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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 sessions
are presented by process equipment and system designers and suppliers
who have real life experiences to share with their audience.
What you will Learn
- To apply
the information presented in a Process Flow Diagram to a Bioprocessing
Facility Design
- Technology
overview and applications guidelines for key unit operations and equipment
- 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.
Instructor/Speaker
Panel:
- Seminar
Director: Paul Kubera, Vice President, Engineering, ABEC, Inc.
- Jay
Ankers, Director, Process/Mechanical, LifeTek Solutions
- Robert
Barloga, Senior Application Engineer, Alfa Laval
- Barbara
Henon, Manager, Technical Publications, Arc Machines, Inc.
- Rolf
Hjorth, Staff Research Engineer, GE Healthcare Bio-Sciences
- Jeff
Mahar, Director of Healthcare, CUNO/3M Company
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers
- Tom
Warf, Product/Process Analyst, U.S. Dept. of Health & Human Services
SCHEDULE
|
Monday,
23
June 2008
|
| 7:30
am - 5:00 pm |
Registration
Desk Open |
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 8:15 am |
Introduction
and Course Overview |
Paul
Kubera
Vice President, Engineering, Associated
BioEngineers & Consultants (ABEC)
|
| 8:15
am - 9:30 am |
Bioreactor
Specification and Design
Scaling-up microbial fermenters 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 is necessary to fully appreciate the small-scale to production
scale-up methodology. Fermenter and bioreactor specification and design
considerations are discussed. |
Paul
Kubera
Vice President, Engineering, Associated
BioEngineers & Consultants (ABEC)
|
| 9:30
am - 10:00 am |
Drain,
Sample & Isolation Valves
Review of valve types, features and applications
practice for aseptic service |
Paul
Kubera
Vice President, Engineering, Associated
BioEngineers & Consultants (ABEC)
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - 11:15 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. |
Paul
Kubera
Vice President, Engineering, Associated
BioEngineers & Consultants (ABEC)
|
| 11:15
am - Noon |
Downstream
Processing: Centrifugation
This presentation will look at the selection
considerations for centrifugation processes. Equipment function, scale
considerations, batch/continuous, cleaning, validation and process
application will be reviewed. |
|
| 12
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
Downstream
Processing: Filtration
This presentation will look at the selection
considerations for filtration processes. Scale considerations, batch/continuous,
single use/cleaning, validation, code compliance, and process application
will be reviewed. |
|
| 2:00
pm - 3:00 pm |
Materials
of Construction and Orbital Welding
A practical discussion on weld configuration
and impact of material constituents. Demonstration of proper orbital
welding techniques and procedures. |
|
| 3:00
pm - 3:30 pm |
Refreshment
Break |
| 3:30
pm - 4:30 pm |
Downstream
Processing: 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. |
Rolf
Hjorth
Staff Research Engineer,
GE Healthcare Bio-Sciences
|
| 4:30
pm - 5:30 pm |
Facility
Planning
Facility layout and organization based on
consideration of product requirements, unit operations, utilities,
workflow, regulatory aspects, etc. |
Jay
Ankers
Director, Process/Mechanical
LifeTek Solutions
|
|
Tuesday,
24
June 2008
|
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 9:00 am |
Applicable
Design Standards & Practices
ASME BPE, EN-285, ASTM, ISPE resources and
guidelines are presented.
|
Jay
Ankers
Director, Process/Mechanical
LifeTek Solutions
|
| 9:00
am - 10:00 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, will
be discussed. |
|
| 10:00
am - 10:30 am |
Refreshment
Break in Exhibits Hall |
| 10:30
am - Noon |
Instrumentation
and Automation of Bioprocess Systems
SCADA, DCS, PLC, Analog control systems will
be reviewed. 21 CFR Part 11 considerations, validation. |
Tom
Warf
Product/Process Analyst
U.S. Dept. of Health & Human Services
|
| 12
Noon - 1:00 pm |
Lunch
w/
Exhibitors |
| 1:00
pm - 2:00 pm |
Cycles
of Learning
Open
forum to discuss design and implementation successes and failures:
what works, what doesn't and what to do when it doesn't.
|
|
| 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 are reviewed.
|
Jay
Ankers
Director, Process/Mechanical
LifeTek Solutions
|
| 3:00
pm - 3:30 pm |
Refreshment
Break in Exhibits Hall |
| 3:30
pm - 5:00 pm |
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
Product/Process
Analyst
U.S. Dept. of Health & Human Services
|
| 5:00
pm - 7:00 pm |
Feature
Presentation and Networking Reception in Exhibits Hall |
|
Wednesday,
25 June 2008
|
| 8:00
am - 9:00 am |
Workshop: Learn about the BPE (BioProcessing Equipment) International
Standard |
| 9:30
am - |
BPE Subcommittee Meetings: Open to the Public |
| 3:30
pm - 5:30 pm |
Plant Tours: GE Healthcare Uppsala / Alfa Laval
Tumba (Seats are limited. Advance sign-up required.) |
REGISTER NOW!
Visit www.asmeconferences.org/BioprocessEurope08
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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