Barrier Isolation Technology Forum: Innovation, Updates and New Case Studies

19-20 September 2011
Advances in Barrier Isolation Technology that will drive Costs Down and Quality Up!

Seminar Leaders:
Jack Lysfjord, Lysfjord Consulting, LLC (USA)
Charlotte Enghave-Fruergaard, NNE Pharmaplan (Denmark)

For 20 years and counting, ISPE’s Barrier Isolator Seminar has been one of the key sources of information regarding today’s best practices and latest technology in aseptic processing.  Whether you are operating, retrofitting, supporting, or designing Restricted Access Barrier Systems (RABS) or Barrier Isolator production lines, this seminar is tailored to ensure attendees can leverage the wealth of experience and industry know-how for the benefit of both project and operational excellence.

Regardless of experience, this seminar promises to provide all attendees with new insights in Barrier systems’ application and operations as the regulatory and technology landscape changes.  Conquer the ‘learning curve’ with the tools, knowledge and experience from industry leaders and subject matter experts. Increase effectiveness and:

  • Share and learn global best practices working in RABS and Isolator based filling operations
  • Discuss and understand the ‘whys’ behind industry practices
  • Learn how to set you, your team, and your organisation up for success in designing, qualifying and operating Barrier systems
  • Dedicate time to plan, understand, and consider opportunities to improve your project or operations for increased effectiveness
  • Train and develop team members (reward and recognition or subject matter expertise building)
  • Collect ideas and solve existing aseptic processing challenges
  • Network with industry peers going through similar challenges as well as meeting vendors providing equipment and services all in one conference and location

Communities of Practice (COPs):
Biotechnology, Commissioning and Qualification (C&Q), Containment, Disposables, Engineering Standards Benchmarking (ESB), Good Automated Manufacturing Practice (GAMP®), Heating, Ventilation and Air Conditioning (HVAC), Investigational Products (IP), Process Analytical Technology (PAT), Process/Product Development (PPD), Project Management (PM), Sterile Products Processing (SPP).

Take Back to Your Job:

  • Better understand technologies applicable to advanced aseptic processing using RABS and Barrier Isolation
  • Describe how robotics can improve manufacturing in Barriers
  • Understand measurement of hydrogen peroxide related to protein sensitivity to residuals
  • Interpret Regulatory Agency perspectives to help streamline your regulatory submission and approval process
  • Better understand costs related to the decision for use of RABS or Isolators for new and renovated facilities
  • Understand what to do and what not to do from those who have done it before
  • Apply best practices from case studies with both RABS and Isolators

Who Should Attend?

  • Aseptic Processing Professionals wishing to stay at the forefront of Barrier Isolation Technologies.

Related Guidance Documents, Articles, and Publications:

  • ISPE Baseline® Guide: Sterile Manufacturing Facilities
  • ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
  • ISPE Knowledge Brief: Risk-Based Approaches to Cross Contamination

Seminar Content Level: Intermediate to Advanced

"Delivering Cost Effective GMP Solutions" Conference Brochurecan be downloaded here ( 0 KB).
"Delivering Cost Effective GMP Solutions" Conference Registration Form can be downloaded here. ( 0 KB)

Latest Agenda:

Monday 19 September 2011
10:0010:10Welcome and Introduction
Jack Lysfjord, Lysfjord Consulting LLC (USA); Patrick Vanhecke, GSK Biologicals (Belgium)
10:1010:502011 Preliminary RABS Survey
Jack Lysfjord, Lysfjord Consulting LLC (USA)
10:5011:30

VPHP Cycle Development and Validation Activities at Vendor and Customer Site
Bernhard Sippel, Robert Bosch GmbH (Germany)

  • General Bio decontamination Cycle Development approach, both for vendor site and customer site
  • Importance of Biological Indicator incoming inspection
  • Scheduling and utilisation of resources and related challenges
  • Transfer of results obtained from cycle development at vendor site to customer site
  • Onsite cycle validation activities and results
  • Lessons learned and conclusions
11:3012:10Enhanced Sterility Assurance in Stopper Processing and Unloading:  A Unique Process and Aseptic Transfer System
Carole Langlois, Sartorius Stedim (France)
12:1013:45Lunch and Networking Break
13:4514:25

H2O2 Decontamination - From Cycle Development to Robust Production Cycles
Christian Doriath, Eli Lilly (France)  

Meanings and interpretations of different testing, cross-influence of the different parameters:

  • D-Value in the isolator
  • Thermal mapping
  • Chemical indicators mapping
  • Air flow pattern mapping

What is recommended, feasible, reasonable, not recommended?

