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2019 Freeze Drying in Practice

Freeze Drying in Practice

Mar 09 - Mar 13, 2020
Osterode am Harz, Germany

This training course is geared to operators of pharmaceutical freeze drying systems.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.

  • Education
  • Europe
Program Highlights
This training course will offer hands-on exercises on freeze drying machinery throughout the 5 training days.

Overview

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 andthermosensitive 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 approx. 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.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Day 5
  • Monday, 09 March 2020

    12:00
    Reception and Welcome Snack


    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 2a – BASIC PRINCIPLES OF FREEZE DRYING PROCESSES

    • Basic principles of freeze-drying processes
      • Physical understanding
      • Critical process parameters
      • Controlled nucleation
    • Product attributes for designing lyophilization cycles
      • Differential scanning calorimetry
      • Freeze-drying microscopy

    THEORY 2b - FORMULATION DEVELOPMENT OF LYOPHILIZATES

    • 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 Hotels


    18:00
    Transfer from the recommended hotels to the Networking Dinner


    18:30
    Networking Dinner


    21:00
    Transfer to the recommended Hotels

  • Tuesday, 10 March 2020

    8:30
    Transfer from the recommended hotels 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?
    • Simulation tools
    • 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)
    • Desorption rate measurement (DRM)
    • Conductance sensor
    • Inline camera (LyoCam)

    11:45
    PRACTICE 2: PROGRAMMING

    • Programming the freeze dryer with the programs developed in Theory 3

    12:45
    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 hotels

  • Wednesday, 11 March 2020

    8:30
    Transfer from the recommended hotels to Martin Christ facility


    9:00
    Recapitulation of Key Learnings from Day 2


    9:10
    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
    IPRACTICE 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

    • Discussion of the current status of the process in the freeze dryer

    12:30
    Lunch Break

    13:30
    PRACTICE 9: WORKSTATION OPERATION SEQUENCE 1(continued)

    • Calibration of pressure sensor/vacuum sensor
    • Calibration of temperature sensor
    • Shelf temperature mapping
    • Roughness measurement

    14:15
    CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 2

    • Calibration of pressure sensor/vacuum sensor
    • Calibration of temperature sensor
    • Shelf temperature mapping
    • Roughness measurement

    15:00
    CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 3(continued)

    • Calibration of pressure sensor/vacuum sensor
    • Calibration of temperature sensor
    • Shelf temperature mapping
    • Roughness measurement

    16:00
    CONTINUATION PRACTICE 9: WORKSTATION OPERATION SEQUENCE 4

    • Calibration of pressure sensor/vacuum sensor
    • Calibration of temperature sensor
    • Shelf temperature mapping
    • Roughness measurement

    16:15
    Coffee Break

    16:30
    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

    17:30
    PRACTICE 10

    • Discussion of the current status of the process in the freeze dryer

    18:15
    Transfer from Martin Christ facility to the recommended hotels

  • Thursday, 12 March 2020

    8:30
    Transfer from the recommended hotels to Martin Christ facility


    9:00
    Recapitulation of Key Learnings from Day 3


    9:15
    THEORY 8 - CIP & SIP

    • Inspection of CIP & SIP systems
    • Cleaning validation
    • Sterilization qualification
    • Turn-around concept

    10:00
    Parallel Practice Sessions [Coffee Break included]

    PRACTICE 11

    • Simulation of major faults with freeze driers
    • Diagnosis (and simulation) of the correction of major faults

    PRACTICE 12

    • Explanation of conductance sensor
    • ꞏ Inspection and explanation of the CIP/SIP-functional modules in an industrial freeze dryer
    • Riboflavin practice

    11:45
    PRACTICE 13

    • Discussion of the current status of the process in the freeze dryer

    12:15
    Lunch Break

    13:00
    THEORY 9 (including equipment demonstration)

    • Introduction to the functioning and operation of the RM measuring instrument
    • Presentation of theory, function and purpose of the most important analysis techniques for lyophilizates
    • Introduction to the measurement of residual moisture

    14:00
    THEORY 10 – CONTROLLED NUCLEATION


    15:00
    Coffee Break


    15:15
    PRACTICE 14

    • Discussion of the current status of the process in the freeze dryer
    • Visual control – examples

    16:00
    THEORY 11 – AUTOMATION

    • Loading and Unloading

    16:45
    Transfer to the recommended hotels

    18:00
    Transfer from the recommended hotels to dinner location


    18:30
    Farewell Dinner


    21:00
    Transfer from dinner location to the recommended hotels

  • Friday, 13 March 2020

    8:30
    Transfer from the recommended hotels to Martin Christ facility


    9:00
    PRACTICE 15

    • 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


    12:00
    End of Course

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.

    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

    Who Should Attend

    This training course is geared to 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.

    who are responsible for the planning, purchasing, operation, usage and qualification/validation of freeze drying systems.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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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.

Martin Christ Gefriertrocknungsanlagen GmbH

An der Unteren Söse 50
Osterode am Harz, Germany

  • Accommodations

    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels. A transfer during the event from and to these hotels is guaranteed.

    The general terms of business are valid at the event hotels.

    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)


    HOTEL ZUM RÖDDENBERG ***
    Steiler Ackerweg 6
    37520 Osterode am Harz
    Tel.: +49/ (0)5522-9054-0
    Fax: +49/ (0)5522-9054-54
    Email: [email protected]
    www.hotel-zum-roeddenberg.de
    Price per Room and Night:Upon Request

    Distance to the venue: 2. 5 km (5min by the car)

  • Amenities

How to Get Here

By Air

Nearest Airport: Hannover Airport - HAJ
Airport Phone:
+49 511 9770

By Car

109 km, 70 min 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

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Registration Type All Participants
Member €2990

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