JP6192030B1 - Method of reducing initial disposal amount of process liquid and process liquid processing system - Google Patents

Abstract

The present invention provides a process liquid reduction method and a process liquid processing system capable of reducing process liquid discarded together with water impregnated in a filter and liquid remaining in a filter device. A method for reducing an initial disposal amount of a process liquid to be discarded together with a liquid remaining in a filter housing 11 in which a filter cartridge 12 is disposed, wherein the filter housing 11 is heated to a pressure higher than a bubble point. Provided in the piping on the primary side 13 so as to prevent the filter cartridge 12 from being damaged by the pressure of the heated aseptic air while supplying the sterile air to dry the wet filter cartridge 12 and supplying the heated aseptic air. The 1st valve A, the 1st valve B, and the 2nd valve C provided in piping of the secondary side 14 are opened and closed intermittently. [Selection] Figure 2

Description

  The present invention relates to a method for reducing an initial waste amount of a process liquid discarded together with a liquid remaining in a filter device provided in a manufacturing pipe, and a process liquid processing system.

  2. Description of the Related Art Conventionally, in a plant that processes liquid process liquids such as injections and eye drops, a process of sterilizing the process liquid by filtering with a filter device including a filter is performed. Typically, this filter has been integrity tested. The filter integrity test is a test for confirming that the filter has no physical defect and has a defined performance. Since it is confirmed by this integrity test that the filtration function of the filter is not impaired, it is possible to ensure that the finally obtained process liquid is sterile (for example, see Patent Document 1).

  As an example of the integrity test, first, the filter is wetted with water so that no gas flows. Then, the primary side of the filter is set to a predetermined pressure, and the primary side pressure is measured. If there is no change in the measured pressure, it is determined that the function of the filter is not impaired. On the other hand, when the pressure decreases, the filter is broken, and it is determined that the function of the filter is impaired.

  After the completion of the integrity test, the filter itself is in a wet state, and water remains in the filter device that houses the filter. Water impregnated in the filter itself and water remaining around the filter are discharged to the downstream side of the filter together with the process liquid when the next process liquid is processed after the integrity test.

  For this reason, the initial portion of the process liquid obtained by filtering with a filter contains the water used in the integrity test, and therefore is discarded (the portion of the process liquid that is discarded in this way. Referred to as initial waste). In particular, since process liquids such as injections are very expensive even in a small amount, an increase in the initial waste amount causes a large loss.

  Such problems generally exist not only for liquid process liquids related to pharmaceuticals such as injections, but also for process liquids that require filtration with a filter.

JP 2014-128780 A

  In view of such circumstances, the present invention can reduce the amount of process liquid discarded together with the water impregnated in the filter and the liquid remaining in the filter device, and the process liquid treatment method and the process liquid treatment method. The purpose is to provide a system.

  A first aspect for achieving the above object is a method of reducing an initial waste amount of a process liquid to be discarded together with a liquid remaining in a filter housing in which a filter cartridge is disposed. Supply the heated sterile air above the pressure of the point to dry the wet filter cartridge so that the filter cartridge is not damaged by the pressure of the heated sterile air while supplying the heated sterile air. Initial waste amount of process liquid characterized by intermittently opening and closing a first valve provided on a primary side pipe of the filter cartridge and a second valve provided on a secondary side pipe of the filter cartridge There is a reduction method.

  According to a second aspect of the present invention, in the method for reducing the initial waste amount of the process liquid described in the first aspect, the differential pressure between the pressure on the primary side and the pressure on the secondary side with respect to the filter cartridge is the filter. In the method for reducing the initial waste amount of the process liquid, the first valve and the second valve are intermittently opened and closed so that the pressure becomes less than the differential pressure at which the cartridge is damaged.

  According to a third aspect of the present invention, in the method for reducing an initial waste amount of process liquid described in the first or second aspect, when the first valve is opened, the second valve is closed, and the first liquid is discarded. In the method for reducing the initial waste amount of process liquid, the first valve and the second valve are opened and closed intermittently so that the second valve is opened when the valve is closed.

