Sterilization device and sterilization control method

Abstract

The invention discloses a sterilization device and a sterilization control method, and relates to the field of biological sterilization, the sterilization device comprises a sterilizer, the sterilizer comprises an inner chamber and an interlayer, and the interlayer adjusts heat conduction through an interlayer steam inlet control assembly and an interlayer steam exhaust hydrophobic assembly; an inner chamber steam inlet buffer assembly is arranged in the inner chamber, so that steam pressure buffer and small-speed accurate control are achieved; the inner chamber air inlet assembly achieves slow cooling through periodic air supply. The sterilization control method comprises the stages of preheating, replacement, pulsation, heating, sterilization and cooling, temperature stratification is eliminated through a micro-negative pressure algorithm, and it is ensured that the pressure change rate and the temperature change rate are within the required range through cooperative control of staged PID and a current limiting device. Air is supplemented periodically through air micro-cooling, and sudden drop of high temperature is avoided. Through multi-stage buffering and cooperative control, the steam pressure is stable, the temperature distribution is uniform, and the performance integrity after ATF sterilization is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of biological sterilization, and more specifically, to a sterilization device and a sterilization control method. Background Art

[0002] ATF filtration system (alternating tangential flow filtration system) is the full name of alternating tangential flow cell retention system. As an effective filtration and throttling device, ATF filtration system can be used in separation of mixtures, cell cultures, molecular mixtures and other scenarios.

[0003] The filter in the ATF filtration system needs to be sterilized before use. Since steam sterilizers have the characteristics of good penetration, high efficiency, speed, safety and environmental protection, ATF is usually sterilized with pure steam. However, during the steam sterilization process of existing steam sterilizers, due to the unstable pure steam pressure or excessive pressure, the pressure in the inner chamber changes greatly when controlling the steam inlet, or the temperature difference or pressure difference between the inside and outside is large, or a single part is subjected to pressure or temperature changes at a fast rate, the above situations cause ATF deformation and damage.

[0004] In summary, how to avoid the above situation and prevent ATF from deformation and damage is a problem that needs to be solved urgently by technical personnel in this field. Summary of the invention

[0005] In view of this, an object of the present invention is to provide a sterilization device and a sterilization control method, which effectively prevents ATF from being deformed and damaged.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] A sterilization device and a sterilization control method, used for sterilizing an ATF filter, comprising a sterilizer, the sterilizer comprising an inner chamber and an interlayer arranged outside the inner chamber, the interlayer being connected to an interlayer steam inlet pipe, the interlayer steam inlet pipe being provided with an interlayer steam inlet control component to control the steam pressure entering the interlayer, the lower part of the interlayer being connected to an interlayer steam exhaust pipe, the interlayer steam exhaust pipe being provided with an interlayer steam exhaust drain component;

[0008] The inner chamber is connected to an inner chamber steam inlet pipe, and an inner chamber steam inlet buffer component is provided on the inner chamber steam inlet pipe to keep the steam entering the inner chamber through the inner chamber steam inlet pipe within a certain pressure range. The inner chamber is provided with an inner chamber drain component for draining the inner chamber, and the inner chamber is provided with an inner chamber evacuation component for adjusting the pressure inside the inner chamber;

[0009] The inner chamber is connected to an inner chamber air inlet pipe, and the inner chamber air inlet pipe is provided with an inner chamber air inlet assembly for introducing air into the inner chamber.

[0010] Preferably, the interlayer steam inlet control assembly includes an interlayer steam inlet valve arranged on the interlayer steam inlet pipe and the interlayer steam inlet flow limiting control device connected in parallel with the interlayer steam inlet valve.

[0011] Preferably, the interlayer steam exhaust drain assembly includes an interlayer steam exhaust valve arranged on the interlayer steam exhaust pipe and an interlayer drain valve connected in parallel with the interlayer steam exhaust valve.

[0012] Preferably, the inner chamber steam inlet buffer assembly includes an inner chamber steam inlet valve arranged on the inner chamber steam inlet pipe, an inner chamber steam inlet flow limiting control device arranged on the inner chamber steam pipe and connected in parallel with the inner chamber steam inlet valve, and a steam buffer device arranged on the inner chamber steam pipe at an end of the inner chamber steam inlet valve away from the sterilizer, and a buffer device steam inlet valve is arranged on the inner chamber steam pipe between the steam buffer device and the steam source.

[0013] Preferably, the steam buffer device includes a steam temporary storage tank, a first pressure transmitter arranged on the steam temporary storage tank, and a steam temporary storage tank drain device arranged on the steam temporary storage tank, wherein the steam temporary storage tank drain device is used to prevent condensed water from being generated and entering the inner chamber.

[0014] Preferably, the inner chamber drain assembly includes an inner chamber drain pipe arranged on the inner chamber and an inner chamber drain flow limiting control device arranged on the inner chamber drain pipe.

[0015] Preferably, the inner chamber evacuation assembly includes an inner chamber evacuation pipe arranged on the inner chamber, an inner chamber evacuation valve arranged on the inner chamber evacuation pipe, and an inner chamber evacuation flow limiting control device arranged on the inner chamber evacuation pipe and connected in parallel with the inner chamber evacuation valve. A vacuum pump is arranged on the inner chamber evacuation pipe, and the vacuum pump is connected in series with the inner chamber evacuation flow limiting control device and the inner chamber evacuation valve.

[0016] Preferably, the inner chamber air inlet assembly includes an inner chamber return valve and an air valve arranged on the inner chamber air inlet pipe, and a compressed air inlet valve is arranged on the inner chamber air inlet pipe, and the compressed air inlet valve is connected in parallel with the air valve.

[0017] Preferably, a filter is provided on the inner chamber air inlet pipe, and the filter is located between the inner chamber return valve and the air valve and the compressed air intake valve, and the inner chamber return valve is connected in series with the air valve and the compressed air intake valve.

