PDA Freeze-Drying in Practice Training Course
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Freeze-drying also termed lyophilization or sublimation drying is a gentle drying technique. It has been widely used in the pharmaceutical industry for many decades to improve the stability of both drug substances and drug products.
Biopharmaceuticals require an especially gentle manufacturing process due to their complex and thermosensitive molecular structure. In this regard, freeze-drying represents the method of choice for improving the storage stability of biopharmaceuticals, which may be insufficient in liquid formulation. While at present approximately 50% of these products are freeze-dried, a further increase in this percentage is to be expected in the coming years.
A freeze-drying process is divided into three stages: the freezing step, primary drying, and secondary drying. The freezer dryers necessary for this are complex, computer-controlled systems. The main components are a vacuum chamber with a vacuum pump and ports for attaching the product as well as the cooled condenser, where a deposit of the subliming steam from the product occurs on its surfaces. Automated cleaning and sterilization units complete the range of functions. Production freeze-dryers are integrated into process lines and equipped with automatic loading and unloading systems to satisfy both aseptic requirements and higher product throughput while at the same time decreasing error rates.
Who Should Attend
This training course is generated for operators of pharmaceutical freeze-drying systems. It particularly addresses employees in the areas of:
- Development
- Production
- Technology
- Qualification/Validation
- Quality Assurance who are responsible for the planning, purchasing, operation, usage, and qualification/validation of freeze drying systems.
Learning Objectives
You will be thoroughly familiar with the freeze-drying process. The structure and operating principle of freeze-dryers are introduced, and the interaction of the different functional groups is explained. Moreover, guidance for developing a freeze-drying recipe is provided.
Emphasis is placed on technical support, calibration of the most important sensors, qualification of the system, and preventative maintenance. You will learn how to identify and remedy the most frequently occurring system malfunctions. Understanding the maintenance plan rounds off your skills in servicing a freeze-drying system.
Cleaning and sterilization requirements are discussed intensively, and their technical application will be demonstrated on the freeze-dryer. Technical concepts are introduced for automatic loading and unloading.
Interactive training elements, exercises, and experiments in the laboratory and production areas constitute a large part of the course. After you have been familiarized with the theoretical background, you will carry out a freeze-drying process to completion under the guidance of experienced experts. The results are examined, and potential errors and their avoidance are discussed thoroughly. You will obtain insight into the procedures for cleaning and sterilization and will also carry out these processes yourself.
The practical character of the meeting is furthermore supported by the fact that you may pose questions from your everyday work, which will then be discussed collectively. You will receive advice from the experts and could exchange it with the other course participants.
Program Highlights
This training course will offer hands-on exercises on freeze-drying machinery throughout the five training days.
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
Monday, 08 September 2025
09:00
Reception and Welcome Coffee
09:30
INTRODUCTION
Collection and clustering of the questions and expectations contributed by the participants
10:00
THEORY 1 – INTRODUCTION TO FREEZE DRYING PROCESSES
- Why lyophilization?
- History and development
- Examples in daily life and the pharmaceutical industry
- The freeze-drying process
- Freeze-drying equipment
- Pros and cons of lyophilization
12:00
THEORY 2a – BASIC PRINCIPLES OF FREEZE DRYING PROCESSES
- Physical understanding
- Critical process parameters
- Development and composition of a (biological) formulation
13:00
Lunch Break
13:45
THEORY 2b – DEVELOPMENT OF A LYOPHILIZATION CYCLE: PRACTICAL ADVICE
- How to approach it? What are the most important parameters?
- How do you choose them for the different phases?
