Upcoming Dates

April 08, 2019 to April 10, 2019

Pricing: $2995 | Instructor: Ruben J. Nieblas, Gregory A. Sacha, Ph.D.
8:00AM - 5:00PM
8:00AM - 5:00PM
8:00AM - 12:00PM

Are you interested in this course, but it is either not offered or not at a time that works with your schedule?

You will be contacted once this course becomes available.

Course Details

Course Outline

Day One:
The first day of the workshop focuses on formulation development with the goal of freeze drying samples by the end of the day. Model molecules are provided to the working groups and each group determines the data needed to support formulation and process development. Their direction is aided by lectures on the selection of possible excipients and thermal analysis. The formulation is needed by the end of the day to provide samples for an initial test cycle.

Day Two:
The focus of the second day is gathering data to support optimization of the lyophilization cycle. The groups will examine their formulations using differential scanning calorimetry and freeze-dry microscopy. Lectures on the lyophilization process, lyophilizer design, and process monitoring will aid the groups in analysis of in-process data and understanding the effect of thermal behavior of the formulation on design of the lyophilization cycle. A second lyophilization cycle will be started by the end of the day and using parameters that support an optimized cycle. 

Day Three:
Day three will conclude with evaluation of the samples and in-process data from both cycles. Lectures on product testing and advances in lyophilization will provide the groups with ideas for future experiments, testing, and factors affecting the quality of the product.

What You Will Learn
  • Basics of freeze drying
  • Physical properties of materials
  • Materials characterization techniques
  • Basics of freezing, annealing, and primary and secondary drying
  • Residual moisture testing
  • Lyophilization cycle development
Student Learning Resources
  • Detailed course manual and instrument data sheets
  • Millrock MicroFD
  • McCrone Freeze Dry Microscope System
  • Mettler-Toledo differential scanning calorimeter
  • Arizona Instrument Computrac Vapor Pro XL (Residual Moisture Testing)
  • JEOL JCM6000Plus NeoScope benchtop scanning electron microscope
  • Coaching and discussions with experts in research and development, and instrumentation
Satisfactory Completion Requirements

Students are expected to successfully complete a variety of tasks in the form of hands-on exercises, laboratory exercises, identifications of unknowns, and quizzes. Students are notified at the end of the course whether or not they have successfully completed the requirements of the course based on:

  • 100% Attendance
  • Class participation
  • Completion of all course material
  • Completed and signed student evaluation form

Upon successfully meeting these requirements, a student is awarded a certificate of completion and CEU credits, if available. Those who have not successfully passed the course requirements do not receive a certificate or CEU credits.

Who Should Enroll

Scientists in the pharmaceutical, biological, tissue and food industries using lyophilization as an analytical method.

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