Apparatus and method for using disinfecting or cleaning liquids

Abstract

To guarantee a sterilization or a washing function without having to increase pressure resistance, in a device and a method for sterilizing or washing a filling machine.SOLUTION: The device comprises: a temperature control part configured to allow heating of the liquid used for sterilizing or washing the filling machine; a circulation path configured to enable the liquid to circulate between the temperature control part and the filling machine; a pumping part that pumps the liquid in the circulation path; and a control part that generates a command. In a process where a temperature of the liquid rises while the circulation path is in a sealed state, the control part gives the command to the pumping part based on an internal pressure in a portion of the filling machine to decrease a flow rate of the liquid.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] SUMMARY OF THE DISCLOSURE The present disclosure relates to an apparatus and method for sterilizing or cleaning a filling machine by supplying a heated sterilizing or cleaning liquid to the filling machine. [Background technology]

[0002] For example, an aseptic filling machine that fills containers with a liquid product such as a beverage is provided with a sterilizing and cleaning device for sterilizing and cleaning the inside of a filling tank and a filling valve in place (for example, Patent Document 1). When product production is complete, the discharge port of the filling valve is closed with a lid member, and a predetermined path is set up that includes the inside of the filling tank and the filling valve. When performing in-place cleaning and in-place sterilization of a filling machine using a liquid such as water or a chemical, the sterilizing and cleaning device supplies the liquid to the predetermined path for a predetermined time while monitoring at least the temperature of the liquid. Cleaning-in-place and sterilization-in-place may be performed sequentially or simultaneously in parallel.

[0003] The sterilizing and cleaning apparatus is equipped with a heat exchanger, a pump, a valve, and measuring instruments for measuring the temperature, concentration, and flow rate of the liquid. The high-temperature liquid, which has been heated to the temperature required for cleaning and sterilization through heat exchange with steam in the heat exchanger, is supplied to the filling machine, where it fills the inside of the filling tank and is returned from the filling machine to the sterilizing and cleaning apparatus through a return path. The high-temperature liquid is circulated through a closed circuit between the sterilizing and cleaning apparatus and the filling machine. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent Publication No. 2021-70488 Summary of the Invention [Problem to be solved by the invention]

[0005] To enhance the sterilization and cleaning capabilities, the liquid used in sterilization-in-place or cleaning-in-place is heated to a temperature well above 100°C, for example. To prevent the liquid from boiling and ensure stable pumping, the circulation path, including the filling tank and filling valve, is sealed by closing the atmospheric release valve before the liquid heats up.

[0006] When the temperature of the liquid circulating in a sealed state rises, the internal pressure of the circulation path increases as the temperature of the liquid rises. Therefore, if the internal pressure of the filling tank, for example, could exceed the withstand pressure, the sterilization and cleaning device could not be operated. In that case, components with higher pressure resistance specifications would have to be used, which would increase the size of the filling machine and the equipment costs. The present invention aims to provide an apparatus and method for sterilizing or cleaning a filling machine that ensures sterilization or cleaning capabilities without the need to increase pressure resistance. [Means for solving the problem]

[0007] The apparatus according to the present disclosure comprises: a temperature control unit configured to heat a liquid used for sterilizing or cleaning the filling machine; a circulation path configured to circulate the liquid between the temperature adjustment unit and the filling machine; a pumping unit that pumps the liquid in the circulation path; a control unit that generates a command, The control unit controls the temperature of the liquid to rise while the circulation path is sealed. Based on the internal pressure in one part of the filling machine, a command is given to the pumping section to reduce the flow rate of the liquid.

[0008] The present disclosure also provides a method for sterilizing or cleaning a filling machine using a heated liquid, the method comprising: a step of pumping a liquid used for sterilization or cleaning by a pumping unit, and circulating the liquid through a sealed circulation path between a temperature adjustment unit configured to be able to heat the liquid and the filling machine; a temperature raising step of raising the temperature of the liquid by a temperature adjusting unit while circulating the liquid, In the temperature rising step, Based on the internal pressure in a part of the filling machine, a command is given to the pumping section to reduce the flow rate of the liquid. [Effects of the Invention]

[0009] In the present disclosure, the liquid is heated while circulating in a sealed state, and during the process of the liquid heating, a command is given to the pumping unit based on the internal pressure in a part of the filling machine to reduce the liquid flow rate, thereby making it possible to suppress the internal pressure of the circulation path below the withstand pressure. According to the present disclosure, it is possible to suppress the increase in internal pressure during the temperature rise process of the liquid, and to keep the internal pressure of the circulation path lower than the withstand pressure while ensuring the sterilization or cleaning ability corresponding to the heating temperature of the liquid. Since there is no need to increase the withstand pressure of the circulation path, it is possible to avoid an increase in the size of the equipment and reduce equipment costs. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a schematic diagram showing the configuration of a sterilizing and washing apparatus and a filling machine according to a first embodiment, illustrating the state during product manufacturing. [Figure 2] FIG. 2 is a schematic diagram showing the state of the configuration shown in FIG. 1 during cleaning-in-place or sterilization-in-place. [Figure 3] FIG. 3 is a timing chart showing an example of control when cleaning-in-place and sterilization-in-place are performed in parallel (CSIP) in the state shown in FIG. 2. [Figure 4] FIG. 1 is a schematic diagram showing a rinsing step as the first step of CSIP. [Figure 5] FIG. 1 is a schematic diagram showing the start of the drug circulation heating process as the second step of CSIP. [Figure 6] This is a schematic diagram to explain that cleaning and sterilization are performed by the chemical circulation heating process as the second process of CSIP. [Figure 7] FIG. 1 is a schematic diagram showing the chemical circulation cooling process as the third process of CSIP. [Figure 8] FIG. 1 is a schematic diagram showing the sterile water rinsing step as the fourth step of CSIP. [Figure 9]FIG. 1 is a schematic diagram showing the water removal process as the fifth process of CSIP. [Figure 10] FIG. 2 is a schematic diagram showing the start of the manufacturing process. [Figure 11] 10 is a schematic diagram showing the configuration of a sterilizing and cleaning apparatus and a filling machine according to a second embodiment, showing the state during cleaning-in-place or sterilizing-in-place. [Figure 12] FIG. 12 is a timing chart showing an example of control when cleaning-in-place and sterilization-in-place are performed in parallel using the configuration shown in FIG. 11. [Figure 13] FIG. 12 is a timing chart showing another example of control when cleaning-in-place and sterilization-in-place are performed in parallel using the configuration shown in FIG. 11. DETAILED DESCRIPTION OF THE INVENTION

[0011] An embodiment will now be described with reference to the accompanying drawings. [First embodiment] [Summary structure] 1 shows a sterilizing and cleaning apparatus 1 and a filling machine 2. The filling machine 2 constitutes a production line for a product such as a beverage, and fills a liquid product into a container (not shown) under sterile conditions. The filling machine 2 fills the liquid product stored in a filling tank 20 into the container through a filling valve 21.

[0012] The sterilizing and cleaning device 1 uses a liquid L (FIG. 2) as a cleaning or sterilizing medium to clean and sterilize the inside of a filling tank 20, a filling valve 21, piping, etc., when a product is not being manufactured. The liquid L corresponds to, for example, water or a chemical such as an aqueous solution of sodium hydroxide. The purity of the water and the type of chemical are selected according to the type of product liquid and the use of the liquid L. Uses of the liquid L include, for example, rinsing, raising the temperature of piping, etc. before cleaning, sterilization, and cleaning of grease and oil.

