Optima Group Pharma has built a processing line for vials with integrated freeze-drying that processes liquids, as well as freeze-dried pharmaceuticals and biopharmaceuticals.
Depending on the format chosen, the transport and distribution system of the Klee line automatically conveys the vials to the feeding and discharge unit of the freeze-drying system, or, in case of products that are marketed as liquids, direct to the closing machine.
The line is equipped with an Inova time-pressure dosing system with 100% in-process control. This is a self-optimising system, which ensures filling precision and guarantees maximum use of products. Filling precision is below 0.5%.
The freeze-drying system distributes an even temperature along a shelf surface of 23.4m2.
Filling quantities from 0.05-20ml can be placed in vials with filling volumes from 2-20ml. Plugs and crimping caps can be processed in nominal dimensions of 13-20mm. Output of the four-digit filling system is 150 containers per minute. Post-processing has been designed for an output of 400units/min to ensure quick unloading of the freeze-drying system.
"We have made no compromises with regard to pharmaceutical safety," said Juergen Schaefer, md of Optima Group Pharma. "To guarantee optimum product protection, the entire line - from the discharge of the sterilisation tunnel to the end of the closing machine - has been equipped with an isolator."
The turn-key line comprises an unpacker, washing machine, sterilising tunnel, filling and closing machine, loading and unloading system to the freeze drying system, isolator and encoder.