[0018] A sterilization control method, applied to any of the above sterilization devices, the control method comprising:

[0019] In the preheating stage, the interlayer steam inlet control component and the interlayer steam exhaust and drain component are controlled to rapidly heat up the interlayer and the inner chamber, and the interlayer steam inlet control component and the interlayer steam exhaust and drain component are controlled to adjust the pressure in the interlayer according to the temperature of the inner chamber, and during this period, the inner chamber evacuation component and the inner chamber drain component are controlled to keep the inner chamber in a slightly negative pressure state;

[0020] In the replacement stage, the inner chamber steam inlet buffer component and the inner chamber evacuation component are controlled to purge and replace the inner chamber with steam;

[0021] In the pulsation stage, the inner chamber evacuation component is controlled to evacuate the inner chamber until the pressure in the inner chamber reaches the minimum value of the specified pressure and is maintained for one minute, the inner chamber steam inlet buffer component is controlled to introduce steam into the inner chamber so that the pressure in the inner chamber reaches the maximum value of the specified pressure and is maintained for twenty minutes, and after repeating the above evacuation and steam inlet operation three times, the inner chamber evacuation component is controlled to evacuate the inner chamber for the fourth time until the pressure in the inner chamber reaches the minimum value of the specified pressure and is maintained for one minute;

[0022] In the heating stage, the inner chamber steam inlet buffer component and the inner chamber hydrophobic component are controlled to heat the inner chamber, wherein the inner chamber heating rate is 0.5-1°C / min, and the inner chamber pressure change rate is 2kPa / min, until the inner chamber temperature and pressure reach the sterilization set value;

[0023] During the sterilization stage, the steam inlet buffer component and the inner chamber hydrophobic component are controlled to keep the temperature and pressure in the inner chamber within the specified sterilization range, and the sterilization lasts for sixty minutes;

[0024] During the steam exhaust cooling stage, the inner chamber drain assembly is controlled to reduce the inner chamber pressure to a set pressure, during which the inner chamber steam inlet buffer assembly is controlled to periodically inlet steam into the inner chamber to control the inner chamber cooling rate to 0.5-1°C / min and the pressure change rate to 2kPa / min;

[0025] In the air slight cooling stage, the inner chamber air inlet assembly is periodically controlled to introduce air into the inner chamber when the pressure in the inner chamber reaches the minimum pressure value so that the pressure in the inner chamber reaches normal pressure and stops, and this is repeated until the temperature in the inner chamber is lower than 90° C.;

[0026] Unload the sterilizer side door seal to connect the inner chamber with the outside until the temperature of the inner chamber is lower than 40°C.

[0027] The sterilization device provided by the present invention is provided with a steam inlet buffer component for the inner chamber. When it is necessary to control the steam inlet into the inner chamber, the steam is first controlled to pass through the steam inlet buffer component for the inner chamber, and then the steam in the steam inlet buffer component for the inner chamber is controlled to maintain a certain pressure range before entering the inner chamber, thereby avoiding the problem of steam directly entering the inner chamber, which would cause the pressure in the inner chamber to change too quickly.

[0028] The sterilization control method provided by the present invention periodically evacuates the inner chamber, thereby maintaining a slight negative pressure in the inner chamber, and replaces the cold air in the ATF with hot air and conducts heat in the interlayer to ensure the uniformity and effectiveness of the ATF temperature rise. The small rate control algorithm is used in conjunction with the current limiting device to achieve precise changes in the inner chamber pressure at a small rate. In conjunction with the inner chamber steam inlet buffer component, the pressure of the pure steam source entering the inner chamber can be guaranteed to be stable regardless of how the pressure of the pure steam source provided by the pharmaceutical factory changes. The slow air heat exchange method allows the ATF to achieve a temperature drop at a slower rate to ensure the integrity of the performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0030] Figure 1 Schematic diagram of the sterilization device in this embodiment.

[0031] Reference numerals include:

[0032] 1. Steam buffer device; 2. Steam inlet valve of buffer device; 3. First pressure transmitter; 4. Steam inlet valve of inner chamber; 5. Steam inlet flow limiting control device of inner chamber; 6. First temperature sensor; 7. Second temperature sensor; 8. Steam temporary storage tank drain device; 10. Inner chamber; 11. Interlayer; 12. Third temperature sensor; 13. Second pressure transmitter; 14. Third pressure transmitter; 15. Steam inlet valve of interlayer; 16. Steam exhaust valve of interlayer; 17. Steam inlet flow limiting control device of interlayer; 18. Interlayer drain valve; 19. Inner chamber evacuation flow limiting control device; 20. Vacuum pump; 21. Inner chamber drain flow limiting control device; 22. Inner chamber evacuation valve; 23. Inner chamber return valve; 24. Filter; 25. Air valve; 26. First rubber strip evacuation valve; 27. Second rubber strip evacuation valve; 28. Compressed air intake valve; 29. ​​Cooling water valve. DETAILED DESCRIPTION

[0033] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0034] Unless otherwise defined, the technical terms or scientific terms used in the disclosure of this application should have the usual meaning understood by people with ordinary skills in the field to which the invention belongs. The "first", "second" and similar words used in the present invention do not indicate any order, quantity or importance. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly. The embodiments of the present application disclose a sterilization device and a sterilization control method.

[0035] The core of the present invention is to provide a sterilization device and a sterilization control method.

[0036] Please refer to Figure 1 .

[0037] The sterilizing device provided by the present invention is as follows Figure 1 As shown, it is used for sterilizing ATF filters, including a sterilizer, the sterilizer including an inner chamber 10 and an interlayer 11 arranged on the outer periphery of the inner chamber 10, the interlayer 11 is connected to an interlayer steam inlet pipe, and an interlayer steam inlet control component is arranged on the interlayer steam inlet pipe to control the steam pressure entering the interlayer 11, and the lower part of the interlayer 11 is connected to an interlayer steam exhaust pipe, and an interlayer steam exhaust drainage component is arranged on the interlayer steam exhaust pipe. The inner chamber 10 is connected to an inner chamber steam inlet pipe, and an inner chamber steam inlet buffer component is arranged on the inner chamber steam inlet pipe to keep the steam entering the inner chamber 10 through the inner chamber steam inlet pipe in a certain pressure range, and the inner chamber 10 is provided with an inner chamber drainage component for drainage of the inner chamber 10, and the inner chamber 10 is provided with an inner chamber evacuation component for adjusting the pressure in the inner chamber 10. The inner chamber 10 is connected to an inner chamber air inlet pipe, and an inner chamber air inlet component is arranged on the inner chamber air inlet pipe for introducing air into the inner chamber 10.

[0038] It should be noted that the ATF filter is placed in the inner chamber 10 of the sterilization device, and sealing doors are provided at both ends of the sterilization device. Sealing strips are provided on the sealing doors to achieve sealing of the sterilization device. Two rubber strips are provided, namely a first rubber strip and a second rubber strip. The first rubber strip and the second rubber strip are even provided with a first rubber strip evacuation valve 26 and a second rubber strip evacuation valve 27, respectively. The two rubber strips are evacuated or inflated by the two evacuation valves, respectively, to achieve the opening and sealing of the sterilization device.

[0039] In this embodiment, the upper part of the interlayer 11 is connected with an interlayer steam inlet pipe, the other end of the interlayer steam inlet pipe is connected with the industrial steam supply source, and an interlayer steam inlet control component is arranged on the interlayer steam inlet pipe. The interlayer steam inlet control component can effectively control the pressure of the industrial steam entering the interlayer 11, thereby effectively adjusting the steam inlet pressure of the interlayer 11 according to demand. In coordination with this, the lower part of the interlayer 11 is connected with an interlayer steam exhaust pipe, and the interlayer steam exhaust pipe is provided with an interlayer steam exhaust drain component. The other end of the interlayer steam exhaust pipe is connected with the main exhaust port, which is used to discharge condensed water and useless steam generated by steam heating in the interlayer 11.

