Lyophilization 101: Scale-Up, Cycle Transfer, and Sonic Water Vapor Flow
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Who Should Attend
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries including:
• Biochemists/Chemists
• Pharmacists
• Production Supervisors
• Chemical Engineers
• R&D personnel
• QA/QC professionals
• Microbiologists
• Pilot Plant Operations
• Managers
Description
This 90-minute accredited 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.
Module 1: Scale-Up
• Critical Parameters in Scale-Up
• Developing a Scale-Up Strategy
• Temperature Mapping Studies
• Development Scale and Production
Scale Equipment Limitations
Module 2: Cycle Transfer
• Critical Parameters in Cycle Transfer
• Developing a Cycle Transfer Strategy
• Dryer Configuration
Module 3: Sonic Water Vapor Flow
• Defining Sonic Water Vapor Flow (Choked Flow) in a
Freeze-Dryer
• Conditions Resulting in Forcing a Freeze-Dryer
into Choked Flow
• Equipment Design Characteristics to Minimize
Choked Flow
• Determining the Conditions for Choking Your Freeze-Dryer
• Case Study in Choking a Freeze-Dryer
Question and Answer Session
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