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  1. Jos Corver lecture on Continuous Freeze Drying

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    14 Feb 2019 | Online Presentations | Contributor(s): Jos Corver

    Jos Corver December 2018 lecture on Continuous Freeze Drying for LyoHUB at Purdue University can be viewed at http://www.kaltura.com/tiny/z0puf   ABSTRACT: The guidelines of FDA’s PAT mention the need for continuous processing in pharma to achieve a mechanism of 100%...

  2. Recommended Best Practices for Process Instrumentation in Freeze Drying

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    28 Jan 2019 | Online Presentations | Contributor(s): Steven L Nail

  3. Fundamentals of Freeze Drying: A Brief Review and Commentary

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    11 Jan 2019 | Online Presentations | Contributor(s): Steven L Nail

  4. Introduction to CFD

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    18 Dec 2018 | Online Presentations | Contributor(s): David Russ

  5. Fundamentals of Freeze Drying II: The Freezing Process

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    18 Dec 2018 | Online Presentations | Contributor(s): Steven L Nail

    OutlineThe Freezing ProcessSupercooling and ice nucleationCharacterization of freezing behaviorEstablishment of upper product temperature limit during primary drying

  6. Fundamentals of Freeze Drying

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    12 Dec 2018 | Courses | Contributor(s): Steven L Nail

    Lyo-Hub Summer School

  7. Fundamentals of Freeze Drying V: Formulation Consderations

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    30 Nov 2018 | Online Presentations | Contributor(s): Steven L Nail

  8. Fundamentals of Freeze Drying IV: Process Monitoring

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    30 Nov 2018 | Online Presentations | Contributor(s): Steven L Nail

  9. Fundamentals of Freeze Drying III: Primary and Secondary Drying

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    30 Nov 2018 | Online Presentations | Contributor(s): Steven L Nail

    OutlinePrimary dryingHeat transfer considerationsMeasurement of the vial heat transfer coefficientMass transfer considerationsMeasurement of the resistance of the dried product layerSecondary dryingCritical process variables during secondary dryingHow dry is “dry enough”

  10. Fundamentals of Freeze Drying I: Introduction and Process Overview

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    30 Nov 2018 | Online Presentations | Contributor(s): Steven L Nail

    Outline Introduction Advantages and limitations of freeze drying Product quality attributes Process overview Freezing Primary drying Secondary drying The Freezing Process Supercooling and ice nucleation Characterization of freezing...

  11. Progress in Vacuum Pressure Measurement

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    08 Nov 2018 | Online Presentations | Contributor(s): Martin Wuest

    For many years standard vacuum pressure measurement sensors consist of capacitance diaphragm gauges, Pirani heat transfer gauges as well as ionization gauges. Development has progressed from passive gauges with a detached controller to combination gauges with integrated electronics. Market...

  12. Dr. Michael Pikal presentation "Modeling in Freeze-Drying:Past, Current State and Future Perspectives"

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    27 Jun 2018 | Online Presentations

    Early Work by Marcus KarelMotivation for Modeling StudiesStead State ModelsThe Non-Steady State Model in Two DimensionsNon-Steady Models for Sublimation and Desorption DryingThe Nonsteady State Modeling of Freeze Drying: In-Process Product Temperature and Moisture Content...

  13. SafeRx Spreadsheets for Mapping Between Data Sources

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    16 Jan 2018 | Downloads

    Spreadsheets for mapping between data sources. Each spreadsheet contains one column listing the identifiers from a specific data source. Two spreadsheets can then be used by CMSA to create a mapping between the identifiers of different sources. Mappings can be one-to-one, many-to-one, or...

  14. Animations to Demonstrate Excipient Risk Assessment

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    06 Mar 2017 | Downloads | Contributor(s): Stephen W. Hoag, Ann Christine Catlin, Chandima Hewanadungodage, Andres Bejarano, Shikhar Singh

    NIPTE-FDA Excipient Risk Assessment DatabaseAs is well established, excipients play a critical role in ensuring manufacturability and clinical performance of dosage forms. It is unfortunate that these materials are commonly referred to as "inactive ingredients" thus creating a blind-spot in our...

  15. FDProtocals

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    06 Feb 2017 | Downloads | Contributor(s): TN Thompson, Qiming Wang, Cindy Reiter

  16. Developing Transferable Freeze Drying Protocols Using Accuflux® and a MicroFD®

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    06 Feb 2017 | Online Presentations | Contributor(s): Taylor N Thompson

  17. Freezing Step in the Lyophilization Cycle Development and its Impact on the Product Stability and Overall Formulation

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    06 Feb 2017 | Downloads | Contributor(s): Tushar Nahata

    Impact of Freezing step on the lyophilization cycle development has been described. This presentation was delivered in Lyotalk 2016, Mumbai, India

  18. Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

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    06 Feb 2017 | Courses | Contributor(s): John Robinson

    Overview:This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA....

  19. Drug Degradation Kinetics Scheme Simulation

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    16 Dec 2013 | Tools | Contributor(s): Lee Kirsch, Stephen Dion Stamatis

    Simulate pH-dependent drug degradation scheme

  20. Kinetic workshop simple degradation scheme

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    17 Dec 2013 | Tools | Contributor(s): Lee Kirsch, Stephen Dion Stamatis

    Simulates simple pH-dependent drug degradation process