[0040] The following is a detailed description of the inner chamber 10. The inner chamber 10 is located on the inner side of the interlayer 11, that is, the interlayer 11 is sleeved on the outer periphery of the inner chamber 10. At the same time, the inner chamber 10 and the interlayer 11 are isolated from each other. The upper part of the inner chamber 10 is connected to the inner chamber steam inlet pipe, and the other end of the inner chamber steam inlet pipe is connected to the pure steam supply source. The inner chamber steam inlet pipe is provided with an inner chamber steam inlet buffer assembly, which is located between the pure steam supply source and the inner chamber 10, and is used to buffer the steam entering the inner chamber 10, so as to avoid the problem of excessive pressure change in the inner chamber 10 caused by the pure steam directly entering the inner chamber 10. At the same time, the inner chamber steam inlet buffer assembly can also effectively adjust the pressure of the pure steam entering the inner chamber 10, so as to supply steam according to demand. In coordination with this, the lower part of the inner chamber 10 is connected to the inner chamber drain assembly, which is used to drain the condensed water in the inner chamber 10. In order to achieve a slightly negative pressure state of the inner chamber 10 and to subsequently evacuate the inner chamber 10, the inner chamber 10 is also provided with an inner chamber evacuation assembly for adjusting the pressure in the inner chamber 10. An inner chamber air inlet pipe is also connected to the upper part of the inner chamber 10, and the other end of the inner chamber air inlet pipe is connected to the air source. An inner chamber air inlet assembly is provided on the inner chamber air inlet pipe, and the pressure of the air entering the inner chamber 10 can be effectively adjusted by controlling the inner chamber air inlet assembly.

[0041] Specifically, the interlayer steam inlet control component cooperates with the interlayer steam exhaust and drain component to adjust the pressure of the interlayer 11 by adjusting the steam inlet and exhaust volume, so as to achieve temperature regulation and control according to the pressure, so as to cooperate with the subsequent sterilization control method. Similarly, the inner chamber steam inlet buffer component cooperates with the inner chamber drain component and the inner chamber evacuation component. According to different process flows, different components are selected for operation to adjust the pressure in the inner chamber so that it meets the pressure change rate and temperature change rate specified by the process, thereby avoiding the problem of device performance damage caused by excessive pressure or temperature changes. The inner chamber air inlet component can periodically replenish the inner chamber 10 according to demand, and cooperate with the inner chamber evacuation component to enable the inner chamber 10 to maintain a slightly negative pressure state, which can ensure the uniformity and effectiveness of the temperature rise of the inner chamber 10. The steam inlet buffer component for the inner chamber can maintain the stability of the steam supply pressure to the greatest extent. Since the pressure of the steam source provided by the pharmaceutical factory varies greatly, the steam inlet buffer component for the inner chamber can ensure that the pressure of the pure steam source entering the inner chamber 10 is stable regardless of how the pressure of the pure steam source provided by the pharmaceutical factory changes.

[0042] The above-mentioned sterilization device effectively solves the problem in the prior art that the ATF filter is easily deformed and damaged during the sterilization process due to unstable steam pressure. At the same time, the above-mentioned sterilization device can not only accurately control the pressure changes of the interlayer and the inner chamber, but also ensure the smooth progress of the entire sterilization process through the synergistic effect of multi-stage components, thereby significantly improving the sterilization effect. In addition, by optimizing the design of the steam inlet buffer component of the inner chamber, no matter how the pressure of the external steam source fluctuates, it can ensure that the steam pressure entering the inner chamber is maintained within a stable range, greatly improving the reliability and adaptability of the system.

[0043] The sterilization device provided by the present invention is described in more detail below with reference to the accompanying drawings and specific embodiments.

[0044] In a specific embodiment, reference Figure 1 The interlayer steam inlet control component includes an interlayer steam inlet valve 15 arranged on the interlayer steam inlet pipe and an interlayer steam inlet current limiting control device 17 connected in parallel with the interlayer steam inlet valve 15 .

[0045] Specifically, the interlayer steam inlet valve 15 is connected in parallel with the interlayer steam inlet flow limiting control device 17, and is used to pass steam into the interlayer 11 according to different situations. In the process preheating stage, when it is detected that the temperature of the inner chamber is less than 60°C or the measured temperature is less than 60°C, it is necessary to quickly heat the interlayer 11 and the inner chamber 10. At this time, the interlayer steam inlet valve 15 needs to be opened to pass steam into the interlayer 11 for heating, so that the temperature of the interlayer 11 and the inner chamber 10 rises rapidly. After the rapid heating stage, the pressure of the interlayer 11 needs to be controlled according to the different temperature values ​​of the inner chamber 10. At this time, the interlayer steam inlet flow limiting control device 17 needs to be opened, and the interlayer steam inlet valve 15 remains closed. The steam pressure entering the interlayer 11 is controlled by the interlayer steam inlet flow limiting control device 17, thereby adjusting the pressure in the interlayer 11. In both of the above processes, the interlayer steam exhaust and drainage assembly needs to be used to exhaust and drain the interlayer 11.

[0046] It should be noted that the interlayer steam inlet flow limiting control device 17 adopts a controllable valve combination, which is not limited to adding a flow limiting valve, a flow limiting joint, a valve limiter, a pipeline reducer and other device combinations that can limit the steam inlet flow rate.

[0047] Based on any of the above embodiments, Figure 1 The interlayer steam exhaust and drain assembly includes an interlayer steam exhaust valve 16 arranged on the interlayer steam exhaust pipe and an interlayer drain valve 18 connected in parallel with the interlayer steam exhaust valve 16.

[0048] Specifically, the interlayer steam exhaust valve 16 and the interlayer steam trap 18 are arranged in parallel on the interlayer steam exhaust pipe, and are used to exhaust steam or drain water from the interlayer 11. Of course, in order to facilitate maintenance or distinction, the interlayer steam exhaust pipe can also be divided into a steam exhaust pipe and a drain pipe, which are used to exhaust steam or drain water from the interlayer 11. The interlayer steam exhaust valve 16 is usually opened when steam is introduced into the interlayer 11 and the pressure in the interlayer 11 needs to be adjusted, and is used to assist in adjusting the pressure in the interlayer 11. At the same time, the interlayer steam trap 18 is used to drain the condensed water generated by the interlayer 11. In order to facilitate automatic draining, the interlayer steam trap 18 can use a mechanical steam trap to automatically drain water from the interlayer 11.

