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Qualification of a freeze-dryer

Freeze-drying (lyophilisation) is a process of drying a product (solvent) without harming the product.

The product is filled on a filling machine as an aqueous solution, then loaded into the freeze-dryer and the product is dried under vacuum to solid state (ice).

The phenomenon of sublimation is then applied:

 Freeze Dryer Graf Ny

The freeze-drying principle is most used in the pharmaceutical and biotechnology industry, for example for production of vaccines.

The steps in a freeze-drying process are:

Freeze Drying Process

 

After end a freeze-drying process the freeze-dryer must be ready for the next batch:

The ice on the ice condenser must be removed by a defrosting process, a clean-in-place program (CIP), filter integrity test program (FIT), a sterilization-in-place program (SIP) and a leak test are executed and approved.

After secondary drying the chamber has to be aerated, the stoppers which were partial inserted on the vials are stoppered and the product can be unloaded and capped on the filling machine.

The challenges in qualification of a freeze-dryer is normally CIP and SIP processes:

CIP process: The cleaning of the freeze dryer is normally done by adding hot water for injection (WFI) into the ice condenser, which acts as reservoir for the cleaning fluid (WFI). The water is recirculated by use of the CIP recirculation pump, which pumps the water in controlled sequences through the different sets of spray nozzles situated in the chamber and ice condenser. After each full sequence, all water is completely drained, and new water is added and yet another sequence takes place.

And the question is: How will you document that the interior freeze-dryer is clean?

SIP process: The sterilization of a freeze-dryer is done using saturated clean steam. Document a uniform temperature distribution without cold spots in the interior freeze-dryer with temperature probes and biological indicators. All sampling points within the interior of the freeze-dryer, a temperature of minimum 121 °C in minimum 15 minutes must be obtained to document the sterility.

A&E can support you in qualification of your freeze-dryer in following activities:

For more information, do not hesitate to contact Andreasen & Elmgaard A/S consultants.

We would like to have an informal meeting with you to discuss how we can support you in your activities.

 


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Per Elmgaard Rasmussen

CEO, Partner

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Ferhat Celik

Senior Consultant

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