| Description
The BioProcessing Industry has seen an increased interest in the use of
Single Use Systems. Mixing technologies and instrumentation have improved
with innovations in design and fabrication. This course is a comprehensive
introduction to the current single use bioprocess options that are available.
We will present factors that influence the selection, design, specification
and qualification of single use bioprocessing equipment. Disposable bioreactors,
single use downstream equipment, industry standards, materials of construction
will be topics of discussion. A Workshop that provides the opportunity
to compare the implementation and design considerations of a facility
using single use systems with that of a traditional stainless steel magnolia
will close the session. The workshop will address economic, regulatory
and risk considerations. The courses are presented by designers and owner/users
who have real life experiences to share with their audience.
What you will Learn
- Where
single use systems are currently used
- Innovations
in construction and design
- Industry
standards
- Sanitization
Considerations
- The cost
and risk impact of single use systems in bioprocessing and facility
design
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 risks
and cost implications of a disposable processing design
- 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
- Jeffrey
Mahar, Director, Healthcare, CUNO/3M
- Jerold
Martin, Senior VP, Scientific Affairs, Pall Life Sciences
- Dan
Klees,
Endress and Hauser
- Jim
Weidner, Director, Process Engineering, Amgen
- Geoff
Hodge, Vice President, Xcellerex
- Mathew
Kennedy, Process Engineer, CRB Consulting Engineers
- Phil
Lyman, Director, CRB Consulting Group
AGENDA
|
Wednesday,
12 November
|
|
8:00-8:15
am
|
Opening
Remarks - Overview and Introduction
- Marc Pelletier, Director,
Strategic Biopharm Solutions Group, CRB Consulting Engineers |
|
8:15-10:00
am
|
Where
can single use systems be used?
Almost all unit operations used in bioprocessing now have a single
use system option. This session will present an introduction to the
systems currently found in bioprocessing today including media and
buffer prep, cell culture, filtration and chromatography systems.
- Marc Pelletier, Director, Strategic
Biopharm Solutions Group, CRB Consulting Engineers
- Jeff Mahar, Director, Healthcare, CUNO/3M
|
|
10:00-10:30
am
|
Coffee
Break |
|
10:30-11:15
|
Instrumentation
used in single use systems
The instruments used yesterday, today and tomorrow are
presented in this comprehensive study.
- Dan Klees, Endress and Hauser
|
|
11:15-Noon
|
Best
Practice Guides to Quality Tests, Irradiation and Sterilization,
Extractables and Leachables and Disposal of Single Use Systems
This
session will discuss best practice recommendations for single use
components and systems as developed by the BioProcess Systems Alliance
(BPSA), an organization of disposable equipment component, system
and service providers. 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. Similarly, the extent of extractables
and leachables testing can be limited within a risk-based approach
to be described.
Also covered will be an overview of quality tests and various methods
of disposal, along with discussion of environmental impact assessment.
-
Jerold Martin, Senior VP, Scientific Affairs, Pall Life Sciences
|
|
Noon-1:00 pm
|
Lunch |
|
1:00-3:00
pm
|
CONT'D.
- Best
Practice Guides to Quality Tests, Irradiation and Sterilization,
Extractables and Leachables and Disposal of Single Use Systems
Workshop
on design and assembly of single use filtration systems
In this workshop, participants will take part on a team assigned
a process to which a single use system will be applied. Teams will
establish the user requirement specifications (URS) for the process,
prepare a drawing of their system design, assemble a system and
present the details of the design and operation of system as a team
using their drawings and assembly.
-
Jerold Martin, Senior VP, Scientific Affairs, Pall Life Sciences
|
|
3:00-3:30
pm
|
BREAK;
coffee/refreshments |
|
3:30-4:15
pm
|
The
Flex Factory
Speed to market, Capital cost expenditures, Undeveloped processes,
cleaning and process validation are all reasons to consider single
use systems in your design program. This session will present an overview
of considerations and comparisons in developing a process using single
use systems vs the traditional stainless steel equipment.
- Geoff Hodge, Vice President, Xcellerex
|
|
4:15-5:00
pm
|
Holistic
approach of evaluating single use systems for a commercial process
This session will examine a holistic approach for evaluating filters
and other single use systems for a commercial process. Topics include
evaluating appropriate shelf lives and extending expiries for disposables;
Qualification of backup suppliers for disposable filters post-commercial
launch; and case studies for non-conformance responses and results
of corrective actions with a focus on mechanical and operational
root causes.
-
Jim Weidner, Director, Process Engineering, Amgen
|
|
Thursday,
13 November
|
|
8:00-9:00
am
|
Case
Studies: Stainless Steel vs Disposable
Product-contact utilities including clean steam, purified water and
sterile gases must be carefully considered in bioprocess designs.
Diversity factors will be discussed as well as utility use matrices.
- Mathew Kennedy, Process Engineer,
CRB Consulting Engineers |
|
9:00-10:00
am
|
Introduction
to Process Modeling
Effective modeling of your bioprocess can reveal design issues and
process bottlenecks. This session will present some standard process
modeling tools and techniques. Cost of goods analysis, debottlenecking,
resource management, will be discussed.
- Phil Lyman, Director, CRB Consulting
Group
|
|
10:00-10:30
am
|
Coffee
Break |
|
10:30-Noon
|
Introduction
to Facility Design
A methodology or approach to conceptual design is presented. Discussion
topics include team building, process definitions, and compliance
considerations.
-
Marc Pelletier, Director, Strategic Biopharm Solutions Group,
CRB Consulting Engineers
|
|
Noon-1:00
pm
|
Lunch |
|
1:00-3:00
pm
|
Facility
Design Workshop
Interactive workshop where participants will develop various cleaning
mechanisms. Effect of velocity and chemical composition of the cleaning
agents is reviewed.
- Facilitators: Marc Pelletier and
Phil Lyman |
|
3:00-3:30
pm
|
BREAK;
coffee/refreshments |
|
3:30-5:00
pm
|
CONT'D.
- Facility Design Workshop
|
|
Friday,
14 November
|
|
9:00 -
11:00: Plant Tour of Amgen-Juncos (Seats are limited. Advance sign-up
is required.) |
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.
|