[0049] Based on any of the above embodiments, Figure 1 The inner chamber steam inlet buffer assembly includes an inner chamber steam inlet valve 4 arranged on the inner chamber steam inlet pipe, an inner chamber steam inlet current limiting control device 5 arranged on the inner chamber steam pipe and connected in parallel with the inner chamber steam inlet valve 4, and a steam buffer device 1 arranged on the inner chamber steam pipe at the end of the inner chamber steam inlet valve 4 away from the sterilizer, and a buffer device steam inlet valve 2 is arranged on the inner chamber steam pipe between the steam buffer device 1 and the steam source.

[0050] Specifically, the inner chamber 10 is connected with an inner chamber steam inlet pipe for introducing steam into the inner chamber 10. The inner chamber steam inlet pipe is provided with a buffer device steam inlet valve 2, a steam buffer device 1 and an inner chamber steam inlet valve 4 in sequence from the steam supply end to the sterilizer. At the same time, in order to adjust the steam pressure from the steam buffer device 1 to the inner chamber 10, an inner chamber steam inlet current limiting control device 5 connected in parallel with the inner chamber steam inlet valve 4 is provided on the inner chamber steam inlet pipe to adjust the steam pressure from the steam buffer device 1 to the inner chamber 10. The steam buffer device 1 is further described in the following coordinated process flow.

[0051] When the process requires controlling the entry of pure steam into the inner chamber 10, first open the buffer device steam inlet valve 2 to control the entry of pure steam into the steam buffer device 1; after reaching the limit, open the inner chamber steam inlet valve 4 or the inner chamber steam inlet flow limiting control device 5 to avoid simultaneous opening of the buffer device steam inlet valve 2 and the inner chamber steam inlet valve 4 or the inner chamber steam inlet flow limiting control device 5, which would cause the steam to directly enter the inner chamber 10 and cause excessive pressure changes.

[0052] It should be noted that the above-mentioned inner chamber steam inlet flow limiting control device 5 adopts a controllable valve combination that is not limited to adding a flow limiting valve, a flow limiting joint, a valve limiter, a pipeline reducer and other device combinations that can limit the steam inlet flow rate.

[0053] Furthermore, the steam buffer device 1 includes a steam temporary storage tank, a first pressure transmitter 3 disposed on the steam temporary storage tank, and a steam temporary storage tank drain device 8 disposed on the steam temporary storage tank, and the steam temporary storage tank drain device 8 is used to prevent condensed water from being generated and entering the inner chamber 10. The steam temporary storage tank can also be replaced with other structures capable of temporarily storing steam.

[0054] Specifically, the first pressure transmitter 3 is used to detect the pressure in the steam storage tank and is set in conjunction with the temperature in the inner chamber 10. When the value of the detected inner chamber temperature is greater than or equal to 112°C, the pressure of the steam storage tank is controlled to be limited to 160kPa. When the value of the detected inner chamber temperature is less than 112°C, the pressure of the steam storage tank is controlled to be limited to 100kPa.

[0055] The steam temporary storage tank drain device 8 is used to drain the steam temporary storage tank to prevent condensed water from being generated and entering the inner chamber 10.

[0056] Based on any of the above embodiments, Figure 1 The inner chamber drain assembly includes an inner chamber drain pipe arranged on the inner chamber 10 and an inner chamber drain flow limiting control device 21 arranged on the inner chamber drain pipe.

[0057] Specifically, the inner chamber drain pipe is connected to the lower part of the inner chamber 10 and is connected to the main discharge port of the system. The inner chamber drain flow limiting control device 21 is arranged on the inner chamber drain pipe. The inner chamber drain flow limiting control device 21 is used to drain the inner chamber 10 or cooperate with other structures to adjust the pressure in the inner chamber 10.

[0058] It should be noted that the above-mentioned inner chamber drain flow limiting control device 21 uses a controllable valve combination that is not limited to adding a flow limiting valve, a flow limiting joint, a valve limiter, a pipeline reducer and other device combinations that can limit the steam inlet flow rate.

[0059] Based on any of the above embodiments, Figure 1 The inner chamber evacuation component includes an inner chamber evacuation pipe arranged on the inner chamber 10, an inner chamber evacuation valve 22 arranged on the inner chamber evacuation pipe, and an inner chamber evacuation flow limiting control device 19 arranged on the inner chamber evacuation pipe and connected in parallel with the inner chamber evacuation valve 22. A vacuum pump 20 is arranged on the inner chamber evacuation pipe, and the vacuum pump 20 is connected in series with the inner chamber evacuation flow limiting control device 19 and the inner chamber evacuation valve 22.

[0060] Specifically, the inner chamber evacuation pipe is arranged at the lower part of the inner chamber 10, and the inner chamber evacuation valve 22 and the inner chamber evacuation flow limiting control device 19 are connected in parallel on the inner chamber evacuation pipe. A vacuum pump 20 for evacuating the inner chamber 10 is also arranged on the inner chamber evacuation pipe. The vacuum pump 20 is connected in series with the inner chamber evacuation valve 22 and the inner chamber evacuation flow limiting control device 19. According to the process requirements, the inner chamber evacuation valve 22 or the inner chamber evacuation flow limiting control device 19 is selectively opened.

[0061] Furthermore, in order to facilitate cooling of the steam discharged during the evacuation stage of the inner chamber 10 and to supply water to the vacuum pump 20, a cooling water supply pipe is connected to the inner chamber evacuation pipe, and a cooling water valve 29 is provided on the cooling water supply pipe for opening and closing the cooling water supply.

[0062] It should be noted that the above-mentioned inner chamber evacuation flow limiting control device 19 uses a controllable valve combination that is not limited to adding a flow limiting valve, a flow limiting joint, a valve limiter, a pipeline reducer and other device combinations that can limit the steam inlet flow rate.

[0063] Based on any of the above embodiments, Figure 1 The inner chamber air inlet assembly includes an inner chamber return valve 23 and an air valve 25 which are arranged on the inner chamber air inlet pipe. A compressed air inlet valve 28 is arranged on the inner chamber air inlet pipe, and the compressed air inlet valve 28 is connected in parallel with the air valve 25.

[0064] Specifically, an inner chamber return valve 23 and an air valve 25 are sequentially provided on the inner chamber air inlet pipe from the sterilizer to the air supply source. The inner chamber return valve 23 and the air valve 25 are opened simultaneously to allow air to enter the inner chamber 10 .

[0065] In order to allow compressed air to be introduced into the inner chamber 10 , a compressed air intake valve 28 is provided on the inner chamber air intake pipe. The compressed air intake valve 28 is connected in parallel with the air valve 25 , and the compressed air intake valve 28 is connected to a compressed air source for allowing compressed air to be introduced into the inner chamber 10 .

[0066] Furthermore, a filter 24 is provided on the air inlet pipe of the inner chamber, and the filter 24 is located between the inner chamber return valve 23, the air valve 25, and the compressed air inlet valve 28. The inner chamber return valve 23 is connected in series with the air valve 25 and the compressed air inlet valve 28. The filter 24 can effectively filter the air entering the inner chamber 10. The compressed air inlet valve 28 is used for manually blowing the inner chamber 10 with compressed air to cool it down or to remove condensed water in the inner chamber 10.

