Non-distillation injection water preparation system

Abstract

The present invention provides a non-distillation injection water preparation system, the non-distillation injection water preparation system comprises a pure water production system and an injection water production system connected to each other, the pure water production system comprises a purification module, a first treatment module and a first storage module, untreated raw material water in an external feed source is purified by the purification module and the first treatment module and then enters the first storage module, the injection water production system comprises a second treatment module, a filtering module and a second storage module, and purified water purified by the pure water production system flows out of the first storage module; and the water enters the second storage module through the second processing module and the filtering module. According to the non-distillation injection water preparation system, purified water and injection water can be produced at the same time through a short non-distillation process, the process preparation standard of pharmacopeia is met, the water using process at the rear end of production can be effectively simplified, and the investment cost and the operation cost of the whole system are reduced.

Description

Technical Field

[0001] The present application relates to the technical field of non-distilled water for injection preparation, and in particular to a non-distilled water for injection preparation system. Background Art

[0002] The current production process of water for injection mainly adopts high-temperature distillation, but this process has the following problems: First, the high-temperature distillation process needs to be equipped with an adequate steam reserve system, resulting in large steam consumption and high energy consumption, which in turn pushes up the unit cost of water for injection; second, since high-temperature distillation produces high-temperature water in the preparation stage, while low-temperature water is required in the actual application stage, it needs to be cooled by a cooling water system, resulting in a large amount of cooling water consumption; third, the operating temperature of the high-temperature distillation process system is relatively high, which can easily cause red rust to grow during the production process, and the existing technology lacks an effective solution. If higher-specification materials are used, the initial investment cost will increase significantly; finally, the high-temperature distillation process usually needs to be equipped with an independent purified water system to supply water to the water for injection preparation system, resulting in the purified water and water for injection systems operating completely independently, the system structure is complex and the investment cost is too high.

[0003] In addition to the aforementioned issues of high system energy consumption, unstable water quality, and susceptibility to red rust caused by high-temperature distillation processes, the production process for water for injection must also meet the specific requirements of various pharmacopoeias. For example, the European Pharmacopoeia provides specific process recommendations for non-distillation methods, recommending the use of single-stage or two-stage reverse osmosis combined with other suitable technologies (such as EDI, ultrafiltration, or nanofiltration). The United States Pharmacopoeia does not restrict the production process, while the Japanese Pharmacopoeia explicitly stipulates that membrane-based water for injection production must include reverse osmosis and ultrafiltration. According to General Chapter 0261 of the 2025 edition of the Chinese Pharmacopoeia, water for injection should be purified water obtained by distillation or produced through a purification process equivalent to distillation.

[0004] In view of the inherent defects of high-temperature distillation process and the limitations of my country's pharmacopoeia standards, there is an urgent need to develop a new non-distilled water for injection preparation system. Summary of the Invention

[0005] In view of this, in order to overcome the defects of the prior art, the present invention provides a non-distilled water for injection preparation system, which effectively solves the problem of preparing water for injection under the inherent defects of high-temperature distillation process and the restrictions of meeting the standards of my country's Pharmacopoeia.

[0006] According to the present invention, a non-distilled injection water preparation system is provided, wherein the non-distilled injection water preparation system includes a pure water production system and an injection water production system connected to each other, the pure water production system includes a purification module, a first processing module and a first storage module, and the untreated raw water in the external feed source is purified by the purification module and the first processing module and then enters the first storage module, the injection water production system includes a second processing module, a filtration module and a second storage module, and the purified water purified by the pure water production system flows out of the first storage module, passes through the second processing module and the filtration module and enters the second storage module.

[0007] Preferably, the first processing module includes a first decomposition unit and a degassing unit connected in sequence, and the purified water purified by the purification module passes through the first decomposition unit to decompose organic matter and passes through the degassing unit to remove gas.

