PDA EU00144 Freeze Drying in Practice
Registration Options
Individual Registration
Group Registration
Program Highlights
This training course will offer hands-on exercises on freeze-drying machinery throughout the 5 training days.Note COVID-19 situation:
The safety and health at our events, have the utmost priority for us. PDA Europe strictly adheres to all national, provincial and local government regulation and guidance. Due to COVID-19, the number of participants at the venue is limited and hygiene and distancing rules apply.
Please note: Access to the site can only be granted with proof of an EU-approved vaccination, recovery or a negative test not older than 24h and an valid ID.
Every event is assessed individually according to this safety and hygiene concept and measures are coordinated correspondingly. Due to the unpredictability of developments regarding the coronavirus pandemic, these measures are subject to constant review and amended as required. The venue site is committed to the highest standards of sanitation and cleanliness, with continuous cleaning throughout the event. Personal hygiene stations will be available across the venue site and airflow will be enhanced. On-site participation is possible by pre-registration only.
If you have any immediate questions or requests, please contact [email protected].
Freeze drying, also termed lyophilization or sublimation drying, is a gentle drying technique. It has been used in the pharmaceutical industry for many years to improve the stability of medications.
Biopharmaceuticals in particular 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 storage stability of biopharmaceuticals, which is insufficient in the liquid formulation. While presently already approximately 60% 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 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 vacuum pump and ports for attaching the product as well as the cooled condenser, where 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.
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.
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
Training Course Inquiries
Registration Customer Care
More information coming soon.
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Monday, 22 November 2021
12:00
Reception and Welcome Coffee
12:30
INTRODUCTION
Collection and clustering of the questions contributed by the participants
13:00
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 for lyophilization
13:45
THEORY 2 – BASIC PRINCIPLES OF FREEZE DRYING PROCESSES
- Basic principles of freeze-drying processes
- Physical understanding
- Critical process parameters
- Product attributes for designing lyophilization cycles
- Differential scanning calorimetry
- Freeze-drying microscopy
- Development and composition of a (biological) formulation
- Primary packaging components
- 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 (visual inspection, 3D scanning, PDMS embedding, SEM, µCT)
15:00
Coffee Break
15:15
PRACTICE 1 - PREPARATION OF SOLUTIONS
- Compounding of formulations
- Calculation of composition
- Compounding
- Filling
- Stoppering
- Freezing experiment with distilled water under vacuum to develop a general understanding of the critical temperature
17:15
Transfer to the recommended hotel
18:15
Transfer from the recommended hotel to networking
18:30
Networking at Christ facility
20:30
Transfer to the recommended hotel
Day 2
Tuesday, 23 November 2021
8:30
Transfer from the recommended hotel to Martin Christ facility
9:00
Recapitulation and summary of Day 1
9:10
THEORY 3 - DEVELOPMENT 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 loading scheme
10:30
Coffee Break
10:45
THEORY 4 - PROCESS CONTROL TOOLS
- Thermal resistance measurement (Lyo-RX)
- Comparative pressure measurement (Pirani/capacitive pressure measurement)
- Barometric temperature measurement (BTM/MTM)
- Wireless temperature measurement (WTM)
- Conductance sensor
- Inline camera (LyoCam)
11:45
PRACTICE 2: PROGRAMMING
- Programming the freeze dryer with the programs developed in Theory 3
13:00
Lunch Break
13:45
PRACTICE 3: FREEZING BEHAVIOR
- Loading of the shelves
- Positioning of the thermo couples
- Start of the lyophilization program
14:45
PRACTICE 4:
- Introduction to the LyoCam technology
- Play-back and discussion of prepared/available video sequences
- Discussion on the correlation of the video sequences with the process parameters using the process graphs
- Time lapse mode for identifying process advancement
15:00
Coffee Break
15:30
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
16:15
THEORY 6 - LYO QUALIFICATION
- Explanation of the sequence DQ-RA-IQ-OQ-PQ
- Measures for maintaining the qualified state
17:00
PRACTICE 5 - A GLANCE AT FREEZE DRYERS
- Discussion of the current status of the process
- What is evident/what is not yet evident
17:45
Transfer from Martin Christ facility to the recommended hotel
Day 3
Wednesday, 24 November 2021
8:30
Transfer from the recommended hotel to Martin Christ facility
09:00
PRACTICE 6
- Discussion of the current status of the process in the freeze dryer
- Recapitulation of key learnings from Day 2
9:30
PRACTICE 7 - 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 8 - INTRODUCTION TO THE GENERAL ORDER OF EVENTS IN OPERATION
- Brief explanation of all workstations
- Explanation and instruction on the logistics
13:00
Lunch Break
13:45
PRACTICE 9: WORKSTATION OPERATION SEQUENCE 1
- Calibration of pressure sensor/vacuum sensor
- Calibration of temperature sensor
- Shelf temperature mapping
- Roughness measurement
14:15
CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 2
15:00
Coffee Break
15:30
CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 3
16:15
CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 4
17:00
PRACTICE 10
- Discussion of the current status of the process in the freeze dryer
17:30
Transfer from Martin Christ facility to the recommended hotel
Day 4
Thursday, 25 November 2021
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 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
THEORY 9 - COOLING TECHNOLOGY
- Introduction and presentation of theory and function of cooling
- Refrigerants – legal changes and technical challenges
12:00
Guest Presentation: Requirements for stoppers in the freeze-drying process
- Method presentation (in theory and practice)
13:00
Lunch Break
14:00
Guest Presentation: Mass Spectroscopy
- Method presentation (in theory and practice)
15:00
THEORY 10 – CONTROLLED NUCLEATION
- Technology Overview
16:00
Coffee Break
16:15
PRACTICE 11
- Discussion of the current status of the process in the freeze dryer
- Visual control – examples
16:45
THEORY 11 – AUTOMATION
- Loading and unloading
17:15
Transfer to the recommended hotel
18:30
Farewell Dinner at Hotel Sauerbrey
Day 5
Friday, 26 November 2021
8:00
Transfer from the recommended hotel to Martin Christ facility
8:30
PRACTICE 12
- Unloading the freeze dryer
- Evaluation of the process chart
- Determination of reconstitution time
- Visual Inspection
- Assessment of the different results
9:00
Q&A and conclusions
11:00
End of course
Sponsorship and exhibit opportunities are not available for this course!
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Martin Christ Gefriertrocknungsanlagen GmbH
An der Unteren Söse 50Osterode am Harz, Germany , Germany
Training Location
Martin Christ Gefriertrocknungsanlagen GmbH
An der Unteren Söse 50
37520 Osterode am Harz, Germany
Hotel Nearby
PDA Europe recommends the reservation at the following hotel. 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)