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2023 PDA_Training-1988x680

PDA EU00144 Freeze-Drying in Practice

Sep 09 - Sep 13, 2024
Osterode am Harz, Germany

  • Education
  • Europe
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Program Highlights

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

Overview

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: 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.

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Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Day 5

  • 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 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,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

  • 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

  • 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 Recomended Hotel

  • 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

Trainers

Julian Lenger
Julian Lenger
Bayer
Bio
Julian Lenger
Bayer

Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for early pipeline development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs.

Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum.
Sascha Pfeiffer
Sascha Pfeiffer
Pharmbiocon
Bio
Sascha Pfeiffer
Pharmbiocon

Sascha Pfeiffer is a Pharma Engineer with over 20 years' experience in Pharma Engineering in the area of API Fill Finish. Sascha is Managing Director of Pharmbiocon, Pharmbiocon is an R+D Company for Freeze Drying Cycles and an Bio Safety Level Laboratory II.

Sascha specializes in Process Engineering, Technical Transfer as well as plant process optimization.

Additional Information

  • Learning Objectives

    Learning Objectives

    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.

  • Who Should Attend

    This training course is geared to 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.

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Travel

PLEASE 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 50
Osterode am Harz, Germany

Training Facility: Martin Christ Gefriertrocknungsanlagen GmbH
  • Accommodations

    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)

  • Amenities

    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.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 3.790

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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