A method and system for preparing non-distilled room temperature water for injection

Abstract

The present invention discloses a method and system for preparing non-distilled normal temperature water for injection, belonging to the technical field of pharmaceutical water. The method includes obtaining a first standard of water for injection based on the qualified standard of water for injection, obtaining a first target water for injection according to the first standard of water for injection, obtaining a second standard of water for injection according to the first target water for injection, obtaining a third standard of water for injection according to the second standard of water for injection, obtaining a third standard of water for injection according to the second standard of water for injection, and finally obtaining a second target water for injection according to the third standard of water for injection. In this way, the water quality of water for injection is improved. The system for preparing non-distilled normal temperature water for injection includes a purified water unit, a water supply pump, a disinfection heat exchange unit, an ultraviolet unit, a CEDI unit and a water storage unit. Through the setting of the inventive method and system, the problem that the existing non-distilled normal temperature water for injection must use an ultrafiltration membrane to filter endotoxin after entering the storage and distribution system is solved.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical water, and in particular to a method and system for preparing non-distilled room-temperature injection water. Background Art

[0002] The use of non-distillation technology to produce water for injection is another method approved by the pharmacopoeias of various countries in addition to distillation to prepare water for injection at room temperature. The distillation method for preparing water for injection separates substances through different evaporation temperatures. The evaporation temperature of endotoxins in water is much higher than that of water. In this way, water and endotoxins can be separated by distillation equipment to obtain qualified water for injection. However, the preparation of water for injection at room temperature does not involve the distillation purification process. For this reason, it is common practice to install an ultrafiltration to remove endotoxins on the pipeline before the water enters the storage tank and is sent to the point of use. The ultrafiltration to remove endotoxins must be certified by relevant regulations and undergo integrity testing before use; in order to control the microorganisms of water for injection at room temperature, the ultrafiltration membrane installed on the distribution pipeline must be frequently thermally disinfected or placed in ozone water, so the ultrafiltration membrane needs to be replaced within a relatively short period of time. The current price of an ultrafiltration membrane that filters 1 ton of injection water / hour is RMB 40,000. Summary of the invention

[0003] In order to solve the problem that the existing non-distilled room temperature water for injection must use an ultrafiltration membrane to filter endotoxins after entering the storage and distribution system, the present invention provides a method and system for preparing non-distilled room temperature water for injection, which controls the key quality indicators of the water for injection, such as endotoxins and microorganisms, through medium-pressure ultraviolet rays and CEDI devices in the terminal processing section of the membrane water for injection system.

[0004] According to a first aspect of the present invention, the present invention provides a method for preparing non-distilled room temperature water for injection, comprising the following steps:

[0005] Based on the qualified standards of water for injection, purified water is obtained to prepare the first target water for injection as the first water for injection standard;

[0006] Obtaining ultraviolet parameters and a first water flow rate of purified water based on the first water for injection standard;

[0007] Obtaining a first produced water based on the ultraviolet parameters and the first water flow rate;

[0008] Obtaining first water for injection based on the first produced water after CEDI;

[0009] Obtaining a first target water for injection based on the first water quality for injection and the first water for injection standard;

[0010] Acquire a second standard of water for injection based on the input and / or output of the first target water for injection;

[0011] Obtaining a second water flow rate of the first target water for injection based on the second water for injection standard;

[0012] obtaining a second produced water based on the ultraviolet parameter and the second water flow rate;

[0013] Based on the second produced water, second water for injection is obtained after CEDI;

[0014] Obtaining a third standard of water for injection based on the second water quality of water for injection;

[0015] A second target water for injection is obtained based on the second water quality for injection and the third water for injection standard.

[0016] According to one embodiment of the present invention, the ultraviolet parameters include ultraviolet wavelength and ultraviolet irradiation dose, the ultraviolet wavelength is 185-254nm, and the ultraviolet irradiation dose is 90-350mJ / cm 2 .

[0017] According to one embodiment of the present invention, when the first target water for injection stops being output and only input is being input, the second standard of water for injection is obtained, then the first target water for injection stops being input, and the second target water for injection continues to be input;

[0018] When the first target water for injection stops being output and only input is being input, and the first target water for injection is below the middle liquid level and the first target water for injection liquid level does not exceed the middle liquid level within two hours, the second water for injection standard is obtained, the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the high liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input;

[0019] When the first target water for injection stops being output and only input is being carried out and the water for injection has not reached the target liquid level, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the target liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input;

[0020] When the first target water for injection output is less than the first target water for injection input, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately.

[0021] According to one embodiment of the present invention, the first injection water standard is lower than or equal to the qualified standard, the second injection water standard is equal to or higher than the first injection water standard, and the third injection water standard is equal to or higher than the second injection water standard.

[0022] According to one embodiment of the present invention, the first injection water standard includes an endotoxin content of less than 0.01EU / m, a TOC content of 5-9ppb, a conductivity of 0.055-0.06us / cm, and a microbial content of less than 1cfu / 100ml.

