What are the requirements for the control system for Bench Top Lyophilizers during lyophilization?
Bench Top Lyophilizers freeze-drying process requirements for the control system, the control system requires manual and automatic two ways to achieve the entire freeze-drying process and automatic plugging, automatic washing control.
The specific requirements for Bench Top Lyophilizers are:
(1) The lyophilization curve value can be stored on the disk, and real-time display and historical data display can be performed on the computer screen, and instant printing is supported. These curves include: A: material temperature curve; B: lamellar temperature curve; C: water vapor condenser curve; D: vacuum degree curve;
(2) Measurement error of the control system: temperature +1.0 ° C, vacuum + 10 Pa. The product moisture content is +1%. (3) The system can set or modify the freeze-drying curve of the product according to different products. During the freeze-drying process, the temperature of the heating plate, the heat supply, the vacuum degree of the cabinet, and the condensation of the water vapor condenser are adjusted. The temperature causes the material to track the set curve;
(4) The dryer performs the setting of the temperature of the water vapor condenser, and controls the temperature regulator of the refrigerator to track the set temperature;
(5) The vacuum degree in the tank can be set, and the required vacuum degree is adjusted by the micro-motion valve; (6) Fault alarm and treatment, including the starting pressure of the vacuum unit, and the vacuum degree exceeds the set value during the freeze-drying process. Alarm and related data display;
(7) Automatic stoppering of medicines: automatic sealing and sealing treatment of medicines and biological products before they are taken out of the box to ensure the clean and frozen state of the products and improve the quality of the frozen products;
(8) Disinfection between batch production before and after: In order to prevent cross-contamination, automatic disinfection in place between two batch production. Requires compliance with GMP standards.