Ceftriaxone sodium sterile closed smart drying system

Abstract

The present application relates to a kind of sterile closed smart drying system of ceftriaxone sodium, including dryer, field device layer, field control layer and monitoring management layer, field device layer includes each sensor and various functional valves, ceftriaxone sodium is cooled in vacuum state first in drying process, each sensor gathers data and is converted into signal transmission to field control layer and monitoring management layer, monitoring management layer shows drying state and each node parameter in real time, when the temperature in dryer drops to the lowest point, and solvent concentration meets process control standard, field control layer starts the heating cycle system of dryer and carries out temperature rising drying, when the temperature in dryer, vacuum, pressure, nitrogen inlet, moisture reaches preset value, various functional valves are automatically started and stopped.Ceftriaxone sodium sterile closed smart drying system of the present application can reduce the risk of contamination, drying process is closed, visual online intelligent control ceftriaxone sodium solvent residue and moisture value.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical and chemical technology, specifically to a sterile, closed, intelligent drying system for ceftriaxone sodium. Background Technology

[0002] During the drying process of sterile ceftriaxone sodium raw material in a desiccator, it is necessary to sample and analyze the moisture and solvent residue of the dried material. In order to ensure that the dried material is not contaminated by bacteria or that foreign objects enter the desiccator, the drying process cannot be frequently paused to open the desiccator for sampling, thus disrupting the sealed environment of the desiccator.

[0003] During the sampling process, operations such as stopping the vacuum, stopping the nitrogen replacement to balance the pressure, and stopping the heating pump are required. When sampling from the open, the solvent odor in the dryer space will overflow, which is not conducive to safety and environmental protection control. Frequent manual start-up and shutdown of the drying equipment is labor-intensive and not conducive to occupational health.

[0004] Even when using open-ended sampling analysis based on experience summarized from conditions such as drying time, drying temperature, and drying vacuum, a certain period of time is required in the process of sampling, sending for testing, and receiving Karl Fischer analysis results. Ceftriaxone sodium, which is relatively sensitive to heat and humidity, may undergo quality changes or changes in the actual moisture content due to moisture absorption during this process, further increasing the risk of bacterial contamination. Summary of the Invention

[0005] To address the technical problems existing in the prior art, this invention provides a sterile, closed, intelligent drying system for ceftriaxone sodium, which can reduce the risk of bacterial contamination. The drying process does not require breaking the vacuum and sterile environment of the dryer, and there is no need for frequent opening for sampling and analysis. The entire process achieves closed, visualized, online intelligent control of the solvent residue and moisture value of ceftriaxone sodium.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows:

[0007] A sterile, closed, intelligent drying system for ceftriaxone sodium includes a dryer, a field equipment layer, a field control layer, and a monitoring and management layer. The field equipment layer includes an online solvent concentration detector, a moisture sensor, a temperature sensor, a pressure sensor, and actuators. The actuators include various functional valves. The field control layer includes a programmable controller. During the ceftriaxone sodium drying process, the system is first cold-pumped under vacuum. The online solvent concentration detector, moisture sensor, temperature sensor, and pressure sensor collect data and convert the data into signals, which are then transmitted to the programmable controller and the monitoring and management layer. The monitoring and management layer displays the drying status and parameters at each node in real time. When the temperature inside the dryer drops to its lowest point and the solvent concentration meets the process control standards, the programmable controller starts the heating circulation system of the dryer to raise the temperature for drying. When the monitoring and management layer detects that the temperature, vacuum, pressure, nitrogen inlet, and online moisture content inside the dryer have reached preset values, the programmable controller controls the automatic start and stop of various functional valves.

[0008] As a preferred technical solution, the actuator includes a nitrogen valve. During the cold pumping process, when the vacuum level is higher than -0.06MPa, the programmable controller controls the nitrogen valve to increase its opening degree, and when the vacuum level is lower than -0.04MPa, the programmable controller controls the nitrogen valve to decrease its opening degree.

[0009] As a preferred technical solution, when the residual solvent value is less than 0.5% and the temperature inside the dryer drops to 0°C, the temperature begins to rise slowly. Once the temperature reaches 5°C, the programmable controller controls the valves of the dryer's heating circulation system to open and begin the heating operation.

