Barrier Isolation Technology Forum: Innovation, Updates, New Case Studies
Monday 20 September - Tuesday 21 September
Seminar Content Level: Intermediate
Seminar Leaders: Charlotte Enghave Fruergaard, NNE Pharmaplan, Denmark; Jack Lysfjord, Principal Consultant, Lysfjord Consulting, LLC, USA
This seminar presents developing technology and regulatory perspectives for barrier isolation, especially in regard to advanced aseptic processing, restricted access barrier systems (RABS), and isolators. It will feature a variety of topics including robotics, E-beam sterilisation of syringe tubs, measurement of hydrogen peroxide, biological sensitivity to hydrogen peroxide, clinical trial materials produced in an isolator, a biotech facility using isolators, and several contract manufacturing examples using these techniques. Content includes multiple case studies and interactive workshops on topics of global importance.
Take Back to Your Job:
- Describe updated technologies applicable to advanced aseptic processing using BFS, RABS, and barrier isolation
- Describe how robotics can improve clinical manufacturing
- Understand protein sensitivity to hydrogen peroxide
- Interpret regulatory agency perspectives to streamline your regulatory submission and approval process
- Participate in peer discussion groups on advanced aseptic processing issues
- Understand what to do and what not to do from those who have done it before
- Apply best practices from case studies
Communities of Practice (COPs):
Biotech, Commissioning and Qualification, Containment, Disposables, Engineering Standards Benchmarking, HVAC, Investigational Products, Product Process Development, Sterile Products Processing, Sustainable Facilities
Related Technical Documents:
- ISPE Baseline® Guide: Volume 3 - Sterile Manufacturing Facilities
Who Should Attend
Engineering, operations, validation, regulatory, and project management personnel from companies in operations as well as equipment vendors that supply the industry with process equipment.
Programme
Day 1, Monday 20 September
10.00 – 10.10 Welcome and Introduction
Charlotte Enghave Fruergaard, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
10.10 – 10.50 Isolator History and Trends 2010 Preliminary Data
Jack Lysfjord, Lysfjord Consulting LLC (US)
- Global numbers for fill finish isolators
- Regional differences: Asia, Europe and North America
- Compare both to prior data and look at trends with isolator usage
10.50 – 11.35 Clinical Aseptic Processing Fill Finish Line for Liquid or Freeze-dry
Products
Mathias Kreher, Bosch (Germany)
- Flexibility for various filling systems
- Minimised product loss
- Modular barrier concept
- Easy to use barriers
11.35 – 12.15 Pharmaceutical Industry Trends and Their Influence on Isolator Technology
Thomas Huber, Skan (Switzerland)
- Fast H2O2 decontamination
- Safe filter change
- H2O2 low ppm impact on product
- E-Beam technology
- Further future developments
12.15 – 13.45 Lunch and Networking Break
13.45 – 14.25 In-situ Characterisation of Vapor Phase H2O2
Ron Chiorello, Jetalon Solutions (US)
- Key physical properties of VHP processes for monitor and control
- Current methods for monitoring VHP processes
- Novel method for simultaneous and real-time monitoring of VHP processes
- Comparison of the current methods and recommendation for a best known method (BKM) for monitor and control of VHP processes
14.25 – 15.10 Case Study – Effects of Residual Vapor Phase Hydrogen Peroxide and In-line
Measurement of Residual VPHP
Sokhorn Yim, Genentech (US)
- New technology to measure low level residual vapor phase hydrogen peroxides (VPHP)
- Protein sensitivity to H2O2
- VPHP cycle development at the new Genentech filling facility
- In depth knowledge of the aeration cycle
15.10 – 15.40 Break
15.40 – 16.25 VPHP Absorption/Desorption and Its Impact with the Use in Barrier Systems
Mike Walsh, Lilly (US)
- VPHP measurement technologies
- Absorption/desorption of H2O2 in different materials
- Aeration studies
16.25 – 17.10 Cycle Development of a Containment Filling Line for Liquid and
Freeze Drying Products - A Case Study
Berthold Duethorn, Robert Bosch GmbH
- Learn about influencing Parameters for Biodecontamination
- Hear about all materials and devices needed for Cycle development
- Get a full overview of the Cycle Development approach for three Isolators
- Review Lessons learned and hear about future prospects for onsite Cycle Verification and Cycle Validation
17.10 – 17.40 A Phased Approach to Applying Barrier Isolation Technology to Cartridge Filling
Carmine Stropoli, Parsons (USA)
- Phasing-in isolation technology
- Intervention and components transfer
- Operational flow and area classification
- Facility, process and mechanical spatial requirements
- Determing whether the approach is viable for specific filling projects
17.40 – 17.45 Summation and Close of Day 1
Charlotte Enghave Fruergaard, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
17.45 – 18.45 Exhibition Networking Reception
Day 2, Tuesday 21 September
09.00 – 09.10 Review of Day 1, Introduction of Day 2
Charlotte Enghave Fruergaard, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA)
09.10 – 10.15 Breakout Discussion Groups
Stay tuned for updated session information
10.15 – 10.45 Break
10.45 – 11.15 Discussion Group Summaries
11.15 – 12.00 Case Study – A New Biotech Production Facility for Aseptic Processing of Vials with
Dual Fill Finish Lines
Sokhorn Yim, Genentech (US)
- Facility overview, product and people flow, cost and schedule
- Isolator decision vs. cleanroom, RABS rationale and cost analysis
- Overview of the isolator filling processes, equipment selection and difference between liquid and lyo
- The validation process and the use of “design of experiments”
- Surprises and learnings
12.00 – 12.45 Contract Production, Multi Product Fill Finish Facility for Vials and
Syringes
Ryan Hawkins, Cook Pharmica (US)
- Facility and line overviews including isolator decision
- Process design and coordination effort
- Product path options including disposables
- Material and component transfer considerations
- Qualification and validation overview
- Lessons learned
12.45 – 14.15 Lunch and Networking Break
14.15 – 15.00 Campaign Filling of Biotech Products in Isolator Setup
Wolfgang Epple, Johnson & Johnson (Switzerland)
- SCF process cycle time reduction for biotech products resulting in production efficiency and capacity increase
- Reduction of changeover time during campaign filling in isolator setup
- Reduction of the average product loss rate by means of process optimisation resulting in significant API cost savings
15.00 – 15.45 Regulatory Comments, Questions and Answers
Ian Thrussell, MHRA (UK)
Stay tuned for updated session information
15.45 – 16.00 Questions and Answers, Close of Seminar
Charlotte Enghave Fruergaard, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)