[0008] Preferably, the purification module includes a reverse osmosis unit and a desalination unit, the reverse osmosis unit is connected to an external feed source, the first decomposition unit is connected to the reverse osmosis unit, and the desalination unit is connected to the first decomposition unit through the degassing unit; the untreated raw water is purified for the first time by passing through the reverse osmosis unit, and the raw water purified for the first time is purified for the second time by passing through the desalination unit.

[0009] Preferably, the desalination unit includes a first passage connected to the first storage module and a second passage for discharging concentrated water.

[0010] Preferably, the second processing module includes a second decomposition unit, the filtration module includes a terminal ultrafiltration unit, and the first storage module is connected to the second storage module via the second decomposition unit and the terminal ultrafiltration unit.

[0011] Preferably, the terminal ultrafiltration unit includes a third passage connected to the second storage module and a fourth passage for draining water.

[0012] Preferably, the injection water production system also includes a continuous circulation purification unit, which is connected to the terminal ultrafiltration unit and the first storage module. Part of the production water treated by the second processing module and the filtration module enters the second storage module, and the other part of the production water returns to the first storage module through the continuous circulation purification unit.

[0013] Preferably, the continuous circulation purification unit further comprises a heat exchanger, and the heat exchanger is used for sterilizing the produced water that passes through the continuous circulation purification unit and returns to the first storage module.

[0014] Preferably, the first storage module includes a first pure water tank, and the second storage module includes a second pure water tank and a water for injection tank.

[0015] Preferably, the pure water production system further includes a first power pump, which is arranged between the external feed source and the purification module; the injection water production system further includes a second power pump, which is arranged between the first storage module and the second processing module.

[0016] The non-distilled water for injection preparation system of the present invention, through the process design of the pure water production system and the water for injection production system, can produce non-distilled water for injection that meets pharmacopoeial standards. The coordination of the purification module, the first processing module, and the first storage module can produce and store purified water that meets the requirements. The second processing module, the filtration module, and the second storage module can also produce non-distilled water for injection that meets pharmacopoeial requirements. This non-distilled water for injection preparation system can simultaneously produce purified water and water for injection using a relatively short non-distillation process, and it meets pharmacopoeial process preparation standards. The cost of the two process waters, purified water and water for injection, is comparable, effectively simplifying the water processing at the back end of production and reducing the overall system investment and operating costs.

[0017] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 An overall flow chart of a system for preparing non-distilled water for injection according to an embodiment of the present invention is shown; Figure 2 A schematic diagram showing a module unit of a system for preparing non-distilled water for injection according to an embodiment of the present invention is shown; Figure 3 A schematic structural diagram of a pure water production system according to an embodiment of the present invention is shown; Figure 4 A schematic structural diagram of an injection water production system according to an embodiment of the present invention is shown.

[0020] Figure markings: 1-pure water production system; 2-injection water production system; 3-purification module; 301-reverse osmosis unit; 302-desalination unit; 303-first passage; 304-second passage; 4-first treatment module; 401-first decomposition unit; 402-degassing unit; 5-first storage module; 501-first pure water tank; 6-second treatment module; 601-second decomposition unit; 7-filtration module; 701-terminal ultrafiltration unit; 702-third passage; 703-fourth passage; 8-second storage module; 801-second pure water tank; 802-injection water tank; 9-continuous circulation purification unit; 901-heat exchanger; 10-first power pump; 11-second power pump; 12-raw water connection port; 13-first drain outlet; 14-second drain outlet. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of this application.

[0022] In the description of the embodiments of the present application, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, or are the orientation or positional relationship in which the product of the application is usually placed when in use. They are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, they should not be understood as limiting the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description and should not be understood as indicating or implying relative importance.

[0023] Furthermore, terms such as "horizontal" and "vertical" do not necessarily mean that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0024] In the description of the embodiments of the present application, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0025] According to the present invention, a non-distilled water for injection preparation system is provided. Figures 1 to 4 As shown, the non-distilled water for injection preparation system is used for preparing water for injection, and the non-distilled water for injection preparation system includes a pure water production system 1 and an injection water production system 2.