  According to a fourth aspect of the present invention, in the method for reducing the initial waste amount of the process liquid according to any one of the first to third aspects, the filter cartridge integrity test or the filter cartridge is dried before the filter cartridge is dried. In the method of reducing the initial waste amount of the process liquid, SIP is performed, the process liquid is filtered through the filter cartridge after the filter cartridge is dried, and then an integrity test is performed.

  According to a fifth aspect of the present invention, a filter cartridge disposed in a filter housing, a first valve provided in a primary side pipe of the filter cartridge, and a secondary side pipe of the filter cartridge are provided. A second valve; a sterile air supply means for supplying heated sterile air to the filter cartridge; and a control device for controlling the first valve, the second valve, and the sterile air supply means. Causes the sterilized air supply means to supply heated sterilized air at a bubble point pressure or higher to the filter housing, and while supplying the heated sterilized air, the filter cartridge is damaged by the pressure of the heated sterilized air. So that the first valve and the second valve are opened and closed intermittently. It is in the process liquid of the processing system.

  ADVANTAGE OF THE INVENTION According to this invention, the reduction method of the amount of initial disposal of a process liquid and the processing system of a process liquid which can reduce the process liquid discarded with the water which impregnated the filter and the liquid which remained in the filter apparatus are provided. .

It is a schematic block diagram of the process liquid processing system. It is the schematic of the processing system in a drying process. It is the schematic of the processing system in a drying process. It is the schematic of the processing system in a drying process.

  FIG. 1 is a schematic configuration diagram of a process liquid processing system according to the present embodiment. The processing system 1 of the present embodiment is a part of a plant that manufactures liquid pharmaceutical products (hereinafter referred to as chemical solutions) as an example of a process liquid.

  Specifically, the processing system 1 includes a filter device 10 provided in a manufacturing pipe 30 that connects the preparation tank 2 and the storage tank 3. The side for supplying the chemical liquid (preparation tank 2 side) is referred to as the upstream side, and the side to which the chemical liquid filtered by the filter device 10 is fed (storage tank 3 side) is referred to as the downstream side.

  The filter device 10 includes a filter housing 11 and a filter cartridge 12 provided therein. The filter cartridge 12 filters impurities, germs, and the like in the chemical solution. The upstream side of the filter cartridge 12, that is, the inside of the filter housing 11 and the outside of the filter cartridge 12 is a primary side 13. A space on the downstream side of the filter cartridge 12, that is, on the downstream side of the filter cartridge 12 is a secondary side 14.

  An upstream pipe 31 communicates with the primary side 13 of the filter cartridge 12, and a downstream pipe 32 communicates with the secondary side 14 of the filter cartridge 12. The upstream pipe 31 and the downstream pipe 32 are collectively referred to as a manufacturing pipe 30.

  The upstream pipe 31 is provided with an upstream valve 38, and the downstream pipe 32 is provided with a downstream valve 39. The upstream valve 38 and the downstream valve 39 are valves that open and close the upstream pipe 31 and the downstream pipe 32, respectively.

  A branch pipe 31 a is connected to the upstream pipe 31 between the upstream valve 38 and the filter housing 11. A branch pipe 32 a is connected to the downstream pipe 32 between the downstream valve 39 and the filter housing 11. The branch pipe 31a and the branch pipe 32a communicate with the outside and are used as piping for discharging aseptic heated air described later to the outside.

  A transport pipe 41 is connected to the upper part of the filter device 10. The transport pipe 41 is a pipe connected to the primary side 13 of the filter device 10 and is a pipe for transporting heated aseptic air into the filter housing 11.

  An air vent valve 37 is provided in the transport pipe 41. Further, a branch pipe 41 a communicating with the outside is connected to the transport pipe 41 between the air vent valve 37 and the sterile air supply means 80. When the chemical solution is supplied to the filter device 10, the air inside the filter housing 11 is discharged to the outside through the transport pipe 41 and the branch pipe 41a. After the filter housing 11 is filled with the chemical solution, the air vent valve 37 is closed. Further, the transport pipe 41 and the branch pipe 41a are used as pipes for discharging heated aseptic air described later to the outside.

