Lyophilizers are widely used in the pharmaceutical, food, biotech, blood product, and vegetable industries for freeze-drying processes. These machines ensure the preservation of sensitive materials by removing water through sublimation under vacuum conditions. The design is tailored to meet high standards of hygiene, efficiency, and safety, particularly in compliance with cGMP regulations.
The chamber is typically designed as a horizontal parallelepiped or cylindrical structure, housing the shelf system. All edges and corners are rounded for easy cleaning, ensuring a smooth surface that minimizes contamination risks. The chamber is built to handle high vacuum environments and can withstand overpressure during steam sterilization, making it suitable for critical applications.
A key feature is the illuminated viewing port on one side, allowing operators to monitor the process from the machine room. The inner surfaces are made of AISI 316L stainless steel and borosilicate glass, providing durability and clarity. The bottom of the chamber is sloped towards the rear, leading to a drainage outlet, which simplifies cleaning using water for injection or integrated CIP systems.
All ports and connections are of the clamp sanitary type, ensuring aseptic conditions. A dedicated validation port is also included for monitoring parameters such as temperature, pressure, and steam sterilization. The chamber is equipped with lifting mechanisms to ease installation and handling.
Standard connections include isolation valves, thermal fluid inlets and outlets, steam and cleaning water lines, hydraulic flanges for shelf movement, validation ports, an illuminated view port, and a drain. For larger units (over 5 m²), a cooling jacket is added to the chamber walls to assist in post-sterilization cooling.
The door is constructed from polished AISI 316L stainless steel, with a surface roughness of less than 0.5 µm, ensuring a clean and hygienic finish. A central viewing window, made of stainless steel and borosilicate glass, allows visibility from the clean room. The door uses a T-shaped or O-shaped silicone gasket, designed for high vacuum and overpressure conditions, ensuring a tight seal without air entrapment.
Two safety interlocks are in place: a limit switch and a latch feedback signal, preventing operation if the door is not properly secured. Temperature and pressure interlocks further enhance safety. A sterile wall flange made of stainless steel 304 connects the chamber to the clean room, with a smooth surface finish to maintain sterility.
Shelves are fabricated from AISI 316L stainless steel, with a ground smooth finish (average roughness < 0.5 µm). They feature internal channels for product freezing and heating via thermal fluid circulation. The design ensures even heat distribution across all shelves, with direct contact between the fluid and both sides of the shelf. Shelf temperatures can be controlled between -55°C and +70°C, depending on the lyophilization stage.
Multiple temperature sensors are installed to monitor product temperature, with cable lengths designed for flexibility. Additional sensors at the silicone oil inlet and outlet measure shelf temperatures accurately. An extra unloaded shelf is positioned above the top usable shelf to balance thermal distribution throughout the system. This ensures optimal performance and product quality during the freeze-drying process.
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