[0026] In the following description, reference will be made to Figures 1 to 4 The detailed structures of the pure water production system 1 and the injection water production system 2 of the non-distilled injection water preparation system are specifically described.

[0027] like Figure 1 As shown, in an embodiment, the preparation process achieves purification and non-distillation treatment of raw water to produce water for injection by connecting a pure water production system 1 and an injection water production system 2 to each other. Specifically, the pure water production system 1 may include a purification module 3, a first processing module 4, and a first storage module 5. Untreated (untreated here means unpurified) raw water (raw water can be understood as drinking water obtained by appropriate pretreatment, and pretreatment can be, for example, filtering through a multi-media filter, softening through a softener, and then secondary filtration through activated carbon, or processing through an ultrafiltration device such as an ultrafiltration membrane, and then softening through a softener) from an external feed source (not shown) enters the purification module 3 through the raw water connection port 12, and then enters the first storage module 5 after being purified by the purification module 3 and the first processing module 4 to obtain purified water. The injection water production system 2 may include a second processing module 6, a filtration module 7 and a second storage module 8. The purified water purified by the pure water production system 1 flows out of the first storage module 5, passes through the second processing module 6 and the filtration module 7 and enters the second storage module 8 to obtain injection water.

[0028] This non-distilled water for injection preparation system, through the process design of pure water production system 1 and water for injection production system 2, can produce non-distilled water for injection that meets pharmacopoeial standards. Through the coordination of purification module 3, first processing module 4, and first storage module 5, it can produce and store purified water that meets the requirements. Through second processing module 6, filtration module 7, and second storage module 8, it can also produce non-distilled water for injection that meets pharmacopoeial requirements. This non-distilled water for injection preparation system can achieve the simultaneous production of purified water and water for injection using a relatively short non-distillation process, and it complies with pharmacopoeial process preparation standards. The cost of the two process waters is comparable, effectively simplifying the water processing at the back end of production and reducing the overall system investment and operating costs.

[0029] Preferably, if Figure 2 and Figure 3 As shown, in an embodiment, the first processing module 4 may include a first decomposition unit 401 and a degassing unit 402 connected in sequence. The purified water purified by the purification module 3 passes through the first decomposition unit 401 to decompose organic matter, and passes through the degassing unit 402 to remove gas. Specifically, the first decomposition unit 401 may use a TOC decomposition lamp (TOC stands for Total Organic Carbon) to decompose organic matter in the raw water and production system. In an embodiment, the TOC decomposition lamp uses 185nm short-wavelength ultraviolet light or the more technologically advanced mercury-free 172nm ultraviolet light. The UV lamp consists of a lamp, a quartz sleeve, a stainless steel cavity, an intensity monitoring and control system, etc. The TOC decomposition lamp is a device in the prior art, and its principle and structure are not further described. Degassing unit 402 is located at the rear end of first decomposition unit 401. Gas entrained in the raw water after passing through first decomposition unit 401 also generates gas (i.e., dissolved and undissolved gases in the water) during decomposition. Degassing unit 402 removes this gas using a degassing membrane. This utilizes the difference in gas-liquid partial pressure across the hollow fiber membranes to remove the gas and discharge it from the system. Similarly, the degassing membrane is a conventional device, and its principles and structure are not further described.

