JPH03187A - Device for producing germfree water - Google Patents

Abstract

PURPOSE:To simplify the device and to expand the applications of permeated water by utilizing a heating tank and thermally sterilizing an ultrafilter in the final treatment of ordinary wafer in addition to the mere complete removal of exothermic materials and other impurities by the ultrafilter and the execution of evaporation with high efficiency and high accuracy. CONSTITUTION:An ultrafilter membrane module 4 which filters the treated water obtd. by removing solids, colloids, impurity electrolytes, etc., from the ordinary water and the heating tank 5 which is introduced with the permeated water from this module and heats this water are provided. Further, a membrane demister 7 which makes the gas liquid sepn. of the steam obtd. in the heating tank and a condenser 8 which condenses the steam separated in the membrane demister are provided. In addition, a circuit which switches the supply of the treated water to the ultrafilter membrane module to the supply into the heating tank to send the treated water through the heating tank to the above-mentioned membrane module and shuts off the communication between the permeation side of the membrane module and the heating tank is installed. Both of a distillation method and an ultrafilter method are possible in this way and are selectable according to the applications of the water for injection.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to an improvement in an apparatus for producing sterile water such as water for injection.

<Prior art> Sterile water used for preparing injections and dissolving agents contains all kinds of microorganisms and endotoxins (pyrogenic substances).
must be removed.

Conventionally, as a device for producing water for injection (distilled water for injection),
As shown in Figure 3, a pump 1', a precision filter 2' for removing solids and colloids, an ion exchanger 3' for removing impurity electrolytes, a precision filter for removing microorganisms and endotoxins, etc. A filter 4', a heating tank 5' for introducing the permeated water from the filter and evaporating it by heating, and a condenser 8'' for condensing the vapor that has passed through the demister to prevent entrainment of droplets. It is known what happens.

In this device, small particles such as bacteria, endotoxins, and other impurities such as small particles and organic substances are finally filtered through a microfilter 4', evaporated through a heating tank 5', and It is removed by the cooperation of the removal of droplets (gas-liquid separation) by the demister 7' from the steam, and a small amount of it is contained in the purified water after passing through the microfiltration membrane of the microfilter 4'. The small particulates and organic substances that are present are removed using a special distillation method. Therefore, the water stored in the heating tank 5' is of poor quality compared to the distilled water that is finally obtained, and during long-term operation, the inner wall of the heating tank 5' becomes fouled and scale adheres to the surface of the heat exchanger. Therefore, a decrease in thermal efficiency cannot be avoided. Even when cleaning, it is necessary to pay close attention to contamination from the outside, which requires excessive labor.

In addition, exothermic substances can easily pass through the precision filter 4',
There is also a risk that the purified water may contain pyrogenic substances, so even if the purified water is sampled, there is also the disadvantage that its uses are limited due to its reliability.

On the other hand, in the production of ultrapure water used in the electronics industry,
It is known that water is treated with an ultrafilter, and it is also possible to distill this ultrapure water or pure water as raw water.

However, these ultrapure water systems are large and complicated, and because they are located outside the heating system, bacteria are likely to grow, including in the ultrafilter, and it is difficult to guarantee sterilization, which poses a problem.

The purpose of the present invention is not only to completely remove pyrogenic substances and other impurities by simply using an ultrafilter in the final treatment of ordinary water, that is, to purify it, and to perform evaporation with high efficiency and precision; To expand the uses of permeated water by making it possible to heat sterilize a filter using the heating tank.

In the present invention, since the heat source of the heating tank can be used as the heat source for the heat sterilization, it is possible to simplify and reduce the cost of the apparatus.

Means for Solving the Problems> The sterile water production apparatus according to the present invention includes an ultrafiltration membrane module that filters treated water from which solids, colloids, impurity electrolytes, etc. have been removed from ordinary water, and an ultrafiltration membrane module that It is equipped with a heating tank that introduces and heats water, a membrane demister that separates the vapor obtained in the heating tank into gas and liquid, and a condenser that condenses the vapor separated by the membrane demister. The treated water supply to the membrane module is switched to the supply into the heating tank, the treated water is sent to the above membrane module through the heating tank, and the communication between the permeation side of the membrane module and the above heating tank is cut off. This configuration is characterized by the addition of a circuit that performs the following steps.

