market by eliminating certain construction activities, enabling simplified scale-up, and increasing operational flexibility.
At the same time, the course addresses key GMP-related questions that arise when using single-use systems—particularly in comparison to stainless-steel equipment—including qualification expectations, GMP implications at the quality system level, the interface and allocation of responsibilities between the manufacturer and the SUT supplier, and the evaluation of extractables and leachables data.
These topics and related practical questions are discussed during the course with contributions from experts from academia, the pharmaceutical industry, and GMP authorities.
Participants will gain a structured understanding of typical drivers for the increasing use of SUT in biotechnological processes and sterile filling, such as avoiding cleaning and cleaning validation, reducing time to market by eliminating certain construction activities, enabling simplified scale-up, and increasing operational flexibility.
At the same time, the course addresses key GMP-related questions that arise when using single-use systems—particularly in comparison to stainless-steel equipment—including qualification expectations, GMP implications at the quality system level, the interface and allocation of responsibilities between the manufacturer and the SUT supplier, and the evaluation of extractables and leachables data.
These topics and related practical questions are discussed during the course with contributions from experts from academia, the pharmaceutical industry, and GMP authorities.
Programm
Single-Use Technology in Biopharmaceutical Production: An Overview from USP to Fill & Finish Technologies
- Categorisation of available single-use systems
- Disposables in Upstream Processing
- Media preparation
- Cell expansion and fermentation - Disposables in Downstream Processing
- Filtration and chromatography
- Buffer preparation and storage - Disposables in formulation and filling
- Freeze technology
- Hybrid/closed technology platforms
Single-Use Systems - GMP Inspector's view
- Overview and evaluation of the latest regulatory documents
- Official guidelines, pharmacopoeias & other papers
- Recent developments
Selected Highlights - Single-use systems versus multi-product Equipment
- Important requirements for GMP-compliance
- Regulatory view on both types of systems - Managing suppliers of single-use Systems
- Requirements for supplier qualification - GMP inspections
- Typical issues and deficiencies
Quality Approach in Manufacturing of Single-Use Systems
- How to assure performance, robustness, and sterility of single use systems
- Single-use assembly Validation
- Qualification of components
- Sterilisation qualification
Manufacturing processes - Quality Control
- Release testing
Certification - Risk mitigation practices
- Process particulate Control
Operator Training - Extractables & Leachables
- Patient safety evaluation, study design
- Support from the supplier
The Role of Extractables and Leachables in the Adoption of Single-Use Systems
Successful adoption of single-use technologies in biopharmaceutical processes depends on confidently selecting fluid-path components that do not compromise product quality or patient safety by leaching hazardous chemicals. This presentation covers:
Successful adoption of single-use technologies in biopharmaceutical processes depends on confidently selecting fluid-path components that do not compromise product quality or patient safety by leaching hazardous chemicals. This presentation covers:
- Regulatory expectations for leachables risk assessment and testing (ICH Q3E)
- Standard extraction protocols (USP <665>)
- Case studies highlighting key stages in leachables evaluation
Case Study Merck: Implementing Single-Use Systems in Biotech Fill & Finish Operations
- Business drivers for implementing single-use systems (SUS)
- Supplier qualification
- Implementation process for SUS:
- Risk management
- On-Site assembly qualification and verification activities
Authorization and use - Logistics control requirements for SUS
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
ECA Members EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. 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. After the event, you will automatically receive your certificate of participation.
Contacts:
Questions regarding content:
Dr Robert Eicher (Operations Director), +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Jessica Frechen (Organisation Manager), +49 6221 84 44-60, frechen@concept-heidelberg.de
Dr Robert Eicher (Operations Director), +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Jessica Frechen (Organisation Manager), +49 6221 84 44-60, frechen@concept-heidelberg.de
Datum & Uhrzeiten
Thu, 18 March 2027, 09:00 to approx. 17:15 h
All times mentioned are CET.
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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