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

Feb 08 - Feb 10, 2022
Göttingen, Germany

  • Education
  • Europe

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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 diversification of products takes place with new therapeutic approaches rising up. 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 to you, then you should sign up to 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 have a look into the manufacturing of single-use bioreactor bags and filters, followed by a visit in the Sartorius Application Center where you can see and test complete process solutions from molecule discovery to large scale biomanufacturing.


  • Day 1
  • Day 2
  • Day 3
  • Tuesday, 8 February 2022

    Welcome & Introduction of Participants

    Introduction to Single-use Bioprocessing

    GMP Update on SUS (Part 1)

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

    Coffee Break

    Hands-on Exercise 1

    • Gowning
    • Experiment on advantages of SUS

    Lunch Break

    GMP Update on SUS (Part 2)

    • New Annex 1 requirements

    Basics in Single-use Bioprocessing

    • Manufacturing of SU Consumables
    • Different bag functionalities
    • Connection/disconnection technologies

    Coffee Break

    Hand-on Exercise 2 (Cleanroom)

    • Bag handling (Storage and mixing bags)
    • Connection/Disconnection

    Wrap-up Day 1

    End of Day 1

  • Wednesday, 9 February 2022

    Sensors and Automation in Single-use Systems

    • Overview and demonstration

    Data Integrity, Data Analysis and Monitoring

    • Regulatory requirements and guidelines
    • ALCOA
    • 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

    Coffee Break

    GMP View on Media Preparation

    • GMP requirements
    • Best practice in equipment and facility design

    Filtration & CCIT

    • Filter integrity testing
    • CCIT for SUS
    • GMP considerations

    Lunch Break

    Hand-on Exercise 3

    • Media preparation
    • Filter Integrity testing

    Coffee Break

    Data Recording & Evaluation

    • Data logging
    • Batch monitoring

    Filter Integrity Testing Fault Handling – GMP View

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

    Wrap-up Day

    End of Course

  • Thursday, 10 February 2022 - Optional Facility Tour

    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

    Coffee Break

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

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

    13:00 - 14:00
    Farewell Lunch

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the training course the participants

    • 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
  • Who Should Attend

    Who Should Attend

    • Operators
    • Manufacturing Supervisors
    • QA Managers
    • Manufacturing Managers
    • QC Managers
    • Auditors

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Sartorius Stedim Biotech

Otto-Brenner Str. 20
Göttingen, Germany

Sartorius Stedim Biotech

How to Get Here

By Air

Nearest Airport: Hannover Airport
Airport Phone:
+49 (0)511 977-0

By Car

More information coming soon.

Other Options

More information coming soon.


Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

All fees given in Euro and excluding VAT

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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