Point cooling control device for injection water system

Abstract

The invention discloses a point cooling control device for an injection water system, which comprises a main pipeline, a branch pipeline and a heat exchanger, and a third valve is arranged on the main pipeline; a heat exchanger is arranged on the branch pipeline; the outlet end of the branch pipeline is connected with a water outlet pipe; the other end of the water outlet pipe can be communicated with the main pipeline through a third valve; and a fifth valve is arranged on the water outlet pipe and is used for closing and opening the water outlet. According to the technical scheme provided by the invention, coexistence of a hot water using point and a low-temperature water using point in the same circulation loop is realized. And automatic control and simple and convenient operation are realized.

Description

Technical Field

[0001] The invention relates to the technical field of temperature reduction control devices, and in particular to a point-of-use temperature reduction control device for a water for injection system. Background Art

[0002] Pharmaceutical water, the most widely used process raw material in the pharmaceutical industry, is involved 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, with its strong dissolving power and minimal impurities, pharmaceutical water is widely used for cleaning pharmaceutical equipment and systems. It directly impacts the pharmaceutical production process and is a crucial component of pharmaceutical companies' GMP quality management and validation.

[0003] From a hygienic perspective in pharmaceutical production, microbial contamination of raw materials, the production environment, and finished products is a significant factor contributing to production failure and substandard finished products. China's 2010 Good Manufacturing Practices (GMP) stipulates in "Appendix 1: Sterile Drugs" that "The production of sterile drugs must meet the requirements of their quality and intended use, minimizing contamination by microorganisms, various particulates, and heat sources. The skills, training, and work attitude of production personnel are key factors in achieving these goals. The production of sterile drugs must be carried out strictly in accordance with 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 testing."

[0004] To ensure drug safety, the final quality of sterile drugs must meet the relevant requirements of the pharmacopoeia. Injections must use an aseptic production process and ensure that the final drug is sterile and pyrogen-free. An aseptic production process refers to a method that must produce sterile preparations under aseptic control conditions. Aseptic packaging and aseptic lyophilization are the most common aseptic production processes. The latter requires filtration sterilization during the process. The aseptic production process should strictly monitor the cleanliness of its production environment, and filtration operations should be performed under a sterile controlled environment. Related equipment, packaging containers, stoppers and other items should be sterilized using appropriate methods and prevented from re-contamination.

[0005] In recent years, the hazards posed by foreign matter and particulate contamination in injectables have garnered widespread attention. Larger particles can cause local circulatory disturbances and vascular embolism; excessive particles can lead to localized blockages and insufficient blood supply, causing tissue hypoxia and edema and phlebitis. Foreign matter invading tissues can cause macrophages to surround and proliferate, leading to granulomas. Furthermore, particles can trigger allergic reactions and pyrogenic reactions. Therefore, the hazards of injectables containing large numbers of invisible foreign particles are potentially long-lasting.

[0006] In pharmaceutical production processes, the particulate matter content of purified water, water for injection, and pure steam must be strictly controlled. In the pharmaceutical water preparation process, the primary function of pharmaceutical water preparation units (such as purified water machines, distilled water machines, and pure steam generators) is to stably provide pharmaceutical water that meets pharmacopoeial quality standards for the storage and distribution system. Unit operations such as mechanical filtration, softening, and distillation all help remove large quantities of particulate matter from the raw water. The pharmacopoeia's regulation of indicators such as clarity and non-volatile matter is also intended to effectively control particulate 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 process, the system itself lacks purification capabilities. Practice has shown that the risk of particulate contamination in pharmaceutical water systems is more likely to occur during storage and distribution.

[0007] Due to production requirements, some water for injection (WFI) points, such as those used for batching, cleaning, and other production processes, require cooling. Designing a system that allows both hot and low-temperature water points to coexist within the same circulation loop has become a research topic for those skilled in the art. Summary of the Invention

[0008] The purpose of the present invention is to provide a point-of-use temperature reduction control device for a water for injection system, in order to solve the technical problems existing in the background technology.

[0009] In order to achieve the above object, the present invention adopts the following technical solutions:

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

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

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

[0013] The water outlet pipe is provided with a fifth valve for closing and opening the water outlet.

[0014] In some embodiments, the device also includes a control panel, which is provided with 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 injection water in the branch pipe enters the use equipment through the water outlet point of the outlet pipe; by activating the cooling water button, the high-temperature injection water in the branch pipe that has been cooled by the heat exchanger enters the use equipment through the water outlet point of the outlet pipe; wherein, when the high-temperature injection water is cooled to the required temperature, the red indicator light turns green.

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

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

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

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

[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 water inlet pipe of the heat exchanger.

[0021] The beneficial effects that may be brought about by the point-of-use temperature control device for water for injection system disclosed in this application include but are not limited to:

[0022] The technical solution provided by this application enables the coexistence of hot water points and low-temperature water points in the same circulation loop, and is automated and easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a structural schematic diagram of the present invention. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solutions and advantages of this application more clearly understood, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0025] On the contrary, this application covers any alternatives, modifications, equivalents, and solutions made within the spirit and scope of this application as defined by the claims. Furthermore, to facilitate a better understanding of this application, certain specific details are described in detail below in the detailed description of this application. Those skilled in the art will be able to fully understand this application without these details.

