Bioprocess Technology Seminars

PD519: Bioreactor & Fermentor Design

This course is now available on CD-ROM. To purchase, please call 800-843-2763.

Description

Bioreactors and fermenters lie at the heart of systems used to produce both large and small-molecule therapeutics. These reactors must produce an environment that is conducive to and optimizes the growth and productivity of microorganisms ranging from fragile cells to robust bacteria.

This course provides a detailed review of the factors that contribute to successful design and operation of cGMP reactors. Bioprocess, unit operation, hardware design and process automation fundamentals will be presented individually and then brought together in case study and workshop format, illustrating key concepts.

What You Will Learn

How to define bioprocess requirements.
Inter-relationships between vessel geometry and agitator mass transfer, heat transfer and blending capability.
Vessel and hardware design features and their impact on aseptic performance.
Instrument and automation approaches for control and GMP compliance.
Integration of CIP/SIP into the reactor process.

Who Should Attend

Engineers, scientists and production personnel involved in the design of bioreactors and fermenters, including component and system suppliers, end-users and engineering design firms. Operations personnel can gain an improved understanding of reactor and ancillary equipment capability and operating strategies.

Schedule

Sunday, October 22, 2006
5:00 pm - 8:30 pm	Registration Open - Avoid the lines on Monday!
Monday, October 23, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast
4:30 pm - 5:30 pm	KEYNOTE Presentation
5:30 pm - 7:00 pm	Opening Reception w/ Exhibitors
Tuesday, October 24, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 8:45 am	Course Introduction Overview of course objectives and content.	Paul Kubera Vice President, Engineering, ABEC, Inc.
8:45 am - 10:00 am	Cell Culture & Fermentation Overview of cell culture and fermentation operations. The relationships between oxygen uptake requirements, agitator power, heat transfer and aeration are explored and linked to discrete design and operating parameters.	Dr. Wayne Herber Senior Scientific Director, Fermentation & Cell Culture, Merck & Co., Inc.
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Agitator Selection Mixing and mass transfer fundamentals as they apply to bioprocessing. Agitator selection & scale-up guidelines to maximize performance while managing shear effects.	Paul Kubera Vice President, Engineering, ABEC, Inc.
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 2:30 pm	Bioreactor Instrumentation and Control Loops Overview of basic instrumentation needs and common approaches to temperature, pH, DO and dissolved CO2 control.	Jeffrey Hamilton Manager, Automation ABEC, Inc.
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	Vessel Design for Bioprocessing Design of vessels and heat transfer surface for GMP applications. Material of construction options, features and benefits.	Mark Herr Sales Manager Stainless Technology
Wednesday, October 25, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 9:00 am	Orbital Welding A practical discussion on weld configuration and impact of material constituents. Demonstration of proper orbital welding techniques and procedures.	Barbara Henon Manager, Technical Publications Arc Machines, Inc.
9:00 am - 10:00 am	Controls and GMP Compliance SCADA, DCS, PLC & analog control systems will be reviewed. Discussion of 21 CFR Part 11 and validation considerations.	Thomas Warf Process Technology Consultant LifeTek Solutions
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Drain, Sample & Isolation Valves Review of valve types, features and applications practice for aseptic service.	John Vitti National Sales Manager Saunders Biopharm
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 1:45 pm	Agitator Mechanical Seals Mechanical seal selection, features and benefits for top and bottom-mounted agitators in aseptic service.	Paul Kubera Vice President, Engineering ABEC, Inc.
1:45 pm - 2:30 pm	Reactor Design Workshop Team-based case study for selection of vessel, agitation system, heat transfer system and related hardware.	Paul Kubera Vice President, Engineering, ABEC, Inc.
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	Reactor Design Workshop (continued) System design considerations; Team presentations and review of reactor design case study results.	Paul Kubera Vice President, Engineering, ABEC, Inc.
Thursday, October 26, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast
8:30 am - 10:00 am	Engineering for Cleaning-In-Place Various cleaning mechanisms and the effect of velocity and chemical composition of the cleaning agents are reviewed.	Alan Powell Senior Project Engineer, Vaccine Process Engineering, Merck & Co., Inc.
10:00 am - 10:30 am	Refreshment Break
10:30 am - 11:15 am	Engineering for Sterilization Review of the challenges and design parameters for successful steam sterilization. Information related to design configuration and kill correlations is presented.	Thomas Warf Process Technology Consultant LifeTek Solutions
11:15 am - 12:00 noon	Reactor Design "Rules of Thumb" Commonly applied guidelines that can be used to quickly estimate bioreactor system design parameters and hardware.	Thomas Warf Process Technology Consultant LifeTek Solutions
12:00 noon - 1:00 pm	Lunch
1:00 pm - 2:30 pm	Workshop: Integrated Design of CIP/SIP for Bioreactors and Fermenters Team-based design of a CIP/SIP system for a fermentation case study.	Alan Powell Senior Project Engineer, Vaccine Process Engineerin, Merck & Co., Inc.
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 4:00 pm	Workshop: Integrated Design of CIP/SIP for Bioreactors and Fermenters (continued) Team presentations and review of CIP/SIPcase study results.	Alan Powell Senior Project Engineer, Vaccine Process Engineering Merck & Co., Inc.
4:00 pm - 5:30 pm	PLANT TOUR: BRI Bioprocess Plant - 50 Maximum
Friday, October 27, 2006
9:00 am - 10:30 am	PLANT TOUR: BRI Bioprocess Plant - 50 Maximum

ASME Travel Policy : ASME is not responsible for the purchase of non-refundable airline tickets or the cancellation/change fees associated with canceling a flight. Please call to confirm that the course is running before purchasing airline tickets. ASME retains the right to cancel a course up until 3 weeks of the scheduled presentation date.


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