[0030] Preferably, if Figure 2 and Figure 3As shown, in this embodiment, the purification module 3 may include a reverse osmosis unit 301 and a demineralization unit 302. The reverse osmosis unit 301 is connected to an external feed source, the first decomposition unit 401 is connected to the reverse osmosis unit 301, and the demineralization unit 302 is connected to the first decomposition unit 401 via a degassing unit 402. Untreated raw water undergoes a primary purification process in the reverse osmosis unit 301, and the purified raw water undergoes a secondary purification process in the demineralization unit 302. The first treatment module 4 is disposed between the reverse osmosis unit 301 and the demineralization unit 302. Specifically, the reverse osmosis unit 301 may purify the raw water using a reverse osmosis membrane, which can remove most impurities such as ions and microorganisms. The reverse osmosis unit 301 may utilize a single-stage or two-stage reverse osmosis system, preferably a heat-resistant reverse osmosis membrane that can achieve regular online sterilization and disinfection (SIP). The reverse osmosis membrane and reverse osmosis system are also conventional devices, and their principles and structure are not further described.

[0031] Furthermore, the raw water is purified by the reverse osmosis unit 301 to remove most impurities such as ions and microorganisms. The reverse osmosis water then enters the TOC decomposition lamp to decompose the organic matter in the system. The decomposed water passes through the degassing membrane, which can effectively remove dissolved and undissolved gases in the water. The water produced by the degassing membrane enters the desalination unit 302 for further purification. The purified water enters the first storage module 5. The desalination unit 302 is arranged after the first decomposition unit 401 and the degassing unit 402. It is preferred to use a heat-resistant electric desalination module to achieve regular online sterilization and disinfection of the module. The electric desalination module can further directional migrate and remove ions missed by the reverse osmosis unit 301 and charged organic molecules or ions produced by decomposition, thereby further removing charged ions and charged particles in the water. The purified water produced by the desalination unit 302 meets the requirements of the purified water preparation process. The electric desalination module is also a device in the prior art, and its principle and structure are not further described.

[0032] Preferably, if Figure 2 and Figure 3 As shown, in this embodiment, the demineralization unit 302 may include a first passage 303 connected to the first storage module 5 and a second passage 304 for discharging concentrated water, which is discharged through the first drain port 13. The concentrated water produced by the demineralization unit 302 is discharged through the first drain port 13 and collected in a pre-reverse osmosis pretreatment tank, which may be a raw water tank or a softened water tank.

[0033] Preferably, if Figure 2 and Figure 4As shown, in an embodiment, the second processing module 6 may include a second decomposition unit 601, and the filtration module 7 may include a terminal ultrafiltration unit 701. The first storage module 5 may be connected to the second storage module 8 via the second decomposition unit 601 and the terminal ultrafiltration unit 701. Specifically, the second decomposition unit 601 may utilize a UV lamp with a wavelength of 254 nm, which can better ensure that the microbial limit in the injection water production system 2 is controllable. Since the system is a non-distilled system, the system uses a low-temperature or room-temperature process, requiring the use of a 254 nm UV lamp for microbial control. The terminal ultrafiltration unit 701 may utilize a terminal ultrafiltration device. Utilizing a terminal ultrafiltration device with a lower molecular weight cutoff can further remove system microorganisms, mycotoxins, and impurity particles. The terminal ultrafiltration unit 701 provides final protection and removal of impurities in the purified water. The water produced after passing through the terminal ultrafiltration unit 701 is standard water for injection. In addition, the produced water can be used as both purified water and non-distilled water for injection. The terminal ultrafiltration device can be operated in a full-flow, cross-flow, or a combination of full-flow and periodic cross-flow flushing modes. The cross-flow produced water enters the pre-reverse osmosis pretreatment tank through the second drain port 14. The ultraviolet lamp and terminal ultrafiltration device are also devices in the prior art, and their principles and structures are not further described.

[0034] Preferably, if Figure 2 and Figure 4 As shown, in an embodiment, the terminal ultrafiltration unit 701 may include a third passage 702 connected to the second storage module 8 and a fourth passage 703 for drainage. The produced water of the terminal ultrafiltration unit 701 flows to the second storage module 8 through the third passage 702, and the cross-flow produced water flows through the fourth passage 703 and the second drain port 14 to enter the pre-reverse osmosis pretreatment tank.

