Online Training 2015 - PRINCIPLES, AND PRACTICAL ASPECTS OF LYOPHILIZATION TECHNOLOGY - By Compliance Global Inc

Overview:
Lyophilization, commonly referred to as freeze drying equipment, is the process of removing water from a product by sublimation and desorbtion. This process is performed in lyophilization equipment which consists of a drying chamber with temperature controlled shelves, a condenser to trap water removed from the product, a cooling system to supply refrigerant to the shelves and condenser, and a vacuum system to reduce the pressure in the chamber and condenser to facilitate the drying process. Lyophilizers can be supplied in a wide variety of sizes and configurations and can be equipped with options that allow system controls to range from fully manual to completely automated.
Why Should You Attend:
The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. Principles and concepts presented are later used to discuss real world practical applications. The long term training sessions include participants in development, operations, engineering, technical services, quality, validation, and regulatory affairs. Brief on-line training addresses critical aspects of freeze drying to ensure compliance, validation and minimization of patient risk based on the development of the product proven to have been during the clinical trials before the product was transferred into commercial scale operations.
Areas Covered in the Session:
Essentially a brief discussion about each of the Critical Aspects and related affects of Variables
Lyophilization 101 ? Comprehension on each step of the Freeze Drying/Lyophilization Process
Understanding why various steps of the process become more advantageous and cost effective
Sublimation Rate Variability
Heat Transfer
Loss of Protein Activity
Freezing Affects on Primary Drying
Optimization of Primary Drying and Proof of the effectiveness of Secondary Drying
Effects of Freezing Method and Excipients on Protein Surface
Influence of Packing Density and the container selection
Residual Moisture Regulatory Considerations by the FDA
Learning Objectives:
Lyophilization process consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. Generating very large frozen particles due to the initial freezing process can cause the sedimentation rate to go way up causing a much longer cycle than effective design of the process can accomplish making the process more cost effective and higher quality.
Who Will Benefit:
Professional Beginners
Professional Intermediates
Advanced Development Professionals
Regulatory Professionals
Validation Professionals
Level:
Beginner
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https://www.complianceglobal.us/product/700057
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