[0023] According to one embodiment of the present invention, the second standard of water for injection includes an endotoxin content of less than 0.01 EU / m, a TOC content of 5 to 9 ppb, and a conductivity of 0.055 to 0.06 us / cm.

[0024] According to one embodiment of the present invention, a higher standard of the first water for injection is directly proportional to the ultraviolet parameter, and the first standard of the water for injection is inversely proportional to the first water flow rate.

[0025] According to one embodiment of the present invention, when the water quality of the first water for injection is less than or equal to the first water for injection standard, a second target water for injection is obtained; when the water quality of the second water for injection is less than or equal to the third water for injection standard, a second target water for injection is obtained.

[0026] According to a second aspect of the present invention, the present invention provides a system for preparing non-distilled room temperature water for injection, comprising:

[0027] A purified water unit, wherein the purified water unit is used for storing purified water;

[0028] a water supply pump connected to the purified water unit;

[0029] A disinfection heat exchange unit, wherein the disinfection heat exchange unit is connected to the water supply pump;

[0030] An ultraviolet unit, wherein the ultraviolet unit is connected to the disinfection heat exchange unit;

[0031] A CEDI unit, wherein the CEDI unit is connected to the UV unit, the CEDI unit is connected to the purified water unit, and a first water quality detector is provided at a water outlet of the CEDI unit;

[0032] A water storage unit, the water storage unit is used to store water for injection, the water storage unit is connected to the water supply pump, the water storage unit is connected to the purified water unit, and the water storage unit is provided with a second water quality detector.

[0033] According to one embodiment of the present invention, the purified water unit includes a water supply tank, which is provided with a first water outlet, a first drain outlet, a first water inlet and a second water inlet. The water supply tank is connected to the water supply pump via the first water outlet, and the water supply tank is connected to the water storage unit via the second water inlet.

[0034] According to one embodiment of the present invention, the CEDI unit includes a hot water disinfection CEDI device, which is provided with a third water inlet, a second water outlet, a concentrated water outlet and an extreme water outlet. The hot water disinfection CEDI is connected to the ultraviolet unit through the third water inlet, the hot water disinfection CEDI is connected to the water storage unit through the second water outlet, and the hot water disinfection CEDI is connected to the purified water unit through the second water outlet.

[0035] According to one embodiment of the present invention, a first flow velocity detector is provided at the water inlet end of the water storage unit, and a second flow velocity detector is provided at the water outlet end of the water storage unit.

[0036] According to one embodiment of the present invention, the water storage unit includes a water storage tank, which is provided with a fourth water inlet and a third water outlet, the water storage tank is connected to the CEDI unit through the fourth water inlet, the water storage tank is connected to the water supply pump through the third water outlet, and the water storage tank is connected to the purified water unit through the third water outlet.

[0037] The present invention has the following advantages:

[0038] 1. In the present invention, the water quality of the first target water for injection is guaranteed to always meet the standard through the circulation treatment method of the first target water for injection, and the water quality of the first target water for injection is avoided to be reduced. It is not necessary to use other ultrafiltration membrane devices, and it is also avoided that the ultrafiltration membrane is frequently replaced and the treatment of the ultrafiltration membrane leads to increased production costs and reduced work efficiency. It is also guaranteed that the ultraviolet treatment and CEDI treatment are carried out continuously, and the microorganisms generated by the two treatment devices are avoided to affect the water quality when the water is treated, and it is also ensured that the ultraviolet treatment and CEDI treatment devices are frequently closed and opened, which affects the life of the device.

[0039] 2. In the present invention, the arrangement and connection relationship of the purified water unit, water supply pump, disinfection heat exchange unit, UV unit, CEDI unit and water storage unit ensure that the injection water in the water storage unit can be circulated for UV and CEDI treatment, ensure that the water quality of the injection water meets the standards, and the system can be disinfected regularly. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 A flow chart of a method for preparing non-distilled room temperature water for injection according to an embodiment is shown;

[0041] Figure 2 A schematic diagram of a system for preparing non-distilled room temperature water for injection according to an embodiment is shown.

[0042] Figure markings: 1-purified water unit; 2-water supply pump; 3-disinfection heat exchange unit; 4-ultraviolet unit; 5-CEDI unit; 6-water storage unit; 7-first valve; 8-second valve; 9-third valve; 10-fourth valve; 11-fifth valve; 12-sixth valve; 13-seventh valve; 14-eighth valve; 15-unqualified water recovery tank; 16-concentrated water return ultrafiltration tank; 17-ultrafiltration water recovery tank; 18-cleaning agent tank. DETAILED DESCRIPTION

[0043] The present disclosure will now be discussed with reference to several exemplary embodiments. It should be understood that these embodiments are discussed only to enable those skilled in the art to better understand and thus implement the present disclosure, rather than implying any limitation on the scope of the present disclosure.

