Lyophilization Technology

Website https://compliance2go.com/product/?topic=lyophilization-technology | Edit Freely

Category Pharmaceutical

Deadline: July 07, 2015 | Date: July 07, 2015

Venue/Country: Online, U.S.A

Updated: 2015-06-08 15:57:21 (GMT+9)

Call For Papers - CFP

Lyophilization, commonly referred to as freeze drying, 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 pracdtical 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.

Attendee Level :

Beginners, Intermediate, Advanced 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

Description of the topic:

Lyophilization cycles 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.

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

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance