PDA EU00144 Freeze-Drying in Practice

Osterode am Harz, Germany
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Program Highlights

This training course will offer hands-on exercises on freeze-drying machinery throughout the five training days.

Note: In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

Freeze drying, also termed lyophilization or sublimation drying, is a gentle drying technique. It has been widely used in the pharmaceutical industry for many years decades to improve the stability of medication 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 the liquid formulation.

While presently 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 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 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 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, 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 have the opportunity to exchange with the other course participants.

Who Should Attend

This training course is generated for operators of pharmaceutical freeze-drying systems. It particularly addresses employees in the areas of:

  • 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.

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, 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 have the opportunity to exchange with the other course participants.

Standard Pricing

Standard Member Price

€ 3.790

Non-Member

€ 3.790

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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, 09 September 2024

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 Training 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,10 September 2024

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

Day 3

Wednesday, 11 September 2024

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

Day 4

Thursday,12 September 2024

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 the Recommended Hotel


Day 5

Friday, 13 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 50
Osterode am Harz, Germany , 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: info@hotel-sauerbrey.de
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.

How to Get Here
By Air Nearest Airport: Hannover Airport - HAJ 109 km, 70 min by car Airport Phone: +49 511 9770
By Car Martin Christ Gefriertrocknungsanlagen GmbH is located at An der Unteren Söse 50, Osterode am Harz, Germany.
By Other Options By Train: Unlock discounted pricing and simply use the provided link below.