A point cooling control device for a water for injection system

Abstract

The utility model discloses a point cooling control device for water for injection system, including main pipeline, branch line and heat exchanger, be equipped with third valve on the main pipeline, be equipped with heat exchanger on the branch line, the export end of branch line is connected with the water outlet pipe, another end of water outlet pipe can pass through third valve and the main pipeline intercommunication, be equipped with fifth valve on the water outlet pipe for realizing the closing and opening of water outlet. Through the technical scheme provided in the application, hot water point and low temperature water point coexist in the same circulation loop. And automatic control, simple and convenient operation.

Description

Technical Field

[0001] This utility model relates to the technical field of cooling control devices, specifically to a point cooling control device for a water for injection system. Background Technology

[0002] Pharmaceutical water, as the most widely used process raw material in the pharmaceutical industry, participates in the entire pharmaceutical production process, including raw material production, separation and purification, and finished product preparation. It can be used as a component, solvent, and diluent for pharmaceuticals. Furthermore, pharmaceutical water has extremely strong dissolving power and very few impurities, making it widely used for cleaning pharmaceutical equipment and systems. It directly affects the pharmaceutical production process and is an important component of GMP quality management and validation in pharmaceutical companies.

[0003] From a hygienic perspective of pharmaceutical production, microbial contamination of raw materials, the production environment, and finished products is a significant factor leading to production failures and substandard products. Appendix 1 of the 2010 Chinese GMP (Good Manufacturing Practice) for Sterile Drugs stipulates that: "The production of sterile drugs must meet the requirements for their quality and intended use, and should minimize contamination by microorganisms, various particles, and pyrogens. The skills, training, and work attitude of production personnel are key factors in achieving these goals. The production of sterile drugs must be strictly carried out according to carefully designed and validated methods and procedures. The sterility or other quality characteristics of the product must never rely solely on any form of final processing or finished product inspection."

[0004] To ensure medication safety, the final quality of sterile drugs must meet the relevant requirements of the pharmacopoeia. Injectable drugs must be manufactured using aseptic processes to ensure the final drug is sterile and pyrogen-free. Aseptic manufacturing processes refer to methods for producing sterile preparations under aseptic control conditions. Aseptic dispensing and aseptic freeze-drying are the most common aseptic manufacturing processes; the latter requires filtration sterilization during the process. The cleanliness of the production environment should be closely monitored during aseptic manufacturing processes, and filtration operations should be performed under aseptic control. Related equipment, packaging containers, stoppers, and other items should be sterilized using appropriate methods to prevent recontamination.

[0005] In recent years, the hazards caused by foreign bodies and particulate contamination in injectable drugs have attracted widespread attention. Larger particles can cause local circulatory disorders and lead to vascular embolism; excessive particles can cause local blockage and insufficient blood supply, resulting in tissue hypoxia, edema, and phlebitis; after foreign bodies invade tissues, they can cause macrophages to surround and proliferate, leading to granulomas. In addition, particles can also cause allergic reactions and pyrogenic reactions. Therefore, if injectable drugs contain a large number of invisible particulate foreign bodies, the harm is latent and long-term.

[0006] In pharmaceutical manufacturing processes, the particulate matter content in purified water, water for injection, and pure steam must be strictly controlled. In the pharmaceutical water preparation stage, the main function of the pharmaceutical water preparation units (such as purified water machines, distilled water machines, and pure steam generators) is to stably provide pharmaceutical water that meets pharmacopoeia quality standards for the storage and distribution system. Unit operations such as mechanical filtration, softening, and distillation all help remove a large number of particles from the raw water. The pharmacopoeia's regulations on clarity and non-volatile matter content are also aimed at effectively controlling particulate matter contamination in pharmaceutical water. Generally, pharmaceutical water preparation equipment can effectively control the particulate matter content of the produced water. However, in the pharmaceutical water storage and distribution stages, the system itself lacks purification capabilities. Practice shows that the risk of particulate matter contamination in pharmaceutical water systems occurs more frequently during the storage and distribution stages.

