Latest Development for Pharmaceutical Freeze-Drying Applications

Telstar has developed a new generation of lyophilisers with an integrated compact automatic vial loading and unloading system that operates under aseptic conditions. The patented technology

incorporates mechanisms driven by a set of three flexible curved steel bands that make it very compact yet easy to clean and the entire system is situated outside the lyophiliser when not in active use. The lateral curvature of the bands gives them high stiffness, reducing requirements for guidance when in use and making system elements accessible for cleaning, while still enabling them to be very thin to reduce storage space when not in use.

Aimed specifically at applications for the pharmaceutical and biotechnology industry, this system has been designed to operate effectively both in aseptic conditions for product protection and under contained conditions for operator protection. The system can unload lyophilisers configured in ‘passthrough’ mode and can also be used to load and unload single-sided lyophilisers when layout conditions restrict application of other technologies.

Pass-through configuration makes it possible to combine, in the same lyophiliser, loading and unloading in areas with different aseptic classifications and different degrees of operator protection. The system is appropriate, for example, for handling low-toxicity liquid products which, when lyophilised, become highly toxic by inhalation, requiring a higher level of operator protection during the unloading process than when loading.

The system dimensions (less than 600mm/24” in depth) readily enable integration into an isolator and all working areas can be accessed easily and safely using gloves for operations such as changes of format, sampling or management monitoring systems.

Telstar is implementing this innovative vial loading and unloading system for the Russian company R-Pharm, which is establishing a facility for the production of cytotoxic lyophilised products under aseptic conditions.