Lyophilization 101: Scale-Up, Cycle Transfer, and Sonic Water Vapor Flow Training Course :

<strong>Course Schedule - February 3, 2009 at 11:00 a.m. - 12:30 p.m. (EST)</strong><br/><br/>This 90-minute <b><i>accredited</b></i> online course is designed to provide an introduction to the basic scientific principles of conducting scale-up and cycle transfer studies for freeze-dried products, in addition to understanding the causes and prevention of sonic water vapor flow (choked flow) within external condenser freeze-dryers. This course will provide insight into scaling-up a lyophilization cycle from development to production scale, transferring a lyophilization cycle to different freeze-dryers, and determining if the lyophilization cycle of interest will force the freeze-dryer into choked flow conditions resulting in failed batches.<br><br> <b><u>Module 1:</u> Scale-Up</b><br>   • Critical Parameters in Scale-Up<br>   • Developing a Scale-Up Strategy<br>   • Temperature Mapping Studies<br>   • Development Scale and Production<br>     Scale Equipment Limitations<br><br> <b><u>Module 2:</u> Cycle Transfer</b><br>   • Critical Parameters in Cycle Transfer<br>   • Developing a Cycle Transfer Strategy<br>   • Dryer Configuration<br><br> <b><u>Module 3:</u> Sonic Water Vapor Flow</b><br>   • Defining Sonic Water Vapor Flow (Choked Flow) in a <br>     Freeze-Dryer<br>   • Conditions Resulting in Forcing a Freeze-Dryer <br>     into Choked Flow<br>   • Equipment Design Characteristics to Minimize <br>     Choked Flow<br>   • Determining the Conditions for Choking Your Freeze-Dryer<br>   • Case Study in Choking a Freeze-Dryer<br><br> <b>Question and Answer Session</b>