JP6059588B2 - Water supply device for injection - Google Patents

Description

  The present invention relates to a water supply device for injection.

  As an apparatus for supplying water for injection to a use point such as a pharmaceutical or drug manufacturing apparatus, for example, the apparatus described in Patent Document 1 is known. In particular, in FIG. 2 of Patent Document 1, a circulation pipe (circulation line) that circulates high-temperature water for injection, a supply line that connects the circulation line and the use point, and a supply line are provided and supplied to the use point. And a cooler (cooling means) for cooling water for injection. According to this apparatus, a part of the water for injection can be cooled and supplied to the use point while preventing the generation of bacteria and microorganisms by circulating and holding the high temperature water for injection.

JP-A-11-321994

  In the above-described device, the supply of the water for injection to the use point is stopped by cutting off the connection between the circulation line and the supply line. For this reason, stagnation of the water for injection occurs in the supply line after the supply is stopped until the supply of the water for injection is resumed (that is, when the water for injection is not supplied). The retention of water for injection leads to a decrease in temperature, which leads to the generation of bacteria and microorganisms, but the risk is further increased in the supply line including the cooling means.

  Accordingly, an object of the present invention is to provide a structure capable of suppressing the occurrence of stagnation of water for injection when the water for injection is not supplied in a water supply device for injection that supplies water for injection to a use point. .

In order to achieve the above-described object, the water supply device for injection of the present invention is a circulation line for circulating water for injection at 80 ° C. or higher, and a supply means for supplying water for injection to a use point. A bypass line that is connected in parallel with a part of the circulation line, and whose downstream end in the flow direction of the water for injection is connected to the circulation line via an outlet valve, and a supply valve. And a supply unit having a supply line to be connected and a cooling unit provided in the bypass line for cooling the water for injection supplied to the use point. In one aspect, the supply means further comprises bypass flow rate control means for controlling the flow rate of the water for injection passing through the bypass line to be a predetermined value or more, and the bypass flow rate control means is provided in a part of the circulation line. A flow rate control valve, and a flow rate indicating controller that measures the flow rate of water for injection passing through the bypass line and adjusts the opening of the flow rate control valve so that the measured value is equal to or greater than a predetermined value. Yes. In another aspect, the supply means includes bypass cutoff means for blocking the flow of water for injection between the circulation line and the bypass line, and steam sterilization means for sterilizing the blocked bypass line with steam of 121 ° C. or higher. The steam sterilization means further includes steam supply means for supplying steam to the bypass line, and purified air supply means for supplying purified air to the bypass line.

  In such a water supply device for injection, by closing the outlet valve and opening the supply valve, the water for injection flowing into the bypass line from the circulation line is cooled by the cooling means and supplied to the use point through the supply line. Can do. On the other hand, when water for injection is not supplied to the use point, the outlet valve is opened, the supply valve is closed, and the operation of the cooling means is stopped, so that the hot water for injection flowing into the bypass line from the circulation line It can be returned to the circulation line as it is. As a result, even when the water for injection is not supplied, the water for injection can be continuously flowed through the bypass line, and the retention of water for injection can be suppressed.

  As described above, according to the present invention, in the water supply device for injection that supplies water for injection to the use point, it is possible to suppress the retention of water for injection when the water for injection is not supplied.

It is the schematic which shows one Embodiment of the water supply apparatus for injection of this invention. It is the schematic which shows the modification of the water supply device for injection of this embodiment. It is a flowchart which shows the steam sterilization process of this embodiment.

  Embodiments of the present invention will be described below with reference to the drawings.

  The water supply device for injection of the present invention is a device that cools and supplies a part of the water for injection to the use point while circulating and holding the high temperature water for injection, and supplies the water for injection to a pharmaceutical or pharmaceutical production device It is suitably used as a device for Here, “water for injection” means water for injection prescribed by the Japanese Pharmacopoeia.

  FIG. 1 is a schematic view showing an embodiment of the water supply device for injection according to the present invention.

  The injection water supply device 1 according to this embodiment includes a circulation line 10 that circulates high-temperature injection water and a supply unit 20 that is provided in the circulation line 10 and supplies the injection water to the use point 2.