[0067] Optionally, the filter 24 can adopt a 0.2 micron high-efficiency air filter to ensure that the air entering the inner chamber 10 is sterile and free of particulate contamination. During the sterilization process, when air needs to be introduced into the inner chamber 10, the air first passes through the filter 24 for double filtration: the first stage filtration intercepts large particles of impurities, and the second stage uses a hydrophobic filter membrane to achieve microbial retention, and the filtration efficiency reaches 99.999%. In the specific work flow, when the pressure of the inner chamber 10 is lower than the set threshold, the control system synchronously opens the inner chamber return valve 23 and the air valve 25, and the external air enters through the parallel compressed air intake valve 28 or the air valve 25. At this time, the air flows through the filter 24 and enters the inner chamber 10 after purification. The compressed air intake valve 28 is enabled when rapid pressurization is required, and its on and off is controlled by real-time feedback from the inner chamber pressure transmitter 14.

[0068] In addition, the filter 24 and each valve can adopt a flange type quick connection structure, which is convenient for disassembly and maintenance. After the sterilizer has been operated for 100 cycles, the sterilizer needs to be sterilized online with steam; after 500 cycles, the filter element of the sterilizer needs to be replaced.

[0069] Based on the above sterilization device, the present application also discloses a sterilization control method, which is applied to the above sterilization device, wherein the control method includes:

[0070] In the preheating stage, the interlayer steam inlet control component and the interlayer steam exhaust and drainage component are controlled to quickly heat up the interlayer 11 and the inner chamber 10, and the interlayer steam inlet control component and the interlayer steam exhaust and drainage component are controlled to adjust the pressure in the interlayer 11 according to the temperature of the inner chamber 10. During this period, the inner chamber evacuation component and the inner chamber drainage component are controlled to keep the inner chamber 10 in a slightly negative pressure state;

[0071] During the replacement phase, the inner chamber steam inlet buffer component and the inner chamber evacuation component are controlled to purge and replace the inner chamber 10 with steam;

[0072] In the pulsation stage, the inner chamber evacuation component is controlled to evacuate the inner chamber 10, wherein the evacuation rate is 6 kPa / min, until the pressure in the inner chamber 10 reaches the minimum value of the specified pressure (specifically -41 kPa in this embodiment) and is maintained for one minute, and the inner chamber steam inlet buffer component is controlled to introduce steam into the inner chamber 10 so that the pressure in the inner chamber 10 reaches the maximum value of the specified pressure (specifically 41 kPa in this embodiment) and is maintained for twenty minutes. After repeating the above evacuation and steam inlet operation three times, the inner chamber evacuation component is controlled to evacuate the inner chamber 10 for the fourth time, wherein the evacuation rate is 6 kPa / min, until the pressure in the inner chamber 10 reaches the minimum value of the specified pressure (specifically -41 kPa in this embodiment) and is maintained for one minute;

[0073] During the heating stage, the inner chamber steam inlet buffer component and the inner chamber drain component are controlled to heat the inner chamber 10, wherein the heating rate of the inner chamber 10 is 0.5-1°C / min, and the pressure change rate of the inner chamber 10 is 2kPa / min, until the temperature and pressure in the inner chamber 10 reach the sterilization set value;

[0074] During the sterilization stage, the steam inlet buffer component and the inner chamber hydrophobic component are controlled to keep the temperature and pressure in the inner chamber 10 within the specified sterilization range, and the sterilization lasts for sixty minutes;

[0075] During the steam exhaust cooling stage, the inner chamber drain assembly is controlled to reduce the pressure of the inner chamber 10 to a specified pressure (specifically 10 kPa in this embodiment), and the inner chamber steam inlet buffer assembly is controlled to periodically inlet steam into the inner chamber 10 to control the cooling rate of the inner chamber 10 to be 0.5-1°C / min and the pressure change rate to be 2 kPa / min;

[0076] In the air slight cooling stage, the inner chamber air inlet assembly is periodically controlled to introduce air into the inner chamber 10 when the pressure in the inner chamber 10 reaches the minimum pressure value so that the pressure in the inner chamber 10 reaches normal pressure and stops, and this is repeated until the temperature in the inner chamber 10 is lower than 90°C;

[0077] The sterilizer side door seal is removed to allow the inner chamber 19 to communicate with the outside until the temperature of the inner chamber 10 is lower than 40°C.

[0078] The above sterilization control method periodically evacuates the inner chamber 10 to maintain a slight negative pressure in the inner chamber 10, and replaces the cold air in the ATF with hot air and conducts heat in the interlayer to ensure the uniformity and effectiveness of the ATF temperature rise. The small rate control algorithm is used in conjunction with the current limiting device to achieve precise changes in the pressure of the inner chamber 10 at a small rate. In conjunction with the inner chamber steam inlet buffer component, the pressure of the pure steam source entering the inner chamber 10 can be guaranteed to be stable regardless of how the pressure of the pure steam source provided by the pharmaceutical factory changes. The slow air heat exchange method allows the ATF to achieve a temperature drop at a slower rate to ensure the integrity of the performance.

[0079] The following is a specific description of the sterilization control method based on the specific structure of the sterilization device. Prior to this, in order to make the sterilization control method clearer, the following first specifically describes the three control schemes adopted in this control method, including a micro-negative pressure scheme, a small rate precision control scheme, and an air micro-cooling control scheme.

[0080] The micro-negative pressure control scheme controls the ATF temperature to rise steadily and evenly during the preheating stage to ensure that the internal temperature is between 60 and 90°C. To ensure the thoroughness of preheating, the preheating time is controlled between 1.5 and 2 hours. The ATF is heated by industrial steam heat conduction heating in the interlayer 11 and the micro-negative pressure change in the inner chamber, which includes a control method for the interlayer pressure and a micro-negative pressure control method for the inner chamber.

[0081] Interlayer control: When the preheating stage is just started, if the temperature of the inner chamber 10 (in order to cooperate with the detection of the temperature of the inner chamber 10, the first temperature sensor 6 and the second temperature sensor 7 can be installed in the inner chamber 10 to detect the temperature of the specified area in the inner chamber 10) is less than 40°C or the temperature of the interlayer 11 (in order to cooperate with the detection of the temperature of the interlayer 11, the third temperature sensor 13 can be installed in the interlayer 11 to detect the temperature of the specified area in the interlayer 11) is less than 60°C, the interlayer steam inlet valve 15 and the interlayer steam exhaust valve 16 are opened for 5 minutes to achieve rapid heating of the interlayer 11. At the same time, the inner chamber 10 is rapidly heated by heat conduction to heat up the sterilizer. During this period, the pressure of the interlayer 11 is detected by the second pressure transmitter 13 set on the interlayer 11. At this stage, the interlayer pressure is controlled not to exceed 60kPa.