[0035] Preferably, if Figure 2 and Figure 4 As shown, in the embodiment, the injection water production system 2 may further include a continuous circulation purification unit 9, which is connected to the terminal ultrafiltration unit 701 and the first storage module 5. A portion of the produced water treated by the second storage module 8 and the filtration module 7 enters the second storage module 8, and the other portion of the produced water returns to the first storage module 5 through the continuous circulation purification unit 9. In this way, the water in the first storage module 5 is continuously purified through the second treatment module 6, the filtration module 7, and the continuous circulation purification unit 9, and the water can be purified in a continuous cycle.

[0036] Preferably, if Figure 2 and Figure 4As shown, in this embodiment, the continuous circulation purification unit 9 may further include a heat exchanger 901, which is used to sterilize the produced water returned to the first storage module 5 after passing through the continuous circulation purification unit 9. Heat exchanger 901 enables regular in-line thermal disinfection (SIP) of the water distribution system. Furthermore, the continuous circulation purification unit 9 enables independent SIP and hierarchical water management during the system preparation and water distribution phases, enabling more rational analysis of system operational risks. The produced water from the water distribution system can be used as purified water and water for injection, enabling non-distilled water for injection production while effectively reducing the complexity of the system's water distribution.

[0037] Preferably, if Figures 1 to 4 As shown, in the embodiment, the first storage module 5 can include a first pure water tank 501. The number of the first pure water tanks 501 can be one or more and can be appropriately adjusted according to production needs. The first pure water tank 501 can realize secondary distribution of purified water. The second storage module 8 can include a second pure water tank 801 and a water for injection tank 802. Similarly, the number of the second pure water tanks 801 and the number of water for injection tanks 802 can also be one or more and can be appropriately adjusted according to production needs.

[0038] Preferably, if Figures 1 to 4 As shown, in the embodiment, the pure water production system 1 may further include a first power pump 10, which is disposed between the external feed source and the purification module 3. The injection water production system 2 may further include a second power pump 11, which is disposed between the first storage module 5 and the second processing module 6. The first power pump 10 and the second power pump 11 are used to drive water to flow along the production line.

[0039] Preferably, necessary detection equipment, such as conductivity, TOC, microorganism or endotoxin detection devices, is configured in the preparation process. By controlling the key quality factors of the online or offline control system, combined with process analysis technology and online monitoring, it can be effectively ensured that the effluent after terminal ultrafiltration meets the injection water properties requirements.

[0040] The production process of this non-distilled water for injection preparation system is as follows: First, pre-treated and filtered drinking water passes through a first power pump 10 and a reverse osmosis unit 301 to effectively remove most impurities such as ions and microorganisms from the influent. Second, it passes through a first decomposition unit 401 to decompose organic matter in the raw water and the production system. Third, a degassing unit 402 removes gases produced by decomposition and gases entrained in the raw water. Fourth, a desalination unit 302 further removes reverse osmosis ions and charged organic molecules or ions produced by decomposition. Fifth, the purified water enters the first storage module 5. Sixth, the first storage module 5 passes through a second decomposition unit 601 via a second power pump 11 to control microbial limits. Seventh, it passes through a terminal ultrafiltration unit 701 to further remove microorganisms, mycotoxins, and impurity particles from the system to produce water for injection. Eighth, the water for injection enters the second storage module 8. Ninth, continuous circulation purification can be achieved by using the continuous circulation purification unit 9. Continuous circulation purification achieves continuous disinfection and filtration through the second decomposition unit 601 and the terminal ultrafiltration unit 701. The terminal ultrafiltration can be set to full-flow filtration or regular cross-flow flushing to effectively ensure continuous purification of the system.

