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凍結乾燥に関する会議 - 1日目
概要 |
1日目 |
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3日目
アジェンダ (英語PDF)
DAY
ONE
Pre-Conference Workshops * Wednesday,
January 9, 2008
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7:30am-12:15pm
Elements of a High
Quality Aseptic Filling Program |
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Robert J. Pallo, BA, MAM, Manager, PSO Fill and Finish Operations, Allergan |
Developing a good
quality aseptic program at your facility
may appear to be a daunting enterprise.
Regulations are tightening, and the
ability to run an aseptic operation in a
quality manner while maintaining
efficiency is often looked upon as
difficult. However, utilization of
effective quality practices can actually
provide an appreciable improvement in
efficiency as well. This session will
discuss the basic elements of a high
quality aseptic program. The discussions
will include a review of efficient batch
record generation, facility disinfection,
gowning, autoclaving, and cleanroom
behavior. Attendance at this seminar will
inform the audience on high quality and
effective ways to perform each of the
following:
- How to create good, clear batch
records, and their importance to the
quality process
- How to train for the gowning process
- How to train for clean room behavior
- How to efficiently sterilize
disinfection tools and materials
- How to efficiently sterilize machine
parts
- How to develop the zero-failure mind
set
*Separate Registration
Required |
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1:00-6:00pm
Lyophilization Fundamentals - Understanding the Basic Concepts: Product and Processes |
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Edward H. Trappler, President and Founder, Lyophilization Technology, Inc. |
Insight into the
lyophilization process is rooted in
understanding the basic concepts,
underlying theories, as well as mechanism
for each process step. Using an example of
a lyophilization cycle, discussions will
entail an overview of the parameters and
conditions for freezing, primary and
secondary drying along with a focus on the
underlying principles. These discussions
will address each step of the process
separately as well as integrated parts of
the process. Real world examples to
illustrate the concepts will be included.
This workshop is designed to introduce the
fundamental aspects of lyophilization and
provide an understanding of the critical
aspects. The information to be presented
is intended as an introduction for those
having a beginning interest as well as a
refresher for the more experienced. An
informal and interactive forum, attendees
will be able to participate in the
discussions on:
-
Principles and
mechanism
- Critical and key process parameters
- Interdependence of the process steps
- Influences of the process on the
product
- Product attributes - formulation
and process factors
*Separate Registration
Required |
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