| 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: Marc Pelletier, Director, Strategic Biopharm Solutions Group,
CRB Consulting Engineers
- Jay
Ankers, Director, Process/Mechanical, LifeTek Solutions
-
Detlef Ahrens, Segment Manager, Alfa Laval
- Guenter
Jagschies, Senior Director, Strategic Customer Relations, GE Healthcare
Life Sciences
- Paul
Kubera, Vice President, Engineering, ABEC, Inc.
- Jeff
Mahar, Director of Sales, CUNO Healthcare Group/a 3M company
- Nuala
Calnan, Principal Consultant, PM Group, Ireland
SCHEDULE
|
Monday,
25
May 2009 |
| 7:30
am - 5:00 pm |
Registration
Desk Open |
| 7:30
am - 8:30 am |
Coffee
& Pastries |
| 8:30
am - 8:45 am |
Introduction
and Course Overview |
Marc
Pelletier
Director,
Strategic Biopharm Services Group, CRB Consulting Engineers
|
| 8:45
am - 10:00 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. The design concepts of a bioprocess
vessel are reviewed. Particular emphasis will be on designing for
CIP, operability and SIP.
|
Paul
Kubera
Vice President, Engineering, Associated BioEngineers & Consultants
(ABEC)
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - Noon |
Downstream
Processing: Centrifugation & Filtration
This presentation will look at the selection considerations
for centrifugation and filtration processes. Equipment function,
scale considerations, batch/continuous, single-use, cleaning, validation,
code and process application will be reviewed.
|
Jeff
Mahar
Director of Sales, CUNO Healthcare Group/a 3M company
Detlef Ahrens
Segment Manager, Alfa Laval
|
| 12
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:00 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.
|
Guenter
Jagschies
Senior Director, Strategic Customer Relations, GE Healthcare Bio-Sciences
|
| 2:00
pm - 3:00 pm |
BioProcess
Equipment Specification and Vendor Qualification. How to take advantage
of the ASME BPE and ISPE Baseline Guidelines
Open forum to discuss design and implementation successes
and failures: What works, what doesn't and what to do when it doesn't.
|
Marc
Pelletier
Director,
Strategic Biopharm Services Group, CRB Consulting Engineers |
| 3:00
pm - 3:30 pm |
Refreshment
Break |
| 3:30
pm - 5:00 pm |
Workshop: Specification, Procurement, Design and Fabrication
of BioProcess Equipment
Workshop focused on the specification, procurement,
design and fabrication of bioprocess equipment. A PFD will be presented
and used as basis for equipment selection
|
|
|
Tuesday,
26
May 2009 |
| 7:30
am - 8:30 am |
Coffee
& Pastries |
| 8:30
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. |
Marc
Pelletier
Director,
Strategic Biopharm Services Group, CRB Consulting Engineers |
| 10:00
am - 10:30 am |
Refreshment
Break in Exhibits Hall |
| 10:30
am - Noon |
Design
and Regulatory Compliance Considerations in a cGMP Multiproduct
Facility. ASTM E2500
Biopharmaceutical Manufacturing is a highly regulated
industry. The regulatory agencies are especially diligent in facilities
that are not dedicated to a single product. This session will present
design considerations when designing for a multi-process/multi-product
facility. A workshop demonstrating an approach to a cGMP review
and risk based basis for process validation is also included.
|
|
|
Noon - 1:00 pm |
Lunch
w/
Exhibitors |
| 1:00
pm - 2:00 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
|
| 2:00
pm - 3:00 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.
|
Jay
Ankers
Director, Process/Mechanical
LifeTek Solutions |
| 3:00
pm - 3:30 pm |
Refreshment
Break in Exhibits Hall |
| 3:30
pm - 5:00 pm |
SIP
and CIP Workshop
Workshop that will present an approach to designing
a bioreactor system for SIP and CIP.
Instructors: Marc Pelletier, Paul Kubera and Jay Ankers
|
|
| 5:00
pm - 7:00 pm |
Feature
Presentation and Networking Reception in Exhibits Hall |
| Wednesday,
27 May 2009 |
| 8:30
am - 9:30 am |
Workshop: Learn
about the BPE (BioProcessing Equipment) International Standard
|
| 10:00
am - 3:00 pm |
BPE Subcommittee Meetings: Open to the Public |
| 10:30
am - 12:30 am |
Plant
Tour: Pfizer-DunLaoghaire (Limited seats. Advance sign-up required.) |
3:30
pm - 5:30 pm |
Plant Tour: Pfizer-DunLaoghaire (Limited seats. Advance sign-up required.) |
REGISTER NOW!
Visit www.asmeconferences.org/BioprocessEurope09
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. |