[0013] The sterilizing and cleaning apparatus 1 can perform cleaning in place (CIP) and sterilization in place (SIP) of the filling machine 2. It is also possible to perform cleaning and sterilization in place (CSIP), in which CIP and SIP are performed simultaneously in parallel.

[0014] [Configuration of filling machine] The following describes the configuration of the filling machine 2. The filling machine 2 is, for example, a rotary type filling machine, and includes a plurality of filling valves 21 provided on a rotating body (not shown), and a filling tank 20 that stores product liquid and supplies the product liquid through piping (not shown) to each filling valve 21. The filling tank 20 may be provided on the rotating body and rotate around the axis of the rotating body, or may be fixed to a stand separate from the rotating body. Cleaning-in-place and sterilization-in-place can be carried out while the rotor of the filling machine 2 is rotating.

[0015] During cleaning and sterilization in place, the entire interior of the filling tank 20 is filled with the liquid L used for cleaning and sterilization. On the other hand, during product production, a gas phase region 20A exists above a liquid level 20B inside the filling tank 20. The interior of the filling tank 20 is preferably pressurized to a pressure higher than atmospheric pressure by feeding an inert gas such as nitrogen gas, or by feeding carbon dioxide gas if the product liquid contains carbon dioxide. For this pressurization, a gas inlet pipe 22 provided in the filling tank 20 is connected to, for example, an N2 supply source or a CO2 supply source. Furthermore, a compressed air supply source is connected to the gas inlet pipe 22 to remove rinsing water and the like from the filling tank 20 and piping.

[0016] The filling tank 20 is provided with a pressure sensor 23 capable of detecting the pressure of the gas phase region 20A. The filling tank 20 is also preferably provided with a liquid level sensor 24 for detecting the liquid level and a temperature sensor 25 for detecting the temperature of the stored liquid.

[0017] The filling tank 20 is disposed above the position of the filling valve 21. The product liquid stored in the filling tank 20 is supplied from the filling tank 20 to the filling valve 21 by its own weight and the internal pressure of the filling tank 20. The filling valve 21 drives a valve element (not shown) using, for example, compressed air to discharge a specified amount of product liquid that is determined for the product. The filling valve 21 is preferably provided with a temperature sensor 26.

[0018] The filling machine 2 is provided with a valve device 30 for supplying the product liquid, water used for cleaning and sterilization, chemicals, etc. to the filling tank 20. The sterilizing and cleaning apparatus 1 also cleans and sterilizes the inside of the valve device 30 provided in the filling machine 2. The control unit 15 of the sterilizing and cleaning apparatus 1 can control the switching state of the valve of the valve device 30.

[0019] The valve device 30 is composed of one or more members (not shown). The member may be a rotary joint. A control valve 27 capable of adjusting the flow rate is preferably provided between the valve device 30 and the filling tank 20.

[0020] 1, the valve device 30 includes a first valve block 31 and a second valve block 32. Each of the valve blocks 31 and 32 may be the entire or partial region of a member. The first valve block 31 is connected to the filling tank 20 via the second valve block 32. During product production, a port 321 of the second valve block 32 is open, and the product liquid is supplied to the filling tank 20 through this port 321. The port 321 is connected to a product liquid tank (not shown).

[0021] [Configuration of the sterilization and cleaning device] The configuration of the sterilizing and cleaning apparatus 1 will be described with reference to Fig. 2. Fig. 2 shows the same configuration as Fig. 1 in the state during cleaning-in-place or sterilizing-in-place. The sterilizing and cleaning device 1 includes a balance tank 11 for storing liquid L used for cleaning and sterilization, a pump 12 as a pressure-feeding unit for pressurizing the liquid L, a heat exchanger 13 as a temperature control unit configured to heat the liquid L, a circulation path C configured to circulate the liquid L, and a control unit 15 for generating commands.

[0022] The balance tank 11 stores the liquid L supplied from a supply source of the liquid L (not shown) through an inlet pipe 111. Inside the balance tank 11, a gas phase region 11A exists above the liquid level 11B throughout the product manufacturing and cleaning and sterilization in place. The balance tank 11 is provided with a valve 11V that switches the interior of the balance tank 11 between a state in which it is open to the atmosphere and a state in which it is sealed off from the atmosphere.

[0023] Although not shown in detail, the pump 12 includes a pump body including a member capable of rotary or reciprocating motion, and a motor that drives the pump body. The pump 12 sucks in and discharges the liquid L by the rotary or reciprocating motion of the member. The pump 12 of this embodiment is disposed between the balance tank 11 and the heat exchanger 13 in the circulation path C, and pumps the liquid L from the heat exchanger 13 toward the filling machine 2.

[0024] The pump 12 of this embodiment is configured to be able to change the flow rate (discharge flow rate) of the discharged liquid L by adjusting the operating speed, such as the number of rotations of the components. As the discharge flow rate changes, the pressure (discharge pressure) of the liquid L discharged from the pump 12 also changes. For example, by giving a command from the control unit 15 to the drive circuit of the motor of the pump 12 and increasing the frequency or duty ratio of the drive current applied to the motor, the discharge flow rate and discharge pressure of the liquid L discharged from the pump 12 can be increased.

[0025] Alternatively, the pump 12 may be a variable displacement type, and the discharge flow rate and discharge pressure may be varied by adjusting the angle of the swash plate, for example. A fixed displacement pump and a flow rate adjustment valve (not shown) capable of adjusting the flow rate of the liquid L discharged from the pump can also be used as the pressure-feeding unit that pressure-feeds the liquid L. In this case, the flow rate is adjusted based on a command from the control unit 15 to the flow rate adjustment valve, thereby making it possible to adjust the flow rate of the liquid L discharged from the pressure-feeding unit.

[0026] The heat exchanger 13 heats or cools a first fluid flowing through a first flow path 131 by exchanging heat with a second fluid acting as a heat medium or a refrigerant flowing through a second flow path 132. For example, the liquid L flows through the first flow path 131, and steam V supplied from a steam source (not shown) flows through the second flow path 132, thereby heating the liquid L. Increasing the flow rate of the steam V can raise the temperature of the liquid L to a higher temperature.

[0027] The sterilizing and cleaning apparatus 1 of this embodiment ensures the required sterilizing ability by raising the temperature of the liquid L to a temperature well above 100°C during steady-state sterilization, for example, 120°C or higher (for example, 130°C). Therefore, during stationary sterilization, in order to prevent boiling of the liquid L and ensure stable liquid delivery by the pump 12, the circulation path C is sealed by closing the valve 11V and a valve (not shown) at the discharge section D.

[0028] In order to adjust the temperature of the liquid L by adjusting the flow rate of the steam V, it is preferable to detect the temperature of the liquid L flowing into the heat exchanger 13 using a temperature sensor 13A and to detect the temperature of the liquid L flowing out of the heat exchanger 13 using a temperature sensor 13B.

[0029] The circulation path C includes an outgoing path C1 along which the liquid L travels from the balance tank 11 through the pump 12, the heat exchanger 13, and the valve device 30 toward the filling tank 20 of the filling machine 2, and a return path C2 along which the liquid L supplied to the filling machine 2 by the outgoing path C1 is returned from the filling valve 21 toward the balance tank 11.

