New Developments in Barrier Systems & Robotics

Objective

Reasons to attend this conference:

  • You will be informed on new regulatory and technological developments in aseptic / sterile manufacturing
  • You learn how current GMP and production requirements have to be implemented technologically in sterile manufacture
  • You will get case studies from pharmaceutical companies

Target Audience

This event is directed at decision-makers from pharmaceutical production, automation, development and quality assurance/control. It also addresses engineers and planners who need to be well informed about current developments in the field of barrier systems and robotics.

Background

The protection against microbial contamination is the most important point for drugs produced by aseptic processes. Today the regulators require a stricter separation between operators and product in the form of an access barrier.
Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators are referred to by the US FDA as advanced aseptic technology. Another consequence of the separation of operator and production process is the increased introduction of Robot Technology in the aseptic environment.
This conference will focus on current questions of barrier systems and robotics coming from FDA regulations as well as from the revised EU-GMP Annex 1, and it will specifically address the subject from the perspectives of pharmaceutical operators, planners and engineers.

Moderator

Didier Meyer, DMCompliance
Frank Studt, gempex

Registration


Detailed Programme

Presentations - 28 March 2023

Retrofitting RABS - Upgrade to V-CRT
Dr Ute Schleyer, Vetter Pharma-Fertigung

  • After Vetter had already built 4 new clean rooms with V-CRT technology, 2 clean rooms have been added.
  • These two clean rooms previously operated as RABS for several years before being upgraded to the V-CRT system.
  • Challenges and differences to the newly built cleanrooms to the retrofitted are presented.

Process Automation in a Small Scale Aseptic Manufacturing Site for Clinical Trial Products.
Dr Tim Stöveken, Merz Therapeutics
Martin Glättli, ProSys Group

  • Presentation of flexible manufacturing concept for sterile liquid products for clinical trials
  • Filling of small batches with automation of the most critical processes
  • Implementation of Isolator technology into an existing building
  • Training and operation concept in a non-routine environment

Replacement of H2O2 Generator from Existing Vial Filling Line
Dr Simone Bläsi, F. Hoffmann-La Roche
Kenan Kanmaz, Metall+Plastic

  • Project challenge from the first step – timeline
  • Production shutdown and realization
  • Risk and other key tasks of upgrading
  • Results of cycles development with the new H2O2 Generator RG4
  • DECOpulse® - effective H2O2 Bio-decontamination System

Barrier Systems and Automation - the Needs and the Potential considering Contamination Control Strategy (CCS)
Robert G. Schwarz, FH Campus, Wien

  • Annex 1 - game-changer for RABS or documented state of the art?
  • RABS vs Isolator - the decision prior robotics
  • Struggling in updating existing Barrier Systems - are all of us ready for robotics in aseptic processing?

Benefits of Robotics in a CDMO Environment – A Case Study at the German CDMO PSM GmbH about using gloveless robotic Filling System in the Light of Contamination Control Strategy (CCS)
Julian Petersen, groninger & co
Thorsten Häfner, PSM

  • Layouts and processes for using a gloveless robotic filler for high value drugs
  • Replacement of manual processes by robots
  • Minimizing humans in the aseptic area
  • Comparison of traditional technologies with robotic applications

Barriers & Robotic Isolators in New Annex 1 (2022 version)
Dr. Daniel Müller, Local Government, Germany

  • Requirements for barriers/ isolators
  • Major changes for barriers (version 2008 vs. 2022)
  • How far are robotic isolators addressed?
  • Challenges, discussion points & GMP inspector's view

Presentations - 29 March 2023

The Use of Robotic Systems in Aseptic Processing and the Pharma-Industry Overall
Jörg Zimmermann, Vetter Pharma-Fertigung

  • Automation and Robotics in the pharmaceutical industry
  • Robots for cleanrooms: things to consider
  • Robotic automation in aseptic processing: implementation examples and outlook
  • Use of robotics in compounding, testing and secondary packaging

Validated Technology for a Flexible Aseptic Robotic Parts Handling in Isolator Environment
Sascha Wittig, WEISS ROBOTICS

  • STERIGRIP – smart solution with plug-in technology reduces complexity in the handling process
  • Challenges, possible applications and technical requirements
  • How process device data can support the GMP monitoring process vs. the manual intervention with gloves

Automated Thawing Process: Combining Robotic and Manual Process Steps
Maren Jahn, Vetter Pharma-Fertigung

  • Concept: the path from process needs to first ideas
  • echnical Challenges: operator safety versus processing time; integration of specific robotic solution in mulit-use facility
  • Implementation Challenges: Comparison of manual versus automated homogenization process of API bottles; integration in batch documentation;
  • interaction between robot and operator

Disposable Isolator and Robotic Input, Why Not?
Frank Pavan, GTP Nano

  • Introduction of fill and finish activities in grade A
  • Use of Disposable filling Grade A isolator for parenteral manufacturing
  • Containment of Highly potent products using Disposable isolator

New Methods to develop Pharma Automation and Robotic Solutions in Warp Speed
Milad Jami, Novo Nordisk
Julien Lora, Stäubli Tec-Systems GmbH Robotics

Fill&Finish Machine for Cell&Gene Therapy: From Requirements to Concept and Realization
Alexandre Daune, UCB
Matteo Tagliabue, Steriline

  • Presentation of UCB’s requirements and drivers
    • for small batches (1000pcs. - 2R vial)
    • RTU vials in nests, SiO2 vials
    • 100% IPC
    • no product loss (also during the production start)
    • conventional stoppering and aluminum capping
    • compact footprint
    • under Isolator
    • Environmental conditions:
      • Outside surface of the outer bag exposed to the decontamination agent under Grade C
      • Tub debagging under Grade A air supply
      • Tub opening under Grade A
      • Filling & Closing Under Grade A
      • Crimping at least Grade A air Supply.
  • Presentation of machine concept
    • 3D drawings and movie clips of our robotic design
    • No-Loss-Philosophy: Re-filling, Re-stoppering, Re-capping functionalities

Programme as PDF

Download the programme of the Conference New Developments in Barrier Systems & Robotics as PDF.

x
Search