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Lyophilizers are widely used in the pharmaceutical, food, biotech, blood product, and vegetable industries for the freeze-drying process. These machines ensure the preservation of sensitive products by removing water through sublimation under vacuum conditions. The system is designed to meet strict cGMP standards, ensuring hygiene, safety, and efficiency throughout the entire process.
The chamber is typically designed as a horizontal parallelepiped or cylindrical structure, housing the shelf package. All edges and corners are rounded to facilitate easy cleaning and comply with cGMP requirements. It is engineered to handle high vacuum environments and withstand overpressure during steam sterilization. A transparent viewing port, made of borosilicate glass and AISI 316L stainless steel, is installed on one side for visual inspection from the machine room. The chamber floor slopes toward the rear, leading to a drainage outlet that simplifies cleaning with water for injection or an integrated CIP system.
All connections, including ports and piping, are of the clamp sanitary type. A reserved clamp port is provided for validation purposes, such as monitoring steam sterilization, pressure, and temperature. The chamber also includes a lifting mechanism to aid in handling and installation. Standard connections include isolation valves, thermal fluid inlets and outlets, steam and cleaning water lines, a hydraulic flange for shelf movement, a validation port, a viewing window, and a drain. For larger units (over 5 m²), a cooling jacket is often added to the chamber wall for efficient 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 smooth finish. A central viewing window, made of the same material and glass, allows for inspection from the cleanroom. The door is sealed using a T-shaped or O-shaped silicone or fluorine gasket, designed for high vacuum and overpressure operation. The gasket is positioned within the frame and compressed against the chamber surface under vacuum to prevent water accumulation during CIP or SIP cycles.
Two safety interlock systems are in place: a limit switch and a latch feedback signal. If either fails, the CIP or SIP process cannot proceed. Temperature and pressure controls are also interlocked to protect both the operator and the equipment. A sterile wall flange made of stainless steel 304 connects the rear sterile wall, featuring a smooth surface (less than 0.75 µm roughness) and sealed with a flexible gasket.
Shelves are constructed from AISI 316L stainless steel, finished to a smooth surface with a roughness of less than 0.5 µm. Internal channels allow for the circulation of thermal fluid, enabling efficient freezing and heating of the product. The direct contact of the fluid with both sides of the shelf ensures uniform temperature distribution across all shelves. Shelf temperatures can be controlled between -55°C and +70°C, depending on the lyophilization stage. Multiple temperature sensors are installed, with cable lengths allowing flexibility for placement in any product container. Two additional sensors monitor the temperature of the silicone oil at the inlet and outlet. An extra unloaded shelf is placed above the top usable shelf to help balance the thermal performance of the entire assembly.