  A first valve A is provided in the branch pipe 31a, and a first valve B is provided in the branch pipe 41a. The first valve A and the first valve B are an example of the first valve provided in the upstream pipe 31 and the transport pipe 41 that are pipes on the primary side 13 of the filter cartridge 12.

  A second valve C is provided in the branch pipe 32a. The second valve C is an example of a second valve provided in the downstream pipe 32 that is the pipe on the secondary side 14 of the filter cartridge 12.

  The first valve A, the first valve B, and the second valve C are closed when the chemical solution is circulated through the manufacturing pipe 30. Further, the first valve A, the first valve B, and the second valve C are opened and closed intermittently when the filter cartridge 12 is dried with heated aseptic air. Details of such opening / closing control will be described later. Further, the first valve A, the first valve B, and the second valve C are collectively referred to as first and second valves.

  The processing system 1 includes aseptic air supply means 80. The aseptic air supply means 80 includes a heat exchanger 81 provided in the transport pipe 41 and an aseptic filter device 82. Air is supplied to the transport pipe 41 as a gas. The heat exchanger 81 heats the air supplied from the transport pipe 41 with a heat medium.

  The aseptic filter device 82 is provided in the transport pipe 41 on the downstream side of the heat exchanger 81. The aseptic filter device 82 is a device that removes impurities and germs in the air using a filter (not shown). Thereby, the air is sterilized by the aseptic filter device 82 and becomes aseptic air.

  As described above, the air is heated to aseptic air (hereinafter referred to as heated aseptic air) by the heat exchanger 81 and the aseptic filter device 82 and is supplied to the primary side 13 of the filter housing 11.

  In addition, the processing system 1 includes a control device (not shown) such as a programmable logic controller (PLC) that controls processing of the processing system 1. The control device can control the supply of the chemical solution from the preparation tank 2 and the supply / stop of the heated sterile air by the sterile air supply means 80. Furthermore, the control device can perform opening / closing control of the various valves described above.

  The preparation tank 2 is a tank for preparing a chemical solution. Although not particularly illustrated, the preparation tank 2 is provided with an inlet for supplying a raw material of the chemical liquid to be manufactured and an outlet for discharging the manufactured chemical liquid, and can be opened and closed by a control signal from the control device. . The preparation tank 2 is connected to a compressed air supply device (not shown) for supplying compressed air therein. The compressed air supply device supplies air to the preparation tank 2 at a pressure specified by control from the control device. Thereby, a chemical | medical solution can be sent from the preparation tank 2 to the piping 30 for manufacture.

  The storage tank 3 is a tank that stores the chemical solution fed from the preparation tank 2 through the manufacturing pipe 30. Although not particularly shown, the storage tank 3 is provided with an inlet for feeding the pumped chemical and an outlet for discharging the chemical, and can be opened and closed by control from the control device. The storage tank 3 is connected to a filling machine that fills the container with the chemical solution, and the chemical solution can be discharged from the discharge port of the storage tank 3 and supplied to the filling machine.

  The operation of the processing system configured as described above will be described. 2 to 4 are schematic views of the processing system 1 when the filter cartridge is dried. In addition, the state which each valve | bulb opened is represented by white, and the closed state is represented by black.

  In the processing system 1, for example, (1) washing sterilization process, (2) integrity test I, (3) drying process, (4) manufacturing process, and (5) integrity test II are performed.

  (1) In the cleaning and sterilization step, stationary cleaning called “Cleaning in Place (CIP)” and stationary sterilization called “Sterilizing in Place (SIP)” are performed. As a result, various devices such as the filter housing 11, the filter cartridge 12, and the manufacturing pipe 30 are cleaned.

  (2) In the integrity test I, an integrity test of the filter cartridge 12 is performed. For example, the integrity test is performed as follows. First, water is supplied to the filter housing 11 to wet the filter cartridge 12. Next, by closing each valve, the primary side 13 of the filter housing 11 is made a closed space. Then, the pressure on the primary side 13 is adjusted to a predetermined pressure, and the pressure on the primary side 13 is measured.

