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PDA EU00171 Optimize Your Freeze-drying Process

Sep 15, 2021
Berlin, Germany

  • Education
  • Europe

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Note   COVID-19 situation up-date 30th March 2020:

PDA is closely monitoring the Corona virus situation. 

Should an event need to be postponed or cancelled, PDA will send email updates to all participants with additional details and information.

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Overview

A successfully optimized freeze-drying cycle will provide reliable, safe processing in an efficient manner. Each stage of the process – freezing, primary drying and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type and amount of product per batch or container, and the capabilities of the processing equipment to be used.  

This training course provides an overview of how to develop an optimized freeze-drying process. It will go through each critical stage required to optimize a cycle including: an overview of the freeze drying process, formulation design of freeze dried products, characterization of the formulation in the frozen state prior to freeze drying, and cycle development, including the iterative approach, and the use of PAT (Process Analytical Technology) for monitoring the process. 

   

Agenda

  • 9:00
    Welcome, Opening Remarks and Introductions

    9.15
    Introduction to Freeze-Drying

    10.00
    Factors Effecting the Rate of Sublimation

    10.30
    Coffee Break

    11.00
    Typical CQAs and Excipients in Freeze Dried Products

    12.30
    Frozen State Characterization

    12.30
    Lunch Break

    13.30
    Overview of Process Analytical Technology Used in Monitoring Primary Drying

    14.30
    Cycle Development and Scale Up: Use of the Iterative Approach

    15.00
    Coffee Break

    15.30
    Cycle Development and Scale up: Use of the Iterative Approach

    16.30
    Round-up Discussion and Questions

    17:00
    End of Course

Trainers

Andrew Bright
Andrew Bright
CPI

Additional Information

  • Learning Objectives

    Learning Objectives

    • Gain a basic understanding of the freeze-drying process, together with the factors that influence the product and process. 
    • Characterization to determine a product critical temperature prior to freeze-drying. 
    • Review formulation development to gain understanding of typical excipients and their purpose in a formulation. 
    • Learn about typical CQAs in freeze dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.  
    • Learn how to develop a freeze-drying process using the traditional iterative (stepwise) approach and how this compares to the use of SMART software. 
    • Gain a basic understanding of typical Process Analytical Technology (PAT) to monitor the freeze-drying process and when primary drying is complete. 

     

  • Who Should Attend

    Who Should Attend

    • R&D Scientists
    • Formulation Scientists
    • Product & Process Scientists/ Managers
    • Quality Control Departments

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Berlin, Germany

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Registration Fees

Regular Price
Registration Type Price
All Participants € 895


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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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