PDA EU00144 Freeze-Drying in Practice
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Program Highlights
This training course will offer hands-on exercises on freeze-drying machinery throughout the 5 training days.
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.
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Standard Pricing
Standard Member Price
€ 3.195GovernmentMember Only
€ 3.195
Health AuthorityMember Only
€ 3.195
Early Career ProfessionalMember Only
€ 3.195
StudentMember Only
€ 3.195
AcademicMember Only
€ 3.195
Non-Member
€ 3.195
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, 24 October 2022
12:00
Reception and Welcome Coffee
12:30
INTRODUCTION
Collection and clustering of the questions and expectations 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 of lyophilization
13:45
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
14:30
Coffee Break
14:45
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
- 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
15:30
THEORY 3 – DEVELOPING OF A FREEZE - DRYING PROCESS
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
Day 2
Tuesday, 25 October 2022
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
- Filling
- Stoppering
Freezing experiment with distilled water under a vacuum to develop a general understanding of the critical temperature
10:45
Coffee Break
11:00
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)
13:00
Lunch Break
13:45
PRACTICE 2 - PROGRAMMING
- Programming the freeze-dryer with the programs developed in Theory 3
14:45
PRACTICE 3: FREEZING BEHAVIOR
- Loading of the shelves
- Positioning of the thermo couples
- Start of the lyophilization program
15:15
Coffee Break
15:45
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
16:45
THEORY 6 - LYO QUALIFICATION
- Explanation of the sequence DQ-RA-IQ-OQ-PQ
- Measures for maintaining the qualified state
17:30
PRACTICE 4 - A GLANCE AT FREEZE DRYERS
- Discussion of the current status of the process
- What is evident/what is not yet evident
18:15
End of Training Course Day 2 & Transfer from Martin Christ Facility to the Recommended Hotel
Day 3
Wednesday, 26 October 2022
8:30
Transfer from the recommended hotel to Martin Christ facility
09:00
PRACTICE 5
- 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
13:00
Lunch Break
13:45
PRACTICE 8: WORKSTATION OPERATION SEQUENCE 1
- Calibration of pressure sensor/vacuum sensor
- Calibration of temperature sensor
- Shelf temperature mapping
- Roughness measurement
14:15
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 2
15:00
Coffee Break
15:15
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 3
16:00
CONTINUATION PRACTICE 8: WORKSTATION OPERATION SEQUENCE 4
16:30
PRACTICE 9
- Discussion of the current status of the process in the freeze dryer
17:15
End of Training Course Day 3 & Transfer from Martin Christ facility to the Recommended Hotel
Day 4
Thursday, 27 October 2022
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
Elastomeric Closures for Lyo Applications
Guest Presentation: Francis Carroll, West
remote
12:00
Modeling of Lyophilization Processes
Guest Presentation: Alex Juckers, Martin Christ
12:45
Lunch Break
13:30
Headspace Moisture and Water Activity Applications for Lyophilized Product
Guest Presentation: Derek Duncan, LIGHTHOUSE Instruments
remote
14:15
THEORY 9 – CONTROLLED NUCLEATION
- Technology Overview
15:15
Coffee Break
16:15
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 Engineering
17:30
End of Training Course Day 4 & Transfer to the Farewell Dinner
18:00
Farewell Dinner
20:30
Transfer to Recomended Hotel
Day 5
Friday, 28 October 2022
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
Sponsorship and exhibit opportunities are not available for this course.
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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.
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 03 October 2022.
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)