[0010] As a preferred technical solution, when the temperature inside the dryer reaches the preset 45°C, the programmable controller controls the heating circulation system valve to automatically close, and constant temperature vacuum drying is carried out. The monitoring and management system displays the temperature, vacuum, and moisture values ​​inside the dryer in real time, and opens the nitrogen valve and the intelligent interlock controller of the pressure and vacuum system in the actuator according to the preset interval.

[0011] As a preferred technical solution, the upper limit of temperature during the constant temperature vacuum drying process is 50±2℃. When the temperature is below 45℃, the dryer starts the heating circulation system.

[0012] As a preferred technical solution, a moisture sensor provides feedback on the moisture content of ceftriaxone sodium, while a temperature sensor provides feedback on the temperature. When the moisture value is less than 9.5%, the system automatically switches the refrigerant circulation. When the temperature drops to 25℃~20℃, the moisture value of ceftriaxone sodium continues to decrease, and the system starts the humidification system of the dryer according to the preset program to linearly increase the humidity of the material in the dryer. When the moisture value meets the process requirements, the system automatically stops vacuuming through the terminal program.

[0013] As a preferred technical solution, the humidification system includes a humidifier, a constant temperature chamber, a constant temperature pipeline, a sterile filter element, a universal nozzle, and a self-regulating valve. The humidifier, constant temperature chamber, self-regulating valve, and universal nozzle are connected sequentially through the constant temperature pipeline. The universal nozzle is installed inside the dryer. The sterile filter element is installed in the constant temperature pipeline between the self-regulating valve and the universal nozzle. Both the humidifier and the self-regulating valve are connected to a programmable controller.

[0014] As a preferred technical solution, when the moisture and solvent residue are dried to the range required by the process, the monitoring and management system opens the nitrogen valve in the actuator through the programmable controller until the pressure data fed back by the pressure sensor reaches the preset pressure value, and then performs automatic pressure holding control.

[0015] As a preferred technical solution, the monitoring and management layer includes an industrial control computer, a remote computer, and a mobile terminal. The industrial control computer is connected to a programmable controller, and the remote computer and mobile terminal display the drying status and parameters of each node in real time to monitor the ceftriaxone sodium drying process. The data is saved and transmitted during the drying process through the drivers built into the remote computer and mobile terminal.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0017] This invention discloses a sterile, closed, intelligent drying system for ceftriaxone sodium, modeled after a distributed control system, achieving centralized management and decentralized control of the equipment. The drying process does not require disrupting the vacuum and sterile environment of the dryer, eliminating the need for frequent opening for sampling and analysis. Throughout the process, the solvent residue and moisture content of ceftriaxone sodium are intelligently controlled online in a closed and visualized state, improving work efficiency, reducing labor intensity, and facilitating the stable control of the quality of sterile ceftriaxone sodium products. Attached Figure Description

[0018] Figure 1 This is a block diagram illustrating the working principle of the ceftriaxone sodium aseptic closed intelligent drying system of the present invention;

[0019] Figure 2 This is a schematic diagram of the structure of the aseptic closed intelligent drying system for ceftriaxone sodium of the present invention.

[0020] In the diagram: 1. Dryer; 21. Online solvent concentration detector; 22. Moisture sensor; 23. Temperature sensor; 24. Pressure sensor; 25. Nitrogen valve; 3. Programmable controller; 41. Industrial computer; 42. Remote computer; 43. Mobile terminal; 51. Humidifier; 52. Thermostatic chamber; 53. Automatic valve; 54. Universal nozzle; 55. Sterile filter element. Detailed Implementation

[0021] The technical solution of the present invention will be further described below with reference to specific embodiments:

