Bioprocess Technology Seminars

PD317: Bioprocessing Equipment Design

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

Description

A comprehensive review 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 and an introduction to facility design. Regulatory compliance and biocontainment considerations will be discussed. The program comprises 3 hands-on interactive workshops. 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.

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, 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
8:30 am - 9:15 am	Course Introduction - Project Description An overview of the test project, introduction of the tools and resources.	Marc Pelletier Director MPP Fermentation Technologies, Inc
9:15 am - 10:00 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 & Company
10:00 am - 10:30 am	Refreshment Break
10:30 am - 11:15 am	Downstream Processing Equipment This presentation will look at the selection considerations for filtration and centrifugation processes. Scale considerations, batch/continuous, single use/cleaning, validatability, code, compliance, and where in process is the unit operation.	Robert Barloga Senior Application Engineer Alfa Laval, Inc. Robert Conway Worldwide Director of Marketing CUNO
11:15 am - 12:00 noon	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
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
1:45 pm - 2:30 pm	Instrumentation and Automation of Bioprocess Systems SCADA, DCS, PLC, Analog control systems will be reviewed. 21 CFR Part 11 considerations, validation	Tom Warf Process Technology Consultant LifeTek Solutions
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 4:30 pm	Bioreactor Design Workshop Four design teams will design bioreactors to accommodate the project process	Marc Pelletier Director MPP Fermentation Technologies, Inc Tom Warf Process Technology Consultant LifeTek Solutions
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 - 9:30 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
9:30 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 LifeTek Solutions
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 11:00 am	Engineering for Sterilization (continued) 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 LifeTek Solutions
11:00 am - 12:00 noon	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 MPP Fermentation Technologies, Inc
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
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.	Tom Warf Process Technology Consultant LifeTek Solutions Alan Powell Senior Project Engineer Merck & Company
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	CIP/SIP Workshop (continued)	Tom Warf Process Technology Consultant LifeTek Solutions Alan Powell Senior Project Engineer Merck & Company
Wednesday, October, 25, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 9:15 am	Design and Development of Biopharm Pilot Plant Facilities This presentation focuses on the various baseline requirements for the successful planning and design of Pilot Plant facilities as utilized in the Biopharmaceutical industry. General concepts, typical suites and their equipment are investigated.	Michelle Gonzalez Principal Corporate Engineer AMGEN
9:15 am - 10:00 am	Bioprocess Equipment Design and Specification Overview ASME BPE, EN-285, ASTM, ISPE resources and guidelines are presented. Vendor Qualifications.	Michelle Gonzalez Principal Corporate Engineer AMGEN
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	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 MPP Fermentation Technologies, Inc
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 2:30 pm	Bioprocess Design Workshop Develop a lab scale bioprocess. Selection and specification of bioprocess equipment for the pilot plant	Marc Pelletier Director MPP Fermentation Technologies, Inc Michelle Gonzalez Principal Corporate Engineer AMGEN
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	Bioprocess Design Workshop (continued) Develop a lab scale bioprocess. Selection and specification of bioprocess equipment for the pilot plant	Marc Pelletier Director MPP Fermentation Technologies, Inc Michelle Gonzalez Principal Corporate Engineer AMGEN
Thursday, October 26, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast
8:30 am - 9:15 am	Regulatory Compliance and Design implication of Multiproduct Facilities Review the cGMP's and their impact on the facility. This presentation covers the problems and requirements of FDA compliance and validation.	Michelle Gonzalez Principal Corporate Engineer AMGEN
9:15 am - 10:00 am	Single Use Systems in the BioPharmaceutical Industry Use of non-metal disposable process equipment is presented.	Tom Warf Process Technology Consultant LifeTek Solutions Michelle Gonzalez Principal Corporate Engineer AMGEN Marc Pelletier Director MPP Fermentation Technologies, Inc
10:00 am - 10:30 am	Refreshment Break
10:30 am - 12:00 noon	Open Forum - Case Studies Elastomers. Rouging, Corrosion. Other contemporary real life issues are discussed.	Marc Pelletier Director MPP Fermentation Technologies, Inc Michelle Gonzalez Principal Corporate Engineer AMGEN
12:00 noon - 1:00 pm	Lunch
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.
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 4:00 pm	Facilities Design Workshop (continued) 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.
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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