  The circulation line 10 is provided with a tank 11 for storing water for injection, a circulation pump 12, and a heat exchanger 13 for heating the water for injection. Thereby, the water for injection heated at high temperature can be circulated along the circulation line 10. When the water for injection is held while circulating, the temperature of the water for injection needs to be 80 ° C. or higher, more preferably 81 ° C. or higher in order to prevent the generation of bacteria and microorganisms. Therefore, in the present embodiment, the heat exchanger 13 is configured to heat the water for injection to, for example, 85 ° C. or higher in consideration that the temperature is lowered due to the influence of heat radiation due to circulation. The tank 11 is connected to a replenishment line 14 for replenishing the tank 11 with water for injection.

  The supply means 20 includes a bypass line 21 connected in parallel with a part of the circulation line 10, and a supply line 22 that connects the bypass line 21 and the use point 2. The end of the bypass line 21 on the downstream side in the flow direction of the water for injection is connected to the circulation line 10 via the bypass outlet valve 21a, and the supply line 22 is provided with a supply valve 22a.

  The supply unit 20 includes a heat exchanger 23 that is provided in the bypass line 21 and serves as a cooling unit that cools the water for injection supplied to the use point 2. The heat exchanger 23 is provided upstream of the connection point of the bypass line 21 with the supply line 22 in the flow direction.

  In such a water supply device for injection 1, when water for injection is supplied to the use point 2, first, the bypass outlet valve 21a is closed and the supply valve 22a is opened. At the same time, the water for injection flowing into the bypass line 21 is cooled to the use temperature (for example, 25 ° C.) by the heat exchanger 23. Thereby, the water for injection cooled to the use temperature can be supplied to the use point 2 through the supply line 22.

  On the other hand, when water for injection is not supplied to the use point 2 (when water for injection is not supplied), the bypass outlet valve 21a is opened, the supply valve 22a is closed, and the operation of the heat exchanger 23 is stopped. Thereby, the hot water for injection which flowed into the bypass line 21 can be returned to the circulation line 10 as it is. As a result, even when the water for injection is not supplied, the water for injection can be continuously flowed through the bypass line 21, and the retention of water for injection can be suppressed.

  Although FIG. 1 shows an example in which one supply means 20 is provided for the circulation line 10, when there are a plurality of use points 2, a plurality of use points 2 corresponding to each use point 2 are shown. The supply means 20 may be provided.

  As described above, when the water for injection is not supplied, the water for injection that flows into the bypass line 21 from the circulation line 10 passes through the bypass line 21 and flows into the circulation line 10 again. At this time, the flow rate of the injection water that passes through the bypass line 21 (bypass flow rate) changes according to the flow rate of the injection water that flows into the bypass line 21 (bypass flow rate), and the bypass flow rate flows through the circulation line 10. It changes according to the flow rate (circulation flow rate) of water for injection. For this reason, when the circulation flow rate fluctuates, the bypass inflow amount also fluctuates accordingly. When the circulation flow rate decreases drastically, it may not be possible to secure a sufficient amount for suppressing the occurrence of stagnation as the bypass passage flow rate. Such a problem of flow rate fluctuation occurs in the supply means 20 in which other use points exist on the upstream side, and particularly remarkably occurs when a plurality of use points exist.

  Therefore, in order to reliably suppress the occurrence of stagnation of water for injection, it is necessary to control the bypass passage flow rate to be a predetermined value or more even when the circulation flow rate fluctuates. In the water supply device for injection 1 of this embodiment, the supply means 20 has a bypass flow rate control means 24 for that purpose.

  The bypass flow rate control means 24 includes a flow rate adjustment valve 24 a provided in the circulation line 10 and a flow rate indicating controller (FIC) 24 b provided in the bypass line 21.

