|
Date:
October 2-4, 2007, (Tuesday-Thursday)
CEUs: 2.25
Description
This
seminar will teach 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.
The program
will discuss some key operations, such as sterilization, filling and
lyophilization, etc. Other considerations related aseptic filling
and finishing operation, such as HVAC design, environmental monitoring
and control and process analytical technology will also be reviewed.
The program will also discuss technology trend such as barrier isolator
technology and their impact on the facility design and daily operation.
This
seminar brings you case studies and best practices detailing proven
strategies to help optimize your aseptic processes.
What
You Will Learn
- 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
- Environmental
monitoring, process validation and case study for aseptic fill
- Network
with industry peers, share knowledge and experience
Who
Should Attend
This course should be useful for process engineers, formulation scientists,
QA/QC specialist, validation engineers, project managers, manufacturing
technicians, or chemists with 0-4 yrs of experience in process development,
research, engineering, validation, manufacturing, etc.
Schedule
|
Monday, October 1, 2007 |
| 7:30
am - 5:00 pm |
Registration Desk Open |
| 5:00
pm - 6:00 pm |
Networking
Hour |
| Tuesday,
October 2, 2007 |
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast |
| 8:30
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. |
|
| 10:00
am - 11:00 am |
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. |
|
| 11:00
am - 11:15 am |
Refreshment
Break |
| 11:15
am - 12:00 noon |
KEYNOTE |
| 12:00
noon - 1:00 pm |
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.
|
| 2:30
pm - 3:00 pm |
Refreshment
Break |
| 3:00
pm - 5:00 pm |
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.
|
| 5:00
pm - 7:00 pm |
Opening
Reception with Exhibitors |
| Wednesday,
October 3, 2007 |
| 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. |
Mark
Hannon
Senior Manager
Process and Plant Engineering
Genentech
|
| 10:00
am - 10:30 am |
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 |
Mark
Hannon
Senior Manager
Process and Plant Engineering
Genentech
|
| 12:00
noon - 1:00 pm |
Lunch
w/ Exhibitors |
|
1:00
pm - 2:30 pm |
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.
|
|
| 2:30
pm - 3:00 pm |
Refreshment
Break w/ Exhibitors |
| 3:00
pm - 4:30 pm |
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
|
| Thursday,
October 4, 2007 |
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast w/ Exhibitors |
| 8:30
am -10:00 am |
Lyophilization
Technology I
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
|
| 10:00
am - 10:30 am |
Refreshment Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
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
|
| 12:00
noon - 1:00 pm |
Lunch
w/ Exhibitors |
| 1:00
pm - 2:30 pm |
Freeze
Dryer 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. |
|
| 2:30
pm - 3:00 pm |
Refreshment
Break |
| 3:00
pm - 5:00 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
STERIS Corporation
|
| 5:00
pm - 6:00 pm |
Networking Hour |
| Friday,
October 5, 2007 |
| 9:00
pm - 10:30 pm |
PLANT TOUR - Genentech Oceanside (Advance sign-up 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.
|