[0044] As used herein, the term "including" and its variants are to be interpreted as open-ended terms meaning "including but not limited to". The term "based on" is to be interpreted as "based at least in part on". The terms "one embodiment" and "an embodiment" are to be interpreted as "at least one embodiment". The term "another embodiment" is to be interpreted as "at least one other embodiment". The orientation or position relationship indicated by the terms "upper", "lower", "left", "right", "front", "back", "top", "bottom", "inner", "outer", "vertical", "horizontal", "lateral", "longitudinal" and the like is based on the orientation or position relationship shown in the accompanying drawings. These terms are mainly for better describing the present application and its embodiments, and are not used to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation. In addition, in addition to being used to indicate an orientation or position relationship, some of the above terms may also be used to indicate other meanings, such as the term "upper" may also be used to indicate a certain dependency or connection relationship in some cases. For those of ordinary skill in the art, the specific meanings of these terms in this application can be understood according to the specific circumstances. In addition, the terms "install", "set", "provided with", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection, or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be an internal connection between two devices, elements or components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to the specific circumstances. In addition, the terms "first", "second", etc. are mainly used to distinguish different devices, elements or components (the specific types and structures may be the same or different), and are not used to indicate or imply the relative importance and quantity of the indicated devices, elements or components. Unless otherwise specified, "plurality" means two or more.

[0045] In the first aspect, this embodiment discloses a method for preparing non-distilled room temperature water for injection, such as Figure 1 As shown, the following steps are included:

[0046] Based on the qualified standards of water for injection, purified water is obtained to prepare the first target water for injection as the first water for injection standard;

[0047] Obtaining ultraviolet parameters and a first water flow rate of purified water based on the first water for injection standard;

[0048] Obtaining a first produced water based on the ultraviolet parameters and a first water flow rate;

[0049] Obtaining first water for injection based on the first produced water after CEDI;

[0050] Obtaining a first target water for injection based on the first water quality for injection and the first water for injection standard;

[0051] Acquire a second standard of water for injection based on the input and / or output of the first target water for injection;

[0052] Obtaining a second water flow rate of the first target water for injection based on the second water for injection standard;

[0053] obtaining a second produced water based on the ultraviolet parameter and the second water flow rate;

[0054] Based on the second produced water, second water for injection is obtained after CEDI;

[0055] Obtaining a third standard of water for injection based on the second water quality of water for injection;

[0056] A second target water for injection is obtained based on the second water quality for injection and the third water for injection standard.

[0057] In this embodiment, the qualified standard of water for injection is implemented according to the standard of "Pharmacopoeia of the People's Republic of China (2020 Edition)". In order to improve the standard of water for injection, the first water for injection standard of the first target water for injection is selected. In order to achieve the first water for injection standard, the ultraviolet parameters for treating purified water and the water flow rate of ultraviolet-treated purified water, that is, the first water flow rate, are set accordingly. By setting the ultraviolet wavelength and ultraviolet power and controlling the size of the first water flow rate, the purified water is treated with ultraviolet to obtain the first produced water, and the water quality of the first water for injection obtained after the first produced water is treated with CEDI (Continuous Electrodeionization technology) meets the first water for injection standard, thereby obtaining the first target water for injection without setting up other ultrafiltration devices. Since the first target water for injection may deteriorate, for example, the first target water for injection may contain other inevitable organic matter, and the first target water for injection in the water storage tank is in contact with the air for a long time, VOC (volatile organic compound) in the air may dissolve into the first target water for injection, forming carbonic acid, which leads to an increase in the conductivity of the first target water for injection. At the same time, the TOC (total organic carbon), microorganism and endotoxin content of the first target water for injection may increase or even exceed the first water for injection standard. There may be a risk of increased conductivity, TOC, microorganism and endotoxin in the first target water for injection. The second water for injection standard can be selected according to the input and / or output of the first target water for injection, and the first target water for injection can be treated by ultraviolet and CEDI circulation to improve the water quality of the water for injection. Then, the standard of the second water for injection is used as the standard of water for injection for recycling treatment of water for injection. Since only the water for injection in the water storage tank is treated during the recycling treatment of water for injection, the standard of water for injection can be reset to the second standard of water for injection. Then the water flow rate of water for injection in the water storage tank, i.e., the second water flow rate, can be set to be different from the first water flow rate. Since the first target water for injection is treated water, i.e., the water quality of the first target water for injection is usually higher than that of purified water, only the second water flow rate is set, and no UV parameters need to be changed. The water quality of the second water for injection obtained after the first target water for injection is treated by UV and the second produced water is treated by CEDI can meet the second standard of water for injection. At this time, according to the water quality of the obtained second water for injection, in some cases, in order to adapt to the system work of preparing non-distilled room temperature water for injection, the second standard of water for injection can be adaptively adjusted to the third standard of water for injection, but at least the third standard of water for injection is guaranteed to be lower than the first standard of water for injection, so as to adapt to the system work of preparing non-distilled room temperature water for injection. Finally, according to the water quality of the second water for injection meeting the third standard of water for injection, the second target water for injection is obtained.