  The flow rate control valve 24a is connected between the branch point of the circulation line 10 and the bypass line 21 and the junction point of the circulation line 10 and the bypass line 21, that is, a portion connected in parallel with the bypass line 21 of the circulation line 10 Is provided. Therefore, the flow rate of the water for injection flowing into the bypass line 21 from the circulation line 10 can be adjusted by adjusting the opening degree of the flow rate adjusting valve 24a. Specifically, the flow rate of the injection water flowing into the bypass line 21 can be increased by reducing the opening degree of the flow rate control valve 24a, and the bypass line can be increased by increasing the opening degree of the flow rate control valve 24a. The flow rate of the water for injection which flows into 21 can be decreased.

  The flow rate indicating controller 24b only needs to measure the bypass flow rate of the water for injection and adjust the opening of the flow rate control valve 24a so that the measured value is equal to or greater than a predetermined value. Therefore, in this embodiment, the flow rate indicating controller 24b is provided on the downstream side of the heat exchanger 23 and upstream of the branch point with the supply line 22, but is not limited thereto. For example, it may be provided upstream of the heat exchanger 23 or downstream of the branch point with the supply line 22.

  The bypass flow rate of the water for injection is set in consideration of not only the fact that the above-mentioned retention is surely suppressed but also that the temperature drop when the water for injection passes through the bypass line 21 is suppressed as much as possible. In other words, the temperature of the water for injection is set in consideration of preventing the temperature of the water for injection from being less than 80 ° C. due to the influence of heat radiation or the like while passing through the bypass line 21. Although depending on the configuration of the bypass line 21 and the surrounding environment, the bypass passage flow rate of water for injection is, for example, a flow rate such that the flow velocity in the pipe is about 0.8 m / s.

  From the viewpoint of maintaining the temperature of the water for injection passing through the bypass line 21 at 80 ° C. or higher, the heat exchanger 23 provided in the bypass line 21 also has a function as a heating means for heating the water for injection. It's okay.

  By the way, in the middle of supplying the water for injection to the use point 2, the supply valve 22a may be temporarily closed to temporarily stop the supply of water for injection. In that case, the water for injection will stay in the bypass line 21. As described above, the retention of water for injection leads to a decrease in the temperature of water for injection, which also leads to the generation of bacteria and microorganisms. Therefore, in order to suppress the temporary retention of the water for injection, in the present embodiment, the supply means 20 has a blow means 25 for discharging the water for injection to the outside.

  The blow means 25 is comprised from the blow line 25a connected to the bypass line 21, and the blow valve 25b provided in the blow line 25a.

  The blow line 25a is in a position where the water for injection cooled by the heat exchanger 23 can be discharged to the outside when the supply of water for injection is temporarily stopped, that is, when both the bypass outlet valve 21a and the supply valve 22a are closed. What is necessary is just to be provided. Therefore, in this embodiment, the blow line 25a is connected to the bypass line 21 on the downstream side of the connection point between the bypass line 21 and the supply line 22, but is connected to the bypass line 21 on the upstream side of the connection point. It may be connected. The blow line 25a may be connected to the supply line 22 on the upstream side of the supply valve 22a. On the other hand, the blow valve 25b may be an orifice.

  On the one hand, the flow rate of the water for injection (blow flow rate) discharged to the outside only needs to be such that no stagnation of the water for injection occurs in the bypass line 21, and on the other hand, as long as it does not affect the running cost. Good. Although depending on the amount of water used for injection at the use point 2 (that is, the flow rate of water for injection flowing into the supply line 22 from the bypass line 21), the blow flow rate is, for example, in the range of 50 to 100 L / h.

  The discharge of the water for injection by the blow means 25 can stably maintain the temperature of the water for injection by the heat exchanger 23 (cooling to the use temperature) when the supply of the water for injection is temporarily stopped. But it is advantageous.

  Next, a modified example of the water supply device for injection of this embodiment will be described.

  FIG. 2 is a schematic view showing an injection water supply apparatus according to this modification. In FIG. 2, for the sake of simplicity, only a part of the circulation line is shown, and the bypass flow rate control means shown in FIG. 1 is not shown.

  In order to prevent the generation of bacteria and microorganisms in the water supply device for injection, not only the water for injection is circulated at a high temperature of 80 ° C or higher, but also the inside of the circulation line or bypass line through which water for injection flows is 121 ° C or higher. It must be sterilized regularly with steam. In this modification, steam sterilization means for sterilizing the bypass line with steam at 121 ° C. or higher is added to the water supply device for injection shown in FIG.

