ASME 20th Annual Bioprocess Technology Seminars & Exhibits

PD519: Bioreactor and Fermenter Design

Date: October 2-4, 2007 (Tuesday-Thursday)
CEUs: 2.25

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

Monday, October 1, 2007
7:30 am - 5:00 pm	Registration Desk Open
5:00 pm - 6:00 pm	Networking Hour
Tuesday, October 2, 2007
7:30 am - 8:30 am	Registration Desk Open; Continental Breakfast
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 - 11:00 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.
11:00 am - 11:15 am	Refreshment Break
11:15 am - 12:00 noon	KEYNOTE
12:00 noon - 1:00 pm	Lunch
1:00 pm - 2:30 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
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 5:00 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.
5:00 pm - 7:00 pm	Opening Reception w/ Exhibitors
Wednesday, October 3, 2007
7:30 am - 8:30 am	Registration Desk Open; Continental Breakfast w/ Exhibitors
8:30 am - 9:30 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.
9:30 am - 10:00 am	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.
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 - 2:30 pm	Controls and GMP Compliance SCADA, DCS, PLC & analog control systems will be reviewed. Discussion of 21 CFR Part 11 and validation considerations.	Thomas Warf Product/Process Analyst U.S. Dept. of Health & Human Services
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:00 pm	Bioreactor Instrumentation and Control Loops Overview of basic instrumentation needs and common approaches to temperature, pH, DO and dissolved CO2 control.	Dennis Healey Automation Engineer ABEC , Inc.
4:00 pm - 4:30 pm	System Design Guidelines Bioreactor system design approaches for cleanliness, mechanical, ergonomic and architectural constraints.	Paul Kubera Vice President, Engineering, ABEC, Inc.
Thursday, October 4, 2007
7:30 am - 8:30 am	Registration Desk Open; Continental Breakfast w/ Exhibitors
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 w/ Exhibitors
10:30 am - 11:30 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 Product/Process Analyst U.S. Dept. of Health & Human Services
11:30 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 Product/Process Analyst U.S. Dept. of Health & Human Services
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
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 Thomas Warf
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 5:00 pm	Workshop: Integrated Design of CIP/SIP for Bioreactors and Fermenters (continued) Team presentations and review of CIP/SIPcase study results.	Alan Powell Thomas Warf
5:00 pm - 6:00 pm	Networking Hour
Friday, October 5, 2007
9:00 am - 10:30 am	PLANT TOUR - Genentech Oceanside (Advance sign-up required)

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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