ASME 20th Annual Bioprocess Technology Seminars & Exhibits

PD317: Bioprocessing Equipment Design and Facility Layout

Date: October 1-4, 2007 (Monday-Thursday)
CEUs: 3.0

Description

A comprehensive introduction of the factors that influence the selection, design, specification and placement of bioprocessing equipment. Topics will include: upstream and downstream processing equipment design, cleaning and sanitization, validation and commissioning, an introduction to single use systems and to facility design. Regulatory compliance and biocontainment considerations will be discussed. The program follows a real life model project from the process flow diagram to the facility layout. Three hands-on interactive workshops encourage the participants to develop systems and models. The courses are presented by owner/users who have real life experiences to share with their audience.

What You Will Learn

To apply the information presented in a Process Flow Diagram into a Bioprocessing Facility Design
The recent trends in Bioprocessing Technology
Procurement: How to specify? What to look for? The FAT.
Cleaning and Sanitization Considerations
The impact of single use systems in bioprocessing and facility design

Who Should Attend

Engineers, scientists and other personnel involved in the design of bioprocessing equipment including suppliers, end-users, contracts and component suppliers. Those involved in operation and maintenance will find that the course provides an excellent introductory overview of equipment and system design. This basic program will introduce those whom are about to design a cGMP bioprocessing suite or facility to the design process.