[0058] This embodiment ensures that the water quality of the first target water for injection always meets the standard through the circulation treatment method of the first target water for injection, avoids the water quality of the first target water for injection from being reduced, does not need to use other ultrafiltration membrane devices, and also avoids the increase of production cost and the reduction of work efficiency caused by frequent replacement of ultrafiltration membranes and treatment of ultrafiltration membranes. It also ensures that the ultraviolet treatment and CEDI treatment are carried out continuously, avoids the generation of microorganisms in the two treatment devices affecting the water quality when the water is treated, and also ensures that the ultraviolet treatment and CEDI treatment devices are frequently closed and opened, which affects the life of the devices.

[0059] In the present invention, the first target water for injection and the second target water for injection should be understood as the water obtained through purified water treatment as the first target water for injection, and the water obtained through the circulation treatment of the first target water for injection as the second target water for injection, that is, the second target water for injection is the water for injection during circulation. Of course, after the first target water for injection has been fully circulated, when the injection water circulated thereafter is only the second target water for injection, it is also understood as the circulation of the first target water for injection. The use of the two names is only for ease of understanding and does not refer to other water not explained in this explanation.

[0060] According to one embodiment of the present invention, the ultraviolet parameters include ultraviolet wavelength and ultraviolet irradiation dose, the ultraviolet wavelength is 185-254nm, and the ultraviolet irradiation dose is 90-350mJ / cm 2 .

[0061] In this embodiment, the ultraviolet wavelength can be set to decompose endotoxins, microorganisms and TOC, and the ultraviolet irradiation dose can be set to decompose TOC, thereby further improving the quality of water for injection. Specifically, 185nm ultraviolet rays can decompose endotoxins and TOC, and 254nm can decompose microorganisms.

[0062] In some embodiments, the UV irradiation dose is 90-180 mJ / cm 2 .

[0063] According to one embodiment of the present invention, when the first target water for injection stops being output and only input is being input, the second standard of water for injection is obtained, then the first target water for injection stops being input, and the second target water for injection continues to be input;

[0064] When the first target water for injection stops being output and only input is being input, and the first target water for injection is below the middle liquid level and the first target water for injection liquid level does not exceed the middle liquid level within two hours, the second water for injection standard is obtained, the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the high liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input;

[0065] When the first target water for injection stops being output and only input is being carried out and the water for injection has not reached the target liquid level, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the target liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input;

[0066] When the first target water for injection output is less than the first target water for injection input, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately.

[0067] In this embodiment, when the first target water for injection stops being output and only input is started, it indicates that the first target water for injection is not used, which may cause the first target water for injection to stay in the water storage tank for too long, increasing the contact with the air, resulting in the water quality of the first target water for injection being reduced. In this case, a second standard for water for injection can be set, and the treatment of purified water can be stopped, that is, the input of the first target water for injection is stopped. At this time, the first target water for injection can be circulated, that is, the continuous input of the second target water for injection is guaranteed. At the same time, the continuous input of the second target water for injection also indicates that the first target water for injection is in the circulation treatment stage.

[0068] The input conditions of the first target water for injection and the second target water for injection can also be determined according to the water level of the first water for injection being at the middle liquid level. Specifically, the water storage tank has three liquid levels, namely, the high liquid level, the middle liquid level and the low liquid level. When the first target water for injection is below the middle liquid level and the liquid level of the first target water for injection has not reached above the middle liquid level within two hours, it indicates that the first target water for injection is input slowly and the first target water for injection is not used, resulting in an increase in the time of the water for injection staying in the water storage tank, and there is a risk of reduced water quality of the water for injection in the water storage tank. The first target water for injection and the second target water for injection are alternately input until the water for injection reaches the high liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input, thereby improving the water quality of the water for injection.

[0069] It is also possible to stop outputting the first target water for injection and only input it, and the water for injection has not reached the target liquid level of the water for injection tank, indicating that the water storage tank can still hold water for injection, and in order to ensure the water quality of the first target water for injection, the first target water for injection and the first target water for injection can be selected to input alternately, indicating that purified water can continue to be processed, ensuring work efficiency, and the first target water for injection liquid is also circulated, until the water for injection reaches the target liquid level, indicating that the water storage tank can no longer hold additional water for injection, at this time, the first target water for injection input should be stopped, that is, the treatment of purified water should be stopped, and the second target water for injection input should be retained, that is, the first target water for injection continues to be circulated. The target liquid level of this embodiment should be understood as the required liquid level, and whether it is a medium liquid level or a high liquid level is not limited.

[0070] When the output of the first target water for injection is less than the input of the first target water for injection, it indicates that a smaller amount of the first target water for injection is used, which will also cause the water quality of the first target water for injection to deteriorate. In this case, the first target water for injection and the second target water for injection can be input alternately to ensure that the water quality of the water for injection in the water storage tank meets the standards.

