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Description
This seminar will discuss the basic aseptic fill and finish theory for
biopharmaceuticals. It will cover typical unit operation for aseptic fill
and finish, associated equipment design, various operational consideration,
related facility and regulatory compliance issues. Key operations such
as sterilization, filling and lyophilization, will be discussed, as well
as other considerations related to aseptic filling and finishing operation
such as HVAC design, and process analytical technology. The seminar will
also discuss technology trend such as barrier isolator and restricted
access barrier and their impact on the facility design and daily operation.
Discussion Topics
- Basic
theory behind the aseptic fill and finish unit operation
- Typical
unit operations associated with aseptic filling and finish operation
- HVAC
and facility design consideration for a parental fill and finish facility
- Common
design concerns associated with fill and finish equipment
- Network
with industry peers, share knowledge and experience
Who
Should Attend
This course should be useful for process engineers, process development
engineer, formulation scientists, validation engineers, project managers,
and manufacturing technicians, with 0-4 yrs of experience in process development,
research, engineering, validation, manufacturing, etc.
Instructor/Speaker
Panel
- Seminar
Director: Wei Huang, Director of Process Engineering, Fluor Corp
- Steve
Chew, Director, Quality, Baxter
- Manuel
del Valle, Technical Director, Fluor Corp
- Matt Hofacre,
Director, Customer Applications Management, Sterris
- Eric Isberg,
Product Manager, Bosch Packaging Technology
- Mike Stella,
Manager, Process Training, BOC Edwards
SCHEDULE
|
Monday,
25
June 2008
|
| 7:30
am - 5:00 pm |
Registration
Desk Open |
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 10:00 am |
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. |
Wei
Huang
Director of Process Engineering, Fluor
Corp.
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - 12:00 noon |
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.
|
| 12
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 3:00 pm |
HVAC
Design Consideration for Fill and Finish Facility
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. |
|
| 3:00
pm - 3:30 pm |
Refreshment
Break |
| 3:30
pm - 5:30 pm |
Environmental
Monitoring and Control
- Basic Microbiology and Use of Data
- Considerations and Practical Applications
- Aseptic Gowning Practices for Cleanrooms |
|
|
Tuesday,
24
June 2008
|
| 7:30
am - 8:00 am |
Coffee
& Pastries |
| 8:00
am - 10:00 am |
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.
|
|
| 10:00
am - 10:30 am |
Refreshment
Break in Exhibits Hall |
| 10:30
am - 12 Noon |
Biopharmaceutical
Product Packaging Design |
|
| 12
Noon - 1:00 pm |
Lunch
w/
Exhibitors |
| 1:00
pm - 3:00 pm |
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,
Sterris Corporation
|
| 3:00
pm - 3:30 pm |
Refreshment
Break in Exhibits Hall |
| 3:30
pm - 5:00 pm |
Process
Simulation (Media Fill) |
|
| 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 BPE (BioProcessing Equipment) International Standard
|
| 9:30
am - 3:00 pm |
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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