PDA EU00144 Freeze-Drying in Practice
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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 yearsdecades to improve the stability of medicationboth drug substances and drug productss.
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 beis insufficient in the liquid formulation. While presently already approximately 560% 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: freezing stepg process, primary drying, and secondary drying. The freeze-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.
You will be thoroughly familiarized 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 of 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, 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 have the opportunity to exchange with the other course participants.
Program Highlights
This training course will offer hands-on exercises on freeze-drying machinery throughout the five training days.
Agenda
Discover What's Happening Each Day
Monday, 12 June 2023
11:00 Reception and Welcome Coffee
11:30
INTRODUCTION
Collection and clustering of the questions and expectations contributed by the participants
12:00
THEORY 1 – INTRODUCTION TO FREEZE DRYING PROCESSES
- Why lyophilization?
- History and development
- Examples in daily life and pharmaceutical industry
- The freeze-drying process
- Freeze-drying equipment
- Pros and cons of lyophilization
12:45 Light Lunch Break
13:15
THEORY 2a – BASIC PRINCIPLES OF FREEZE DRYING PROCESSES
- Basic principles of freeze-drying processes
- Physical understanding
- Critical process parameters
- Development and composition of a (biological) formulation
- Primary packaging components
14:45 Coffee Break
15:00
THEORY 2b – BASIC PRINCIPLES OF FREEZE DRYING PROCESSES
- Product attributes for designing lyophilization cycles
- Differential scanning calorimetry
- Freeze-drying microscopy
- Analytical characterization of lyophilizates including solid state characterization
- Residual moisture (Karl Fischer, NIR)
- Reconstitution time
- Thermodynamic state (X-ray powder diffraction)
- Specific surface area (BET)
- Cake appearance at different levels
15:45
THEORY 3 – DEVELOPING OF A FREEZE - DRYING PROCESS
- Development of a lyophilization cycle
- Which are the most important parameters?
- How to choose them?
- What happens if they are not chosen adequately?
- Finalization of cycles
- Discuss the loading scheme
17:00 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, 13 June 2023
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 ( in the conference room)
- Calculation of composition
- Compounding (in the lab)
- Filling
- Stoppering
Extra: Freezing experiment with distilled water under a vacuum to develop a general understanding of the critical temperature
9:45
PRACTICE 2: PROGRAMMING
Programming the freeze-dryer with the programs developed in Theory 3
11:00
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 CONTROL TOOLS
- Thermal resistance measurement (Lyo-RX)
- Comparative pressure measurement (Pirani/capacitive pressure measurement)
- Wireless temperature measurement (WTM)
- Conductance sensor
- Method presentation (in theory and practice)
15:00 Coffee Break
15:15
THEORY 5 - OPERATING PRINCIPLES OF THE FREEZE DRYER
- Overview of different operating and construction principles of freeze dryers
- Construction principle of the freeze dryer and its device modules
- Performance figures (port sizes, condenser sizes, evacuation times)
- Chamber system
- Cooling & vacuum systems
- Filter systems
- CIP/SIP
- Interaction of the device modules in the freeze-drying process
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, 14 June 2023
8:30
Transfer from the recommended hotel to Martin Christ facility
09:00
PRACTICE 5 - A GLANCE 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
PRACTICE 7 - INTRODUCTION TO THE GENERAL ORDER OF EVENTS IN OPERATION
- Brief explanation of all workstations
- Explanation and instruction on the logistics
12:00
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
14:30
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 3
15:15 Coffee Break
15:30
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 4
16:15
PRACTICE 9 - A GLANCE AT THE FREEZE - DRYERS
- 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, 15 June 2023
8:30
Transfer from the recommended hotel to Martin Christ facility
9:00
Recapitulation of key learning 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 explanation of the causes
10:15
THEORY 8 - CIP & SIP
- Inspection of CIP & SIP systems
- Cleaning validation
- Sterilization qualification
- Turn-around concept
11:00 Coffee Break
11:15
Mass Spectrometry Theory
12:15
Modeling of Lyophilization Processes
Guest Presentation: Alex Juckers, Martin Christ
13:00 Lunch Break
13:45
Headspace Moisture and Water Activity Applications for Lyophilized Product
Guest Presentation: Derek Duncan, Lighthouse Instruments
14:30
THEORY 9 – CONTROLLED NUCLEATION
- Technology Overview
15:30 Coffee Break
15:45
PRACTICE 10
- Discussion of the current status of the process in the freeze dryer
- Visual control – examples
16:30
Conceptual Planning of Lyoloading in Projects
Guest Presentation: Alexander Wagner, MOTUS
17:15 End of Training Course Day 4 & Transfer from Martin Christ facility to the Recommended Hotel
18:40 End of Training Course Day 4 & Transfer to the Farewell Dinner
19:00 Farewell Dinner
21:15 Transfer to Recomended Hotel
Friday, 16 June 2023
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 Germany
Hotel Nearby
PDA Europe recommends the reservation at the following hotel and PDA Europe reserved a limited number of rooms until 15 April 2023.
A transfer during the event from and to this hotel is guaranteed.
The general terms of business are valid at the hotel.
HOTEL SAUERBREY ****
Friedrich-Ebert-Str. 129
37520 Osterode am Harz / Lerbach
Tel.: +49/ (0)5522-5093-0
Fax: +49/ (0)5522-5093-50
Email: [email protected]
www.hotel-sauerbrey.de
Price per Room and Night: Upon Resquest
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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Sponsorship and exhibit opportunities are not available for this course.
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