New vacuum nucleation induction method in the freeze-drying process suitable for any type of freeze-dryer

A new vacuum nucleation induction method in the freeze-drying process suitable forany type of freeze-dryer without modifying its main elements or adding gases or external substances has been developed. After years of research, Telstar’s innovation department has unveiled the solution for effectively inducing the start of nucleation in the freeze-drying process which, using prescriptions adapted to the specifications of each product, enables the pharmaceutical industry to run the freeze-drying process of product batches more efficiently, quickly, productively and uniformly. This new method –Telstar Lyonuc- will be presented and demonstratedat CPhI (Madrid 2018, 9-11 October).

The vacuum-induced nucleation system produces a change in the solid structure of the solution and manages to homogenise the moment when the freezing starts so that all the vials nucleate at the same time in a few seconds, instead of taking 30-45 minutes which is how long the spontaneous nucleation process can last. This method based on controlling the temperature and pressure and inducing the start of the freezing phase, also ensures the uniformity and homogenisation of the vials in all the batches, respecting the product’s physiochemical properties.

The new vacuum nucleation induction method can be adapted to any type, model or brand of freeze-dryer. This is possible because unlike other methods being studied on the market, where it is necessary to add gases external to the process or use decompression processes requiring special equipment, this new method only requires measuring and controlling the temperature, vacuum and time parameters and it uses the actual tools of a freeze-drying prescription. This new method is particularly indicated for long duration freeze-drying cycles, where the benefit of reducing the drying time is much greater.

As well as improving the theoretical vacuum nucleation induction process developed by Kramer and Liu at the beginning of this century, the research developed by Telstar has delved into the aesthetic behaviour of the freeze-dried solution which is usually altered during the vacuum nucleation induction process.