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Introduction to Freeze Drying 4: How can BTL help? Despite its wide use, many regard freeze-drying as something of an art. This is not surprising, given the complexity of the process itself and the lack of available texts relating to it, with most published articles tending to describe specific applications of the process. Here at BTL we prefer to approach it from a rational and scientific approach, believing that qualitative analysis and knowledge of the product and process leads to results that are proveable and repeatable. Freeze drying is a balance between vacuum and temperature. If the product temperature is allowed to become too high, undesirable changes may occur in the product, for example collapse. If the product temperature is too low, the drying process will be much longer. Meanwhile the pressure inside the freeze drying chamber must be precisely balanced to ensure that the flow of vapour away from the product is maintained. The different stages of the freeze drying process will require different balances of temperature and vacuum, and each stage must be properly completed before the next is begun. Every product will have a characteristic “critical temperature”, above which it will suffer processing defects during freeze-drying. It is therefore invaluable to know the critical temperature of each product in order to design a freeze-drying cycle that is safe but efficient. The critical temperature of each product is affected by precise formulation of that product - the different chemicals involved in its makeup, and their ratio to one another. It is invaluable, if not essential, to know the critical temperature of a formulation prior to freeze-drying, in order that suitable conditions can be adopted for its successful and safe processing in a reasonable timeframe. This is where BTL comes in. Using our own unique instruments, Lyostat2 and Lyotherm2, we are able to characterise your products scientifically to pinpoint their critical temperatures and determine whether your product is suitable for freeze drying in its current state. With our extensive knowledge of buffers, lyoprotectants and excipients, we can help you formulate or reformulate your product to make it less fragile, more bio-active and easier to freeze-dry. Once your formulation is ready, we can help you calculate freeze-drying cycles to make sure your product is dried thoroughly and safely but without wasting your time and money. We can run small production or pilot-scale production batches for you in our dedicated freeze-drying laboratory. And we can also run moisture analysis tests to ensure that your product is properly dried. Need more information? Why not contact us to discuss your requirements. For freeze drying equipment, why not check out our sister company Biopharma Process Systems ?
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