[0082] At the end of 5 minutes, when the inner chamber temperature is less than 60°C, the interlayer pressure is controlled between 55 and 60 kPa; when the inner chamber temperature is greater than or equal to 60°C, the interlayer pressure is controlled between 30 and 40 kPa; when the inner chamber temperature is greater than or equal to 90°C, the interlayer pressure is controlled between 5 and 10 kPa; when the inner chamber temperature is greater than or equal to 95°C, the steam supply to interlayer 11 is stopped; the pressure change of interlayer 11 is repeatedly controlled according to the value of the inner chamber temperature.

[0083] It should be noted that at this stage, the steam inlet pressure of the interlayer 11 is regulated by controlling the interlayer steam inlet flow limiting control device 17 (the interlayer steam inlet valve 15 remains closed during the opening stage of the interlayer steam inlet flow limiting control device 17), and automatic drainage is performed by controlling the interlayer drain valve 18, thereby achieving precise control of the interlayer pressure.

[0084] Micro-negative pressure control: Start at the preheating stage of the process flow, control the inner chamber water-repellent flow-limiting control device 21 to open, and at the same time open the inner chamber return valve 23, the air valve 25 and the filter 24 to allow air to enter the inner chamber 10 through the filter 24, periodically control the vacuum pump 20 to start and stop, specifically with an opening time of 120 seconds and a stopping time of 240 seconds, and periodically control the inner chamber evacuation flow-limiting control device 19 to start and stop, specifically with an opening time of 2 seconds and a closing time of 10 seconds, and finally control the pressure in the inner chamber 10 to remain between normal pressure (i.e., the pressure value of the inner chamber 10 detected when the sterilizer door is opened) and normal pressure minus 5kPa. The specific pressure value of the inner chamber 10 can be detected by the third pressure transmitter 14 set on the inner chamber 10. In this stage, the inner chamber water-repellent flow-limiting control device 21 is always kept open, the inner chamber air inlet assembly is kept open, and the vacuum pump 20 and the inner chamber evacuation flow-limiting control device 19 coordinated with the vacuum pump 20 are periodically opened and closed, thereby realizing micro-negative pressure control of the inner chamber 10.

[0085] The small rate precision control scheme, the sterilizer cooperates with the inner chamber steam inlet flow limiting control device 5, the inner chamber evacuation flow limiting control device 19 and the inner chamber drain flow limiting control device 21, combined with the small rate control algorithm, to achieve precise control of the small rate change of the pressure in the inner chamber 10. The stages of using this scheme include the pulsating inner chamber evacuation stage, the pulsating inner chamber steam inlet stage, the heating stage and the cooling and exhausting stage.

[0086] Pulsating inner chamber evacuation stage: the inner chamber pressure change rate is required to be 6kPa / min. When the pressure of the inner chamber 10 is detected to be greater than or equal to 15kPa, the inner chamber drain flow limiting control device 21 is continuously opened to reduce the pressure of the inner chamber. When it is detected that the pressure change exceeds the limit value, the inner chamber steam inlet flow limiting control device 5 is opened to allow steam to be introduced once (specifically, the limit value and the time for introducing steam once are adjusted according to the pressure change detection cycle. The preferred scheme is to detect once every 10 seconds, that is, the inner chamber pressure drops by 6 / 60*10=1kPa. When the pressure drop of the inner chamber is detected to be more than 1kPa after 10 seconds, the inner chamber steam inlet flow limiting control device 5 is opened to allow steam to be introduced for 1 second. When the pressure drop of the inner chamber is detected to be less than 1kPa after 10 seconds, the steam inlet is not opened); when the pressure of the inner chamber 10 is detected to be less than 15kPa, the inner chamber evacuation flow limiting control device 19 and the vacuum pump 20 are continuously opened to reduce the pressure of the inner chamber 10. When it is detected that the pressure change exceeds the limit value (the detection limit value and the preferred scheme for introducing steam once are the same as above), the inner chamber steam inlet flow limiting control device 5 is opened to allow steam to be introduced once. If the pressure in the inner chamber 10 is low to negative pressure, the vacuum pump 20 is required to evacuate the chamber to reduce the pressure.

[0087] Pulsating inner chamber steam inlet stage: The inner chamber 10 pressure change rate is required to be 15kPa / min. Since the chamber pressure changes greatly under the same steam inlet conditions within the same time, in order to ensure the uniform increase of the inner chamber 10 pressure, on the one hand, a steam buffer device 1 is configured to create the most consistent steam inlet conditions, and on the other hand, the control algorithm controls the steam inlet switch time frequency in stages according to the inner chamber 10 pressure value. The pressure increase of the inner chamber 10 is achieved by controlling the steam inlet of the inner chamber steam inlet current limiting control device 5;

[0088] The above preferred solution: when the pressure of the inner chamber 10 is detected to be less than -30kPa, the steam flow limiting control device 5 for entering the inner chamber is controlled to be opened for 0.5 seconds and closed for 4.5 seconds; when the pressure of the inner chamber 10 is detected to be greater than -30kPa, the steam flow limiting control device 5 for entering the inner chamber is controlled to be opened for 1 second and closed for 4 seconds; when the pressure of the inner chamber 10 is detected to be greater than -10kPa, the steam flow limiting control device 5 for entering the inner chamber is controlled to be opened for 2 seconds and closed for 3 seconds; when the pressure of the inner chamber 10 is detected to be greater than 10kPa, the steam flow limiting control device 5 for entering the inner chamber is controlled to be opened for 3 seconds and closed for 2 seconds; when the pressure of the inner chamber 10 is detected to be greater than 30kPa, the steam flow limiting control device 5 for entering the inner chamber is controlled to be opened for 4 seconds and closed for 1 second.

[0089] It should be noted that the opening of the inner chamber steam inlet flow limiting control device 5 is also controlled by the pressure change limit detected by the pressure, and the pressure change limit can be adjusted according to the pressure change detection cycle. At the same time, when the pressure of the inner chamber 10 is greater than 10kPa, the inner chamber drain flow limiting control device 21 is always opened to drain the inner chamber condensate.

[0090] Heating stage: the temperature of the inner chamber 10 is required to have a numerical heating rate within the range of 0.5-1°C / min, and the temperature of the inner chamber 10 is controlled by controlling the pressure of the inner chamber 10. Specifically, the pressure change rate of the inner chamber 10 is controlled to be 2 kPa / min.

