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Chamber:
The chamber will be horizontal parallelepiped or cyclindrical design,in which the shelf package is located,with all the edges and corners rounded off to facilitate cleaning,as specified by cGMP.It is designed for high vacuum application as well as to withstand overpressure during steam sterilization.
Door:
The door is clad in polished stainless steel AISI 316L ,roughness of average less than 0.5um,to profive a clean smooth finish
Door sealing with a T-shaped or O-shaped solid single silicone or fluorine material with air-release free gasket designed for high vacuum and overpressure operation,placed in the chamber frame.
Shelves:
Shelves are built in AISI 316L steel and they are ground smooth finish to a roughness of average less than 0.5mm.
Shelf temperature range can be controlled between -55℃ and +70 ℃ depensing on the lyophilization step being performed.There are several temperature sensors for monitoring the product temperature and the number of sensors depends on customer requirments.
Stoppering system:
Stoppering system and shelves movement up and down.At the end of the drying process,vials loaded pn shelves can be stopped either under vacuum or under controlled atmosphere of inert gas.
What’s more,the device is convenience for bulk drug loading and unloading/For later purpose,the device can also be named shelves movement up and down device.
Condenser:
Ice condenser assembly suitable for vacuum and steam sterilization over-pressures with horizontal or vertical cylindrical shape or rectangular shaped,made of AISI 316L stainless steel.
Refrigerating system:Refrigerating system is used to cool the thermal fluid for the shelves during the freezing,and eventually during evacuation and drying sequences,and to cool the condenser coil during the evacuation and the drying sequences.
Vacuum system:
The vacuum pump group consisting of vaccum drying and its related valve during the freezing and drying operation.the inside vacuum is connected with refrigerating system through AISI 304L stainless steel.The automatic and pneumatic butterfly is used between the vacuum system and condenser to make the vacuum system isolate the freeze dryer.
CIP System:Optional
Usign suitable rotary or fixed sprayers and fixed wide-angle nozzles to sprinkle the cleaning water to the surface of shelves and chamber.Moving up and down the shelves is helpful for washing in the process.
SIP System:Optional
Sterilizable freeze dryers offer the most adequate solution to process sterile products,ensuring the lowest contamination risk
