Scale Up Cycle Transfer And Maximum Throughput Capability For Lyophilized

Apr 23, 18 Scale Up Cycle Transfer And Maximum Throughput Capability For Lyophilized

Scale Up Cycle Transfer And Maximum Throughput Capability For Lyophilized Products

Cycles which have been designed on development-scale devices, and so are producing acceptable item, can suddenly start experiencing both physical and chemical substance instability when scaled-up to a more substantial freeze-dryer, or transferred between creation freeze-dryers.

Without understanding the scientific concepts behind scale-up and cycle transfer, many companies will attempt tweaking the cycle parameters when problems are encountered during scale-up. While this process may work occasionally, frequently, it will result in additional complications such as for example excessively long cycle moments, shattered vials, higher residual wetness content, etc. Making the effort to create and execute a well-planned scale up research, will make sure that cycles and items will transfer seamlessly from dryer to dryer without pricey time delays and item rejection. One issue specifically that is observed during scale-up, is certainly lack of vacuum control within the merchandise chamber of the freeze-dryer. Good sense would dictate vacuum pressure pump failing or a vaccumleak as the foundation of failure; nevertheless, the phenomenon referred to as, “choked stream”, is something totally unrelated to vacuum pumps and vacuum leakages. Being able to recognize the difference between vacuum program issues and choked circulation makes correcting the issue easier, saving both money and time in diagnosing and correcting the issue.

Why you need to attend: Many complications have arisen previously when making and scaling-up lyophilization cycles because this technique was more of a skill than a technology, and cycles were designed and scaled-up predicated on a “learning from your errors” approach. Companies that don’t realize the scientific concepts behind their cycles operate the risk to be delayed in obtaining their items approved and available on the market, that may have a dramatic effect on their profit percentage. By far, probably the most difficult jobs in obtaining a lyophilized item from the laboratory bench to the industrial freeze-dryer is usually scale-up, or routine transfer. Issues that typically occur from scale up problems consist of shattered vials, meltback, collapse, higher residual dampness amounts, and decreased shelf existence. By firmly taking the time to recognize the critical problems for a specific product and understanding gear differences, the advancement scientist or engineer includes a much higher potential for successfully producing constant, quality, product whether it’s becoming dried in a development-scale dryer, a clinical-level dryer, or a big commercial-scale dryer. Finally, period will be focused on discussing the phenomenon referred to as sonic drinking water vapor circulation or, “choked circulation” in a freeze-dryer. That is a issue that typically manifests itself when scaling-up a lyophilization routine or transferring that routine to some other freeze-dryer, and is seen as a a lack of control over the vacuum in the sample chamber. As chamber pressure rises in the sample chamber, product temperature rises aswell, often leading to product reduction. This webinar covers the reason why for choked circulation, how exactly to recognize choked circulation is occurring, and preventing this from occurring in future cycles.

Areas Covered in the Program:Critical parameters in scale-up and routine transferScale-up strategyMapping studiesDryer configurationDetermining and preventing choked circulation conditionsLearning goals:Understanding the variations between advancement, pilot, and productions dryersProper info gathering (IO, OQ, producer specs, operator knowledge, etc.)Style and execution of a well-planned level up strategyIdentifying choked stream conditions, and developing a cycle to avoid choked stream from occurringWho Will Advantage: This webinar provides valuable assist with those companies mixed up in development and scale-up of therapeutic and diagnostic lyophilized items.Quality Control ScientistsDevelopment ScientistsProduction ManagementQuality Assurance

Tuesday, June 26, 201210:00 AM PDT 01:00 PM EDT