[0007] Due to the demands of production processes, some injection water points require cooling, such as water for ingredient preparation, cleaning, and other process water. How to design a system where hot water and low-temperature water points coexist within the same circulation loop has become a research direction for those skilled in the art. Summary of the Invention

[0008] The purpose of this invention is to provide a point cooling control device for a water for injection system, in order to solve the technical problems existing in the background art.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A point cooling device for a water-for-injection system includes a main pipeline, branch pipelines, and a heat exchanger, wherein a third valve is provided on the main pipeline;

[0011] A heat exchanger is installed on the branch pipe; a water outlet pipe is connected to the outlet end of the branch pipe.

[0012] The other end of the outlet pipe can be connected to the main pipeline through a third valve;

[0013] The water outlet pipe is equipped with a fifth valve, which is used to close and open the water outlet.

[0014] In some embodiments, the device further includes a control panel, which has a high-temperature water button, a cooling water button, and red and green indicator lights. By activating the high-temperature water button, the high-temperature water for injection in the branch pipeline enters the device through the outlet point of the outlet pipe. By activating the cooling water button, the high-temperature water for injection in the branch pipeline, after being cooled by the heat exchanger, enters the device through the outlet point of the outlet pipe. When the high-temperature water for injection reaches the required temperature, the red indicator light turns green.

[0015] In some embodiments, a fourth valve is provided on the side of the outlet pipe near the third valve for draining water through the fourth valve.

[0016] In some embodiments, the third valve is a pneumatically operated normally open diaphragm valve.

[0017] In some embodiments, the fourth valve is a pneumatically operated normally closed diaphragm valve.

[0018] In some embodiments, a manual diaphragm valve is provided on the main pipeline.

[0019] In some embodiments, a manual diaphragm valve is provided on the branch line.

[0020] In some embodiments, a ninth valve is provided on the inlet pipe of the heat exchanger.

[0021] The beneficial effects that the point cooling control device for a water-for-injection system disclosed in this application may bring include, but are not limited to:

[0022] The technical solution provided in this application enables the coexistence of hot water and low-temperature water usage points in the same circulation loop. Furthermore, it features automated control and is simple and convenient to operate. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of this utility model. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0025] Conversely, this application covers any substitutions, modifications, equivalent methods, and schemes made within the spirit and scope of this application as defined in the claims. Furthermore, to provide the public with a better understanding of this application, certain specific details are described in detail below. However, this application can be fully understood by those skilled in the art even without these detailed descriptions.

[0026] like Figure 1 As shown, a point cooling device for a water-for-injection system includes a main pipeline 6, a branch pipeline 7, and a heat exchanger 8. A third valve is installed on the main pipeline 6; the heat exchanger 8 is installed on the branch pipeline 7; an outlet pipe is connected to the outlet end of the branch pipeline 7; the other end of the outlet pipe can be connected to the main pipeline 6 through the third valve; a fifth valve is installed on the outlet pipe for closing and opening the outlet. A fourth valve is installed on the side of the outlet pipe near the third valve for draining water.

[0027] In some embodiments, the third valve is a pneumatically operated normally open diaphragm valve. The fourth valve is a pneumatically operated normally closed diaphragm valve. A manual diaphragm valve is provided on the main pipeline 6. A manual diaphragm valve is provided on the branch pipeline 7. A ninth valve is provided on the inlet pipe of the heat exchanger 8.

[0028] 1) When cooling water points are used for equipment locations, valve settings are as follows: Figure 1 As shown, the control panel has three buttons and one indicator light. The three buttons are the high-temperature water button, the cooling water button, and the stop button.

[0029] When a point is not in use, the red / green indicator light will show red. Valve 4, valve 5, and valve 9 remain closed, while valve 3 remains open.

[0030] When the high-temperature water button is pressed, valve 3 closes and valve 5 opens, allowing high-temperature water for injection to enter the equipment. When the stop button is pressed, valve 5 closes and valve 3 opens, allowing the high-temperature water for injection to return to the main pipeline 6 for recirculation.

[0031] When the cooling water button is pressed, valve 3 closes and valve 9 opens, allowing the injection water entering heat exchanger 8 to begin cooling. If the cooling water does not reach the required temperature, the red-green indicator light illuminates red, and valve 4 remains open, allowing the injection water to drain into the drain pipe. When the cooling water reaches the required temperature, the red indicator light illuminates green, valve 4 closes, and valve 5 opens. The cooling injection water then enters the equipment in use. Pressing the stop button closes valves 5 and 9, and valve 4 opens, discharging the cooling injection water in the pipe into the drain pipe. Once the detected temperature reaches the circulation temperature, valve 3 opens and valve 4 closes, the red-green indicator light illuminates red, and the high-temperature injection water returns to the main pipeline 6 for circulation.

