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 considerations, and related facility and regulatory compliance issues. Sessions 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 seminar will also discuss technology trend such as barrier isolator technology and their impact on the facility design and daily operation.

Participants will learn how to:

• Apply the appropriate aseptic processing technology
  
• Choose between isolators and RABs
  
• Implement aseptic processing risk assessment
  
• Define the underlying processing expectations
  
• Learn the relevant engineering principles for aseptic processing
  
• Understand applicable sterilization, sanitation and decontamination concepts
  
• Review current and future designs for aseptic processing
  
• Master the key validation concepts
  
• Follow the latest regulatory trends in aseptic processing
  
• Develop an appropriate environmental monitoring program
  
• Avoid errors in design and implementation
  

Who Should Attend
This seminar 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.

EXPERT PANEL:

• DIRECTOR: Wei Huang, VP, Process Development and Engineering, LS9, Inc.
• Douglas Stockdale, President, Stockdale Associates, Inc.
  
• Steve Chew, Director, Baxter Healthcare
  
• Manuel Del Valle, Title Technical Director, Fluor Corporation
  
• Dr. Michael Pikal, Professor of Pharmaceutical Science, University of Connecticut
  
• Mike Stella, Sales Development Manager, BOC Edwards
  
• Matt Hofacre, Director Customer Applications Management, Sterris Corporation
  
  
  

AGENDA

             REGISTER NOW! Visit www.asmeconferences.org/Bioprocess08

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