The freeze drying process

It is said from Einstein that you are not understanding something until you are not able to formulate it simple. From Lyoptimus we adapt ourselves to our customers for easing the conversation and take the best of it. Then we are able to share  our advise in the best way possible.

Basics are the knowledge fundations, sometimes key explanations are missing and it is not possible to have a solid comprehension to further progress.

The very basics as the water state diagram are crucial, to have a clear understanding, linking it to the whole lyophilization process.

Partly because the lyophilization process is complex involving multiple variables, but also due recipes were developed and validated long time ago, freeze drying cycles  can be improved, sometimes, only by looking to past trends. Lets us review what is the improvement potential of your process to evaluate if it is worthy to modify it and revalidate it.

The physics behind lyophilization were parametrized more than four decades ago, now together with the computational progress of personal computers, accurate calculations are more available than ever. Let us introduce you to the secrets of lyophilization, then you will be aware about the possibilities of simulation and your collaboration with Lyoptimus will be enhanced for reaching the desired results.

Considering your freeze drying process a black box means accepting trial-and-error approaches when designing a lyophilization process. Only well balanced development,  by Design Of Experiments (DOE), suported by simulation can lead to robust, reliable and efficient recipes.

The limits of the the pharmaceutical product, together with the limits of the lyophilizer needs to be defined to then stablish the apropiate margins to build the Design Space (conditions where the production is considered acceptable).