<Explanation of Examples> Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is an explanatory diagram showing one embodiment of the present invention.

In FIG. 1, 1 is a regular water supply pump.

2 is a precision filter for removing solids, colloids, etc. from ordinary water, and the precision filtration membrane has a
A pore size of ~20 μm was used.

3 is an ion exchanger for removing impurity electrolytes in ordinary water, and both regenerative and non-regenerative types can be used, but in the case of a small device, it is better to use a non-regenerative type because it requires less installation space and space.
This is advantageous in terms of maintenance.

These pretreatment devices A are provided to reduce the load on ultrafiltration, distillation, or gas-liquid separation, which will be described later.Depending on the water quality, residual chlorine removal devices such as activated carbon, Coagulation equipment, sedimentation separation equipment, etc. can be added.

The ultrafiltration membrane module 41 is a stock solution chamber, 42 is a permeate chamber, and the stock solution inlet 43 is communicated with the ion exchanger via a valve v1 and a raw water supply pipe P1. 44 is a permeate extraction pipe, and v2 is a valve. The ultrafiltration membrane used in this module has a molecular weight cut-off of 6000 or less. Therefore, the number of fine particles of 0.2 μm or more in permeated water can be reduced to a few particles/mQ to more than ten particles/mQ,
Endotoxin, a pyrogenic substance, can be completely removed.

V3 is a pressure regulating valve provided at the stock solution outlet 45 of the ultrafiltration module, and is used to set the stock solution chamber pressure to a predetermined operating pressure. A heating tank 5 includes a heat exchanger 51 whose heat source is a burner, an electric heater, a boiler, or the like. This heating tank 5 and the permeate chamber 42 of the module 4
The water pipe P2 communicates with the water pipe P2 via the valve 4. 7 is a membrane demister provided in the upper space of the heating tank 5.
A hydrophobic porous membrane is used for the membrane, and the droplets (liquid phase) in the vapor entrained in the heating tank are not allowed to pass through due to the membrane's water repellency, allowing only water vapor to pass through. obtain. This hydrophobic porous membrane is made of fluorine-based membranes such as polytetrafluoroethylene, polysulfone-based membranes such as polyethersulfone, or a hydrophilic membrane is coated with a water-repellent resin such as fluorine or silicone to impart hydrophobicity. You can use the 8 is a condenser for condensing pure vapor from the membrane demister, and 9 is a distilled water sampling pipe.

In Fig. 1, P3 is the stock solution branch pipe, and valve v5
The raw water supply pipe P1 is connected to the heating tank 5 at the inlet side of the valve v1. P4 is a hot water pipe, which has a valve v6, and connects the heating tank 5 to the raw water supply pipe P1.
The outlet side of the valve v1 communicates with the outlet side of the valve v1.

The ultrafiltration membrane module mentioned above includes a hollow fiber membrane module,
Although spiral membrane modules, plate-type membrane modules, tubular membrane modules, etc. can be used, it is advantageous to use hollow fiber membrane modules from the standpoint of miniaturization. FIG. 2 shows an example of a hollow fiber membrane module, in which a hollow fiber membrane bundle 10 is housed in a heat-resistant cylindrical case 11, and heat-resistant resin partition walls 12 are formed at both ends of the case. Each end is open on the outer surface of each partition wall), and the case has a stock solution inlet 43 and an outlet 4
5, and permeated liquid outlet caps 13 and 14 are attached to both ends of the case (one cap 13 is provided with the above-mentioned permeated liquid extraction pipe 44, and the other cap 14 is connected to the above-mentioned heating tank 5). .

According to the above-mentioned apparatus, water for injection can be produced by the distillation method and the ultrafiltration method described in the 11th revised Japanese Pharmacopoeia supplement by the Ministry of Health and Welfare.

