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This
course is now available on CD-ROM. To purchase, please call 800-843-2763.
PD578: Aseptic Fill and Finish for Biopharmaceuticals
This comprehensive training course will deal with the complex and
critical issues that fill and finish facility design and operation
must address today. This program was designed after research with
industry experts and delegates and will address your most pressing
business concerns and opportunities. Our distinguished speakers bring
in more than 200 years of industry and academic experience collectively.
A step-by-step overview of aseptic fill-finish requirements will be
reviewed. You will learn about basic theory, process development activities,
and related facility and regulatory compliance requirements. Key unit
operations, such as sterilization, filling and lyophilization, etc.
will be discussed. Other considerations related to aseptic fill and
finishing operation, such as HVAC design, environmental monitoring,
process simulation, and process analytical technology will be examined
in great detail. Technology trends such as barrier isolator technology,
disposable technology, and their impact on the facility design and
daily operation will be explored.
This course brings you case studies and best practices detailing proven
strategies to help optimize your aseptic processes.
What you will learn:
1. Understanding of the basic theory behind the aseptic fill and finish
unit operation
2. Typical unit operations associated with aseptic fill and finish
operation
3. Gain HVAC and facility design consideration for a parental fill
and finish facility
4. Understanding of common design concerns associated with fill and
finish equipment
5. Environmental monitoring, process validation and case study for
aseptic fill
6. Identify high-speed aseptic fill-finish design and operations to
reduce filling time
7. How to conduct media fill and process simulation
8. Determine sterilization qualification of components for aseptic
fill-finish to ensure most accurate results
9. Implementing best practices for aseptic filling and sharing best
practices techniques
10. Determine essential characteristics of barrier isolation technology
for your aseptic filling facility
11. Understand and identify the sterilization operation to improve
your aseptic processes
12. Technology qualification and process validation
13. Gain knowledge of proven methodology of effective fill and finish
facility design
14. Catch up on industry trends on PAT, barrier isolator and disposable
technology
Who Should
Attend?
This course should be useful for process engineers, formulation scientists,
validation engineers, project managers, manufacturing technicians,
or chemists with 0-4 yrs of experience in process development, research,
engineering, validation, manufacturing, etc.
Schedule
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Sunday,
October 22, 2006
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| 5:00
pm - 8:30 pm |
Registration Open - Avoid the lines on Monday! |
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Monday, October 23, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
| 4:30
pm - 5:30 pm |
KEYNOTE
Presentation |
| 5:30
pm - 7:00 pm |
Opening
Reception w/ Exhibitors |
|
Tuesday,
October 24, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
|
8:30
am - 10:00 am
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Overview
of Fill and Finish Operations
This session will provide a comprehensive overview
of the aseptic fill/finish manufacturing process. Principal systems
that define the aseptic fill/finish process: drug product, facilities
& equipment, sterile components, and personnel will be addressed.
FDA Sterile Manufacturing Guidance will be examined in more detail
in the context of the regulatory guidance for producing aseptic
drugs. Process validation of aseptic processing and requirements
of media simulations will also be discussed in detail. |
|
|
10:00
am - 10:30 am
|
Refreshment
Break |
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10:30
am - 12:00 noon
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Cold
Chain Management
Most of biopharmaceuticals are temperature
sensitive materials. Environmental maintenance during product
shipping and distribution become an increasing concern within
the industry. This session will teach how to define product distribution
requirements for different products, understand basic packaging
and distribution design and their implementation, how to develop
and qualify control and monitoring systems suitable for cold chain
supply. |
|
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12:00
noon - 1:00 pm
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Lunch |
|
1:00
pm - 2:30 pm
|
Design
of Parental Fill and Finish Facility
The design of a parental fill and finish facility
can be a long and complex task. A step by step overview of the
evolution of a conceptual design of fill and finish facility will
be presented. A proven methodology of developing project assumptions
and major process design issues will be discussed to illustrate
how to include options for flexibility, how to integrate user
and designer expectations and resolutions. The process and documents
needed for a systematic, well-established approach to the conceptual
design of the parental fill & finish facility will also be
discussed.
|
Wei
Huang
Director of Process Engineering Fluor Corp.
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|
2:30
pm - 3:00 pm
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Refreshment
Break |
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3:00
pm - 4:30 pm
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Isolator
and Barrier Technology
The industry has seen increasing growth in
the use of isolator and barrier technology for the aseptic filling
operation. An overview of the isolator and barrier technology,
the history, implementation statistics, general parameters and
design features will be provided. The benefits and limitation
of implementing isolators for filling operation will be addressed.
The characteristics and differences of barrier vs. isolator system
will be discussed in detail, including the HVAC, product transport,
operation, maintenance, cleaning and sterilization, etc. |
Wei
Huang
Director of Process Engineering Fluor Corp.
|
|
Wednesday,
October, 25, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
| 8:30
am - 10:00 am |
HVAC
Design Consideration for Fill and Finish Facility - I
The need of clean rooms for aseptic processing
areas of biopharmaceutical facilities will be defined in this
session. How to ensure compliance with the global standard (ISO
14644-1) that defines clean rooms and US and European Commissions
Good Manufacturing Practices for aseptic processing areas. The
difference between ISO, EU, 209E, FDA guideline on the environmental
requirement for clean room design will be discussed in detail.
