Expert View: Reaching for the (lyo) stars – the unmatched development and scale-up platform for freeze drying
This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.
IN THE EARLY days of freeze-drying cycle design, many pilot scale runs were required to develop acceptable recipes for each product. In some cases, exactly the same freeze-drying recipe was used for multiple products in different formats.
During these processes, several criteria are assessed based on parameters such as the physical appearance of the dried product, the reconstitution time, the residual moisture content and the stability of the active ingredient. At commercial scale, excessive drying times impede throughput and have a profound economic impact – the cost increases dramatically the longer the product spends in the freeze dryer.