  Since the filter cartridge 12 is wet, it is difficult for air to permeate from the primary side 13 to the secondary side 14 of the filter cartridge 12 if the filter cartridge 12 is not damaged. Therefore, if there is no change in the pressure on the primary side 13 or the change is within an allowable range, it is determined that the filter cartridge 12 is not damaged.

  On the other hand, if the filter cartridge 12 is damaged even though the filter cartridge 12 is wet, air passes from the primary side 13 to the secondary side 14 and the pressure on the primary side 13 decreases. If such a pressure drop on the primary side 13 is detected, it is determined that the filter cartridge 12 is damaged.

  In this way, the integrity test of the filter cartridge 12 is performed. Such an integrity test can be performed by a known integrity test apparatus.

  (3) In the drying step, the filter cartridge 12 wetted with water by the integrity test I is dried. Further, the drying process may be executed after the SIP is executed, not after the integrity test I. In this case, in the drying process, the filter cartridge 12 wetted by SIP is dried. A specific drying method will be described later.

  (4) In the manufacturing process, the chemical solution is pumped from the preparation tank 2 to the filter cartridge 12, and the chemical solution is filtered. The filtered chemical solution is stored in the storage tank 3, and other necessary processing is performed as needed to fill the container with the chemical solution.

  (5) In the integrity test II, after the chemical solution is filtered through the filter cartridge 12, the same test as the integrity test I is performed.

  Here, the drying process will be described in detail. First, as shown in FIG. 2, the control device closes the upstream valve 38 and the downstream valve 39. This is to prevent heated sterile air from flowing into the preparation tank 2 and the storage tank 3.

  Then, the control device causes the sterile air supply means 80 to supply heated sterile air to the filter housing 11. Specifically, heated air is formed in the heat exchanger 81 by heating the air and sterilizing the air with the sterile filter device 82. The heated aseptic air thus obtained is supplied to the filter housing 11. In addition, the heat source for heating heated aseptic air is not specifically limited.

  The temperature of the heated sterilized air is set to a temperature at which the filter cartridge 12 can accept the water, and the temperature of the filter cartridge 12 can be dried.

  The pressure of the heated aseptic air is not less than the pressure at the bubble point of the filter cartridge 12. The pressure at the bubble point refers to the pressure at which bubbles are generated from the pores of the filter when the filter is impregnated with a liquid such as water and air is supplied from one side.

  At the beginning of the drying process, the first valve A, the first valve B, and the second valve C are opened, and heated aseptic air is pressurized with a pump or the like and is pumped to the filter housing 11. As a result, the pressure on the primary side 13 of the filter housing 11 gradually increases and becomes equal to or higher than the pressure at the bubble point. The bubble point pressure is predetermined for each filter cartridge 12.

  Next, the control device determines whether the pressure of the heated aseptic air is equal to or higher than the bubble point pressure. For example, the time until the pressure at the bubble point is reached after supplying heated sterile air is measured in advance. And when the said time passes after actually supplying heated aseptic air, it determines with the pressure of heated aseptic air becoming more than the pressure of a bubble point. Of course, not limited to this, it is possible to determine whether the pressure of the heated aseptic air has reached the bubble point pressure by comparing the pressure value of the primary side 13 measured by the pressure gauge and the pressure of the bubble point. Good.

  As shown in FIGS. 3 and 4, after the pressure of the heated aseptic air becomes equal to or higher than the bubble point pressure, that is, after the water impregnated in the filter cartridge 12 is blown off, the control device The first valve B and the second valve C are opened and closed intermittently. Opening and closing the first valve A intermittently means opening for a predetermined time and then closing for a predetermined time. The same applies to the first valve B and the second valve C. Specifically, the first and second valves are opened and closed intermittently so that the filter cartridge 12 is not damaged by the pressure of heated aseptic air. Thus, while the first and second valves are opened and closed intermittently, the pressure of the heated aseptic air need not be equal to or higher than the bubble point pressure. Preferably, the first and second valves are opened and closed intermittently so that the pressure is less than the bubble point pressure.

  The operation of supplying heated sterile air at the above pressure and intermittently opening and closing the first and second valves will be described.

