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Development of a Freeze Drying Process

Nov 29 - Nov 30, 2018
Seville, Spain

This workshop will give a thorough introduction into the Physics and Thermodynamics of Freeze-Drying. It comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market.

  • Education
  • Europe

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Program Highlights
Bring your own samples for discussion.

Overview

This workshop will give a thorough introduction into the Physics and Thermodynamics of Freeze-Drying. It comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market. It is created to introduce all people who are professionally linked to Freeze-Drying and might be of special interest for cycle developers (R&D), upscale & transfer specialists, project managers & engineers, process & site engineers, qualification & validation specialists. Open problem examination allows you to bring in a current problem linked to Freeze-Drying. The group will discuss and evaluate possible approaches for troubleshooting.

Who Should Attend

This course is designed specifically for:

  • Cycle Developers (R&D)
  • Upscale & Transfer Specialists
  • Project Managers & Engineers
  • Process & Site Engineers
  • Qualification & Validation Specialists
  • Members of Parenteral Production Teams

Learning Objectives

Upon completion of this course participants will know the basic principles of all Freeze Drying aspects:
  • Physical / Thermodynamic Theory of Nucleation, Sublimation and Desorption
  • Technical & Technological Solutions to accomplish a standard process
  • Based on the prior theory, several hands-on-sessions provide practical knowledge to design a Freeze-Drying process
  • Basics of qualification of a freeze dryer

Instructor

Georg Frinke, Bayer Pharma
Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engineer for Optima (Klee) and GEA Lyophil / Steris. Among others, he is specialized in the development of customized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

Agenda

  • Thursday, 29 November 2018

    THEORY

    9:00
    Introduction

    • Introduction to Drying Technologies
    • Overview of the Freeze Drying Process
    • Properties of Water
    • Properties of Heat Transfer during Lyophilization

    10:00
    Nucleation (with Parallel Hands-on)

    • Scientific Basics
    • Freezing Process
    • Sensors & PAT

    11:00
    Coffee Break

    11:30
    Nucleation (Cont.)

    • Hands-on: Freezing of Sucrose in a Lyo with integrated thermo-resistant measurement

    12:45
    Lunch Break

    13:45
    Sublimation

    • Scientific Basics
    • Drying Process
    • Sensors & PAT
    • Hands-on: Ice-temperature calculation based on manometric temperature measurement

    16:00
    Coffee Break

    16:30
    Desorption

    • Scientific Basics
    • Residual Moisture
    • Sensors & PAT
    • Hands-on: Preparation and start of a lyo-process

    Bring in your Questions: Real problems of Freeze Drying can be presented and will be discussed in the group


    18:30
    End of Day 1

    Friday, 30 November 2018

    TECHNOLOGIES & PRACTICE

    8:30
    Repetition of Previous Day Theory


    9:00
    Hands-On: Recipe Development


    11:00
    Coffee Break

    11:30
    Process Design
    Derive design requirements from process requirements

    • Process requirements
    • Process steps of Lyo-cycle
    • Auxiliary processes for parenteral production

    12:30
    Lunch Break

    13:30
    Design of a Lyophilizer - From Engineering to Qualification

    • Vessel system
      • Shelf system
      • Chamber system
      • Condenser system)
    • CIP / SIP-Equipment
    • Qualification procedures
      • CIP-Process
      • SIP-Process
      • Leak Test

    15:30
    Auxiliary Systems of a Lyophilzer

    • Aeration System with Filter test
    • Sensor Equipment / PAT Methods
    • Vacuum System
    • Heat Transfer System

    15:00
    Coffee Break

    16:30
    Hands-on:

    • Evaluation of the Lyo experiment & samples of collapsed probe

    17:00
    End of Training Course

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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

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MELIÁ SEVILLA

Calle Dr. Pedro de Castro 1
Seville, Spain

How to Get Here

By Air

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By Car

More information coming soon.

Other Options

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Directions

Registration Fees

Regular Price

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

1,495 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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