The way in which HVAC systems are applied to maintain required
cleanliness in the aseptic processing areas in compliance with
the cGMPs in a Fill/Finish facility will be addressed. A case
study of a fill and finish facility will be presented to illustrate
the HVAC design. |
|
|
10:00
am - 10:30 am
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Refreshment
Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
HVAC
Design Consideration for Fill and Finish Facility - II
Continuation of HVAC Design Consideration for Fill
and Finish Facility - I |
|
|
12:00
noon - 1:00 pm
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Lunch
w/ Exhibitors |
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1:00
pm - 2:30 pm
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Environmental
Monitoring and Control
This session describes the basics of aseptic microbiology
for aseptic processing. The speaker will address how to establish
a compliant environmental monitoring program for quality control,
which is extremely important in aseptic processing. The identification
and characterization of microorganisms using microbiological identification
methods and validation of microbiological test procedures during
process simulation will be discussed. Understand the FDA's current
microbiology guidelines and trends as well as cGMP testing requirements.
This session also teaches microbiological control methods for
pharmaceutical and biotechnology clean room manufacturing.
|
|
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2:30
pm - 3:00 pm
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Refreshment
Break w/ Exhibitors |
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3:00
pm - 4:30 pm
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Aseptic
Filling for Biopharmaceuticals
An
overview of aseptic filling system design and operation will
be presented. Different filling technology, such as time pressure
filling, rotary valve piston pumps, rolling diaphragm pump,
mass flow filling and peristaltic pumps will be explained. Case
studies will be discussed as to their suitability for various
products as well as pros and cons for each technology. Design
consideration for nested syringe filling, high speed filling,
micro-dosing, system cleaning, product change over, inert gas
overlay, etc. will be discussed. Detailed description of mechanical
design, as well as operational pros and cons of various design
options, such as the use of disposables and special product
handling will also be discussed.
|
Eric
Isberg
Product Manager,
Robert Bosch Packaging Technology, Inc.
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Thursday,
October 26, 2006
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| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
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8:30
am -10:00 am
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Lyophilization
Technology
This session is designed to provide attendees with
an up-to-date understanding of the basic theory and practice of
lyophilization. Topics covered will include vacuum physics, phase
behavior during freezing, glassy state behavior, collapse phenomena,
desorption phenomena, product formulation, heat and mass transfer,
development of freeze-drying cycles, end point determination,
residual moisture, product stability, process scale-up, process
control and optimization, and validation. Case studies will be
presented to emphasize the discussion topics. Process analytical
technology (PAT) as it relates to lyophilization technology will
also be discussed.
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Dr.
Michael Pikal
Professor,
University of Connecticut and
Pfizer Distinguished Chair in Pharmaceutical Technology
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10:00
am - 10:30 am
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Refreshment Break |
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10:30
am - 12:00 noon
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Lyophilization
Technology II
This session is designed to provide attendees
with an up-to-date understanding of the basic theory and practice
of lyophilization. Topics covered will include vacuum physics,
phase behavior during freezing, glassy state behavior, collapse
phenomena, desorption phenomena, product formulation, heat and
mass transfer, development of freeze-drying cycles, end point
determination, residual moisture, product stability, process
scale-up, process control and optimization, and validation.
Case studies will be presented to emphasize the discussion topics.
Process analytical technology (PAT) as it relates to lyophilization
technology will also be discussed.
|
Dr.
Michael Pikal
Professor
University of Connecticut and
Pfizer Distinguished Chair in Pharmaceutical Technology
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12:00
noon - 1:00 pm
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Lunch |
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1:00
pm - 2:30 pm
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Freeze
Dryer and Loading System Design
A detailed
discussion on the freeze dryer mechanical design and operational
consideration will be presented. Topics include how to size the
freeze dryer capacity appropriately, different types of cooling
system design and their pros and cons, general equipment lay-out,
freezer chamber design, main-door & slot-door design, condenser,
cleaning validation, shelf stack assembly and stoppering system.
Multiple freezer loading mechanism design and their impact on
facility design and operations will also be illustrated with both
detailed discussion and case studies. |
|
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2:30
pm - 3:00 pm
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Refreshment
Break |
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3:00
pm - 4:00 pm
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Sterilization
Technology for Aseptic Filling Operation
Basic
theory of low and high temperature sterilization technology for
aseptic operation will be provided. Attendees will learn about
basic sterilization concepts (such as D-value, Fo, and thermometric
properties) and steam sterilizer cycle types and how they apply
to different products. Steam sterilizer design and layout consideration
and cycle development and validation will be addressed. Low temperature
hydrogen peroxide process description and its use in isolators
and room decontamination will also be discussed. |
Matt
Hofacre
Director Customer Applications Management
STERIS Corporation
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4:00
pm - 5:30 pm
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PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
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Friday,
October 27, 2006
|
|
9:00
am - 10:30 am
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PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
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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