| Description
This seminar provides a comprehensive look at the factors that influence
the selection, design, specification and placement of bioprocessing equipment.
Topics will include: upstream and downstream processing equipment design,
cleaning and sanitation, C&Q, single use systems and the facility
of the future. Industry standards and regulatory guidelines that can be
used to facilitate the process are presented. 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.
What you will Learn
- How to
Transition from Process Flow Diagram into a Bioprocessing Facility Design
- The recent
trends in Bioprocessing Technology including the Facility of the Future.
- Procurement:
How to specify? What to look for? Enhanced commissioning.
- How to
design with Cleaning and Sterilization in mind
- 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.
Instructor/Speaker
Panel:
- Seminar
Director: Marc Pelletier,
Director, Strategic Consulting Group, CRB Consulting Engineers
- Mark
Herr, Product/Sales Manager, Stainless Technology
- Paul
Kubera, Vice President, Engineering, Associated
Bio Engineers & Consultants (ABEC)
- Robert
Barloga, Senior Application Engineer, Alfa Laval,
Inc.
- Jeff
Mahar, Cuno
- Alan
Powell, Principal Engineer, Process Engineering,
Merck
- Jim
Vogel, Principal, Process Facilities Services
Incorporated
- Alan
Williams, Senior Applications Manager, GE Healthcare
|
Monday,
June
14 |
| 8:00
am - 8:15 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 Consulting Group, CRB Consulting
Engineers
|
| 8:15
am - 9:15 am |
Bioprocess
Equipment Specification
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. ASME BPE, EN-285, ASTM,
ISPE resources and guidelines are presented. Vendor Qualification
programs.
- Marc Pelletier, Director, Strategic Consulting Group, CRB Consulting
Engineers
|
| 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.
-Alan Powell, Principal Engineer,
Process Engineering, Merck
|
| 10:00
am - 10:30 am |
Coffee
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 lecture presents the principles of sedimentation and will provides
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 - 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 for purification and buffer exchange
processes.
-Jeff Mahar, Cuno |
| Noon
- 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
Chromatography
This presentation will look at the selection considerations for chromatography processes. Scale considerations, column design, separation material options, process application and future trends will be reviewed.
-Alan
Williams, Senior Applications Manager, GE Healthcare
|
| 2:00
pm - 3:00 pm |
Engineering
for Cleaning-In-Place
The various cleaning mechanisms and effect of velocity and chemical
composition of the cleaning agents is reviewed.
-Alan
Powell, Principal Engineer, Process Engineering, Merck
|
| 3:00
pm - 3:30 pm |
Coffee
Break |
| 3:30
pm - 5:00 pm |
Bioprocess
Equipment Design Workshop
Four design teams will design bioreactors and specify downstream
equipment to accommodate the project process.
- Marc Pelletier, Jeff Mahar,
Robert Barloga, Al Williams |
|
Tuesday,
June 15 |
| 8:30
am - 9:00 am |
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 Consulting Group, CRB Consulting
Engineers
|
| 9:15
am - 10:00 am |
Risk
Assessments, Paradigm Shift in C&Q
ASTM E2500 and Risk Based Approaches to C&Q. Tools for
integration of C&Q into the process and facility design are presented.
The importance of a good Basis of Design and URS is discussed.
-
Marc Pelletier, Director, Strategic Consulting Group, CRB Consulting
Engineers
|
| 10:00
am - 10:30 am |
Coffee
Break |
| 10:30
am - 11:15 am |
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.
-
Jim Vogel, Principal, Process Facilities Services Incorporated |
| 11:15
am - Noon |
Cycles
of Learning
Recent designs and fabrications that did not meet user expectations.
Open forum on the groups issues and experiences
-
Marc Pelletier, Director, Strategic Consulting Group, CRB Consulting
Engineers |
|
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
Instrumentation,
Controls & GMP Compliance
- Ray Emerson, New England Controls
|
| 2:00
pm - 3:00 pm |
Bioprocess
Design Considerations, 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;
considerations when multi-product, pilot, clinical or manufacturing
facility is required.
-
Marc Pelletier, Director, Strategic Consulting Group, CRB Consulting
Engineers
|
| 3:00
pm - 3:30 pm |
Coffee
Break |
| 3:30
pm - 5:00 pm |
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 Consulting Group, CRB Consulting
Engineers
|
| 5:00
pm - 7:00 pm |
Keynote
and Cocktail Reception (with Exhibitors) |
| Wednesday,
June 16 |
| 8:00
am - Noon |
Application of
ASME Bioprocessing Equipment (BPE) Standard
Separate registration required. Click
here for more details |
| 1:00
pm - 5:00 pm |
ASME
BPE Committee Meetings (June 16-18). Open to the public.
No registration required. |
REGISTER NOW! Visit www.asmeconferences.org/Bioprocess10
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. |
