This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
This webinar will help you identify the critical scale-up issues for your lyophilized product and understand equipment differences. You will learn how to use this knowledge to successfully produce a consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer. The presenter will also discuss the phenomenon known as sonic water vapor flow or, “choked flow” in a freeze-dryer. This is a problem that typically manifests itself when scaling-up a lyophilization cycle or transferring that cycle to another freeze-dryer, and is characterized by a loss of control over the vacuum in the sample chamber. This webinar will cover the reasons for choked flow, how to recognize choked flow is occurring, and how to prevent this from happening in future cycles.
Why Should You Attend:
By far, one of the most difficult tasks in getting a lyophilized product from the laboratory bench to the commercial freeze-dryer is scale-up, or cycle transfer. Problems that typically arise from scale up issues include shattered vials, melt back, collapse, higher residual moisture levels, and decreased shelf life.This webinar will help you identify the critical scale-up issues for your lyophilized product and understand equipment differences. You will learn how to use this knowledge to successfully produce a consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer. The presenter will also discuss the phenomenon known as sonic water vapor flow or, “choked flow” in a freeze-dryer. This is a problem that typically manifests itself when scaling-up a lyophilization cycle or transferring that cycle to another freeze-dryer, and is characterized by a loss of control over the vacuum in the sample chamber. This webinar will cover the reasons for choked flow, how to recognize choked flow is occurring, and how to prevent this from happening in future cycles.
Areas Covered in the Webinar:
- Critical parameters in scale-up and cycle transfer
- Scale-up strategy
- Mapping studies
- Dryer configuration
- Determining and preventing choked flow conditions
- Understanding the differences between development, pilot, and productions dryers
- Proper information gathering (IQ, OQ, manufacturer specifications, operator knowledge, etc.)
- Design and execution of a well thought out scale up strategy
- Identifying choked flow conditions, and designing a cycle to prevent choked flow from occurring
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:- Development scientists
- Product and process engineers
- QA/QC
- Product managers
- Manufacturing
- Operations
Speaker
J. Jeff SchwegmanCourse Provider
J. Jeff Schwegman,