[0030] When the filling machine 2 operates to switch from product manufacturing to fixed-place cleaning and sterilization, the discharge port of the filling valve 21 is blocked by a member not shown, and the internal flow path of the filling valve 21 is connected to the return path C2 by switching a flow path not shown provided in the filling valve 21. At the same time, a command is given to the valve device 30 from the control unit 15 to switch the open / close state of the valve of the valve device 30 so that the liquid L passes through the valve device 30 from the heat exchanger 13 toward the filling tank 20. This allows the circulation path C to be configured so that the liquid L can circulate between the sterilizing and cleaning apparatus 1 and the filling machine 2.

[0031] In this embodiment, the liquid L is pumped through the circulation path C by the pump 12, which is arranged only on the outgoing path C1 of the circulation path C. The liquid L is discharged from the pump 12, passes through the inside of the filling machine 2, and is sucked into the pump 12 via the return path C2 and the balance tank 11. Since the return line C2 does not include a member with high resistance such as the heat exchanger 13, the return line C2 has a smaller pressure loss than the forward line C1.

[0032] Further, near the end of the return line C2, a discharge section D is provided for discharging liquid L used for rinsing and other purposes. On the return line C2, closer to the filling machine 2 than the discharge section D, a temperature sensor 16, a concentration meter 17, and a flow meter 18 are provided for measuring and detecting the temperature, concentration, and flow rate of the liquid L. A pressure sensor 19 may also be provided at this location. The concentration meter 17 must be provided at least near the discharge part D of the circulation path C in order to determine the end of substitution during rinsing based on the concentration of the liquid L. By providing the flow meter 18 downstream of the filling machine 2, it is possible to ensure a flow rate that is sufficient to clean the inside of the filling machine 2 based on the flow rate of the liquid L.

[0033] A conductivity meter is typically used as the concentration meter 17, based on the correlation between the conductivity of the liquid L, which is an aqueous solution containing a chemical component that contributes to sterilization or cleaning, and the concentration of the chemical. Because there is also a correlation between the conductivity and temperature of the liquid L, the control unit 15 measures the concentration of the liquid L in a timely manner during the cleaning-in-place sterilization process, as described below, and adjusts the concentration of the liquid L to a target concentration. The sterilizing and cleaning apparatus 1 preferably includes a concentration adjustment unit 17C configured to adjust the concentration of the liquid L by adding or diluting the chemical component. The concentration adjustment unit 17C is connected to a path through which the liquid L flows so that the chemical concentrate or water can be added. The concentration adjustment unit 17C may be connected to the balance tank 11, as shown in FIG. 1, or to the piping between the balance tank 11 and the pump 12.

[0034] [Conditions for cleaning and sterilizing in place] Cleaning-in-place and sterilization-in-place in this embodiment are established, for example, when the following physical quantities satisfy all of the following requirements: The following conditions are applicable when cleaning-in-place and sterilization-in-place are performed separately and sequentially at different times, such as when sterilization-in-place is started after cleaning-in-place is completed, and are also applicable when cleaning-in-place and sterilization-in-place are performed simultaneously in parallel as cleaning-in-place sterilization (CSIP).

[0035] (Condition CC for Cleaning in Place) Temperature of liquid L: T1 or higher (for example, 80°C or higher) Concentration of liquid L: M1 or more (for example, volume concentration 3% or more) Flow rate of liquid L: Q1 or more Time that meets all three of the above requirements: t1 (for example, 10 minutes) When water is used as the liquid L, the concentration requirement is excluded from the conditions for establishment.

[0036] (Conditions for Stationary Sterilization) Temperature of liquid L: T2 or higher (for example, 130°C) Time that meets the above requirements: t2 (for example, 30 minutes)

[0037] According to the conditions for implementing cleaning and sterilization in place in this embodiment, during SIP or CSIP, in which cleaning in place and sterilization in place are performed in parallel, the liquid L is heated to a temperature T2 exceeding 100°C. In this case, the circulation path C is made into a closed circuit before the temperature of the liquid L is raised. This causes an increase in volume accompanying the temperature rise of the liquid L and an increase in the saturated vapor pressure in the balance tank 11, which pressurizes the liquid L in the circulation path C to a pressure higher than atmospheric pressure, thereby preventing the liquid from boiling in the circulation path C.

[0038] [An example of Cleaning and Sterilizing in Place (CSIP) control] An example of the procedure of CSIP using a drug as the liquid L will be described with reference to FIGS. Figure 3 corresponds to the process of circulating the drug in CSIP, and in terms of the liquid transfer circuit diagram, corresponds to Figures 5 to 7. In Figures 6 and 7, the closed valve 11V is shown in black. 3 is detected by temperature sensors 13A, 13B, 16, 25, and 26. Flow rate Q is measured by flow meter 18. Pressure P (internal pressure) inside filling tank 20 is measured by pressure sensor 23 of filling tank 20. The sterilization condition SC indicates the cumulative time measured up to the sterilization time t2. The cleaning condition CC indicates the cumulative time measured up to the cleaning time t2. Indicates the accumulated time measured up to time t1.

[0039] Typically, prior to use of the chemical, a rinsing step is performed using water W at room temperature or heated (e.g., about 60°C) as shown in Fig. 4. In the rinsing step, water W is supplied from a water W supply source (not shown) through an inlet pipe 111 to a balance tank 11 for a predetermined rinsing time, while the pump 12 is driven to pump the water W with the outlet D open.

[0040] When the rinsing process (FIG. 4) is completed, the water W in the piping is replaced with liquid L (chemical) and the liquid L is circulated, as shown in FIG. 5. At the start of this chemical circulation process, liquid L is supplied to balance tank 11, and a command to operate the motor of pump 12 at a constant rotation speed is given to operate the motor at a constant discharge flow rate and discharge pressure (liquid delivery start step S01 in FIG. 3). Then, for a predetermined time until the replacement of water W with liquid L is completed, the water W is pushed by the liquid L and discharged from the discharge part D. Thereafter, the supply of liquid L to the balance tank 11 is stopped, and the liquid L that has spread throughout the entire circulation path C is circulated at a constant flow rate Q (circulation start step S02 in FIG. 3, FIG. 6). The flow rate Q is equal to or greater than the flow rate Q1 of the cleaning condition CC.

[0041] Simultaneously with the start of circulation of the liquid L, or before or after the start of circulation, the valve 11V and the valve of the discharge part D are closed in response to a command from the control part 15, thereby sealing the circulation path C (sealing step S03). 6, steam V is supplied to the second flow path 132 of the heat exchanger 13 to start raising the temperature of the liquid L (first temperature raising start step S04). In order to pressurize the liquid L to prevent boiling of the liquid L, it is preferable to seal the circulation path C while the liquid L is as close to room temperature as possible, without a significant delay in starting to raise the temperature. Also, in order to minimize the effect on temperature control of the liquid L, it is preferable to seal the circulation path C while the liquid L is as close to room temperature as possible.

[0042] As the liquid L is heated within the closed circulation path C, the pressure within the circulation path C, including the pressure P within the filling tank 20, increases. When the temperature T of the liquid L reaches the temperature T1 of the cleaning condition CC, the control unit 15 stabilizes the liquid temperature at or above the temperature T1 by adjusting the flow rate of the steam V. When the control unit 15 determines that the concentration M of the liquid L is equal to or higher than the concentration M1 of the cleaning condition CC, the temperature T of the liquid L is equal to or higher than the temperature T1 of the cleaning condition CC, and the flow rate Q of the liquid L is equal to or higher than the flow rate Q1 of the cleaning condition CC, it starts timing the cleaning time t1 (cleaning timing start step S05).

