RAPS pre-approved webinar on "Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products" from GlobalCompliancePanel
Many problems have arisen in the past when designing and scaling-up lyophilization cycles because this process was subjective, being more of an art than a science, and cycles were designed and scaled-up based on a "trial and error" approach.
- Fresno, CA (1888PressRelease) February 07, 2013 - Description:
That has changed. Today, companies that do not understand the scientific principles behind their cycles run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.
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, meltback, collapse, higher residual moisture levels, and decreased shelf life.
By taking the time to identify the critical issues for a particular product and understanding equipment differences, the development scientist or engineer has a much higher chance of successfully producing consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer.
Finally, time will be dedicated to discussing 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. As chamber pressure rises in the sample chamber, product temperature rises as well, often resulting in product loss. 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.
When:February 7, 10:00 AM PDT | 01:00 PM EDT
By whom:
Jeff Schwegman, Ph. D., develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC at his firm, AB BioTechnologies, of which he is the founder and CEO.
Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University.
Dr. Schwegman holds patents and develops new technologies in lyophilization. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
For whom:
The webinar will benefit
- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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