[0071] This embodiment selects the first target injection water circulation treatment and purified water treatment according to the output situation of the first target injection water, further improving the work efficiency, ensuring the water quality of the injection water, and ensuring that there is always water flowing through the ultraviolet treatment device and the CEDI treatment device and they are in working condition, thereby avoiding the breeding of microorganisms in the ultraviolet treatment device and the CEDI treatment device and reducing the frequency of their closing and opening, thereby reducing their service life.

[0072] In some embodiments, the frequency of alternating input of the first target water for injection and the second target water for injection can be selected according to demand, such as the first target water for injection input time is less than, equal to or greater than the second target water for injection alternating input frequency. The first target water for injection input amount can also be controlled to be less than, equal to or greater than the second target water for injection alternating input. Specifically, when the first target water for injection stops outputting and only inputting and the water for injection does not reach the target liquid level or the first target water for injection output is less than the first target water for injection input, the second target water for injection input frequency or / input amount can be less than the first target water for injection input frequency or / input amount.

[0073] In the present invention, the first target water for injection output indicates that the first target water for injection is used by the downstream end, and the first target water for injection input indicates that the purified water enters the water for injection tank after being treated by UV and CEDI to meet the corresponding standards.

[0074] According to one embodiment of the present invention, the first water for injection standard is higher than or equal to the qualified standard, the second water for injection standard is equal to or higher than the first water for injection standard, and the third water for injection standard is equal to or higher than the second water for injection standard.

[0075] In this embodiment, by setting the relationship between the first water for injection standard, the second water for injection standard and the third water for injection standard, the water quality of the water for injection is further improved while ensuring that the water quality of the water for injection meets the qualified standards.

[0076] According to one embodiment of the present invention, the first injection water standard includes an endotoxin content of less than 0.01EU / m, a TOC content of 5-9ppb, a conductivity of 0.055-0.06us / cm, and a microbial content of less than 1cfu / 100ml.

[0077] In this embodiment, the water quality of the water for injection is further improved by setting the parameters of the first water for injection standard, and the microbial content of the water for injection obtained by this embodiment can reach 0 cfu / 100 ml.

[0078] According to one embodiment of the present invention, the second standard of water for injection includes an endotoxin content of less than 0.01 EU / m, a TOC content of 5 to 9 ppb, and a conductivity of 0.055 to 0.06 us / cm.

[0079] In this embodiment, the water quality of the water for injection is further improved by setting the parameters of the second water for injection standard.

[0080] According to one embodiment of the present invention, when the water quality of the first water for injection is less than or equal to the first water for injection standard, the second target water for injection is obtained; when the water quality of the second water for injection is less than or equal to the third water for injection standard, the second target water for injection is obtained. Preferably, when the water quality of the first water for injection is less than the first water for injection standard, the second target water for injection is obtained; when the water quality of the second water for injection is less than the third water for injection standard, the second target water for injection is obtained.

[0081] In this embodiment, the water quality of the water for injection is further improved according to the relationship between the water quality of the first water for injection and the first standard of the water for injection, and the relationship between the water quality of the second water for injection and the third standard of the water for injection.

[0082] In a second aspect, this embodiment discloses a system for preparing non-distilled room temperature water for injection, such as Figure 2 As shown, this may include:

[0083] A purified water unit 1, wherein the purified water unit 1 is used for storing purified water;

[0084] A water supply pump 2, wherein the water supply pump 2 is connected to the purified water unit 1;

[0085] A disinfection heat exchange unit 3, wherein the disinfection heat exchange unit 3 is connected to the water supply pump 2;

[0086] An ultraviolet unit 4, wherein the ultraviolet unit 4 is connected to the disinfection heat exchange unit 3;

[0087] CEDI unit 5, the CEDI unit 5 is connected to the UV unit 4, the CEDI unit 5 is connected to the purified water unit 1, and a first water quality detector is provided at the water outlet of the CEDI unit 5;

[0088] A water storage unit 6, wherein the water storage unit 6 is used to store water for injection, the water storage unit 6 is connected to the water supply pump 2, the water storage unit 6 is connected to the purified water unit 1, and the water storage unit 6 is provided with a second water quality detector.

[0089] In the present embodiment, specifically, the water outlet of the CEDI unit 5 is connected in parallel to the water inlet of the water storage unit 6, the water outlet of the water storage unit 6 and the water inlet of the purified water unit 1, and the CEDI unit 5 is connected to the water inlet of the disinfection heat exchange unit 3 connected to the water supply pump 2 through the water outlet of the water storage unit 6. When the purified water unit 1 is in a connected state with the water supply pump 2, the water storage unit 6 stops communicating with the water supply pump 2, the water storage unit 6 stops communicating with the purified water unit 1, and the CEDI unit 5 stops communicating with the disinfection heat exchange unit 3; when the water storage unit 6 is in a connected state with the water supply pump 2, the purified water unit 1 stops communicating with the water supply pump 2, and the water storage unit 6 stops communicating with the purified water unit 1. The CEDI unit 5 stops communicating with the purified water unit 1; when the water storage unit 6 is in a communicating state with the purified water unit 1, the purified water unit 1 can be in communication with the water supply pump 2, the water storage unit 6 stops communicating with the water supply pump 2, and the CEDI unit 5 stops communicating with the disinfection heat exchange unit 3; when the CEDI unit 5 is in a communicating state with the purified water unit 1, the water storage unit 6 stops communicating with the water supply pump 2, and the water storage unit 6 stops communicating with the purified water unit 1; when the ultraviolet unit 4 and the CEDI unit 5 are in a working state, the disinfection heat exchange unit 3 stops working; when the ultraviolet unit 4 and the CEDI unit 5 are in a stopped working state, the disinfection heat exchange unit 3 can work.