[0022] like Figure 1 As shown, a sterile, closed, intelligent drying system for ceftriaxone sodium includes a dryer 1, a field equipment layer, a field control layer, and a monitoring and management layer. The field equipment layer includes an online solvent concentration detector 21, a moisture sensor 22, a temperature sensor 23, a pressure sensor 24, and an actuator. The actuator includes a nitrogen valve 25. The field control layer includes a programmable controller 3. The monitoring and management layer includes an industrial computer 41, a remote computer 42, and a mobile terminal 43. The industrial computer 41 is connected to the programmable controller 3. The remote computer 42 and the mobile terminal 43 display the drying status and parameters of each node in real time, monitor the ceftriaxone sodium drying process, and complete the data storage and transmission during the drying process through the driver programs built into the remote computer 42 and the mobile terminal 43. During the drying process of ceftriaxone sodium, the system is first cold-pumped under vacuum. The online solvent concentration detector 21 and temperature sensor 23 collect data and convert the data into signals, which are then transmitted to the programmable controller 3 and the monitoring and management layer. The monitoring and management layer displays the drying status and parameters of each node in real time. When the temperature inside the dryer 1 drops to the lowest point and the solvent concentration meets the process control standard, the programmable controller 3 starts the heating circulation system of the dryer 1 to heat up and dry. When the monitoring and management layer detects that the temperature, vacuum, pressure, nitrogen inlet, and online moisture content inside the dryer 1 have reached the preset values, the programmable controller 3 controls the actuator to start and stop automatically.

[0023] like Figure 2 As shown, in this embodiment, the operation mode of the ceftriaxone sodium aseptic closed intelligent drying system is as follows:

[0024] The wet ceftriaxone sodium is added into dryer 1 through a closed feeding device, and the stirring is turned on to start the intelligent drying system.

[0025] The system performs a vacuuming operation inside dryer 1 according to the program. During this process, when the vacuum level is higher than -0.06 MPa (absolute value), the programmable controller 3 controls the nitrogen valve 25 to increase its opening appropriately; when the vacuum level is lower than -0.04 MPa (absolute value), the programmable controller 3 controls the nitrogen valve 25 to decrease its opening appropriately. The remote computer 42 and mobile terminal 43 can display the solvent concentration, temperature, vacuum level, and opening / closing status of the nitrogen valve 25 inside dryer 1 in real time. When the residual solvent value is less than 0.5% and the temperature inside dryer 1 drops to 0℃, it begins to slowly heat up. After the temperature reaches 5℃, the industrial control computer 41 automatically controls the valves of the heating circulation system of dryer 1 to open through the programmable controller 3 to perform the heating operation.

[0026] When the temperature inside dryer 1 reaches the preset 45℃, the system automatically stops heating and performs constant temperature vacuum drying. During the constant temperature vacuum drying process, the temperature can be buffered up to 50±2℃. When the temperature drops below 45℃, the system starts the heating circulation system. The remote computer 42 and mobile terminal 43 display the temperature, vacuum level, and moisture content inside dryer 1 in real time, and open the nitrogen valve 25 in the actuator and the intelligent interlock controller of the pressure and vacuum system according to the preset interval.

[0027] Moisture sensor 22 provides feedback on the moisture content of ceftriaxone sodium, while temperature sensor 23 provides feedback on the temperature. When the moisture content is less than 9.5%, the system automatically switches to refrigerant circulation. When the temperature drops to 25℃~20℃, and the moisture content of ceftriaxone sodium continues to decrease slowly, the system automatically activates the humidification system to linearly increase the humidity of the material in dryer 1, automatically controlling the moisture content in dryer 1 within the range of 8.8%~9.8%. The humidification system includes a humidifier 51, a constant temperature chamber 52, constant temperature piping, a sterile filter element 55, a universal nozzle 54, and a self-regulating valve 53. The humidifier 51, constant temperature chamber 52, self-regulating valve 53, and universal nozzle 54 are connected sequentially through constant temperature piping. The universal nozzle 54 is installed inside dryer 1, and the sterile filter element 55 is installed in the constant temperature piping between the self-regulating valve 53 and the universal nozzle 54. Both the humidifier 51 and the self-regulating valve 53 are connected to the programmable controller 3. The humidification system, combined with the moisture sensor 22 and linear temperature change, can realize online moisture monitoring and interlocking intelligent control. It has the advantages of timely feedback, continuous drying to near the target moisture value, avoiding blind drying and sampling, and reliable technology.

[0028] Once the moisture content meets the process requirements, the system automatically stops vacuuming via the terminal program. Simultaneously, the monitoring and management layer opens the nitrogen valve 25 via the programmable controller 3 to replenish pressure into the dryer 1. When the pressure data fed back by the pressure sensor 24 reaches the preset pressure value of 0.02 MPa, automatic pressure maintenance control is implemented to maintain a certain positive pressure inside the dryer 1, thereby intelligently protecting the quality and safety of the ceftriaxone sodium material.