[0091] At the beginning of the temperature rise phase, the inner chamber pressure is detected at the beginning. When the pressure value is greater than 40kPa, the inner chamber water-draining and flow-limiting control device 21 is always opened to drain the condensed water of the inner chamber 10. The pressure of the inner chamber 10 is increased by controlling the steam inlet flow-limiting control device 5 of the inner chamber to enter steam, and the inner chamber steam-inlet flow-limiting control device 5 is controlled to open and close periodically, specifically to open for 4 seconds and close for 1 second. At the same time, it is controlled by the pressure change limit value detected by the third pressure transmitter 14, and the pressure change limit value can be adjusted according to the pressure change detection cycle. The key to this control is that the inner chamber water-draining and flow-limiting control device 21 is always opened, and the inner chamber steam-inlet flow-limiting control device 5 is opened periodically and opened according to the pressure change detection cycle to perform steam inlet control.

[0092] Cooling and exhaust steam stage: The numerical cooling rate of the temperature of the inner chamber 10 is required to be 0.5~1℃ / min, and the temperature of the inner chamber 10 is controlled by controlling the pressure of the inner chamber 10. Specifically, the pressure change rate of the inner chamber 10 is controlled to be 2kPa / min. The inner chamber water-draining and flow-limiting control device 21 is continuously opened to reduce the pressure of the inner chamber 10, and the inner chamber steam inlet flow-limiting control device 5 is opened once every 6 seconds to allow steam to flow in for 0.5 seconds until the pressure of the inner chamber 10 reaches 10kPa, thereby stopping the periodic steam inlet, and closing the inner chamber water-draining and flow-limiting control device 21 and the inner chamber steam inlet flow-limiting control device 5. The key to this control is that the inner chamber water-draining and flow-limiting control device 21 is always opened, and the inner chamber steam inlet flow-limiting control device 5 is opened periodically for steam supplement control.

[0093] Air micro-cooling control scheme, after the cooling and exhausting stage is completed, the inner chamber 10 is now a closed space, and the pressure of the inner chamber 10 decreases with the natural cooling of the inner chamber 10 and the condensation of steam in the inner chamber 10. When it is detected that the pressure of the inner chamber 10 is less than the normal pressure (the normal pressure here is the same as the normal pressure described above, and it will not be repeated again) minus 3kPa, the inner chamber return valve 23 is opened, and the air valve 25 is opened, so that air enters the inner chamber 10 through the filter 24, until the pressure of the inner chamber 10 reaches the normal pressure and then the above valves are closed; the above operation is repeated until it is detected that the temperature of the inner chamber is lower than 90°C. After that, the first rubber strip evacuation valve 26 and the second rubber strip evacuation valve 27 can be used to evacuate the first rubber strip and the second rubber strip, so that the inner chamber 10 is connected to the external environment, and the sterilizer and ATF are cooled by heat conduction with the external environment until the temperature of the inner chamber is detected to be lower than 40°C, the sterilization process is completed, and the unloading door can be opened to remove the ATF.

[0094] The above describes in detail the micro-negative pressure scheme, small rate precision control scheme and air micro-cooling control scheme in the sterilization control method. The following further describes the control method based on this.

[0095] In a specific embodiment, the preheating stage in the above sterilization control method is specifically:

[0096] Through the above-mentioned interlayer control method, the inner chamber is preheated to 60°C by heating the interlayer 11 in 1 to 1.5 hours, and the temperature of the ATF system after preheating reaches 60°C through the convection heat of the inner chamber. At this stage, the above-mentioned micro-negative pressure control method is also used to make the inner chamber 10 always in a micro-negative pressure state, and at the same time, the interlayer control is coordinated to ensure that the temperature of the inner chamber 10 is between 60 and 90°C. In order to ensure the thoroughness of preheating, the preheating time is controlled between 1.5 and 2 hours, and the ATF is heated by the heat conduction heating of industrial steam entering the interlayer 11 and the micro-negative pressure change of the inner chamber pressure.

[0097] In a specific embodiment, the replacement phase in the above sterilization control method is specifically:

[0098] The inner chamber 10 is replaced for 5 minutes, and the pressure of the inner chamber 10 is controlled not to exceed 41 kPa. The inner chamber evacuation valve 22 and the inner chamber steam inlet valve 4 are opened to purge and replace the air in the inner chamber 10 with steam after the preheating is completed and before the pulsation stage. At the same time, the inner chamber evacuation valve 22 is controlled to be continuously opened, and the inner chamber steam inlet valve 4 is opened and closed according to the pressure of the inner chamber 10, so that the pressure of the inner chamber 10 is controlled at 20~25 kPa, and the temperature of the inner chamber 10 is controlled at about 100°C.

[0099] In a specific embodiment, the pulsation stage in the above sterilization control method is specifically three repeated evacuation and steam inlet operations and a fourth evacuation operation, wherein the first three repeated evacuation and steam inlet operations and the fourth evacuation operation are specifically:

[0100] The evacuation operation controls the evacuation rate to 6 kPa / min and the minimum pressure to -41 kPa. When the minimum pressure value is reached, it is maintained for 1 minute, and then steam is injected to make the pressure of the inner chamber 10 reach 41 kPa and maintained for 20 minutes. Repeat the above operation three times, and then perform the fourth evacuation operation, and control the evacuation rate to 6 kPa / min, the minimum pressure to -41 kPa, stop when the minimum pressure value is reached and maintain for 1 minute.

[0101] The specific control scheme for the above-mentioned evacuation operation and steam admission operation is performed according to the control of the pulsating inner chamber evacuation stage and the pulsating inner chamber steam admission stage in the above-mentioned small-rate precise control scheme.

[0102] It should be noted that the pressure of the interlayer 11 needs to be controlled to ensure that the temperature of the inner chamber 10 is maintained between 85 and 90°C when the inner chamber 10 is evacuated to the lower pressure limit of -41 kPa and maintained for 1 minute, and the temperature of the inner chamber is maintained between 108 and 112°C when the steam inlet to the inner chamber 10 reaches the upper pressure limit of 41 kPa and maintained for 20 minutes. The specific operation is to control the interlayer steam inlet flow limiting control device 17 and the interlayer steam exhaust valve 16, when the pressure of the inner chamber 10 is less than 15 kPa, the pressure of the interlayer 11 is controlled between 30 and 35 kPa; when the steam inlet to the inner chamber 10 reaches the upper pressure limit of 41 kPa and maintained for 20 minutes, the pressure of the interlayer 11 is controlled between 40 and 45 kPa.

[0103] In a specific embodiment, the temperature rise stage in the above sterilization control method adopts the temperature rise stage in the above small rate precision control scheme, so that the steam injected into the inner chamber 10 reaches the sterilization set value pressure of 103kPa and temperature of 122.6°C, and the temperature rise rate is limited to within 1°C / minute. This step takes 30-35 minutes. Preferably, the temperature rise rate of the inner chamber 10 is controlled to be 0.5~1°C / min, and the pressure of the inner chamber 10 is 115kPa and the temperature of the inner chamber 10 is about 122°C after the temperature rise.

