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1. CHAMBER
The chamber will be horizontal parallelepiped or cylindrical 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.
Chamber is equipped on its one side with an illuminated viewing port, and inner part made of AISI 316L stainless steel and borosilicate glass, for inspection from the machine room.
The chamber bottom is sloped towards the rear part, where there is a drainage outlet, in order to ease the cleaning of the chamber either with water for injection or with an eventual integrated CIP.
All ports and piping connections are clamp sanitary type. At one side or on top of the chamber there is a clamp port as a reservation for validation, such as steam sterilization process, pressure, temperature and so on.
The chamber is fitted with a means for lifting to assist handling and installation.
Generally, the following connections are provided:
Isolation valve, inlet and outlet of thermal fluid, inlet and outlet of steam and cleaning water, hydraulic flange (for shelves movement only), reservation port for validation, illuminated view port and drain.
Generally, for big machine, more than 5sq. M, the chamber wall is provided with a jacket to cool after sterilization.
2. DOOR
The door is clad in polished stainless steel AISI 316L, roughness of average less than 0.5um, to provide a clean smooth finish. In the center part height about 1.5m, there is a viewing port, made internally of AISI 316L stainless steel and borosilicate glass, for inspection from the clean room.
Door sealing is, 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. The door presses on gasket to make it the same level with the chamber internal surface under vacuum, so that there is no collective water around this area during CIP and SIP.
There are two safety interlock devices to check the situation of locking. One is a limited switch; The other is latch feedback signal. In case of any failure, the process of CIP or SIP cannot run. Whats more, temperature and pressure are interlock to protect the operator and machine.
A flat sterile wall flange with stainless steel 304, surface on clean room side roughness of average less than 0.75um, is connected with the rear sterile wall by flexible gasket sealing.
3. SHELVES
Shelves are built in AISI 316L stainless steel and they are ground smooth finish to a roughness of average less than 0.5m. with internal channeling for product freezing and subsequent heating by circulation of thermal fluid. Direct contact of the fluid on both faces of the shelf and high flow-rate through the channeling ensure excellent temperature uniformity at all points on all shelves.
Shelf temperature range can be controlled between 55ºC and +70ºC depending on the lyophillization step being performed. There are several temperature sensors for monitoring the product temperature and the number of sensors depends on customer requirements. The sensor with enough lengths cable will be for flexible movement, so that it can be inserted to any product container on any shelf. Meanwhile there are two temperature sensors located at the silicone oil inlet and outlet separately to measure the shelves temperature.
Above the top useable shelf there is an extra-unloaded shelf to thermally balance the complete assembly.
Lyophilizer is used for pharmaceutical, food, bio product, blood product, vegetable and other goods.