SCHEDULE

Sunday, September 30, 2007
3:00 pm - 7:00 pm	Registration Open - Avoid the lines on Monday!
Monday, October 1, 2007
7:30 am - 8:00 am	Registration Desk Open. Continental Breakfast
8:00 am - 8:30 am	Course Introduction and Project Description An overview of the model project, introduction of the tools and resources that will be used during the 4-day program.	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
8:30 am - 9:15 am	Cell Culture and Fermentation Scaling-up microbial fermentors and cell culture bioreactors can present challenges to the process and equipment designer. A thorough understanding of the inter-relationships between vessel geometry, aeration, agitation needs, oxygen transfer rates, and heat transfer are necessary to fully appreciate the small-scale to production scale-up methodology. The lecture will explore oxygen uptake requirements, agitator power needs, heat transfer, and aeration. What to expect or require at FAT, specification process, roller bottle technology, P&ID	Wayne Herber Senior Scientific Director Fermentation & Cell Culture Merck
9:15 am - 10:00 am	Vessel Design The design concepts of a bioprocess vessel are reviewed. Particular emphasis will be on designing for cleanability, operability and sterilization. Design details will be provided.	Mark Herr Product/Sales Manager Stainless Technology
10:00 am - 10:30 am	Refreshment Break
10:30 am - 11:15 am	Centrifugation Centrifugation is a technology which is critical for successful cell culture harvest and other liquid-solid and liquid-liquid separations. This session presents the principles of sedimentation and will provide end users and designers the tools necessary for the specification of the ideal system for their application.	Robert Barloga Senior Application Engineer Alfa Laval, Inc.
11:15 am - 12:00 noon	Filtration Filtration is used in almost all bioprocesses. Sterile vent and addition filters are used for sterile liquid and gas transfers. TFF systems are used for cell harvest as well as for purification and buffer exchange processes.	Jeff Mahar Director, Healthcare CUNO/a 3M company
12:00 noon - 1:00 pm	LUNCH
1:00 pm - 1:45 pm	Bioreactor Specification and Design The fermentor and bioreactor specification and design considerations are discussed in this presentation. Aeration, agitation and vessel parameters are presented.	Paul Kubera Vice President, Engineering Associated Bio Engineers & Consultants (ABEC)
1:45 pm - 2:30 pm	Bioreactor Design Workshop Four design teams will design bioreactors and specify downstream equipment to accommodate the project process.	Marc Pelletier Paul Kubera Jeff Mahar Robert Barloga
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 5:00 pm	Bioreactor Design Workshop - con'td.	Marc Pelletier Paul Kubera Jeff Mahar Robert Barloga
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 - 9:15 am	Engineering for Cleaning-In-Place The various cleaning mechanisms and effect of velocity and chemical composition of the cleaning agents is reviewed.	Alan Powell Senior Project Engineer Merck & Company
9:15 am - 10:00 am	Engineering for Sterilization Review the difficulties and design parameters to successfully steam sterilize systems. Information is provided that relates to the design configuration and kill correlations.	Tom Warf Process Technology Consultant U.S. Human Health Services
10:00 am - 11:15	System Infrastructure Design Considerations All product-contact utilities including clean steam, purified water and sterile gases must be carefully considered in bioprocess designs. Diversity factors. Utility use matrices.	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
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	CIP/SIP Workshop Designing integrated CIP & SIP systems into the process is covered. Topics addressed include vessel and in-line component considerations. Design optimization of the CIP & SIP piping is reviewed from conceptualization through configuration on final flow paths. Integration of the validation into the design process is emphasized.	Alan Powell/ Tom Warf
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 5:00 pm	CIP/SIP Workshop (continued)	Alan Powell/ Tom Warf
5:00 pm - 7:00 pm	Opening Reception with Exhibitors
Wednesday, October, 3, 2007
7:30 am - 8:30 am	Registration Desk Open; Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am	Validation/Commissioning & Integration of the Design Process Tools for integration of the validation/commissioning process into the design phase are presented. Classical and Risk based approaches to the Qualification Process	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 11:15 am	Stainless Steel as Utilized in Bioprocessing Systems Controversial Aspects - Some of the most controversial issues dealing with materials selection will be presented and examined; additionally, a discussion of systems design considerations, systems maintenance practices and methods such as how to deal with product contact surfaces and their associated treatments, including electropolishing, the Lotus Effect, passivation, inspection of surfaces, "rouge" and all its myths and realities, will be offered.	Michelle Gonzalez (Ret.) AMGEN
11:15 am - 12:00 noon	A Different Paradigm: Design and Development of Biopharmaceutical Pilot Plants This presentation delves in the general requirements for the design and development and diverse strategies for the successful and flexible conception of pilot plant involved in the development of biologics license application (BLA) and its requirements. It will include key issues for bioprocess pilot plants, typical suites and equipment for both upstream and downstream processes, and support facilities.	Michelle Gonzalez (Ret.) AMGEN
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 2:30 pm	Plastics, Elastomers and Single-use systems in Bioprocessing Not all EPDM is created equal. Understanding your process and the impact of elastomers used in mechanical joints and seals is critical for a successful operation. More and more plastics are now used in bioprocessing with the increased acceptance and use of single use systems. Impact to facility design and capital costs will be discussed.	James Dean Vogel (Ret.) AMGEN
2:30 pm - 3:00 pm	Refreshment break w/ Exhibitors
3:00 pm - 4:30 pm	Bioprocess design considerations, regulatory compliance and design implication of multiproduct facilities Review the cGMPs and their impact on the facility. This presentation covers the problems and requirements of FDA compliance and validation; considerations when multi-product, pilot, clinical or manufacturing facility is required.	Marc Pelletier Michelle Gonzalez James Dean Vogel
Thursday, October 4, 2007
7:30 am - 8:30 am	Registration Desk Open; Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am	Open Forum - Case studies Elastomers. Rouging, Corrosion, 483s. Other contemporary real life issues are discussed.	Marc Pelletier, Michelle Gonzalez, James Dean Vogel
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Introduction to Facilities Design One approach to develop a conceptual design is presented. Concepts such as suite programming, unit operation adjacencies, infrastructure layout and design, material, personnel and waste flows are discussed.	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
12:00 noon - 1:00 pm	LUNCH w/ Exhibitors
1:00 pm - 2:30 pm	Facilities Design Workshop Space optimization principles are important in designing a modern biotech facility. General factors considered include people, material and process flow. Process equipment placement and gray space/sterile boundary concepts are also reviewed. The results of the Facility Design Workshop will be presented to the group of attendees. A discussion of the pros and cons of the developed design will follow.	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 5:00 pm	Facilities Design Workshop (continued)	Marc Pelletier Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
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 is 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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