Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers. Without understanding the scientific principles behind scale-up and cycle transfer, many companies will try tweaking the cycle parameters when problems are encountered during scale-up. While this approach may work occasionally, often, it will lead to additional problems such as excessively long cycle times, shattered vials, higher residual moisture content, etc.
Taking the time to design and execute a well thought out scale up study, will ensure that cycles and products will transfer seamlessly from dryer to dryer without costly time delays and product rejection. One issue in particular that has been observed during scale-up, is loss of vacuum control within the product chamber of the freeze-dryer. Common sense would dictate a vacuum pump failure or a vaccum leak as the source of failure; however, the phenomenon known as, “choked flow”, is something completely unrelated to vacuum pumps and vacuum leaks. Being able to identify the difference between vacuum system issues and choked flow makes correcting the problem much easier, saving both time and money in diagnosing and correcting the problem.
Why Should you Attend:
Many problems have arisen in the past when designing and scaling-up lyophilization cycles because this process was more of an art than a science, and cycles were designed and scaled-up based on a “trial and error” approach. 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.
Objectives of the Presentation:
To guide in the understanding and performance of:
Who can Benefit:
- 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 (IO, 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
This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods.
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