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

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

[0028] 1) When cooling water point is used for equipment. Valve setting is as follows Figure 1 As shown in the figure, the control panel is provided with three buttons and an indicator light. The three buttons are a high temperature water button, a cooling water button and a stop button.

[0029] When the point is not in use, the red and green indicator light shows red. The fourth valve 4, the fifth valve 5, and the ninth valve 9 remain closed, and the third valve 3 remains open.

[0030] When the high-temperature water button is pressed, the third valve 3 is closed, the fifth valve 5 is opened, and the high-temperature injection water enters the device. When the stop button is pressed, the fifth valve 5 is closed, the third valve 3 is opened, and the high-temperature injection water returns to the main line 6 for circulation.

[0031] When the cooling water button is pressed, the third valve 3 closes and the ninth valve 9 opens, and the injection water entering the heat exchanger 8 begins to cool. If the cooling water does not reach the required temperature, the red and green indicators illuminate red, and the fourth valve 4 remains open, allowing the injection water to drain into the drainage pipe. When the cooling water reaches the required temperature, the red indicator lights green, the fourth valve 4 closes, and the fifth valve 5 opens. The cooled injection water enters the device. Pressing the stop button closes the fifth and ninth valves 5 and opens the fourth valve 4, allowing the cooled injection water in the pipeline to drain into the drainage pipe. Once the temperature reaches the circulation temperature, the third valve 3 opens and the fourth valve 4 closes. The red and green indicators illuminate red, and the high-temperature injection water returns to the main line 6 for circulation.

[0032] 2) When the cooling water point is used at the pool point. Figure 1 As shown in FIG, the sixth valve 6 is cancelled and the fifth valve 5 is replaced by a manual diaphragm valve and installed above the pool. The control panel is provided with three buttons and an indicator light.

[0033] When the point is not in use, the red and green indicator light shows red. The fourth valve 4, the fifth valve 5, and the ninth valve 9 remain closed, and the third valve 3 remains open.

[0034] When the high-temperature water button is pressed, the third valve 3 is closed, the fifth valve 5 is opened, and the high-temperature injection water enters the water tank. When the stop button is pressed, the fifth valve 5 is closed, the third valve 3 is opened, and the high-temperature injection water returns to the main line 6 for circulation.

[0035] When the cooling water button is pressed, the third valve 3 is closed and the ninth valve 9 is opened, and the injection water entering the heat exchanger 8 begins to cool down: when the cooling water does not reach the required temperature, the red and green indicator lights are red, and the fourth valve 4 remains open, and the injection water is discharged into the drainage pipe; when the cooling water reaches the required temperature, the red indicator light is green, and the fourth valve 4 is closed. The fifth valve 5 can be manually opened to use the cooling injection water. When not in use, the fifth valve 5 is manually closed. If it is not used for a long time, press the stop button, the ninth valve 9 is closed, the fourth valve 4 is opened, and the cooling injection water in the pipeline is discharged into the drainage pipe. When the temperature is detected to reach the circulation temperature, the third valve 3 is opened and the fourth valve 4 is closed. At this time, the red and green indicator lights are red, and the high-temperature injection water returns to the main line 6 for circulation.

[0036] For the use point of cooling the pool, the valve is manually operated when used in the above manner. When the user considers full automatic control, the fifth valve 5 can be cancelled and the fourth valve 4 can be installed above the pool.

[0037] A manual diaphragm valve is provided on the main line 6, and the manual diaphragm valve is provided on the branch line 7 to better regulate the flow entering the main branch line, while better controlling the flow rate in the pipeline, ensuring turbulence 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 provided with mechanical limits, which can well control the size of the valve opening and better control the flow rate and flow velocity of the outlet.

[0039] When there is a need for more accurate control of the cooling temperature, the ninth valve 9 can be changed to a pneumatically regulated angle seat valve to achieve more accurate temperature control.

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

Claims

1. A point-of-use cooling device for a water for injection system, comprising a main line, a branch line, and a heat exchanger, characterized in that: A third valve is provided on the main pipe; A heat exchanger is provided on the branch pipe; the outlet end of the branch pipe is connected to a water outlet pipe; The other end of the water outlet pipe can be connected to the main pipe through a third valve; The water outlet pipe is provided with a fifth valve for closing and opening the water outlet.

2. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: The device also includes a control panel, which is provided with 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 injection water in the branch pipe enters the use equipment through the water outlet point of the outlet pipe; by activating the cooling water button, the high-temperature injection water in the branch pipe that has been cooled by the heat exchanger enters the use equipment through the water outlet point of the outlet pipe; wherein, when the high-temperature injection water is cooled to reach the required temperature, the red indicator light turns green.

3. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: A fourth valve is provided on one side of the water outlet pipe close to the third valve for draining water through the fourth valve.

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

5. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: The fourth valve is a pneumatic normally closed diaphragm valve.

6. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: A manual diaphragm valve is provided on the main pipe.

7. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: A manual diaphragm valve is provided on the branch pipeline.

8. The point-of-use cooling device for water for injection system according to claim 1, characterized in that: A ninth valve is provided on the water inlet pipe of the heat exchanger.

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