[0041] This non-distilled water for injection preparation system, through the process design of a pure water production system and a water for injection production system, can produce non-distilled water for injection that meets pharmacopoeial standards. The coordination of the purification module, the first treatment module, and the first storage module enables the production and storage of purified water that meets the requirements. The second treatment module, the filtration module, and the second storage module also produce non-distilled water for injection that meets pharmacopoeial requirements. This non-distilled water for injection preparation system can simultaneously produce purified water and water for injection using a shorter non-distillation process that meets pharmacopoeial process preparation standards. The cost of the two process waters is comparable, effectively simplifying the water processing at the back end of production and reducing the overall system investment and operating costs.

[0042] Finally, it should be noted that the above-described embodiments are only specific implementation methods of the present application, which are used to illustrate the technical solutions of the present application, rather than to limit them. The scope of protection of the present application is not limited thereto. Although the present application has been described in detail with reference to the above-described embodiments, those skilled in the art should understand that any person skilled in the art can modify or easily conceive of changes to the technical solutions described in the above-described embodiments within the technical scope disclosed in the present application, or perform equivalent replacements for some of the technical features thereof. These modifications, changes, or replacements do not deviate from the spirit and scope of the technical solutions of the embodiments of the present application, and should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application shall be subject to the scope of protection of the claims.

Claims

1. A system for preparing non-distilled water for injection, characterized in that: The non-distilled injection water preparation system includes a pure water production system and an injection water production system connected to each other. The pure water production system includes a purification module, a first processing module and a first storage module. The untreated raw water in the external feed source is purified by the purification module and the first processing module and then enters the first storage module. The injection water production system includes a second processing module, a filtration module and a second storage module. The purified water purified by the pure water production system flows out of the first storage module, passes through the second processing module and the filtration module, and enters the second storage module.

2. The non-distilled water for injection preparation system according to claim 1, characterized in that: The first processing module includes a first decomposition unit and a degassing unit connected in sequence. The purified water purified by the purification module passes through the first decomposition unit to decompose organic matter and passes through the degassing unit to remove gas.

3. The non-distilled water for injection preparation system according to claim 2, characterized in that: The purification module includes a reverse osmosis unit and a desalination unit, the reverse osmosis unit is connected to an external feed source, the first decomposition unit is connected to the reverse osmosis unit, and the desalination unit is connected to the first decomposition unit through the degassing unit; The untreated raw water is purified for the first time by passing through the reverse osmosis unit, and the raw water purified for the first time is purified for the second time by passing through the desalination unit.

4. The non-distilled water for injection preparation system according to claim 3, characterized in that: The desalination unit includes a first passage connected to the first storage module and a second passage for discharging concentrated water.

5. The non-distilled water for injection preparation system according to claim 1, characterized in that: The second processing module includes a second decomposition unit, the filtration module includes a terminal ultrafiltration unit, and the first storage module is connected to the second storage module via the second decomposition unit and the terminal ultrafiltration unit.

6. The non-distilled water for injection preparation system according to claim 5, characterized in that: The terminal ultrafiltration unit includes a third passage connected to the second storage module and a fourth passage for draining water.

7. The non-distilled water for injection preparation system according to claim 6, characterized in that: The injection water production system also includes a continuous circulation purification unit, which is connected to the terminal ultrafiltration unit and the first storage module. Part of the production water treated by the second processing module and the filtration module enters the second storage module, and the other part of the production water returns to the first storage module through the continuous circulation purification unit.

8. The non-distilled water for injection preparation system according to claim 7, characterized in that: The continuous circulation purification unit further comprises a heat exchanger for sterilizing the produced water which passes through the continuous circulation purification unit and is returned to the first storage module.

9. The non-distilled water for injection preparation system according to claim 1, characterized in that: The first storage module includes a first pure water tank, and the second storage module includes a second pure water tank and a water for injection tank.

10. The non-distilled water for injection preparation system according to claim 1, characterized in that: The pure water production system further includes a first power pump, which is disposed between the external feed source and the purification module; The injection water production system further includes a second power pump, which is disposed between the first storage module and the second processing module.

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