| Fundamentals of Freeze Drying in Pharmaceutical Context is an in-depth comprehensive lyophilisation course that combines Biopharma Groups’s 30 plus years of freeze drying expertise with the University of Limerick's commitment to building the level of excellence in the pharmaceutical lyophilisation community.
It is aimed at the commercial pharmaceutical market to reinforce the technical knowledge of the employees in this sector. |
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Accredited by University of Limerick |
Completion of this course is worth 6 European Credit Transfer System (ECTS) credits at European Qualification Framework (EQF) Level 6 (Bachelors degree standard) and counts towards a degree. |
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Starting on April 30th 2025 |
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Includes 2 days of practical laboratory sessions at Biopharma House in Winchester, UK which can be conducted online for those unable to attend. |
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There are different financing options available including paying in stages and a student rate. |
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Practical laboratory sessions |
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Assignments and self study |
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Virtual Lectures (12 x 2.5h sessions) |
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- Introduction to Freeze Drying
- Freezing of Aqueous solutions
- Primary drying (sublimation)
- Concepts of formulation for freeze-dried pharmaceuticals
- Formulation characterisation methods part 1 – freeze drying microscopy
- Formulation characterisation methods part 2 – frozen state thermal analysis
- Container-closure systems and their impact on the process and shelf stability
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- Process monitoring and process analytical technology (PAT) in freeze drying
- Scaling up from benchtop trials to full-scale production
- Freeze-dried product analysis part 1 – residual moisture analysis
- Freeze-dried product analysis part 2 – dry state thermal analysis and stability
- Freeze-dried product analysis part 3 – mechanical properties and rehydration
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Laboratory Sessions (total of 2 days) |
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- Hands on analysis of liquid samples with freeze drying microscopy/DSC/DTA/impedance – part 1 analysis of simple dextran solution
- Hands on analysis of liquid samples with freeze drying microscopy/DSC/DTA/impedance – part 2 analysis of a complex liquid formulation
- Start freeze drying cycle for dextran formulation
- Remove samples from freeze dryers; retrieve and review cycle data
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- Visual inspection of dried products, analysis of freeze-dried product with KF, DSC, start DVS analysis, send samples for SEM, and MicroPress
- Review cycle data with additional data from KF, DSC, DVS, SEM, MicroPress
- Appearance and visual defects inspection for comparison to cycle traces and critical temperature for root cause determination of example freeze drying cycles.
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Individual Work (Write-ups, Assignments, Self Study, Background Reading) |
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- Practical laboratory sessions will need to be written up in a formal report format, with methods described, and data presented and discussed.
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- Students will be set further learning activities including background reading and other assignments as part of the module.
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Sign up today, spots are limited! |
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- Understanding the science of how freeze drying works:
- Physics and chemistry of freezing, sublimation and desorption
- Aspects of equipment design to effect heat and mass transfer
- Control and monitoring of the process and the lyophiliser
- Learning about aspects of formulation design and the value of characterization methods that can be applied prior to freeze drying
- Gaining knowledge of the different approaches to developing a freeze drying cycle for products with various critical quality attributes
- Learning about the range of methods available for characterisation of the final product
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Psychomotor (Physical Skills) |
- Programming, loading, operating and unloading a freeze dryer
- Preparing a liquid formulation and pipetting it into containers in defined ‘doses’
- Operating analytical instruments and interpreting the data:
- Freeze Drying Microscope (Lyostar 5)
- Thermal and impedance analyser (Lyotherm 3)
- MicroPress Mechanical Tester
- Recognising physical defects in products by observation
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How this course will develop graduates attributes: |
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| Knowledgeable
- About what the science of lyophilisation is: freezing, sublimation, desorption.
- On how to design and characterise a formulation.
- In how to develop a freeze drying cycle based on the critical temperature(s) of a formulation, its concentration, volume and the heat transfer properties of its container.
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| Articulate
- Be able to explain the process of freeze drying, how it compares to other methods of preservation (freezing, other drying/heating methods), the science and challenges of formulation, freezing and sublimation, aspects of freeze drying equipment design and their influence on the process and the product.
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| Creative
- In terms of developing the formulation and process in a way that goes beyond it being simply an exercise ‘on paper’.
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| Collaborative
- Learning to work in collaboration with operators, production and quality control people.
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| Assessment methods will vary depending on whether participants are from the university (and completing the module as part of a qualification) or from external organisations (typically paying for the training). For the latter, attendance of the lectures and completion of practical sessions might be considered sufficient in itself.
For academic students, assessment would be by: |
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- Attendance at lectures and practical laboratory sessions
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- Practical write-ups (in the form of written reports)
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- A series of marked assignments
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Learn more about the course from our brochure. |
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Sign up today, spots are limited! |
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