[0043] The control unit 15 measures and adjusts the concentration of the liquid L containing the pharmaceutical component when the temperature of the liquid L is 100°C or less. Here, from the start of increasing the temperature of the liquid L (step S04), the concentration of the liquid L is measured by the concentration meter 17, and the concentration adjustment of the liquid L is started by the concentration adjustment unit 17C, which receives a command from the control unit 15 (concentration adjustment step Sa). Then, before the temperature of the liquid L reaches a temperature exceeding 100°C, the concentration of the liquid L is adjusted to the target concentration M1 at the start of increasing the temperature toward the temperature T2 for stationary sterilization (step S06), thereby ending the concentration adjustment (concentration adjustment end step Sb). The start of timing the cleaning time t1 (step S05) occurs after the end of the concentration adjustment. Note that 100° C. is between temperatures T1 and T2.

[0044] The control unit 15 can measure the concentration M based on data indicating the correlation between the conductivity and the concentration indicated by the concentration meter 17, which is provided in a temperature range of 100°C or less. The conductivity correlates not only with the concentration M of the liquid L but also with the temperature T of the liquid L. If the concentration M is measured and adjusted using the concentration meter 17 in a temperature range above 100°C, the concentration must be derived from the conductivity indicated by the concentration meter 17 using data provided in a temperature range below 100°C. However, the concentration adjustment is performed based on the conductivity indicated by the concentration meter 17, which is higher than the conductivity corresponding to the temperature range of the data. As a result, the actual concentration M of the liquid L becomes lower than the target concentration M1. Therefore, as described above, before the temperature of the liquid L rises to a temperature exceeding 100°C, the concentration adjustment is completed by adjusting the concentration M of the liquid L to the target concentration M1 (step Sb). After the adjustment of the concentration M (step Sb) is completed, the measurement of the cleaning time t1 is started simultaneously with Sb in the example shown in FIG. 3 (step S05). In this way, the inside of the filling machine 2 can be reliably cleaned while avoiding imperfect cleaning. It is preferable that the concentration M is adjusted to the target concentration M1 when the temperature T is 100° C. or near it, for example, 85 to 95° C. If the concentration M is equal to or higher than the target concentration M1 at that time, it can be said that the concentration requirement is met even if the temperature T exceeds 100° C.

[0045] 3, since stationary sterilization is performed in addition to stationary cleaning, when timing of the cleaning time t1 starts, the temperature starts to rise toward the temperature T2, which is the temperature requirement for stationary sterilization (second temperature rise start step S06). As the temperature of the liquid L further rises, the pressure inside the circulation path C including the filling tank 20 further increases.

[0046] Here, the pressure increase from the pressure in the gas phase region 11A of the balance tank 11 before sealing (atmospheric pressure) to the saturated vapor pressure inside the balance tank 11, which increases due to the temperature rise of the liquid L in the sealed state, is applied to the inside of the circulation path C. As a result, during the temperature rise process HP of the liquid L, the pressure P inside the filling tank 20 increases significantly compared to the pressure inside the balance tank 11. This is because, unlike the balance tank 11, there is no compressible gas phase region 20A inside the filling tank 20 during stationary cleaning and sterilization. Therefore, a pressure equivalent to the pressure loss in the piping from the outlet of the filling tank 20 to the balance tank 11 and the internal pressure of the balance tank 11 is applied to the filling tank 20. When the pressure inside the balance tank 11 increases at P, the internal pressure of the filling tank 20 approaches its withstand pressure. If the circulation path C is sealed, the pressure P inside the filling tank 20 increases due to the residual pressure and the increase in pressure inside the balance tank 11 due to the temperature rise, even if the temperature T2 is below 100°C. The higher the temperature T of the liquid L, the greater the increase in pressure P.

[0047] Therefore, when the pressure P reaches an upper limit P1, which is predetermined in consideration of the withstand pressure of the filling tank 20, during the temperature rise process HP in which the temperature of the liquid L rises, the control unit 15 controls the pump 12 to reduce the flow rate Q of the liquid L so that the pressure P does not exceed the withstand pressure. When the flow rate Q decreases, the pressure P of the filling tank 20 decreases, and when the flow rate Q increases, the pressure P of the filling tank 20 increases.

[0048] In order to reduce the flow rate Q, the control unit 15 issues a command to the pump 12 to reduce the discharge flow rate (flow rate reduction step S07). The command to reduce the discharge flow rate corresponds to a command to reduce the discharge pressure. For example, the control unit 15 issues a command to the motor of the pump 12 to reduce the drive frequency by a predetermined frequency (e.g., several Hz). After issuing the command to the pump 12, the control unit 15 may use a timer to not issue the next command for a predetermined time (e.g., several seconds to about 20 seconds) so that the inside of the circulation path C is stabilized to a balanced state as much as possible. Although not shown in FIG. 3, when the flow rate Q decreases, the rate of increase of the temperature T decreases slightly. As a result, the rate of increase of the pressure P in the filling tank 20 is slightly reduced.

[0049] Although the pressure P decreases due to the decrease in the flow rate Q, the temperature T of the liquid L increases, so the pressure P increases again. Therefore, when the pressure P reaches the upper limit P1, the control unit 15 issues a command to the pump 12 to decrease the discharge flow rate and discharge pressure so as to further decrease the flow rate Q. By repeating this process several times until the liquid L reaches temperatures T2 and T3, and gradually decreasing the flow rate Q, the pressure P of the filling tank 20 can be kept lower than the withstand pressure.

[0050] It is preferable to avoid a sudden change in the flow rate Q in order to suppress the influence on the temperature control of the liquid L. However, it is not necessary to reduce the flow rate Q in stages, and it is also possible to gradually reduce the flow rate Q in a non-stage manner while monitoring the pressure P and temperature T with the control unit 15.

[0051] If the flow rate Q is reduced so that it falls below the required flow rate Q1 of the cleaning condition CC, or if the temperature T is lower than the required temperature T1, the measurement of the cleaning time t1 is stopped (cleaning time measurement stop step S08). The remaining time of the cleaning time t1 is measured after the flow rate Q is restored.

[0052] When the temperature T of the liquid L reaches the temperature T2 of the stationary sterilization condition SC, the control unit 15 starts measuring the sterilization time t2 while maintaining the temperature T at or above the temperature T2 (for example, T3) (sterilization time measurement start step S09). Here, the higher the temperature T of the liquid L, the higher the time efficiency of sterilization. Therefore, by raising the temperature of the liquid L to the temperature T3 and performing sterilization, the sterilization time t2 can be shortened. The temperature rising process HP (a step of raising the temperature of the liquid L) in which the liquid L is heated by the heat exchanger 13 corresponds to the period from the first temperature rise start step S04 until the liquid L reaches the target temperature (here, temperature T2). When the sterilization time t2 has elapsed while the temperature T of the liquid L is maintained at or above the temperature T2, the stationary sterilization condition SC is met (sterilization condition meeting step S10).

[0053] The sterilization process is thus completed, and as shown in FIG. 7, cooling of the liquid L is started by supplying a refrigerant R such as cold water to the second flow path 132 of the heat exchanger 13 (cooling start step S11). In order to promote the cooling of the liquid L to the necessary extent, the flow rate Q may be increased, for example, stepwise, in the same manner as in the above-mentioned flow rate decreasing step S07, while decreasing the temperature T of the liquid L, to the extent that the pressure P of the filling tank 20 does not exceed the withstand pressure (flow rate increasing step S12).

