Freeze-Drying Fundamentals

This course must be taught at a BioNetwork location.

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Freeze-Drying Fundamentals
Level: Intermediate
Lecture Hours: 10.00
Lab Hours: 10.00
Total Contact Hours: 20.00

Description

Learn the principles and techniques of manufacturing lyophilized biopharmaceutical products. Biologics, vaccines, and other pharmaceutical ingredients may require freeze-drying and moisture analysis for product stabilization and long-term storage. This course gives you a theoretical foundation and practical experience in lyophilization.

Topics Include

The course is 20 hours, conducted in two 8-hour sessions and one 4-hour session on the third day and covers:

  • Principles of lyophilization: primary drying, secondary drying, eutectic points, and collapse temperatures
  • Lyophilization cycle set up and operation
  • Thermal analysis of product formulations using Differential Scanning Calorimetry (DSC) and Freeze-Drying Microscopy
  • Residual moisture content analysis of finished product
  • Troubleshooting lyophilization failures

Learning Objectives

  • Discuss the principles and theory underlying lyophilization
  • Perform freeze-dryer cycle development
  • Relate product formulations to freeze-drying success
  • Troubleshoot freeze-dried product failures

Audience

Technicians in pharmaceutical manufacturing including:

  • Lyophilization specialists
  • Validation Engineers
  • Process Technicians
  • Production Technicians
  • Quality Control/Quality Assurance personnel