(1) By introducing a material dissolution equipment, which has the Closed Full-Automatic System of Dissolution System we have developed, it becomes possible to eliminate the present requirement of manual works related to containers and also the inside of the equipment itself can be through with steam sterilization treatment.
(2) With this equipment, the completely dissolved solution (Material to be dried) is fed with pressure directly to the ICS/FD equipment in Process B, via the piping with sterile filter.
(1) The ICS/FD equipment is based on the Ice Lining Method and equipment both on which we have patents already. We solved problems that are found in conventional type of freeze dryer with sealed and upright shell tube so that it can be improved and utilized through practical application.
(2) Specifically, we cool down each of independent tube with cylindrical jacket and spray the injection water to form prescribed ice lining. In the meantime, the solution is supplied in sterile manner from raw material dissolution equipment in Process A to spray collection tank, where it will be pre-cooled (below 5 degrees C).
(3) Prior to spray freezing of this pre-cooled solution on the ice lining, tube temperature is lowered down to the prescribed point. After confirming the tube temperature reached the prescribed point, we make the solution freezing layer form uniformly on the ice lining.
(4) After spray freezing, set up prescribed conditions (temperature, time, etc.) first and then carry out the pre-freezing process.
(5) Start and keep evacuation until the prescribed degree of vacuum is confirmed. Then heat the tube and start the drying process while keeping the prescribed level of temperature. As drying process proceeds, the ice lining layer sublimes, and gaps will be generated between dried goods and the tube, thereby the cylindrical dried goods having been formed inside the tube will be exfoliated. After that, the secondary drying process proceeds until the prescribed degree of dryness is achieved.
(6) After confirming that the drying process has been completed, re-pressurize and immediately go to Process C, the milling process.
(Partially connected to the lower section of B Zone)
(1) In the lower section of the tube in ICS/FD equipment, a coarse milling equipment with milling nozzle is connected.
The cylindrical dried goods formed inside the tube with jacket get collapsed by the impact of the compressed air sprayed from the milling nozzle, and get coarsely milled into particles (max. a few mm bore) available to be air transported.
(2) The coarsely-milled drying goods are fed, through sterilized piping, with the sterile air having been used for milling, to the pulverizing process.
(3) The pulverizing process consists of jet mill and cyclone. By a jet mill (high-speed jet of sterile compressed air of 0.3-0.7 MPa) with internal mechanism that applies semi-free vortex, the coarsely-milled products will be pulverized into a prescribed particle size of product without over-grinding and then caught and collected by the cyclone.
(4) In all milling and pulverizing process described above, sterile air only is used without using any rotating body, therefore milling and pulverizing in sterile conditions can be achieved.