- Development of cycles for practical work
15:30
THEORY 3 –ANALYTICAL CHARACTERIZATION OF LYOPHILIZES
- Product attributes for designing lyophilization cycles
o Differential scanning calorimetry
o Freeze-drying microscopy
- Solid state characterization after lyophilization
o Residual moisture (LOD, Karl Fischer, NIR, FMS)
o Thermodynamic / Solid state (X-ray powder diffraction)
o Specific surface area (BET)
o Cake appearance at different levels (Vis. Inspec., SEM, µ-CT)
o Reconstitution
17:15
End of Traning Course Day 1 & Transfer to the Recommended Hotel
18:40
Transfer from the Recommended Hotel to Networking Event
19:00
Networking Dinner sponsored by Martin Christ
21:15
Transfer to the Recommended Hotel
Tuesday, 09 September 2025
8:30
Transfer from the Recommended Hotel to Martin Christ Facility
9:00
Recapitulation and Summary of Day 1
9:15
PRACTICE 1 - PREPARATION OF SOLUTION
- Compounding of formulations
- Calculation of composition
- Compounding
9:45
PRACTICE 1 - PREPARATION OF SOLUTION
- Compounding
- Filling
- Stoppering
Freezing experiment with distilled water under a vacuum to develop a general understanding of the critical temperature
10:30
PRACTICE 2 - PROGRAMMING
Programming the freeze-dryer with the programs developed in Theory 3
11:30
PRACTICE 3 - FREEZING BEHAVIOR
- Loading of the shelves
- Positioning of the thermocouples
- Start of the lyophilization program
13:00
Lunch Break
13:45
THEORY 4 - PROCESS ENGINEERING TOOLS
- PT Sensors
- Pressure and Vacuum Sensors
- Vacuum Sensors
- Conductivity Sensors
- Mass Spectrometer Theory
- Camera systems
- Alternatives Sensors
15:00
Coffee Break
15:15
THEORY 5 - LYOPHILISATOR
- Construction of freeze dryers
- Systems of freeze dryers
- Different types of freeze dryers
- Existing lines of freeze dryers
- Parameters of freeze dryers
16:00
THEORY 6 - LYO QUALIFICATION
- Explanation of the sequence DQ-RA-IQ-OQ-PQ
- Measures for maintaining the qualified state
16:45
PRACTICE 4 - A GLANCE AT FREEZE DRYERS
- Discussion of the current status of the process
- What is evident/what is not yet evident
17:30
End of Training Course Day 2 & Transfer from Martin Christ Facility to the Recommended Hotel
Wednesday, 10 September 2025
8:30
Transfer from the recommended hotel to Martin Christ facility
09:00
PRACTICE 5 - A GLANZE AT THE FREEZE-DRYERS
- Discussion of the current status of the process in the freeze dryer
- Recapitulation of key learnings from Day 2
9:30
PRACTICE 6 - TOUR OF THE PRODUCTION ROOMS OF MARTIN CHRIST [Coffee Break included]
- Introduction to the different size classes of freeze dryers
- Introduction to the functional modules of the freeze dryer
- Visualization of the basic analogy of the functional modules across the size classes
- Explanation of the step-by-step production process for freeze dryers
11:30
GUEST PRESENTATION - NATURAL REFRIGERATNS
12:15
PRACTICE 7 - INTRODUCTION TO THE GENERAL ORDER OF EVENTS IN OPERATION
- Brief explanation of all workstations
- Explanation and instruction on the logistics
12:30
PRACTICE 8: WORKSTATION OPERATION SEQUENCE 1
- Calibration of pressure sensor/vacuum sensor
- Calibration of temperature sensor
- Shelf temperature mapping
- Roughness measurement
13:00
Lunch Break
13:45
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 2
15:00
Coffee Break
15:15
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 3
16:30
PRACTICE 9 - A GLANCE AT THE FREEZE-DRYER
- Discussion of the current status of the process in the freeze-dryer
17:00
End of Training Course Day 3 & Transfer from Martin Christ facility to the Recommended Hotel
Thursday, 11 September 2025
8:30
Transfer from the recommended hotel to Martin Christ facility
9:00
Recapitulation of key learnings from Day 3
9:15
THEORY 7 - MAINTENANCE AND FAULT CORRECTION
- Introduction to the most frequently occurring faults
- Diagnosis
- Most probable causes
- Correction
- Introduction to a preventative maintenance concept
- Presentation of examples of defective components with an explanation of the causes
10:15
THEORY 8 - CLEANING & STERILISATION
- CIP/SIP systems
- Acceptance of CIP / SIP systems
- Cleaning validation
- Sterilization qualification
- Turnaround process
- In-process testing during Lyophilization
11:00
Coffee Break
11:15
Mass Spectrometry Practice - If Available
12:15
Guest Presentation to be Announced
13:00
Lunch Break
13:45
Guest Presentation to be Announced
14:30
THEORY 9 – THE IMPORTANCE OF THE FREEZING STEP
- Controlled nucleation technology overview and annealing
15:30
Coffee Break
15:45
PRACTICE 10 - A GLANCE AT THE FREEZE DRYER
- Discussion of the current status of the process in the freeze-dryer
- Visual control – examples
16:30
Guest Presentation to be Announced
17:15
End of Traning Course Day 4 & Transfer to the Recommended Hotel
18:40
Transfer from the Recommended Hotel to Networking Event
19:00
Networking Dinner sponsored by PDA Europe
21:30
Transfer to the Recommended Hotel
Friday, 12 September 2024
8:30
Transfer from the recommended hotel to Martin Christ facility
9:00
PRACTICE 11
- Unloading the freeze dryer
- Evaluation of the process chart
- Determination of reconstitution time
- Visual Inspection
- Assessment of the different results
10:00
Q&A and Conclusions
11:00
End of Training Course
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Training Facility: Martin Christ Gefriertrocknungsanlagen GmbH
An der Unteren Söse 50Osterode am Harz, Germany 37520 Germany
Hotel Nearby
PDA Europe recommends the reservation at the following hotel.
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HOTEL SAUERBREY ****
Friedrich-Ebert-Str. 129
37520 Osterode am Harz / Lerbach
Tel.: +49/ (0)5522-5093-0
Fax: +49/ (0)5522-5093-50
Email: info@hotel-sauerbrey.de
www.hotel-sauerbrey.de
Price per Room and Night: Upon Request
Distance to the venue: 7. 5 km (11min by the car)
The hotel offers a wellness facility including sauna and pool area.
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