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The BioProcessing Industry has seen an increased interest
in and use of Single-Use Systems. The mixing technologies and instrumentation
have improved with innovations in design and fabrication. This seminar
is a comprehensive introduction of the current single-use bioprocess options
that are available. It will also present factors that influence the selection,
design, specification and qualification of single use bioprocessing equipment.
Topics include: upstream and downstream equipment, industry standards,
materials of construction with key discussions in economics and implementation.
A roundtable discussion on future directions and end-user concerns will
close the session.
Discussion
topics include
- Current
innovations in single use system and isolation technology
- Design
considerations for introduction of single use systems into a bioprocess
- Validation
and testing of single use systems
- Current
applications using disposable systems
- Economics
of single use systems
Who
Should Attend
Engineers, Scientists, Quality and Validation Specialists working in a
Biopharmaceutical Manufacturing environment. Those involved in process
development, facility design and process validation will also benefit
from this presentation.
Instructor/Speaker
Panel
- Seminar Director: Marc Pelletier, Director, Strategic Biopharm Solutions Group,
CRB Consulting Engineers
- Reinhard
Hanselka, Principal Chemical Engineer, Integrated Engineering Services
- Dan Klees,
Sr. Industries Manager, Life Sciences, Endress &Hauser, Inc.
- Jeffrey
Mahar, Director, Healthcare, CUNO/3M Company
- Jerold
Martin, BioProcess Systems Alliance (BPSA)
- Myriam
Monge, Industry Consultant
- Helene
Pora, PhD, Global Marketing Director, Pall Life Sciences
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 |
Introductions
and Overview |
Marc
Pelletier
Director, Strategic Biopharm Solutions
SBSG, CRB Consulting Engineers
|
| 8:15
am - 10:00 am |
Use
of Disposables in Bioprocessing: Upstream and Downstream
Almost
all unit operations used in bioprocessing now have a single use
system option. An introduction to the systems currently found in
bioprocessing today including media and buffer prep, cell culture,
filtration and chromatography systems.
|
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - 11:30 am |
Instrumentation
used in Single-use Systems
The instruments used yesterday, today and
tomorrow are presented in this comprehensive study. |
|
| 11:30
am - 12:00 noon |
Materials
used in BioProcess Single-use Systems
The different materials used in single use
systems are presented. A presentation of the ASME BPE standards for
polymers |
|
| 12
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
cont'd.
- Materials used in BioProcess Single-use Systems
The different materials used in single use
systems are presented. A presentation of the ASME BPE standards for
polymers |
|
| 2:00
pm - 3:00 pm |
An
Approach to Extractables/Leachables Studies from Integrated Single
Use Systems
As single-use technology is evolving, it tends
to be used in more complex applications and particularly in formulation
and filling applications. However, more than their stainless steel
counterparts, single-use systems draw concerns about extractables
and leachables from organic-based plastics and elastomers from which
some compounds may migrate to finished products. Therefore, it is
imperative to develop suitable and convenient methods to study extractables/leachables
from single-use systems in order to address regulatory requirements.
This
session will present a systematic study of extractables from single-use
systems into water and ethanol via novel concepts, practical design,
and analytical detection using advanced techniques.
|
Helene
Pora, PhD
Global Marketing Director
Pall Life Sciences
|
| 3:00
pm - 3:30 pm |
Refreshment
Break |
| 3:30
pm - 5:30 pm |
Vendor
and Technology Selection Standards: Key Points to Consider
As single-use technologies gain wider acceptance
in the pharmaceutical and biotech industries, both the complexity
of disposable systems is increasing and these systems are being increasingly
used in critical applications. Consequently, it is essential that
the relationship between the supplier and the end user goes beyond
a simple purchasing relationship to ensure ongoing successful implementation
of single use technologies, especially in critical applications under
GMP. |
Miriam
Monge
Industry
Consultant
Helene
Pora
Global
Marketing Director
Pall Life Sciences
|
|
TUESDAY,
24
JUNE 2008
|
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 9:00 am |
Irradiation,
Sterilization and Disposal of Single-use Systems
This presentation will provide an overview
of best practice recommendations and standards for irradiation and
sterilization validation of single-use components and systems developed
by the Technology Committee of the BioProcess Systems Alliance (BPSA).
As validation of sterilization can represent a significant cost burden
to single use systems, rationales for selection of where bioburden
control or sterilization should be specified, along with suggestions
for evaluating product bioburden and sterility will be discussed.
Also covered will be an overview of disposal issues for single use
versus cleanable reusable systems and discussion of incorporating
disposal costs in economic impact analyses.
|
Jerold
Martin
Sr.
Vice President, Global Scientific Affairs
Pall Life Sciences
|
| 9:00
am - 10:00 am |
Towards
simpler multi-product facilities: The impact of single-use technologies
Single-use technologies have revolutionized
our approach to facility design over the past 10 years - this session
will illustrate their impact on facility design & project implementation.
The talk will work through the key points to consider, and the change
in mindset required to maximise the benefit of single-use technologies.
A series of end-user case studies will be used to illustrate the different
points.
|
|
| 10:00
am - 10:30 am |
Refreshments
Break in Exhibits Hall |
| 10:30
am - 12:00 noon |
CASE
STUDY: Disposable or Steel Magnolia?
A detailed conceptual study comparing the
single use disposable factory to a traditional stainless steel facility.
New vs. Retrofit considerations. Scale considerations. Economic review.
|
|
| 12
Noon - 1:00 pm |
Lunch
w/
Exhibitors |
| 1:00
pm - 2:00 pm |
The
process Economics of single-use systems
Exploration
of techniques used to evaluate the cost impact of single-use technologies
will be discussed. Which technologies have the biggest impact? What
tools are available to determine the best fit of single-use &
stainless steel systems? Insight into a Universal mAb cost model
decision making tool will be provided. The presentation will bring
in end-user experience to illustrate how they have used cost modelling
as part of the decision making process.
|
|
| 2:00
pm - 3:00 pm |
Component
Quality Test Methods and Determination of Extractables from Single-use
Process Fluid Contact Equipment
This presentation will review the consensus of component quality test
methods recognized by single use component manufacturers to support
suitability of use in biopharmaceutical GMP manufacturing. Also discussed
will be the requirements and basic principles of extractables testing
of single use process fluid-contact equipment, sourcing extractables
test data from component suppliers, how to assess applicability to
specific processes, and discussion of when and how additional extractables
data should be generated. |
Jerold
Martin
Sr.
Vice President, Global Scientific Affairs
Pall Life Sciences
|
| 3:00
pm - 3:30 pm |
Refreshment
Break in Exhibits Hall |
| 3:30
pm - 5:00 pm |
PANEL
ROUNDTABLE DISCUSSION
An
audience-interactive panel discussion to summarize the state of the
industry and to discuss the needs for the future. |
|
| 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 BioProcessing Equipment (BPE) 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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