During the freezing phase, the goal is to freeze the mobile water of the product. Significant super cooling may be encountered, so the product temperature may have to be much lower than 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.
Lyophilization, commonly referred to as freeze drying, is the process of removing water from a product by sublimation and desorption. 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.
Objectives of the Presentation:
The key objectives of the presentation are to discuss about:
Who can Benefit:
- 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
Development, Regulatory and Validation individuals attempting to demonstrate effective lyophilization that is of consistent (meeting current validation statistical standards), high quality and minimizing patient risk