System is being implemented by R-Pharm in Russia
Telstar Group, based in Terrassa, Spain, 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, which make it compact yet easy to clean. In addition, the entire system is outside the lyophiliser when not in use.
The technology incorporates mechanisms driven by a set of three flexible curved steel bands
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 also enabling them to be very thin to reduce storage space when not in use.
Aimed at applications for the pharmaceutical and biotechnology industry, the system operates in aseptic conditions for product protection and under contained conditions to protect operators. It can unload lyophilisers configured in ‘pass-through’ mode and also be used to load and unload single-sided lyophilisers.
Pass-through configuration makes it possible to combine, in the same lyophiliser, loading and unloading in areas with different aseptic classifications and different levels of operator protection. The system can handle low-toxicity liquid products, for example, 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 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, the company says.
Telstar is currently implementing this system for Russian pharmaceutical firm R-Pharm, which is establishing a facility for the production of cytotoxic lyophilised products under aseptic conditions.