[0054] In order to suppress the influence on the temperature control of the liquid L, it is preferable that the circulation path C be kept sealed throughout the cooling process CP of the liquid L by the heat exchanger 13.

[0055] When the flow rate Q reaches the required flow rate Q1 of cleaning condition CC, the temperature T is equal to or higher than the temperature T1 of cleaning condition CC, and the concentration M measured at a liquid temperature of 100°C or less is equal to or higher than the concentration M1 of cleaning condition CC, the measurement of the suspended cleaning time t1 is resumed (cleaning time measurement restart step S13). The temperature T at this time may be, for example, less than 100°C, about 90°C. When the remaining time of cleaning time t1 has elapsed, the integrated time reaches cleaning time t1, and cleaning condition CC is met (cleaning condition fulfillment step S14). In the example shown in FIG. 3, the chemical circulation process ends when cleaning condition CC is fulfilled (chemical circulation process end step S15). Non-productive time can be reduced by timing the cleaning time t1 in parallel with the cooling of the liquid L. However, if the temperature T is close to the temperature T1 under the cleaning condition CC when the flow rate Q reaches the required flow rate Q1 under the cleaning condition CC in the cooling process CP, it is advisable to interrupt the cooling of the liquid L and restart timing the cleaning time t1 while maintaining the temperature T at or above the temperature T1, as shown in Figure 3.

[0056] Thereafter, the process can proceed to a step of rinsing the drug with sterile water W1, as shown in Figure 8. In this sterile water rinsing step, sterile water W1 is supplied from port 311 of first valve block 31 to the piping of outbound line C1, and the sterile water W1 pushes the liquid L, causing it to be discharged from discharge section D. This replaces the liquid L in the section from first valve block 31 to discharge section D with sterile water W1. The supply and discharge of sterile water W1 can be carried out for a predetermined time required to sufficiently rinse the drug.

[0057] 9, sterile air (sterile compressed air) is introduced into the filling tank 20 through the gas introduction pipe 22 to pressurize the filling tank 20, thereby removing the sterile water W1 from inside the outgoing line C1 and the returning line C2. The sterile air pushes the sterile water W1 from the filling tank 20 toward the discharge part D of the returning line C2, causing it to be discharged from the discharge part D, and also pushes the sterile water W1 from the filling tank 20 toward the discharge part 312 of the first valve block 31 on the outgoing line C1, causing it to be discharged from the discharge part 312. When the water drainage is complete, the valves of the discharge part 312 and the discharge part D are closed to maintain a sterile state.

[0058] Thereafter, as shown in FIG. 10, the supply of the product liquid to the filling machine 2 begins through the port 321 of the second valve block 32, and the process moves to the manufacturing process. At this time, the liquid L present in the section between the valve 313 of the first valve block 31 and the balance tank 11 is discharged from the discharge section D by a rinsing process (not shown). In the rinsing process, the liquid L is pushed out from the discharge section D by water supplied to the balance tank 11 through the inlet pipe 111. This completes the Cleaning and Sterilization in Place (CSIP) process.

[0059] [An example of cleaning-in-place (CIP) control] When only cleaning-in-place is performed without simultaneously performing sterilization-in-place, for example, after a rinsing step (Fig. 4), water W is replaced with liquid L (Fig. 5), and liquid L is circulated through circulation path C while being heated to a temperature T1 or higher under cleaning conditions CC (Fig. 6). Liquid L is not limited to a chemical agent and may be water. Here, when the temperature T1 is below 100°C, it is not necessary to seal the circulation path C, and therefore the balance tank 11 may be open to the atmosphere via the valve 11V. Furthermore, if the circulation path C is not sealed, there is no need to issue a command to the pump 12 to reduce the flow rate Q of the liquid L during the temperature rise process HP, and the flow rate Q can be maintained constant throughout the temperature rise process HP. When the temperature T of the liquid L reaches the temperature T1 under cleaning condition CC and the flow rate Q reaches the flow rate Q1 under cleaning condition CC, and the time measurement for the cleaning time t1 is completed (cleaning condition CC is met), the liquid L is cooled to a predetermined temperature (Fig. 7). If a chemical agent has been used, rinsing is performed (Fig. 8), otherwise the process proceeds directly to draining (Fig. 9) and then to product manufacturing.

[0060] Even in stationary cleaning, when the liquid L is heated to a temperature T1 exceeding 100°C, it is preferable to seal the circulation path C before heating the liquid L, and to reduce the flow rate Q during the temperature rise process HP by issuing a command to the pump 12 based on the pressure P. Even if the temperature T1 is less than 100°C, when the circulation path C is sealed, it is preferable to reduce the flow rate Q during the temperature rise process HP based on the pressure P. If the flow rate Q falls below the required flow rate Q1 as a result of the reduction in the flow rate Q, the measurement of the cleaning time t1 is interrupted and then restarted, as in steps S08 and S12 described above.

[0061] [An example of control for Sterilization in Place (SIP)] When only sterilization-in-place is performed without simultaneous cleaning-in-place, for example, after a rinsing step (Fig. 4), water W is replaced with liquid L (Fig. 5), and liquid L is circulated through circulation path C while being heated to a temperature T2 or higher under sterilization conditions SC (Fig. 6). Liquid L is not limited to a chemical agent and may be water. When the temperature T2 exceeds 100°C, the circulation path C is sealed before the temperature of the liquid L is increased. Note that the circulation path C may be sealed even when the temperature T2 is less than 100°C. When the circulation path C is sealed, during the process HP in which the temperature of the liquid L rises, the flow rate Q of the liquid L is reduced by issuing a command to the pump 12 to reduce the discharge flow rate and discharge pressure so that the pressure P of the filling tank 20 does not exceed the upper limit value P1, as in step S07 described above. When the temperature T of the liquid L reaches the temperature T2 of the sterilization condition SC and the measurement of the sterilization time t2 is completed (sterilization condition SC is met), the liquid L is cooled to a predetermined temperature (FIG. 7). At this time, by increasing the flow rate Q to the extent that the pressure P does not exceed the withstand pressure, the cooling can be accelerated and the cooling step can be ended early. If a chemical agent is used as liquid L, rinsing is performed (Figure 8); otherwise, the process proceeds directly to draining (Figure 9) and then to product manufacturing.

[0062] When the temperature T2 under the sterilization conditions SC is less than 100°C, the temperature of the liquid L can be raised without sealing the circulation path C. In this case, it is not necessary to reduce the flow rate Q during the temperature raising process HP.

[0063] [Effects of the first embodiment] In the first embodiment described above, the liquid L is heated while circulating in a sealed state, and during the process HP in which the temperature of the liquid L rises, a command is given to the pump 12 based on the pressure P of the filling tank 20 to reduce the flow rate Q of the liquid L. In this way, it is possible to use pressurized liquid to ensure sterilization ability commensurate with a liquid temperature sufficiently exceeding 100°C, while keeping the internal pressure of the circulation path C, including the filling tank 20, lower than the withstand pressure. If, for example, a thick tank were used for the filling tank 20 in order to increase the pressure resistance of the circulation path C, the equipment would become larger and the equipment costs would increase. According to this embodiment, there is no need to increase the pressure resistance of the circulation path C, and by controlling the pump 12 to issue a command based on the pressure P of the filling tank 20, it is possible to avoid an excessive increase in the internal pressure of the circulation path C due to heating of the liquid L to a high temperature. When the sterilizing and cleaning apparatus 1 of this embodiment is applied to an existing filling machine 2, it is sufficient to simply add control to the control unit 15; there is no need to change the configuration of the existing apparatus, and the difficult task of replacing the filling tank 20 with a tank with a higher pressure resistance is not required.