When using the distillation method, first close the valves V and 6, open the valves 2 and 4, and then open the outlet of the pretreatment section A (the outlet of the ion exchanger 3) and the ultrafiltration membrane module 4.
The pump 1 is then driven, and the operating pressure of the module 4 is controlled by the valve. The pressure is set to a predetermined value through the adjustment in Step 3, and the raw water pumped from the pretreatment section A is treated with the ultrafiltration membrane of the module 4, and the permeated water is advected into the heating tank 5. When the liquid level in the tank 5 reaches a predetermined level, the heating tank 5 is heated to 100"C or higher to evaporate the permeated water, and the membrane demister 7 separates pure vapor, which is condensed in the condenser 8. to obtain distilled water.

In addition, endotoxins and small particle impurities can be removed by the ultrafiltration membrane, heat sterilization can be performed by heating in the tank 5, and even if the droplets in the steam contain impurities, these impurities can be removed by the membrane demister 7. Since it can be removed, the distilled water is completely sterile and can be used as water for injection. In addition, since the water stored in the heating tank 5 is treated with an ultrafiltration membrane and is highly pure, it is possible to prevent scale formation in the tank 5, which is advantageous for maintaining the thermal efficiency of heat exchange inside the tank and for other purposes. It is.

In addition, in the above, it is also possible to use pure steam as it is without operating the air conditioner 8 (cooling water is not passed through).

On the other hand, in the case of using the ultrafiltration method, valve ① and row v4 are closed, valves V and v6 are opened, the pretreatment section A is connected to the heating tank 5, and the heating tank 5 is connected to the ultrafiltration membrane module 4. The raw water is treated in the ultrafiltration membrane module 4 through the route shown by the dotted line in FIG. The permeated water is taken out from the passed water extraction pipe 44. In the case of this ultrafiltration method, since the temperature of the hot water in the heating tank 5 is 100°C or less, distillation is not substantially performed.

Even when using this ultrafiltration method, endotoxins and other particulate impurities can be removed by the ultrafiltration membrane module 4, and heat sterilization can be performed by heating at 80 to 95°C, so the permeated water from the module can be used as water for injection. It is possible to use.

The above-mentioned distillation method and ultrafiltration method can be appropriately selected and used depending on the current use of water for injection (preparation of injection preparation, solubilizing agent for injection preparation). In addition, when heating the inside of the heating tank to a temperature that allows distillation, 80 to 100°C during temperature rise.
Ultrafiltration methods may be used during periods when distillation methods cannot yet be used within the temperature range of .

Note that in order to store and use the sterile water obtained by the above-mentioned distillation method or ultrafiltration method, or to lower the temperature to a predetermined temperature for use, an airtight storage container or a cooler can be attached.

<Effects of the Invention> According to the method for producing sterile water according to the present invention, as described above,
In addition to obtaining sterile water using the distillation method, sterile water can also be obtained by combining sterilization using a heated tank and ultrafiltration using an ultrafiltration membrane module. The inside of the filtration membrane module can be maintained in a sterile state, and the permeated water of the module can be kept in a good sterile state even during the distillation process. Therefore, the permeated water can be extracted and used for a wide range of medicinal purposes.

[Brief explanation of the drawing]

FIG. 1 is an explanatory diagram showing an embodiment of the present invention, FIG. 2 is an explanatory diagram showing an ultrafiltration membrane module used in the present invention, and FIG. 3 is an explanatory diagram showing a conventional example. 1... Pump 2... Precision filter 3... Ion exchanger 4... Ultrafiltration membrane module 5... Heating tank 7・−・・Membrane demister-8・・・・Capacitor

Claims (1)

[Claims] An ultrafiltration membrane module that filters treated water from which solids, colloids, impurity electrolytes, etc. have been removed from ordinary water, a heating tank that introduces and heats the filtrated water of the module, and entrained vapor obtained in the heating tank. It is equipped with a membrane demister that separates gas and liquid, and a condenser that condenses the vapor separated by the membrane demister, and in addition, the treated water is heated by switching the treated water supply to the ultrafiltration membrane module to the supply inside the heating tank. An apparatus for producing sterile water, characterized in that it is provided with a circuit that sends the water to the membrane module through the inside of the tank and blocks communication between the permeation side of the membrane module and the heating tank.