  In the water supply device for injection 1 according to this modification, the supply unit 20 includes a steam sterilization unit 30 for sterilizing the bypass line 21 with steam of 121 ° C. or higher.

  The steam sterilization means 30 includes a steam supply line 31 that supplies steam at 121 ° C. or higher to the bypass line 21, and an air supply line 32 that supplies air to the bypass line 21. The steam supply line 31 is provided with a steam supply valve 31a, and the air supply line 32 is provided with an air supply valve 32a and an air vent filter (filter means) for removing contaminants contained in the air, particularly dust and bacteria. 32b. The steam supply line 31 and the air supply line 32 are each connected to the introduction line 33, and the introduction line 33 is connected to the bypass line 21 via the introduction valve 33a.

  With the addition of this steam sterilization means 30, in this modification, a bypass inlet valve 21b is provided at the end of the bypass line 21 on the upstream side in the flow direction of the water for injection. The bypass inlet valve 21b functions as the bypass blocking means 26 together with the bypass outlet valve 21a. That is, the flow of the water for injection between the circulation line 10 and the bypass line 21 can be interrupted by closing the bypass inlet valve 21b and the bypass outlet valve 21a. The bypass inlet valve 21b is closed only in the steam sterilization process of the bypass line 21 to be described later, and remains open otherwise.

  Next, a series of steps related to steam sterilization using the steam sterilization means 30 shown in FIG. 2 will be described along the flowchart shown in FIG.

  First, the bypass line 21 is substantially separated from the circulation line 10 (step S1). Specifically, both the bypass inlet valve 21b and the bypass outlet valve 21a are closed to block the flow of water for injection between the circulation line 10 and the bypass line 21. At this time, if water for injection was used immediately before the use point 2, the operation of the heat exchanger 23 is stopped and the supply valve 22a of the supply line 22 is closed.

  Thereafter, water is drained from the bypass line 21 (step S2). Specifically, first, the introduction valve 33a is opened, and the blow valve 25b is opened. Then, the air supply valve 32 a is opened, and air is supplied from the air supply line 32 to the bypass line 21. Thereby, the water for injection in the bypass line 21 is discharged | emitted outside.

  After circulating air through the bypass line 21 for a certain time, the air supply valve 32a is closed. Thus, the supply of clean air from the air supply line 32 is stopped, and draining of the bypass line 21 is completed.

  Thereafter, the steam supply valve 31a is opened, and steam at 121 ° C. or higher is supplied from the steam supply line 31 to the bypass line 21 (step S3). That is, steam sterilization of the bypass line 21 is performed by circulating steam at 121 ° C. or higher through the bypass line 21.

  After flowing steam at 121 ° C. or higher through the bypass line 21 for a certain time, the steam supply valve 31a is closed to stop supplying steam to the bypass line 21 (step S4). Then, the air supply valve 32a is opened, and the air purified by the air vent filter 32b (clean air) is supplied from the air supply line 32 to the bypass line 21 (step S5). As a result, the steam in the bypass line 21 is replaced with clean air and discharged to the outside from the blow line 25a.

After the steam in the bypass line 21 is replaced with clean air, the blow valve 25b is closed. Here, after the blow valve 25b is closed, clean air is continuously supplied to the bypass line 21 through the air supply line 32 and the air vent filter 32b. Then, when the pressure in the bypass line 21 becomes positive (positive pressure) with respect to the outside, the air supply valve 32a is closed to stop the supply of clean air to the bypass line 21 (step S6).
The bypass line 21 that has become high temperature due to steam sterilization is gradually cooled by the supply of clean steam, and the pressure in the bypass line 21 gradually decreases accordingly. Therefore, even if the pressure in the bypass line 21 is a positive pressure at the time when supply of clean air to the bypass line 21 is stopped, it may turn to a negative pressure (negative pressure) thereafter. This is not preferable because it causes inflow of unpurified air from the outside (ambient environment).