[0029] This embodiment is merely a further explanation of the present invention and is not intended to limit the present invention. Those skilled in the art can make non-inventive modifications to this embodiment as needed after reading this specification, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A sterile, closed, intelligent drying system for ceftriaxone sodium, comprising a dryer, characterized in that, It also includes a field equipment layer, a field control layer, and a monitoring and management layer. The field equipment layer includes an online solvent concentration detector, a moisture sensor, a temperature sensor, a pressure sensor, and actuators. The actuators include various functional valves. The field control layer includes a programmable controller. During the drying process of ceftriaxone sodium, it is first cold-pumped under vacuum. The online solvent concentration detector, moisture sensor, temperature sensor, and pressure sensor collect data and convert the data into signals, which are then transmitted to the programmable controller and the monitoring and management layer. The monitoring and management layer displays the drying status and parameters of each node in real time. When the temperature inside the dryer drops to the lowest point and the solvent concentration meets the process control standard, the programmable controller starts the heating circulation system of the dryer to heat up and dry. When the monitoring and management layer detects that the temperature, vacuum degree, pressure, nitrogen inlet, and online moisture inside the dryer reach preset values, the programmable controller controls the various functional valves to start and stop automatically. The actuator includes a nitrogen valve. During the cold pumping process, when the vacuum level is higher than -0.06MPa, the programmable controller controls the nitrogen valve to increase its opening degree, and when the vacuum level is lower than -0.04MPa, the programmable controller controls the nitrogen valve to decrease its opening degree. When the residual solvent value is less than 0.5% and the temperature inside the dryer drops to 0℃, it begins to slowly heat up. Once the temperature reaches 5℃, the programmable controller controls the valves of the dryer's heating circulation system to open and begin the heating operation. When the temperature inside the dryer reaches the preset 45℃, the programmable controller controls the heating circulation system valve to automatically close, and constant temperature vacuum drying is carried out. The monitoring and management system displays the temperature, vacuum, and moisture content inside the dryer in real time, and opens the nitrogen valve and the pressure and vacuum system intelligent interlock controller in the actuator according to the preset interval. The moisture sensor provides feedback on the moisture content of ceftriaxone sodium, while the temperature sensor provides feedback on the temperature. When the moisture value is less than 9.5%, the system automatically switches the refrigerant circulation. When the temperature drops to 20-25℃, the moisture value of ceftriaxone sodium continues to decrease, and the system starts the humidification system of the dryer according to the preset program to linearly increase the humidity of the material in the dryer. When the moisture value meets the process requirements, the system automatically stops vacuuming through the terminal program.

2. The aseptic closed intelligent drying system for ceftriaxone sodium according to claim 1, characterized in that, The upper limit of temperature during constant temperature vacuum drying is 50±2℃. When the temperature is below 45℃, the dryer starts the heating circulation system.

3. The aseptic closed intelligent drying system for ceftriaxone sodium according to claim 1, characterized in that, The humidification system includes a humidifier, a constant temperature chamber, a constant temperature pipeline, a sterile filter element, a universal nozzle, and a self-regulating valve. The humidifier, constant temperature chamber, self-regulating valve, and universal nozzle are connected sequentially through the constant temperature pipeline. The universal nozzle is installed inside the dryer. The sterile filter element is installed in the constant temperature pipeline between the self-regulating valve and the universal nozzle. Both the humidifier and the self-regulating valve are connected to a programmable controller.

4. The aseptic closed intelligent drying system for ceftriaxone sodium according to claim 1, characterized in that, When the moisture and solvent residue have dried to the range required by the process, the monitoring and management layer opens the nitrogen valve in the actuator through the programmable controller until the pressure data fed back by the pressure sensor reaches the preset pressure value, and then performs automatic pressure holding control.

5. The aseptic closed intelligent drying system for ceftriaxone sodium according to claim 1, characterized in that, The monitoring and management layer includes an industrial control computer, a remote computer, and a mobile terminal. The industrial control computer is connected to a programmable controller, and the remote computer and mobile terminal display the drying status and parameters of each node in real time to monitor the ceftriaxone sodium drying process. The data is saved and transmitted during the drying process through the drivers built into the remote computer and mobile terminal.

Images