Application and Design of Bioprocessing Equipment

In this advanced course gain an understanding that the principles and the component design details of bioprocess equipment necessary for late stage phase III clinical trials or an FDA approved drug are vital to successful and on time start-up and long term operations. Review the key factors influencing the design of biotech components, equipment, and systems. Topics include equipment design criteria, materials of construction, fluid mechanics,
corrosion resistance, welding, sterility, cleanability, and regulatory issues. Learning is used immediately in equipment design workshops.

Course Directors

Ernest Stadler, Director Bioprocess Systems Sales, Sartorius BBI Systems, Inc.

• BSME with graduate studies in biotechnology
• Ernest has experience in automation, process and mechanical design for a wide range of bioprocess equipment. He has served in the biotechnology industry for over 20 years. He is a frequent speaker, teacher, and workshop leader on the design and application of fermentors and bioreactors particularly relating to biotechnology process scale-up and optimizing performance.

Steven R. Miller, Director of Facilities, Centocor Biologics

• BS in chemical engineering and a MBA
• Steven has over 25 years of experience in process automation and facility design, start-up validation, and operations at GlaxoSmithKline, Genentech, and Eli Lilly and Company.

Bioprocessing Overview Icon
A (B) next to a course description indicates that it is part of the “Bioprocessing Overview.”

Monday, May 21

08.30 - 10.00
Multiproduct Plant GMP Compliance (B)
Gretchen Bowker, Director Regulatory Compliance Consultant, Safis Solutions, LLC.

10.30 - 12.00
Engineering Principles for Fermentors and Bioreactors (B)
Ernest Stadler, Director Bioprocess Systems Sales, Sartorius BBI Systems, Inc.

13.00 -13.45
Mixing Principles for Fermentors and Bioreactors (B)
Steven Miller, Director of Facilities, Centocor Biologics

13.45 - 17.00
DESIGN WORKSHOP: Large Scale Bioreactors and Fermentors
Ernest Stadler, Director Bioprocess Systems Sales, Sartorius BBI Systems, Inc.
Steven R. Miller, Dir. of Facilities, Centocor Biologics

Tuesday, May 22

08.30 - 10.00
Mammalian Cell Fluid Mechanics and Scale Up Considerations (B)
Jeffrey Chalmers, Professor of Chemical
Engineering, Ohio State University

10.30 - 12.00
Centrifuge Design and WORKSHOP (B)
Marc Pellitier, President, MPP Fermtech

13.00 - 14.30
Crossflow Filtration Design and WORKSHOP (B)
Mike Dosmar, Regional Manager, Sartorius, Inc

15.00 - 16.30
Disposable and Disposable Tubing Welding (B)
Goeff Hodge, VP Technology, Xcellerex

Wednesday, May 23

08.30 - 10.00
SIP Engineering, Theory and Implementation (B)
David Marks, President, DME Alliance

10.30 - 12.00
Bioprocess Vessel Design (B)
Bill Dodson, Sales Director, Stainless Fabrication, Inc.

13.00 - 14.30
CIP Theory and Implementation (B)
Sam Lebowitz, Technical Sales Manager, ESC

15.00 - 16.30
DESIGN WORKSHOP CIP/SIP- Challenges for a Bioprocess System
David Marks, President, DME Alliance
Sam Lebowitz, Technical Sales Manager, ESC

Thursday, May 24

08.30 - 10.00
Principles of Corrosion Control Applied to Bioprocessing (B)
Richard Avery, Principle, Avery Consulting Assoc., Inc.

10.30 - 12.00
Application of Orbital Welding to Bioprocess Piping Systems (B)
Barbara Henon, Technical Publications Manager, ARC Machines N.W.

13.00 - 14.30
Alternate Materials
Reinhard Hanselka, CEO, Integrated Eng. Svcs.

15.00 - 16.30
Chromatography Systems Design and WORKSHOP
Gail Sofer, Dir. of Regulatory Svcs.,
GE Healthcare