[0064] Furthermore, in this embodiment, even if the flow rate Q reduced based on the pressure P deviates from the required flow rate Q1, the flow rate Q is restored to the required flow rate Q1 in the cooling process CP, and then the remaining time of the cleaning time t1 is measured. This control makes it possible to provide a sterilizing and cleaning apparatus 1 that complies with the cleaning conditions CC.

[0065] [Second embodiment] Next, a second embodiment of the present disclosure will be described with reference to Figures 11 and 12. The following description will focus on differences from the first embodiment. Components similar to those in the first embodiment are denoted by the same reference numerals. Unless otherwise specified, the configuration of the second embodiment is the same as the configuration of the first embodiment, and the actions and effects obtained from the configuration are also the same as those of the first embodiment. Therefore, repeated explanations of similar matters will be avoided, and the actions and effects described in the first embodiment will be cited.

[0066] 11, the sterilizing and cleaning apparatus 4 according to the second embodiment differs from the sterilizing and cleaning apparatus 1 according to the first embodiment in that it includes two pumps 121 and 122. The pumps 121 and 122 may each be configured similarly to the pump 12 according to the first embodiment. However, because the same flow rate Q1 as in the first embodiment is achieved by the two pumps 121 and 122, it is sufficient for the pumps 121 and 122 to each have a lower capacity than the pump 12 according to the first embodiment.

[0067] The first pump 121 as a first pumping section pumps the liquid L from the heat exchanger 13 towards the filling machine 2. The first pump 121 can be disposed in the same position as the pump 12 of the first embodiment.

[0068] The second pump 122 as a second pumping section pumps the liquid L from the filling machine 2 toward the heat exchanger 13. The second pump 122 is disposed on the return line C2 into which the liquid L flows from the filling valve 21. The second pump 122 sucks in the liquid L discharged from the first pump 121 and whose pressure has dropped due to resistance in the piping, etc., and discharges the liquid at a pressure higher than the suction pressure. The return path C2 has a smaller pressure loss than the outgoing path C1 in which the heat exchanger 13 is disposed. Therefore, it is sufficient for the second pump 122 to have a capacity lower than that of the first pump 121.

[0069] In the second embodiment, by operating the first pump 121 arranged on the outbound path C1 and the second pump 122 arranged on the return path C2, the internal pressure of the filling tank 20 can be suppressed below the withstand pressure without reducing the flow rate Q, unlike the first embodiment. When the liquid L is circulated in a sealed state at a constant flow rate Q equal to or greater than the required flow rate Q1 using only the pump 12 arranged on the outbound path C1 as in the first embodiment, if the maximum pressure of the circulation path C (pressure P of the filling tank 20) ​​exceeds the withstand pressure during the temperature rise process HP, the flow rate Q must be reduced relative to the required flow rate Q1. On the other hand, in the second embodiment, the same flow rate Q as in the first embodiment can be achieved by using two pumps 121, 122, for example by applying discharge pressures p1, p2 to the pumps 121, 122, respectively, and therefore the discharge pressure p1 of the first pump 121 is smaller than the discharge pressure of the pump 12 in the first embodiment when liquid is fed by a single pump 12. As a result, the force pushing the liquid L from the first pump 121 towards the filling tank 20 is smaller than the force pushing the liquid L from the pump 12 in the first embodiment towards the filling tank 20, so the pressure P in the filling tank 20 is reduced compared to the first embodiment. Moreover, the pressure P in the filling tank 20 is also reduced compared to the first embodiment by the second pump 122 sucking the liquid L from the downstream side of the filling tank 20.

[0070] From the above, by providing the first pump 121 and the second pump 122, the required flow rate Q1 is ensured throughout the temperature rise process HP of the liquid L, and the areas in the circulation path C where the pressure is relatively high are distributed among the discharge port of the first pump 121, the interior of the filling tank 20, and the discharge port of the second pump 122. Therefore, even if the internal pressure of the circulation path C increases during the temperature rise process HP, it does not become excessively high, and the internal pressure of the circulation path C can be suppressed below the withstand pressure. Therefore, as in the first embodiment, the pressurized liquid can be used to ensure sterilization ability appropriate for high liquid temperatures well above 100°C, while the internal pressure of the circulation path C, including the filling tank 20, can be suppressed below the withstand pressure. By suppressing the internal pressure of the circulation path C, there is no need to increase the withstand pressure of the circulation path C, making it possible to avoid an increase in the size of the equipment and reduce equipment costs.

[0071] In addition to providing the first pump 121 and the second pump 122, by performing the control described below, for example, the pressure P of the filling tank 20 can be suppressed more sufficiently relative to the withstand pressure. FIG. 12 shows an example of control when cleaning-in-place and sterilization-in-place are performed in parallel using the configuration of the second embodiment, that is, cleaning-in-place sterilization (CSIP). After the rinsing step, the supply of liquid L begins (liquid supply start step S01 in FIG. 12), and after water is replaced with liquid L, circulation of liquid L begins through circulation path C (circulation start step S02 in FIG. 12). At this time, control unit 15 imparts a constant rotation speed to the motor of first pump 121 and also imparts a constant rotation speed to the motor of second pump 122, thereby allowing first pump 121 and second pump 122 to be driven at constant discharge flow rate and discharge pressure, respectively. At this time, flow meter 18 measures a flow rate Q that is equal to or greater than flow rate Q1 under cleaning condition CC.

[0072] Furthermore, by closing valve 11V and the valve of discharge section D, circulation path C is sealed (sealing step S03), and steam V is supplied to the second flow path 132 of heat exchanger 13 to start heating liquid L (first heating start step S04).

[0073] When the temperature T of the liquid L reaches the temperature T1 of the cleaning condition CC and the concentration M, temperature T, and flow rate Q of the liquid L satisfy the requirements of the concentration M1, temperature T1, and flow rate Q1, respectively, the control unit 15 starts timing the cleaning time t1 (cleaning timing start step S05).

[0074] To avoid poor cleaning, the measurement and adjustment of the concentration of the liquid L is performed when the temperature of the liquid L is 100°C or less (concentration adjustment step Sa), as in the first embodiment. Then, before the temperature of the liquid L rises to exceed 100°C, the concentration adjustment is completed by adjusting the concentration M of the liquid L to the target concentration M1.

[0075] When timing of the cleaning time t1 starts, the temperature starts to rise toward the temperature T2, which is the temperature requirement for stationary sterilization (second temperature rise start step S06). In the second embodiment, in the process of raising the temperature of the liquid L above the temperature T1 of the cleaning condition CC, a command is given to the first pump 121 to decrease the discharge pressure p1 (first pump discharge pressure decrease step S07-1), and a command is given to the second pump 122 to increase the discharge pressure p2 (second pump discharge pressure increase step S07-2).