[0090] The arrangement of the purified water unit 1, water supply pump 2, disinfection heat exchange unit 3, ultraviolet unit 4, CEDI unit 5 and water storage unit 6 of the present embodiment ensures that the water for injection in the water storage unit 6 can be circulated for ultraviolet and CEDI treatment, ensuring that the water quality of the water for injection meets the standard, and also making the CEDI unit 5 always in an extreme pH state (extreme pH is pH greater than 14 and pH less than 1), which is conducive to the control of microorganisms. When the water for injection is circulated, the disinfection heat exchange unit 3, ultraviolet unit 4, and CEDI unit 5 have water flow passing through to avoid the breeding of microorganisms. At the same time, the ultraviolet unit 4 and CEDI unit 5 continue to work to avoid frequent closing and opening, which affects their lifespan. For example, if the ultraviolet unit 4 is frequently opened, the lifespan of the ultraviolet lamp will be affected. When the ultraviolet unit 4 and the CEDI unit 5 stop working, the disinfection heat exchange unit 3 performs circulated disinfection treatment for the ultraviolet unit 4 and the CEDI unit 5. That is, the disinfection heat exchange unit 3 performs regular disinfection treatment for the ultraviolet unit 4 and the CEDI unit 5. Specifically, the disinfection heat exchange unit 3 provides 80°C water for injection for pasteurization to the UV unit 4 and the CEDI unit 5. The first water quality detector is provided to facilitate monitoring the water quality of the water for injection from the CEDI unit 5, and the second water quality detector is provided to facilitate monitoring the water quality of the water for injection in the water storage unit 6, thereby facilitating the selection of the standard of water for injection.

[0091] In some embodiments, the UV unit 4 includes a medium-pressure UV device, which is provided with a fifth water inlet and a fourth water outlet, the medium-pressure UV device is connected to the disinfection heat exchange unit 3 through the fifth water inlet, and the medium-pressure UV device is connected to the CEDI unit 5 through the fourth water outlet. This facilitates the preparation of non-distilled room temperature water for injection.

[0092] Among them, the UV device can emit ultraviolet wavelengths of 184-254nm at the same time, so that it can degrade endotoxins, microorganisms and TOC at the same time. The UV device can emit different ultraviolet wavelengths at the same time. This technology is an existing technology. For example, a coating is designed on the low-pressure lamp tube to block most of the 185nm wavelength (ultraviolet) output or maximize the output of 185nm wavelength (ultraviolet) according to application needs.

[0093] In some embodiments, Figure 2As shown, a first valve 7 is provided at the connection end between the purified water unit 1 and the water supply pump 2, and a seventh valve 13 is provided at the connection end between the water storage unit 6 and the disinfection heat exchange unit 3. A third valve 9 is provided at the connection end between the CEDI unit 5 and the pure water unit, a fourth valve 10 is provided at the connection end between the CEDI unit 5 and the water storage unit 6, and a fifth valve 11 is also provided at the water outlet end of the CEDI unit 5. The fifth valve 11 is used to control the discharge of the water outlet of the CEDI unit 5 into the unqualified water quality recovery tank 15 when the water quality is unqualified. According to the water outlet direction of the CEDI unit 5, the fifth valve 11 is located before the third valve 9 and the fourth valve 10. A sixth valve 12 and a second valve 8 are provided at the connection end between the water storage unit 6 and the water supply pump 2 in sequence, and an eighth valve 14 is provided at the connection end between the water storage unit 6 and the purified water unit 1. According to the direction of the water outlet of the water storage unit 6 toward the purified water unit 1, the eighth valve 14 is located after the sixth valve 12. The specific setting positions and locations of the valves are determined according to the water outlet direction of the water storage unit 6. Figure 2 shown.

[0094] In this embodiment, the water flow direction can be precisely controlled by setting multiple valves. When the system for preparing non-distilled room temperature water for injection is periodically pasteurized with hot water, the UV unit 4 and the CEDI unit 5 stop working, the disinfection heat exchange unit 3 starts to heat the water for injection in the system with industrial steam to the set temperature, and the liquid level of the purified water unit 1 is controlled at the set liquid level during the disinfection period. Figure 2 As shown, the first valve 7, the third valve 9, the seventh valve 13, and the eighth valve 14 are opened, the second valve 8, the fourth valve 10, and the sixth valve 12 are closed, and the water supply pump 2 delivers 80°C hot water according to the established pipeline to circulate and disinfect the equipment and pipelines on the pipeline. After the disinfection is completed, the disinfected water is discharged through the wastewater outlet on the purified water unit 1. Thereafter, the first valve 7 and the fourth valve 10 are opened, the second valve 8, the third valve 9, the seventh valve 13, and the eighth valve are closed, and after the purified water unit 1 enters the purified water production water to a certain liquid level, the water supply pump 2 is started to prepare new low endotoxin injection water.