14:2515:10High Speed Filling Line for Pre-Sterilised Syringes
Jörg Zimmermann, Vetter (Germany)

In this case study, a high-speed filling line for pre-sterilised syringes is presented. Several innovative concepts are integrated into this 50,000 syringes/hour line: a spray-tunnel for the introduction of the tubs, a bale-compactor for waste, vision systems for process-controls etc. The current status of the line will be discussed as well as the lessons learned so far.
15:1015:40Networking Break
15:4016:25

Confirmation of the Effectiveness of Hydrogen Peroxide Gas Decontamination System
Koji Kawasaki, Airex Co. Ltd. (Japan)

  • Applications scales of the bio-decontamination using Hydrogen peroxide gas in Japan
  • Issues and challenges for the bio-decontamination using Hydrogen peroxide gas
  • Existence of the Dead Leg and how to understand and deal with it
  • Decontamination method inside the packed syringe
  • Effectiveness of Hydrogen peroxide gas against insects, eggs and moulds
16:2517:15FOYA Case
Simone Dahlmanns, Hamelin (Germany)
17:1517:20Summation and Close of Day 1
Jack Lysfjord, Lysfjord Consulting LLC (USA); Patrick Vanhecke, GSK Biologicals (Belgium)
17:3018:30Exhibition Networking Reception

 

Tuesday 20 September 2011
9:009:10Review Day 1, Introduction of Day 2
Jack Lysfjord, Lysfjord Consulting LLC (USA); Charlotte Enghave-Fruergaard, NNE Pharmaplan (Denmark)
9:1010:153 Discussion Groups
10:1510:45Networking Break
10:4511:153 Discussion Group Summaries
11:1512:45Cost Analysis Comparison of Conventional, RABS and Isolator Applications for Aseptic Processing
Sterling Kline, IPS (USA)
12:4513:45Lunch and Networking Break
13:4515:00

Formulation Process Under Isolator, an Enhancement of the Isolated Process Chain
Patrick Vanhecke, GSK Biologicals (Belgium); Volker Sigwarth, Skan AG (Switzerland)

GSK Bio Presentation:

  • When and why GSK Bio has decided to move to isolators technology?
  • What are the Processes covered by this Technology?
  • Our Approach in the Conceptual Design for an Isolator dedicated to Formulation
  • The Process to define the equipment to build
  • The Challenges of the Project (MAL VHP cycle, cycle time, cold loads, potential impact on the material and products)
  • The Success of this Project based on our Efficient Partnership

Skan Presentation:

  • Target of Project and the Process
  • Development vs. Qualification, Structure and Validity of the generated Data
  • Evaluation of physical Parameter and their Influence on Process Performance
  • Overview and Challenges of the applied analysing Methods  
  • Process compatibility of Materials; Deco Effect, Penetration, Aeration
  • Process Challenges of cold Loads
  • Resulting Process and its Performance  
  • Data Transfer from Prototype to Production Systems
  • Summary and Conclusion of the Project
15:0015:45

Powders Not Liquids, Large Batches Not Small, Sterile and Toxic Products – What Do I Do? A Process Overview
Ewart Richardson, DEC Group (Switzerland)

  • Key differences between liquids handling and powder handling in isolators
  • Challenges of dealing with products that are both toxic and sterile
  • Characteristics and challenges of powders; fine powders; and powders in large volumes
  • Case studies on regulatory expectations and principles of system design
 
15:4516:00Questions and Answers, Close of Seminar
Jack Lysfjord, Lysfjord Consulting LLC (USA); Charlotte Enghave-Fruergaard, NNE Pharmaplan (Denmark)