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LYOPHILIZER is used for pharmaceutical, food, bio product, blood product,vegetable - details see: https://www.machineto.com/lyophilizer-10306385

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.

The chamber is fabricated from stainless steel AISI 316L. The internal surfaces of the chamber are ground smooth finish to a roughness of average less than 0.5m. Non ferrous materials have been avoided in its manufacturing.

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 front part is equipped with a stainless steel fascia with ground smooth finish average less than 0.75m, tightly closing the transition between the chamber flange and the aperture through the wall separating the clean room 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.

The hinges can be placed on the left or the right hand side at the customer's convenience, and the angle opening will be more than 110^o.

Multiple periphery latches mounted around the front chamber frame lock the door. The locking mechanism is surrounding latches inserting into or drawing out from the wedged groove of the door under condition of vacuum state during CIP and SIP. The mechanism is pneumatically driven and operated by an automatic program. In addition, there is a manual handle, which is provided to auxiliary close or open the door.

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.

Each useful shelf has a raised stainless steel edge around the sides and rear to ensure correct location of the product trays and proper stability of ampoules or vials.

Shelf temperature range can be controlled between 55C and +70C 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.

[small scale lyophilizer,we can design diffrent size according to reqirment]

At the bottom there is a stack shelf to support shelves when they are lifted down