[0095] In some embodiments, valves may be provided at the water inlet, water outlet or water outlet of other units as required.

[0096] According to one embodiment of the present invention, the purified water unit 1 includes a water supply tank, which is provided with a first water outlet, a first drain outlet, a first water inlet and a second water inlet. The water supply tank is connected to the water supply pump 2 through the first water outlet, and the water supply tank is connected to the water storage unit 6 through the second water inlet.

[0097] In this embodiment, the provision of a water supply tank further facilitates the preparation of non-distilled room temperature water for injection.

[0098] According to one embodiment of the present invention, the CEDI unit 5 includes a hot water disinfection CEDI device, which is provided with a third water inlet, a second water outlet, a concentrated water outlet and an extreme water outlet. The hot water disinfection CEDI is connected to the ultraviolet unit 4 through the third water inlet, the hot water disinfection CEDI is connected to the water storage unit 6 through the second water outlet, and the hot water disinfection CEDI is connected to the purified water unit 1 through the second water outlet.

[0099] In this embodiment, the hot water disinfection CEDI device is set to further facilitate the preparation of non-distilled room temperature water for injection. The water discharged from the concentrated water outlet and the extreme water outlet can be purified and then enter the purified water unit 1, and then prepared into qualified water for injection.

[0100] In some embodiments, the hot water disinfection CEDI device is provided with a temperature sensor to facilitate temperature monitoring of hot water in the hot water disinfection CEDI device.

[0101] In some embodiments, the CEDI unit 5 further includes a detergent tank 18, and the detergent tank 18 and the hot water disinfection CEDI device are connected so that when the hot water disinfection CEDI device needs to be cleaned, the detergent tank 18 can pass the detergent into the hot water disinfection CEDI device to clean the hot water disinfection CEDI device.

[0102] In some embodiments, the CEDI unit 5 further includes a concentrated water return ultrafiltration water tank 16, which is connected to the hot water disinfection CEDI device, so that the concentrated water discharged from the hot water disinfection CEDI device enters the concentrated water return ultrafiltration water tank 16 for storage.

[0103] In some embodiments, the CEDI unit 5 further includes an extreme water recovery tank, which is connected to the hot water disinfection CEDI device, so that the extreme water discharged from the hot water disinfection CEDI device enters the extreme water recovery tank 17 .

[0104] According to one embodiment of the present invention, a first flow velocity detector is provided at the water inlet end of the water storage unit 6, and a second flow velocity detector is provided at the water outlet end of the water storage unit 6.

[0105] In this embodiment, the first flow rate detector is provided to facilitate monitoring of the water flow of purified water, i.e., the first water flow rate. The second flow rate detector is provided to facilitate monitoring of the amount of water supplied from the water storage tank to the water supply pump 2, thereby facilitating selection of the first water flow rate and the second water flow rate.

[0106] According to one embodiment of the present invention, the water storage unit includes a water storage tank, which is provided with a fourth water inlet and a third water outlet. The water storage tank is connected to the CEDI unit 5 through the fourth water inlet, the water storage tank is connected to the water supply pump 2 through the third water outlet, and the water storage tank is connected to the purified water unit 1 through the third water outlet.

[0107] In this embodiment, the provision of a hot water sterilized CEDI device further facilitates the preparation of non-distilled room temperature water for injection and the use of the water for injection.

[0108] In some embodiments, the water storage tank is also provided with a water supply port for injection, and a third flow rate detector is provided at the water supply port for injection to monitor the amount of water used for injection. The second flow rate detector is provided at the third water outlet, and the first flow rate detector is provided at the fourth water inlet.

[0109] In some embodiments, the water storage tank is provided with a high liquid level line, a middle liquid level line and a low liquid level line, so as to facilitate obtaining the liquid level of the water for injection stored in the water storage tank.

[0110] In the present invention, the water in the purified water tank and the water in the water storage tank alternately enter the water supply pump 2 according to the liquid level of the water storage tank, and the medium-pressure ultraviolet device and the CEDI device work 24 hours a day, so that the CEDI device is always in an extreme pH state, which is conducive to the control of microorganisms, and the medium-pressure ultraviolet device does not need to be frequently turned on, which prolongs the life of the medium-pressure ultraviolet lamp. The water in the purified water tank and the water in the water storage tank can also alternately enter the water supply pump 2 according to the water quality of the water storage tank.

[0111] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present disclosure, and in actual applications, various changes may be made thereto in form and detail without departing from the scope of the present disclosure.