  When heated sterile air having a pressure higher than the bubble point is supplied to the filter cartridge 12, the liquid film formed in the micropores of the filter cartridge 12 is blown away by the heated sterile air. As a result, the heated aseptic air flows from the primary side 13 to the secondary side 14 of the filter cartridge 12. Since the heated aseptic air having the above pressure circulates through the filter cartridge 12, the filter cartridge 12 can be dried in a short time.

  If the heated aseptic air is less than the pressure at the bubble point, a liquid film is stretched in the micropores of the filter cartridge 12, and the filter cartridge 12 cannot be dried or takes a considerable time to dry. End up.

  Further, the water impregnated in the filter cartridge 12 is heated by heated aseptic air to become water vapor. Here, the filter housing 11 is not a sealed space by intermittently opening and closing the first and second valves. Therefore, the water vapor is discharged to the outside together with the heated aseptic air. In other words, by intermittently opening and closing the valve, water vapor is discharged to the outside, and new heated and sterile air can be constantly supplied into the filter housing 11. As a result, dry and sterile air is always supplied to the filter housing 11, so that drying of the filter cartridge 12 can be promoted.

  If the first and second valves are not opened and closed intermittently, the filter housing 11 is hermetically sealed in a closed state. For this reason, the water impregnated in the filter cartridge 12 becomes water vapor, and the heated aseptic air is saturated. If the heated aseptic air is saturated in this way, the filter cartridge 12 cannot be dried. In addition, an excessive pressure may be applied to the sealed filter housing 11 and filter cartridge 12. Also, if the first and second valves are not opened and closed intermittently but are always opened, the inside of the filter housing 11 is an open space. In this state, since the pressure of the heated aseptic air is lowered, the temperature of the heated aseptic air is lowered and the drying efficiency is lowered.

  However, in the processing system 1 and the method for reducing the initial waste amount according to the present embodiment, the filter cartridge 12 is dried after the integrity test I or SIP is performed and the filter cartridge 12 is wetted. In this drying, heated aseptic air having a pressure higher than the bubble point is supplied to the filter housing 11, and the first and second valves are intermittently opened and closed. Thereby, the filter cartridge 12 can be dried in a short time. Further, in the drying process, heated aseptic air having a pressure equal to or higher than the bubble point pressure is supplied to the filter cartridge 12, but by opening and closing the first and second valves intermittently, an excessive differential pressure is applied to the filter cartridge 12. Prevents hanging. Thereby, damage to the filter cartridge 12 can be prevented. In the manufacturing process (4), the chemical solution is filtered through the dried filter cartridge 12 (inside the filter device 10). As a result, even when the chemical solution is filtered through the filter cartridge 12, the water used for the integrity test is not included, so there is no need to discard the initial portion of the chemical solution. That is, when the next chemical solution is processed after drying, the initial amount of the chemical solution can be reduced.

  Further, as an aspect of intermittently opening and closing the first and second valves, the differential pressure between the pressure on the primary side 13 and the pressure on the secondary side 14 is less than the differential pressure at which the filter cartridge 12 is damaged. It is preferable to open and close intermittently. Thereby, the possibility that the filter cartridge 12 is damaged can be reduced.

  Further, as a mode of intermittently opening and closing the first and second valves, as shown in FIG. 3, when the first valve A and the first valve B are opened, the second valve C is closed, and as shown in FIG. Thus, it is preferable to open and close these valves intermittently so that the second valve C is opened when the first valve A and the first valve B are closed. That is, the first valve A and the first valve B on the primary side 13 and the second valve C on the secondary side 14 are not closed simultaneously and are not opened simultaneously. Thereby, damage to the filter cartridge 12 can be prevented more reliably.

  In this embodiment, the integrity test I or SIP is performed before the drying process, and the integrity test II is performed after the chemical solution is filtered by the filter cartridge 12 in the drying process and the manufacturing process. As described above, in the drying process, the filter cartridge 12 is prevented from being damaged by opening and closing the first and second valves. By performing the integrity test II after such a drying step, it can be confirmed that the filter cartridge 12 is not damaged. That is, it can be confirmed that the initial discard amount of the chemical solution is reduced and the integrity of the filter cartridge 12 is secured.