[0076] As a result, the pressure P in the filling tank 20 decreases due to a decrease in the force with which the first pump 121 pushes the liquid L as the pressure p1 decreases, and the pressure P in the filling tank 20 also decreases due to an increase in the amount of liquid suctioned from the filling tank 20 by the second pump 122 as the pressure p2 increases. Since the discharge pressure p1 is decreased while the discharge pressure p2 is increased, the required flow rate Q1 can be secured without reducing the flow rate Q. To ensure stable liquid delivery throughout the entire circulation path C, the control unit 15 may monitor the pressure P and the flow rate Q and issue commands to the pumps 121 and 122. Since the required flow rate Q1 is secured during the temperature rise process HP, the measurement of the cleaning time t1 is not interrupted. When the flow rate Q is equal to or greater than the required flow rate Q1, the concentration M measured at a liquid temperature of 100°C or less is equal to or greater than the required concentration M1, and the temperature T is equal to or greater than the required temperature T1, and the cleaning time t1 is reached from the start of timing, the cleaning condition CC is met (cleaning condition meeting step S14).

[0077] According to the drive control of the pumps 121, 122 in the temperature rising process HP of the second embodiment, the inside of the filling tank 20 can be maintained at a pressure P that is sufficiently lower than the upper limit value P1. The decrease in discharge pressure p1 and the increase in discharge pressure p2 during the temperature rise process HP can be performed in stages while stabilizing the pressure P and the flow rate Q within a predetermined range, on the premise that the pressure P does not exceed the upper limit value P1 and the flow rate Q is equal to or greater than the required flow rate Q1. For example, the drive frequencies of the motors of the pumps 121 and 122 may be changed by several Hz increments based on a command from the control unit 15. It is also possible to change the discharge pressures p1 and p2 steplessly.

[0078] When the temperature T of the liquid L reaches the temperature T2 of the stationary sterilization condition SC, the measurement of the sterilization time t2 starts (sterilization time measurement start step S09). Thereafter, when the sterilization time t2 has elapsed while the temperature T of the liquid L is maintained at or above the temperature T2, the stationary sterilization condition SC is met (sterilization condition meeting step S10). 12, the cleaning condition fulfillment step S14 is located between the sterilization time measurement start step S09 and the sterilization condition fulfillment step S10, but this is not limited to this. Depending on the cleaning time t1, etc., the cleaning condition fulfillment step S14 may be located, for example, between the sterilization condition fulfillment step S10 and the drug circulation process end step S15.

[0079] When the sterilization conditions are met, cooling of the liquid L starts (cooling start step S11). At this time, while the temperature T of the liquid L is being lowered, for example, in the opposite direction to the temperature rising process HP, the discharge pressure p1 of the first pump 121 may be increased and the discharge pressure p2 of the second pump 122 may be decreased. When the temperature of the liquid L is cooled to a predetermined temperature T4 by the heat exchanger 13, the medicine circulation process is ended (medicine circulation process ending step S15). In the second embodiment, the required flow rate Q1 is ensured during the temperature rise process HP, so the measurement of the cleaning time t1 is not interrupted, and there is no need to accumulate the shortage of the cleaning time t1 after the sterilization process. As a result, the chemical circulation process ends earlier than the end of the chemical circulation process (S15) in the control shown in FIG.

[0080] Thereafter, similarly to the first embodiment, a series of processes relating to Cleaning and Sterilizing in Place (CSIP) is completed through the steps shown in FIGS.

[0081] The sterilizing and cleaning apparatus 4 of the second embodiment can perform cleaning-in-place that is not performed simultaneously with sterilization-in-place. The procedure for cleaning-in-place (CIP) is basically the same as that of the first embodiment.

[0082] The sterilizing and cleaning apparatus 4 of the second embodiment can perform sterilization-in-place that is not performed simultaneously with cleaning-in-place. The procedure for sterilization-in-place (SIP) is basically the same as that of the first embodiment.

[0083] As described above, the second embodiment is provided with two pumps 121, 122, and therefore can suppress an increase in the internal pressure of the filling tank 20 during the temperature rise process HP compared to the first embodiment. Therefore, in both cleaning-in-place and sterilizing-in-place, it is not necessarily necessary to issue a command to the pumps 121, 122 to reduce the flow rate Q during the temperature rise process HP.

[0084] [Modification of the second embodiment] 13, during the temperature rise process HP, the control unit 15 may issue a command to change the discharge pressure only to the second pump 122, thereby increasing the discharge pressure p2 of the second pump 122 while keeping the discharge pressure p1 of the first pump 121 constant. Even in this case, the force with which the first pump 121 presses the liquid L is reduced compared to when the liquid is sent only by the pump 12 of the first embodiment, and the amount of liquid suctioned from the filling tank 20 by the second pump 122 is increased, so the pressure P inside the filling tank 20 can be maintained at a pressure P lower than the upper limit value P1. Note that if the discharge pressure p1 is kept constant and the discharge pressure p2 is increased, the flow rate Q gradually increases. Furthermore, although not shown in the figure, the control unit 15 can also reduce the discharge pressure p1 of the first pump 121 while keeping the discharge pressure p2 of the second pump 122 constant, thereby reducing the force with which the first pump 121 presses the liquid L and suctioning the liquid L from the filling tank 20 by the second pump 122, thereby maintaining the pressure P inside the filling tank 20 at a lower value than the upper limit value P1.

[0085] In addition to the above, it is possible to select and discard the configurations given in the above embodiments, or to change them to other configurations as appropriate. In the first embodiment, a plurality of pumps 12 serving as pumping units may be arranged in series in the outgoing path C1 of the circulation path C. For example, a pump 12 is arranged between the balance tank 11 and the heat exchanger 13, and between the heat exchanger 13 and the valve device 30. Furthermore, in the second embodiment, a plurality of first pumps 121 serving as a first pumping unit may be arranged on the outgoing route C1 of the circulation path C, and a plurality of second pumps serving as a second pumping unit may be arranged on the returning route C2. For example, a first pump 121 may be arranged between the balance tank 11 and the heat exchanger 13, and between the heat exchanger 13 and the valve device 30. For example, a second pump 122 may be arranged on the returning route C2 at a position near the filling machine 2 and a position near the balance tank 11. Furthermore, it is sufficient for the sterilization / cleaning device of the present disclosure to have the function of at least one of sterilizing and cleaning the filling machine 2. In other words, the device of the present disclosure that uses the sterilizing or cleaning liquid L includes a cleaning device that exclusively cleans the filling machine 2 using the liquid L, and a sterilization device that exclusively sterilizes the filling machine 2 using the liquid L. The same applies to the device as well as to the method of the present disclosure that uses the sterilizing or cleaning liquid L.

[0086] [Note] The above disclosure allows understanding of the following configurations. [1] A temperature control unit configured to heat a liquid used for sterilizing or cleaning a filling machine; a circulation path configured to be able to circulate the liquid between the temperature adjustment unit and the filling machine; a pumping unit that pumps the liquid in the circulation path; a control unit that generates a command, The control unit, during a process in which the temperature of the liquid increases with the circulation path sealed, and reducing the flow rate of the liquid by issuing the command to the pumping unit based on the internal pressure in a part of the filling machine. Device.

[0087] [2] The temperature control unit is configured to be able to cool the liquid in addition to heating the liquid; the control unit starts timing a predetermined cleaning time while the temperature of the liquid is rising, and then suspends the timing as the flow rate decreases; restarting the timing while the liquid is being cooled by the temperature adjustment unit; The device described in item [1].

[0088] [3] The temperature control unit heats the liquid to a temperature exceeding 100°C. The device described in [1] or [2].

[0089] [4] a liquid storage tank that supplies the liquid to the temperature adjustment unit; a filling tank as part of the filling machine; A gas phase region exists inside the liquid storage tank. [1] to [3]. The device described in any one of [1] to [3].