Claims

1. A method for preparing non-distilled room temperature water for injection, characterized in that: The steps include: Based on the qualified standards of water for injection, purified water is obtained to prepare the first target water for injection as the first water for injection standard; Obtaining ultraviolet parameters and a first water flow rate of purified water based on the first water for injection standard; Obtaining a first produced water based on the ultraviolet parameters and the first water flow rate; Obtaining first water for injection based on the first produced water after CEDI; Obtaining a first target water for injection based on the first water quality for injection and the first water for injection standard; Acquire a second standard of water for injection based on the input and / or output of the first target water for injection; Obtaining a second water flow rate of the first target water for injection based on the second water for injection standard; obtaining a second produced water based on the ultraviolet parameter and the second water flow rate; Based on the second produced water, second water for injection is obtained after CEDI; Obtaining a third standard of water for injection based on the second water quality of water for injection; Obtaining a second target water for injection based on the second water quality for injection and the third water for injection standard; The ultraviolet parameters include ultraviolet wavelength and ultraviolet irradiation dose. The ultraviolet wavelength is 185-254nm, and the ultraviolet irradiation dose is 90-350mJ / cm 2 .

2. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: When the first target water for injection stops being output and only input is being carried out, the second standard of water for injection is obtained, then the first target water for injection stops being input and the second target water for injection continues to be input; When the first target water for injection stops being output and only input is being input, and the first target water for injection is below the middle liquid level and the first target water for injection liquid level does not exceed the middle liquid level within two hours, the second water for injection standard is obtained, the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the high liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input; When the first target water for injection stops being output and only input is being carried out and the water for injection has not reached the target liquid level, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately until the water for injection reaches the target liquid level, the first target water for injection stops being input, and the second target water for injection continues to be input; When the first target water for injection output is less than the first target water for injection input, the second water for injection standard is obtained, and the first target water for injection and the second target water for injection are input alternately.

3. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: The first injection water standard is higher than or equal to the qualified standard, the second injection water standard is equal to or higher than the first injection water standard, and the third injection water standard is equal to or higher than the second injection water standard.

4. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: The first injection water standard includes an endotoxin content of less than 0.01EU / m, a TOC content of 5-9ppb, a conductivity of 0.055-0.06us / cm, and a microbial content of less than 1cfu / 100ml.

5. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: The second standard of water for injection includes an endotoxin content of less than 0.01 EU / m, a TOC content of 5 to 9 ppb, and a conductivity of 0.055 to 0.06 us / cm.

6. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: The higher the standard of the first water for injection is, the more it is proportional to the ultraviolet parameter, and the first standard of the water for injection is inversely proportional to the first water flow rate.

7. The method for preparing non-distilled room temperature water for injection according to claim 1, characterized in that: When the water quality of the first water for injection is less than or equal to the first water for injection standard, the second target water for injection is obtained; when the water quality of the second water for injection is less than or equal to the third water for injection standard, the second target water for injection is obtained.

8. A system for preparing non-distilled room temperature water for injection, characterized in that: A method for preparing non-distilled room temperature water for injection as described in any one of claims 1 to 7, wherein the system for preparing non-distilled room temperature water for injection comprises: A purified water unit, wherein the purified water unit is used for storing purified water; a water supply pump connected to the purified water unit; A disinfection heat exchange unit, wherein the disinfection heat exchange unit is connected to the water supply pump; An ultraviolet unit, wherein the ultraviolet unit is connected to the disinfection heat exchange unit; a CEDI unit, the CEDI unit being connected to the UV unit, and the CEDI unit being connected to the purified water unit; A water storage unit, the water storage unit is used to store water for injection, the water storage unit is connected to the water supply pump, and the water storage unit is connected to the purified water unit.

9. A system for preparing non-distilled room temperature water for injection according to claim 8, characterized in that: The purified water unit includes a water supply tank, which is provided with a first water outlet, a first drain outlet, a first water inlet and a second water inlet. The water supply tank is connected to the water supply pump through the first water outlet, and the water supply tank is connected to the water storage unit through the second water inlet.

10. A system for preparing non-distilled room temperature water for injection according to claim 8, characterized in that: The CEDI unit includes a hot water disinfection CEDI device, which is provided with a third water inlet, a second water outlet, a concentrated water outlet and an extreme water outlet. The hot water disinfection CEDI is connected to the ultraviolet unit through the third water inlet, the hot water disinfection CEDI is connected to the water storage unit through the second water outlet, and the hot water disinfection CEDI is connected to the purified water unit through the second water outlet.

11. A system for preparing non-distilled room temperature water for injection according to claim 8, characterized in that: The water inlet end of the water storage unit is provided with a first flow velocity detector, and the water outlet end of the water storage unit is provided with a second flow velocity detector.

12. A system for preparing non-distilled room temperature water for injection according to claim 8, characterized in that: The water storage unit includes a water tank, which is provided with a fourth water inlet and a third water outlet. The water tank is connected to the CEDI unit via the fourth water inlet, the water tank is connected to the water supply pump via the third water outlet, and the water tank is connected to the purified water unit via the third water outlet.

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