  As mentioned above, although one embodiment of the present invention has been described, of course, the present invention is not limited to the above-described embodiment, and addition, omission, replacement, etc., of a configuration is possible without departing from the spirit of the present invention. And other changes are possible.

  Although the processing system 1 which concerns on this embodiment illustrated two, the 1st valve | bulb A and the 1st valve | bulb B, as a 1st valve | bulb, it is not limited to this. The number is not particularly limited as long as it is provided in a pipe connecting the primary side 13 of the filter cartridge 12 and the outside. The same applies to the second valve.

  The processing system 1 according to the present embodiment sent the chemical solution from the preparation tank 2 to the storage tank 3. However, there is no particular limitation on the device configuration installed on the upstream side and the downstream side of the filter housing 11.

  The processing system 1 according to the present embodiment has sent a chemical liquid as a process liquid, but is not limited thereto, and can be applied to a case where an arbitrary process liquid such as a beverage is fed.

  In the processing system 1 according to the present embodiment, the filter cartridge 12 is in a wet state by performing the integrity test, but the present invention is not limited to such a state. That is, the present invention can be applied even when the filter cartridge 12 is moistened due to a cause other than the integrity test. Further, in the processing system 1 according to the present embodiment, the filter cartridge 12 is to be dried. However, the present invention is not limited to this, and the valves provided in the manufacturing pipe 30 and the manufacturing pipe 30 for feeding a chemical solution are dried. It can also be targeted. For example, heated aseptic air is supplied to the manufacturing pipe 30 and each valve, and at that time, the valves (corresponding to the first valve and the second valve) provided in the pipe for discharging the air in the manufacturing pipe 30 to the outside. Intermittently open and close). Note that the pressure of the heated aseptic air need not be higher than the pressure at the bubble point.

DESCRIPTION OF SYMBOLS 1 ... Processing system, 10 ... Filter apparatus, 11 ... Filter housing, 12 ... Filter cartridge 12, 13 ... Primary side, 14 ... Secondary side, 30 ... Manufacturing piping, 80 ... Aseptic air supply means

Claims (5)

A method for reducing an initial waste amount of a process liquid to be discarded together with a liquid remaining in a filter housing in which a filter cartridge is disposed,
Supplying heated aseptic air above the bubble point pressure to the filter housing, drying the wet filter cartridge,
A first valve provided in a pipe on the primary side of the filter cartridge and a secondary of the filter cartridge so that the filter cartridge is not damaged by the pressure of the heated sterile air while the heated sterile air is supplied. A method for reducing the initial waste amount of process liquid, characterized by intermittently opening and closing a second valve provided in a side pipe. In the method for reducing the initial waste amount of the process liquid according to claim 1,
The first valve and the second valve are opened and closed intermittently so that the differential pressure between the pressure on the primary side and the pressure on the secondary side of the filter cartridge is less than the differential pressure at which the filter cartridge is damaged. A method for reducing the initial waste amount of process liquid. In the method for reducing the initial waste amount of the process liquid according to claim 1 or claim 2,
The first valve and the second valve are opened and closed intermittently so that the second valve is closed when the first valve is opened, and the second valve is opened when the first valve is closed. A method for reducing the initial disposal amount of process liquid, characterized by: In the method for reducing the initial waste amount of the process liquid according to any one of claims 1 to 3,
Before drying the filter cartridge, perform an integrity test or SIP of the filter cartridge,
A method for reducing the initial waste amount of process liquid, comprising: drying the filter cartridge, filtering the process liquid through the filter cartridge, and then performing an integrity test. A filter cartridge disposed within the filter housing;
A first valve provided in a primary side pipe of the filter cartridge, and a second valve provided in a secondary side pipe of the filter cartridge;
Sterile air supply means for supplying heated sterile air to the filter cartridge;
A control device for controlling the first valve, the second valve, and the sterile air supply means,
The controller is
The sterilized air supply means supplies heated sterilized air having a bubble point pressure or higher to the filter housing,
The first valve and the second valve are opened and closed intermittently so that the filter cartridge is not damaged by the pressure of the heated sterile air while the heated sterile air is supplied. Processing system.

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