Freeze drying and sterilisation expertise

Telstar offers complete product freeze drying and sterilization consultancy service for the development, qualification and validation of process cycles. 

Freeze drying: An in-depth study of product thermal characteristics, freezing and drying steps can result in a significant improvement in product quality and productivity.

Sterilization: Optimization of process conditions will enable container (vial, ampoule, bottle, bag, etc.) integrity to be maintained and result in shorter cycles with lower cost.

Design and optimisation of the freeze drying recipe and obtaining of test batches

The preliminary analyses of the product enables definition of the freeze drying recipe with confidence.  Optimisation of this initial recipe will be achieved by successive tests in which defects such as collapse, excessive cycle duration, turbidity, excessive reconstitution time, excessive residual moisture, and breakage of vials will be corrected or improved.

Sterilisation of Client product in the laboratory's autoclave

Tests in the autoclave can determine the optimum conditions for sterilisation for all types of product: solid, porous, liquid, plastic, and so on.

Product formats which usually require an in-depth study are plastic containers with liquid inside.  The overpressure exerted by the gas inside the container during sterilisation may permanently deform it so as to render it unusable.

The external counter-pressure which needs to be exerted throughout the process to prevent deformation of the container is determined in the laboratory autoclave.  This counter-pressure may be exerted with the steam-air mixture or with superheated water.  The choice of which system is most appropriate will depend upon the state in which the container is to emerge from the autoclave: dry or wet.

The small volume of the autoclave chamber makes it possible to carry out tests with small quantities of containers. The results can then be easily transferred to an industrial scale plant.