  Therefore, after the supply of clean air to the bypass line 21 is stopped, whether or not the pressure in the bypass line 21 is maintained at a positive pressure (that is, whether or not it remains higher than the ambient pressure) is a pressure sensor (not shown). ) To monitor (step S7). When the pressure in the bypass line 21 changes from positive pressure to negative pressure, clean air is supplied again (steps S5 to S6). Thereafter, steps S5 to S6 are repeated until the pressure in the bypass line 21 is maintained at a positive pressure. When the pressure is maintained at the positive pressure, the introduction valve 33a is closed, and a series of steps related to steam sterilization is performed. finish.

  This modified example is suitably applied when water for injection is supplied to other use points in addition to the illustrated use point 2. That is, it is preferable in that steam sterilization is possible only for a specific bypass line 21 without stopping the supply of water for injection to other use points.

DESCRIPTION OF SYMBOLS 1 Water supply apparatus for injection 2 Use point 10 Circulation line 11 Tank 12 Circulation pump 13 Heat exchanger 14 Replenishment line 20 Supply means 21 Bypass line 21a Bypass outlet valve 21b Bypass inlet valve 22 Supply line 22a Supply valve 23 Heat exchanger (cooling means) )
24 Bypass flow control means 24a Flow control valve 24b Flow indicator controller 25 Blow means 25a Blow line 25b Blow valve 26 Bypass shut-off means 30 Steam sterilization means 31 Steam supply line 31a Steam supply valve 32 Air supply line 32a Air supply valve 32b Air vent filter 33 Introduction line 33a Introduction valve

Claims (8)

A circulation line for circulating water for injection at 80 ° C. or higher;
A supply means provided in the circulation line for supplying the water for injection to a use point, connected in parallel with a part of the circulation line, and an end on the downstream side in the flow direction of the water for injection passes through an outlet valve. A bypass line connected to the circulation line, a supply valve, a supply line connecting the bypass line and the use point, and the water for injection supplied to the use point provided in the bypass line. A supply means having cooling means for cooling, and bypass flow rate control means for controlling the flow rate of the water for injection passing through the bypass line to be a predetermined value or more ,
I have a,
The bypass flow rate control means measures a flow rate control valve provided in the part of the circulation line and the flow rate of the water for injection passing through the bypass line, and the measured value is equal to or greater than the predetermined value. A flow rate indicating controller for adjusting the opening degree of the flow rate control valve,
Water supply device for injection. The supply means includes bypass cutoff means for blocking the flow of the water for injection between the circulation line and the bypass line, and steam sterilization means for sterilizing the blocked bypass line with steam at 121 ° C. or higher. The water supply device for injection according to claim 1 which has. The injection water supply device according to claim 2 , wherein the steam sterilization means includes: a steam supply means for supplying the steam to the bypass line; and a purified air supply means for supplying purified air to the bypass line. . A circulation line for circulating water for injection at 80 ° C. or higher;
A supply means provided in the circulation line for supplying the water for injection to a use point, connected in parallel with a part of the circulation line, and an end on the downstream side in the flow direction of the water for injection passes through an outlet valve. A bypass line connected to the circulation line, a supply valve, a supply line connecting the bypass line and the use point, and the water for injection supplied to the use point provided in the bypass line. Cooling means for cooling, bypass shut-off means for shutting off the flow of water for injection between the circulation line and the bypass line, steam sterilization means for sterilizing the shut-off bypass line with steam at 121 ° C. or higher, I have a,
The steam sterilization means includes steam supply means for supplying the steam to the bypass line, and purified air supply means for supplying purified air to the bypass line.
Water supply device for injection. 5. The water supply for injection according to claim 2 , wherein the bypass shut-off means includes the outlet valve and an inlet valve provided at an end of the bypass line on the upstream side in the flow direction. apparatus. The injection water supply apparatus according to any one of claims 1 to 5 , wherein the supply means includes a blow means for discharging the injection water cooled by the cooling means to the outside. The water supply device for injection according to claim 6 , wherein the blowing means has an orifice. Having a plurality of said supply means, the injection water supply apparatus according to claims 1 7.

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