[0090] [5] a concentration meter that measures the concentration of the liquid containing a chemical component that contributes to the sterilization or cleaning; a concentration adjusting unit configured to adjust the concentration by adding or diluting the pharmaceutical component; Equipped with When the temperature of the liquid is 100°C or less, the concentration is adjusted by the concentration adjusting unit while measuring the concentration by the concentration meter, and the concentration adjustment is terminated when the concentration is adjusted to a predetermined concentration before the temperature of the liquid rises to a temperature exceeding 100°C; After the adjustment of the concentration in the temperature increasing process of the liquid is completed, clocking of a predetermined cleaning time is started. [1] to [4]. The device described in any one of [1] to [4].

[0091] [6] A method for sterilizing or cleaning a filling machine using a heated liquid, comprising: a step of pumping the liquid used for the sterilization or the cleaning by a pumping unit, and circulating the liquid through a sealed circulation path between a temperature adjustment unit configured to be able to heat the liquid and the filling machine; a temperature increasing step of increasing the temperature of the liquid by the temperature adjusting unit while circulating the liquid, In the temperature increasing step, The method further comprising: commanding the pumping section to reduce the flow rate of the liquid based on an internal pressure in a portion of the filling machine.

[0092] [7] In the temperature increasing step, a step of starting to measure a predetermined cleaning time; interrupting the timing as the flow rate decreases; and restarting the timing while the liquid is being cooled by the temperature adjustment unit. The method described in [6].

[0093] [8] A cooling step of cooling the liquid by the temperature adjustment unit following the temperature increase of the liquid, In the cooling step, giving a command to the pumping unit to increase the flow rate of the liquid; The method described in [7].

[0094] [9] a concentration adjusting step of adjusting the concentration of the liquid containing a chemical component contributing to the sterilization or cleaning by adding or diluting the chemical component while measuring the concentration of the liquid containing the chemical component contributing to the sterilization or cleaning when the temperature of the liquid is 100°C or less; a step of ending the concentration adjustment by adjusting the concentration to a predetermined concentration before the temperature of the liquid reaches a temperature exceeding 100°C; and starting to measure a predetermined cleaning time after the end of the adjustment of the concentration during the temperature increase process of the liquid. The method according to any one of [6] to [8]. [Explanation of symbols]

[0095] 1,4 Sterilization and cleaning equipment 2 Filling machine 11 Balance tank (liquid storage tank) 11A Gas Phase Region 11B Liquid level 11V bulb 12 Pump (pressure delivery section) 13 Heat exchanger (temperature control section) 13A, 13B Temperature sensor 15 Control Unit 16 Temperature Sensor 17 Densitometer 17C Concentration adjustment section 18 Flow meter 19 Pressure Sensor 20 Filling Tank 20A Gas Phase Region 20B Liquid level 21 Filling valve 22 Gas inlet pipe 23 Pressure Sensor 24 Liquid level sensor 25 Temperature Sensor 26 Temperature Sensor 27 Control Valve 30 Valve device 31 First valve block 32 Second valve block 111 Introductory tube 121 First pump (first pressure delivery section) 122 Second pump (second pressure delivery section) 131 First Channel 132 Second Channel Port 311 312 Discharge section 313 Valve Port 321 C. Circulation Route C1 Outbound C2 Return CP cooling process D Discharge section HP temperature rise process L liquid P pressure P1 upper limit Q flow rate Q1 Required flow rate p1, p2 discharge pressure R refrigerant S01 Start of liquid transfer step S02 Circulation start step S03 Sealed Step S04 First temperature rise start step S05 Cleaning timing start step S06 Second temperature rise start step S07 Flow reduction step S07-1 First pump discharge pressure reduction step S07-2 Second pump discharge pressure increase step S08 Cleaning time measurement interruption step S09 Sterilization time count start step S10 Sterilization condition fulfillment step S11 Cooling start step S12 Flow rate increase step S13 Washing time count restart step S14 Cleaning condition fulfillment step S15 Drug circulation process end step Sa concentration adjustment step Sb concentration adjustment end step T temperature T1,T2 required temperature T3,T4 temperature t1 cleaning time t2 sterilization time V Steam W water W1 Sterile water

Claims

1. a temperature control unit configured to heat a liquid used for sterilizing or cleaning the filling machine; a circulation path configured to be able to circulate the liquid between the temperature adjustment unit and the filling machine; a pumping unit that pumps the liquid in the circulation path; a control unit that generates a command, The control unit, during a process in which the temperature of the liquid increases with the circulation path sealed, An apparatus that issues the command to the pumping section to reduce the flow rate of the liquid based on an internal pressure in a portion of the filling machine.

2. the temperature adjustment unit is configured to be able to cool the liquid in addition to heating the liquid, the control unit starts timing a predetermined cleaning time while the temperature of the liquid is rising, and then suspends the timing as the flow rate decreases; The device according to claim 1 , wherein the timing is restarted while the liquid is being cooled by the temperature adjustment unit.

3. The temperature control unit heats the liquid to a temperature exceeding 100°C.

10. The apparatus of claim 1.

4. a liquid storage tank that supplies the liquid to the temperature adjustment unit; a filling tank as part of the filling machine; A gas phase region exists inside the liquid storage tank.

10. The apparatus of claim 1.

5. a concentration meter for measuring the concentration of the liquid containing a chemical component that contributes to the sterilization or cleaning; a concentration adjusting unit configured to adjust the concentration by adding or diluting the pharmaceutical component; Equipped with When the temperature of the liquid is 100°C or less, the concentration is adjusted by the concentration adjusting unit while measuring the concentration by the concentration meter, and the concentration adjustment is terminated when the concentration is adjusted to a predetermined concentration before the temperature of the liquid rises to a temperature exceeding 100°C; After the adjustment of the concentration in the temperature increasing process of the liquid is completed, clocking of a predetermined cleaning time is started.

10. The apparatus of claim 1.

6. 1. A method for sterilizing or cleaning a filling machine using a heated liquid, comprising: The liquid used for the sterilization or cleaning is pumped by a pumping unit, and the liquid is circulated between a temperature adjusting unit configured to be able to heat the liquid and the filling machine through a sealed circulation path. and a temperature increasing step of increasing the temperature of the liquid by the temperature adjusting unit while circulating the liquid, In the temperature increasing step, The method further comprising: commanding the pumping section to reduce the flow rate of the liquid based on an internal pressure in a portion of the filling machine.

7. In the temperature increasing step, a step of starting to measure a predetermined cleaning time; interrupting the timing as the flow rate decreases; and restarting the timing while the liquid is being cooled by the temperature adjustment unit. The method of claim 6.

8. a cooling step of cooling the liquid by the temperature adjustment unit following the temperature increase of the liquid; In the cooling step, giving a command to the pumping unit to increase the flow rate of the liquid; The method of claim 6.

9. a concentration adjusting step of adjusting the concentration of the liquid containing a chemical component contributing to the sterilization or cleaning by adding or diluting the chemical component while measuring the concentration of the liquid containing the chemical component contributing to the sterilization or the cleaning when the temperature of the liquid is 100°C or less; a step of ending the concentration adjustment by adjusting the concentration to a predetermined concentration before the temperature of the liquid reaches a temperature exceeding 100°C; The method according to claim 6 , further comprising: starting to measure a predetermined cleaning time after completion of the adjustment of the concentration during the temperature increase process of the liquid.

Images