Lyophilization Technology – Practical Application of the Scientific Principles

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COURSE DETAILS

Course Description

This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of the science and engineering behind modern freeze-drying. The practicality of the course allows the attendees to get a firm understanding of the theoretical applications of freeze-drying and how these can be easily used and applied to their day to day lyophilization projects.

Topics covered will include:

  • History of lyophilization
  • Properties of water and ice
  • Supercooling and supersaturation
  • Phase behavior during freezing
  • Thermal characterization
  • Annealing
  • Visco-elastic properties of amorphous phases
  • Collapse phenomena
  • Vacuum physics
  • Product formulation
  • Heat and mass transfer
  • Cycle development
  • End point determination
  • Residual moisture
  • Process scale-up and sonic water vapor flow
  • IQ/OQ/PQ
  • Process control and optimization
  • Fault finding and problem solving of systems and formulations
  • Freeze dryer mechanical and control systems
  • Recipe development
  • Following the process

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend

This two-day lyophilization training course is designed for those in the pharmaceutical, biomedical, medical device/diagnostic, and biotechnology industries who develop and/or produce lyophilized (freeze-dried) products. This includes, but is not limited to, professionals in Quality Control, Quality Assurance, Validation, Pharmacists, Managers, Microbiologists, R&D Groups, Biochemists, Pilot Plant Operators, Chemical Engineers, Production Supervisors, Chemists, Equipment Maintenance, and Mechanical Engineers. The course will also benefit those in other departments who find lyophilization among their responsibilities.

Learning Objectives

Upon completion of this course, attendees will have a clear understanding of both the scientific and practical principles behind the formulation and development of lyophilized products. Additionally, participants will gain a firm understanding of lyophilization equipment including system operation, system components, system maintenance, system troubleshooting, IQ/OQ, and system validation. Attendees will also gain practical experience in applying what they have learned by working through several case studies in failed products and cycles. This course is presented in a very practical manner, so attendees will be able to quickly apply what they have learned to their lyophilization projects.

Past Participants' Comments

"The lyophilization training course has great technical and very informative material to understand the science behind lyophilization process and the potential problems that may occur during production." Ella H., QA Manager, Gilead Sciences
"The Course Director was very knowledgeable and his real life experiences made the course that much better. He knows what he is talking about!" Kevin D., Director of Manufacturing, J&J
"Since I don’t operate the machines or design product cycles I came to this course not knowing what to expect. The result of the course and discussions with instructors and attendees has given me the inspiration to become involved with the freeze-drying processes at my company in the future. The discussions not only gave technical information but brought the processes to my level of interest." Dan M., Bioreagents Technologist, Instrumentation Laboratory
"This was a very good review/introduction to lyophilization. I didn’t have much background in any of this when I arrived, but now I feel like I can begin to ask the right questions and to focus on our particular application of freeze drying." John C., Bioreagent Technologist, Instrumentation Laboratory

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