PDA EU00161 Single-Use-Systems – A New Age of Drug Making

Göttingen, Germany
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Program Highlights

Using single-use systems in GMP regulated biomanufacturing – a practical approach

This course will take place at the Sartorius Stedim facilities in Göttingen.

In the biomanufacturing world, a huge product diversification occurs place with new therapeutic approaches rising. Novartis e.g., recently released a new gene therapy drug for two Million Euros per dose, while other companies are still in the development phase for drugs targeting the same disease. Wouldn’t it be great for them to have released these drugs faster to be the first one and to make two Million Euros per dose themselves? And what technologies might have helped to reach this goal?

One possibility to get drugs faster to the market is the use of single-use systems. But are they robust enough when the product contact layer is made from polymers? And what will the authorities say? If the equation SUS plus GMP results in SOS, then you should sign up for this two-day course. Here you will learn and discuss with technical trainers and specialists for data handling and GMP regulations how to implement and operate single-use technologies in a GMP-controlled environment.

During an optional third day, you can look into the manufacturing of single-use bioreactor bags and filters, followed by a visit to the Sartorius Application Centre where you can see and test complete process solutions from molecule discovery to large-scale biomanufacturing.

Who Should Attend
  • Operators
  • Manufacturing Supervisors
  • QA Managers
  • Manufacturing Managers
  • QC Managers
  • Auditors
Learning Objectives

Upon completion of this course, attendees will be able to:

  • have understood the regulations and relevant guidelines for single-use system (SUS) handling
  • can explain basics in single-use processing, bag functionalities, connection-disconnection technologies
  • can operate bags, tubings, filters, and sensors
  • have understood Data Integrity and Data Analysis / Monitoring for SUS handling
  • have understood possible setups for filter and container closure integrity testing in single-use assemblies

Standard Registration

Member Price

€ 2.090


€ 2.090

See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Monday, 30 September 2024 - Optional Facility Tour

13:00 - 14:00

Insight Into the Production of Bag Assemblies

  • Injection molding of components (e.g. connectors, filter housings, etc.)
  • Production of 50 and 200 L bags for SU bioreactors (STR)

Insight Into the Production of Filters

  • Membrane production
  • Cartridge, capsule, and filter modules production


Overview of Complete Single-use Bioprocesses From Molecule Development to Final Filling

  • Tour through the Application Center
  • With the option for further hands-on tests

End of Facility Tour

Joint Dinner

Day 2

Tuesday, 01 October 2024

Welcome & Introduction of Participants; Safety Briefing

Introduction to Single-use Bioprocessing

GMP Update on SUS (Part 1)

  • Current GMP regulation
  • FDA requirements
  • Technical guidelines
  • Regulatory expectations

Coffee Break

GMP Update on SUS (Part 2)

  • New Annex 1

Hands-on Exercise 1

  • Gowning
  • Experiment with the advantages of SUS

Lunch Break

Basics in Single-use Bioprocessing Focus on Bags

  • Manufacturing of SU Consumables
  • Different bag functionalities

Coffee Break

Hands-on Exercise 2 (Cleanroom)

  • Connection/Disconnection

Wrap-up Day 1

End of Training Course Day 1

Joint Dinner

Day 3

Wednesday, 02 October 2024

Sensors and Automation in Single-use Systems

  • Overview and demonstration

Hands-onof  Exercise 3

  • Overview bag types

Coffee Break

Data Integrity, Data Analysis and Monitoring

  • Regulatory requirements and guidelines
  • Data integrity for computer, paper, and hybrid systems
  • Control of meta-data
  • Data integrity strategies for compliance
  • Checking for Data Integrity issues in practice
  • Experimental approach

Lunch Break

Filtration & CCT

  • Filter Integrity Testing in SUS
  • Bag Assembly Integrity Testing

Hands-on Exercise 4

  • Filter Integrity Testing

Coffee Break

Filter Integrity Testing Fault Handling – GMP View

  • GMP requirements
  • Pre- and Post-use integrity testing
  • Impact of new EU GMP Annex 1 requirements

GMP Practical Session

  • Failed filter IT - what to do under GMP?
  • What are the differences between media preparation and final filtration of a drug product prior filling?
  • 'Bioburden Reduction' vs. 'Sterile Filtration'

Data Recording & Evaluation

  • Data logging
  • Batch monitoring

Wrap-up Day 2

End of Training Course

Agenda is subject to change.

Featured Trainers

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sartorius Stedim Biotech

Otto-Brenner Str. 20
Göttingen, Germany 37079, Germany
Reservation Instructions

PDA Europe recommends to reserve a hotel room close to the trainings location.

Best Western Hotel Am Papenberg

Hermann-Rein-Straße 2
37075 Göttingen

How to Get Here
By Air Nearest Airport: Hannover Airport Airport Phone: +49 (0)511 977-0
By Other Options By Train: Around 25 minutes away from station Göttingen.
Special Deutsche Bahn Train Fares
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Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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