Pharmaceutical lyophilizer

This lyophilizer is applicable for processing blood products, API, vaccine and antibiotic medicine in pharmacy filed.

TECHNICAL DESCRIPTION

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.

2. 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 -55°C and +70°C depending on the lyophillization step being performed.

                Above the top useable shelf there is an extra-unloaded shelf to thermally balance the complete assembly.

3. 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.

                The vessel is fabricated from stainless steel AISI 316L. Non ferrous materials have been avoided in its manufacturing.

4. Refrigerating system

                The compressor is semi-hermetic two piston reciprocating type with sub-cooling device.               

                The compressor is provided with a dual-purpose operation system: to freeze the product, cooling of the shelves via direct expansion of refrigerant in the plate heat-exchanger installed on the shelf silicone oil circuit, to cool the condenser coils by direct expansion of refrigerant to collect the water vapor from product during the drying sequence.

5. Vacuum system

                Vacuum pump plus mechanical booster pump (for big machine only) are used to evacuate the complete system (i.e. less than 0.01 mbar vacuum). 

                      

6. CIP function

                Using 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,

7. SIP function

              Sterilizable freeze dryers offer the most adequate solution to process sterile products, ensuring the lowest contamination risk.The freeze dryer chamber and ice condenser are designed for sterilization with pure steam and in compliance with pressure vessel regulations and norms.

Pharmaceutical lyophilizer