|
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 sessions are presented by designers and 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
- How to
use Visio™ to facilitate the design layout process
Who
Should Attend
- Owners/Users who have just designed or are about to
design a new bioprocessing facility
- Designers with 0-5 years bioprocessing experience wanting
to understand the subtleties of this highly regulated industry
- Vendors wishing to provide goods and services in the
biopharmaceutical industry
- Academics looking to develop skills before entering
this industrial setting
EXPERT
PANEL:
- DIRECTOR:
Marc
Pelletier, Director, Strategic Biopharm Solutions Group,
CRB Consulting Engineers
- Robert
Barloga, BioProcess Specialist, Alfa Laval
- Wayne
Herber, Assistant Vice President, Vaccine Development, Wyeth
Vaccines
- Mark
Herr, President, Stainless Technology
- Paul
Kubera, Vice President Engineering, ABEC, Inc.
- Jeffery
Mahar, Director, Cuno/3M
- Alan
Powell, Principal Engineer, Process Engineering, Merck
& Co., Inc.
- Tom
Warf, Advisor, U.S. Dept. of Health & Human Services
AGENDA
|
Monday,
10 November |
| 8:00-8:15
am |
Opening
Remarks: Course Introduction & Overview
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
8:15-10:00
am |
Introduction
to Process and Facility Design
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 will be reviewed as well as team building strategies.
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers
|
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon |
Vessel Design
The design concepts of a bioprocess vessel will be reviewed
with particular emphasis on designing for cleanability, operability
and sterilization. Design details will be provided.
- Mark
Herr, President, Stainless Technology |
|
Noon-1:00 pm |
Lunch |
|
1:00-2:00
pm |
Bioreactor
Specification and Design
Fermenter and bioreactor specification and design considerations will
be discussed in this presentation, as well as aeration, agitation
and vessel parameters.
- Paul
Kubera, Vice President, Technology, ABEC, Inc. |
|
2:00-3:00
pm |
Instrumentation
and Automation of Bioprocess Systems
SCADA, DCS, PLC, Analog control systems will be reviewed
including 21 CFR Part 11 considerations and validation.
- Tom
Warf, Advisor, U.S. Dept. of Health & Human Services |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
pm |
Validation,
Commissioning, Critical Component Impact Assessments: Integration
of the Design Process
Understanding process and project risks is critical to project
success. Several platforms used in assessing and mitigating risk will
be presented. Tools for integration of the validation/ commissioning
process into the design phase of a project are presented. Classical
and Risk based approaches to the Qualification Process will be compared.
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
Tuesday,
11 November |
|
8:00-10:00
am |
System
Infrastructure Design Considerations
Product-contact utilities including clean steam, purified water
and sterile gases must be carefully considered in bioprocess designs.
Topics include diversity factors and utility use matrices.
-
Marc Pelletier,
Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers
Engineering for Sterilization
This session will review the difficulties and design parameters
to successfully steam sterilize systems. Information will be provided
relating to the design configuration and kill correlations. Alternative
sterilization systems will be reviewed as well as validation of
the sterilization process.
- Tom
Warf, Advisor, U.S. Dept. of Health & Human Services
|
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon |
Engineering
for Cleaning in Place
The various cleaning mechanisms and effect of velocity and
chemical composition of the cleaning agents will be discussed.
- Alan
Powell, Principal Engineer, Process Engineering, Merck & Co.,
Inc. |
|
Noon-1:00 pm |
Lunch |
|
1:00-3:00
pm |
Bioreactor
Design Workshop
- Mark
Herr, President, Stainless Technology
- Paul
Kubera, Vice President Engineering, ABEC, Inc.
|
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
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.
- Alan
Powell, Principal Engineer, Process Engineering, Merck & Co.,
Inc.
- Tom Warf, Advisor,
U.S. Dept. of Health & Human Services |
| 5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November |
| 8:00-9:00
am |
BioProcess
Equipment Specification and Vendor Qualification. How to take advantage
of the ASME BPE and ISPE Baseline Guidelines.
A workshop style presentation of the baseline guidelines
and their use as tools in process and facility design.
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
9:00-10:00
am |
An
Introduction to Single Use Systems in BioProcessing
This session will provide an introduction to the use of disposables
in bioprocessing. Discussion topis include what is available? risk
evaluation, validation, impact to facility design and capital costs.
-
Marc Pelletier,
Director, Strategic Biopharm Solutions Group, CRB Consulting Engineers |
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon |
Centrifugation
The centrifuge is one of the most important post harvest process tools
used in bioprocessing. The science of sedimentation processes and
the operation, function and cleaning of the centrifuge will be discussed.
The different types of centrifuges will be presented.
-
Robert Barloga, BioProcess Specialist, Alfa Laval |
| Noon-1:00
pm |
Lunch |
| 1:00-2:00
pm |
Filtration
This session will present the different types of filtration technologies
- Tangential flow filtration, depth filtration, sterilizing, single
and multiple use, as well as qualification of the filtration process.
- Jeffery
Mahar, Director, Cuno/3M |
|
2:00-3:00
pm |
Downstream
Processing Workshop
Downstream Processing Equipment Design and Specification Workshop.
The participants will prepare specification datasheet for filtration
and centrifugation equipment.
- Jeffery
Mahar, Director, Cuno/3M
-
Robert Barloga, BioProcess Specialist, Alfa Laval |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-4:30
pm |
Downstream
Processing Workshop (Continued) |
|
4:30-5:00
pm |
Regulatory
Compliance Considerations in a Multiproduct Facility
Are all bioprocess facilities multiproduct facilities? This session
will review the cGMP’s and their impact on the facility. This
session will discuss the problems and requirements of FDA compliance
and validation as well as considerations when multi-product, pilot,
clinical or manufacturing facility is required.
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
Thursday,
13 November |
|
8:00-10:00
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. Topics also include: what to expect or
require at FAT, specification process, roller bottle technology, P&ID.
-
Wayne Herber, Assistant
Vice President, Vaccine Development, Wyeth Vaccines |
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon
|
Facility
Layout Workshop
Participants will design facilities to house the program process
-
Wayne
Herber, Assistant Vice President, Vaccine Development, Wyeth Vaccines
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
Noon-1:00 pm |
Lunch |
|
1:00-3:00
pm |
Facility
Layout Workshop (continued) |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
pm |
Facility
Layout Review
Teams will present their proposed facility designs. The audience will
appraise the facilities from a compliance, operability, flow and maintenance
standpoint.
-
Wayne
Herber, Assistant Vice President, Vaccine Development, Wyeth Vaccines
- Marc
Pelletier, Director, Strategic Biopharm Solutions Group, CRB Consulting
Engineers |
|
Friday,
14 November |
|
9:00
am - 11:00 am: Plant Tour of AMGEN-Juncos (Seats are limited.
Advance sign-up is required.) |
REGISTER
NOW! Visit www.asmeconferences.org/Bioprocess08
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. |
