A promising new technology to accelerate pharmaceutical freeze-drying processes
When it comes to manufacturing parenteral drugs, lyophilization is considered by many to be a time consuming and energy intensive process. Nevertheless, it has long been used to preserve heat-sensitive products such as biologics or vaccines.
Yet, with the increasing cost of energy and GEA’s overarching goals to be more environmentally friendly and reduce our impact on the environment, improving the overall efficiency of the freeze-drying process has become an imperative.
During our research, GEA experts identified a critical bottleneck that significantly contributed to the freeze-drying process being a long and relatively inefficient one: the heat transfer from the temperature-regulated shelves of the plant into the product to be dried.
As a result, we started to look at ways to overcome this rate-limiting step. Our investigations led us to the proven concept of using microwave radiation to accelerate drying processes. So-called microwave-assisted freeze drying (MFD) was found to drastically improve energy transfer into the product.
Currently, this technique is mostly used to dry foodstuffs. But in partnership with EnWave Corporation (www.enwave.net), a global leader in microwave-assisted drying technology, we are now developing this promising technology for pharmaceutical freeze-drying applications.
At our technology center in Hürth, Germany, we’re using a specially designed laboratory scale freeze-dryer to evaluate the possibilities of MFD. Already, when we compare MFD drying times with those of conventional freeze-drying processes, time savings of 70% and more have been recorded.
Beyond faster drying times, though, we’re also investigating the final properties of products that have been dried using ultra-fast MFD. In a direct comparison with samples from conventional systems, no major differences in critical quality attributes were detected. As such, we can achieve very fast drying times without impairing the quality of the final product.
As well as doing in-house studies to better understand this novel lyophilization process, our MFD machine is also available for customers to conduct feasibility studies using their own products in our laboratory.
Another major benefit of much-shortened process times is the ability to transfer the typically batch-wise lyophilization process into a continuous one. By shifting the operational mode, we can offer more energy efficient, sustainable machines with a smaller footprint that still meet the production capacity demands of our customers. Moreover, the switch to a continuous operation typically leads to better overall quality of the product and reduces the risk of losing large batches because of irregularities occurring during long production runs.
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