Single-Use Systems - What you need to know - Live Online Training
Technology, Quality and GMP-Requirements
Thursday, 18 March 2027 9 .00 - 17.15 h
Course No. 23093
Speakers
Dr Simone Biel
Merck
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
Target Group
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.
Objectives
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.
Programme
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
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:
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
Further Information
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.
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.
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.
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
Date & Time
Thu, 18 March 2027, 09:00 to approx. 17:15 h All times mentioned are CET.
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