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Follow on Google News | Lyophilization Process Development and Cycle Design - Webinar By ComplianceOnlineThis webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.
By: ComplianceOnline The development scientist who understands and can apply these principles, will be much better equipped to develop robust cycles that can be used to produce quality products consistently, in the shortest amount of time possible, saving time and money. This seminar will start out with an introduction to thermal characterization including differential scanning calorimetry (DSC) and freeze-dry microscopy (FDM) and how the information gained from these techniques can be used as the foundation for optimized cycle design. Next, we will discuss, in detail, the process of designing the freezing, primary, annealing (if used), and secondary drying protocols for the cycle. In each case, the process will be broken down to understand the correct choice of the different controllable lyopohilizer parameters including shelf temperature, chamber pressure, and hold times. We will also discuss some of the specialized tools that can be used to aid the development scientist in cycle development including, the sample thief, the Pirani gauge, and thermocouples. Areas Covered in the Seminar: - Thermal characterization including DSC and FDM. - Understanding the effects of working with crystalline vs. amorphous components. - The problem with working with a metastable glassy system and the use of annealing to correct this problem. - Determining optimal shelf temperatures for the freezing step. - Determining optimal shelf temperatures and chamber pressures for the primary drying step. - Determining optimal shelf temperatures and chamber pressures for the secondary drying step. - Characterization of the finished lyophilized product. Learning objectives: Attendees will learn how to - Interpret a lyophilization cycle chart - Develop optimal conditions for freezing, primary, and secondary drying - Distinguish between amorphous and crystalline components and how they affect cycle design - Understand the need and techniques of characterizing the dried solids Who Will Benefit: This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods. Personnel who will benefit include: - Quality Control Scientists - Development Scientists - Production Management - Quality Assurance # # # Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates. End
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