[0032] 2) When the cooling water point is used as a water tank location. For example... Figure 1 As shown, the sixth valve (6) is removed, and the fifth valve (5) is replaced with a manual diaphragm valve, installed above the water tank. The control panel has three buttons and one indicator light.

[0033] When a point is not in use, the red / green indicator light will show red. Valve 4, valve 5, and valve 9 remain closed, while valve 3 remains open.

[0034] When the high-temperature water button is pressed, the third valve 3 closes and the fifth valve 5 opens, allowing high-temperature water for injection to enter the water tank. When the stop button is pressed, the fifth valve 5 closes and the third valve 3 opens, allowing the high-temperature water for injection to return to the main pipeline 6 for recirculation.

[0035] When the cooling water button is pressed, valve 3 closes and valve 9 opens, allowing the injection water entering heat exchanger 8 to begin cooling. If the cooling water does not reach the required temperature, the red / green indicator light illuminates red, and valve 4 remains open, allowing the injection water to drain into the drain pipe. When the cooling water reaches the required temperature, the red indicator light illuminates green, and valve 4 closes. Valve 5 can be manually opened to use the cooling injection water; when not in use, valve 5 should be manually closed. If the system is not in use for an extended period, pressing the stop button closes valve 9 and opens valve 4, allowing the cooling injection water in the pipe to drain into the drain pipe. Once the detected temperature reaches the circulation temperature, valve 3 opens and valve 4 closes, the red / green indicator light illuminates red, and the high-temperature injection water returns to the main pipeline 6 for circulation.

[0036] For water tank cooling applications, the valves are manually operated when using the above method. If the user wants fully automatic control, the fifth valve 5 can be removed and the fourth valve 4 can be installed above the water tank.

[0037] A manual diaphragm valve is installed on the main pipeline 6, which, together with the manual diaphragm valve on the branch pipeline 7, can better regulate the flow rate entering the main branch pipeline, while also better controlling the flow velocity in the pipeline, ensuring turbulent flow of the injection water in the pipeline, and reducing the risk of microbial growth.

[0038] The fourth valve 4 and the fifth valve 5 are equipped with mechanical limit switches, which can effectively control the valve opening size and better control the outlet flow rate and velocity.

[0039] When more precise temperature control is required for cooling, the ninth valve (9) can be replaced with a pneumatic regulating angle seat valve to achieve more accurate temperature control.

[0040] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A point cooling control device for a water for injection system, comprising a main pipeline, branch pipelines, and a heat exchanger, characterized in that: A third valve is installed on the main pipeline; A heat exchanger is installed on the branch pipe; a water outlet pipe is connected to the outlet end of the branch pipe. The other end of the outlet pipe can be connected to the main pipeline through a third valve; The water outlet pipe is equipped with a fifth valve, which is used to close and open the water outlet.

2. The point cooling control device for a water for injection system according to claim 1, characterized in that: The device also includes a control panel, which has a high-temperature water button, a cooling water button, and red and green indicator lights. By activating the high-temperature water button, the high-temperature water for injection in the branch pipeline enters the equipment through the outlet point of the outlet pipe. By activating the cooling water button, the high-temperature water for injection in the branch pipeline, after being cooled by the heat exchanger, enters the equipment through the outlet point of the outlet pipe. When the high-temperature water for injection reaches the required temperature, the red indicator light turns green.

3. The point cooling control device for a water for injection system according to claim 1, characterized in that: A fourth valve is provided on the side of the water outlet pipe near the third valve, which is used to drain water.

4. The point cooling control device for a water for injection system according to claim 1, characterized in that: The third valve is a pneumatic normally open diaphragm valve.

5. The point cooling control device for a water for injection system according to claim 3, characterized in that: The fourth valve is a pneumatic normally closed diaphragm valve.

6. The point cooling control device for a water for injection system according to claim 1, characterized in that: A manual diaphragm valve is installed on the main pipeline.

7. The point cooling control device for a water for injection system according to claim 1, characterized in that: The branch pipeline is equipped with a manual diaphragm valve.

8. The point cooling control device for a water for injection system according to claim 1, characterized in that: The heat exchanger is equipped with a ninth valve on its inlet pipe.

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