[0104] In a specific embodiment, the sterilization stage in the above-mentioned sterilization control method is specifically to keep the inner chamber hydrophobic flow limiting control device 21 open to drain the condensed water in the inner chamber 10, and control the steam inlet of the inner chamber steam limiting flow control device 5 according to the numerical value of the temperature of the inner chamber 10 to ensure that the numerical value of the inner chamber temperature is maintained between 122±0.2℃, and the sterilization time is maintained between 55 and 60 minutes.

[0105] In a specific embodiment, the specific control scheme for the exhaust and cooling stage in the above-mentioned sterilization control method is specifically controlled according to the cooling and exhaust stage in the above-mentioned small-rate precise control scheme, so that the temperature of the inner chamber 10 is cooled at a rate of 0.5-1°C / minute until the pressure of the inner chamber 10 is as low as 10kPa.

[0106] In a specific embodiment, the air micro-cooling stage in the above sterilization control method is specifically controlled according to the above air micro-cooling control scheme to make the temperature of the inner chamber 10 lower than 90°C.

[0107] It should be noted that between the above-mentioned exhaust cooling stage and the air micro-cooling stage, since the inner chamber 10 is a closed space, the pressure of the inner chamber 10 will cause steam condensation as the inner chamber 10 naturally cools down, thereby reducing the pressure of the inner chamber 10. When it is detected that the pressure of the inner chamber 10 is less than the normal pressure minus 3kPa, the air micro-cooling stage is carried out.

[0108] After the air micro-cooling stage, the temperature of the inner chamber 10 is lower than 90°C, and the first rubber strip evacuation valve 26 and the second rubber strip evacuation valve 27 can be used to evacuate the first rubber strip and the second rubber strip, so that the inner chamber 10 is connected to the external environment, and the sterilizer and ATF are cooled by heat conduction with the external environment until the inner chamber temperature is detected to be lower than 40°C. The sterilization process is completed and the unloading door can be opened to take out the ATF.

[0109] According to the principle of hot air rising, in the prior art, when heat conduction is only conducted through the interlayer 11, temperature stratification will occur in the inner chamber 10 and the ATF, that is, the top temperature is high and the bottom temperature is low. In the present sterilization control method, the inner chamber is kept at a slight negative pressure by periodically controlling the start and stop of the vacuum pump 20 and the opening and closing of the inner chamber evacuation current limiting control device 19, and the uniformity and effectiveness of the ATF temperature rise (temperature range is between 60~90℃) is ensured by the replacement of the cold air in the ATF with hot air and the heat conduction of the interlayer 11.

[0110] Since the pressure and temperature change rate requirements for the inner chamber 10 during the sterilization process are too small, the conventional steam-only or steam-exhaust method may directly exceed the rate requirements at the moment the valve is opened. However, this sterilization control scheme realizes precise control of the small rate change of the inner chamber pressure by configuring multiple flow limiting devices (including but not limited to the inner chamber steam flow limiting control device 5, the interlayer steam flow limiting control device 17, the inner chamber vacuum flow limiting control device 19 and the inner chamber hydrophobic flow limiting control device 21) in conjunction with the small rate control algorithm. The core of the small rate control is that the exhaust device (the inner chamber vacuum flow limiting control device 19 and the inner chamber hydrophobic flow limiting control device 21) is always open, and the steam inlet device (the inner chamber steam flow limiting control device 5) is controlled to be opened periodically or opened below the rate value according to the rate and the pressure value of the inner chamber 10, and the pressure is adjusted in combination with the steam buffer device 1 to realize precise control of the small rate.

[0111] Since the ATF exhaust steam is cooled from a high temperature of over 121°C, the internal temperature is still above 100°C at this time, and the temperature must be lowered in a gentle manner. The existing technology uses compressed air cooling or direct door opening to cause large temperature differences, which in turn damages the ATF performance. This sterilization control solution uses slow air heat exchange to allow the ATF to achieve a slower temperature drop at a slower rate, ensuring performance integrity.

[0112] The above-mentioned sterilization control method periodically evacuates the inner chamber 10, thereby maintaining a slight negative pressure in the inner chamber 10, and replaces the cold air in the ATF with hot air and interlayer heat conduction to ensure the uniformity and effectiveness of the ATF temperature rise. The small rate control algorithm is used in conjunction with the current limiting device to achieve a small rate and precise change in the pressure of the inner chamber 10. In conjunction with the inner chamber steam inlet buffer component, no matter how the pressure of the pure steam source provided by the pharmaceutical factory changes, the pressure of the pure steam source entering the inner chamber 10 can be guaranteed to be stable. The slow air heat exchange method allows the ATF to achieve a temperature drop at a slower rate to ensure the integrity of the performance.

[0113] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0114] The above is a detailed introduction to a sterilization device and a sterilization control method provided by the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present invention, the present invention can also be improved and modified in a number of ways, and these improvements and modifications also fall within the scope of protection of the present invention.

Claims

1. A sterilization device for sterilizing an ATF filter, comprising a sterilizer, the sterilizer comprising an inner chamber (10) and an interlayer (11) arranged on the outer periphery of the inner chamber (10), characterized in that: The interlayer (11) is connected to an interlayer steam inlet pipe, and an interlayer steam inlet control component is provided on the interlayer steam inlet pipe to control the pressure of steam entering the interlayer (11); the lower part of the interlayer (11) is connected to an interlayer steam exhaust pipe, and an interlayer steam exhaust drain component is provided on the interlayer steam exhaust pipe; The inner chamber (10) is connected to an inner chamber steam inlet pipe, and an inner chamber steam inlet buffer component is provided on the inner chamber steam inlet pipe so that the steam entering the inner chamber (10) through the inner chamber steam inlet pipe is kept within a certain pressure range. The inner chamber (10) is provided with an inner chamber drain component for draining the inner chamber (10). The inner chamber (10) is provided with an inner chamber evacuation component for adjusting the pressure in the inner chamber (10); The inner chamber (10) is connected to an inner chamber air inlet pipe, and an inner chamber air inlet assembly is provided on the inner chamber air inlet pipe for introducing air into the inner chamber (10).

2. A sterilization device according to claim 1, characterized in that: The interlayer steam inlet control assembly comprises an interlayer steam inlet valve (15) arranged on the interlayer steam inlet pipe and the interlayer steam inlet flow limiting control device (17) connected in parallel with the interlayer steam inlet valve (15).

3. A sterilization device and sterilization control method according to claim 1, characterized in that: The interlayer steam exhaust and drain assembly comprises an interlayer steam exhaust valve (16) arranged on the interlayer steam exhaust pipe and an interlayer drain valve (18) connected in parallel with the interlayer steam exhaust valve (16).

4. A sterilization device according to claim 1, characterized in that: The inner chamber steam inlet buffer assembly comprises an inner chamber steam inlet valve (4) arranged on the inner chamber steam inlet pipe, an inner chamber steam inlet flow limiting control device (5) arranged on the inner chamber steam pipe and connected in parallel with the inner chamber steam inlet valve (4), and a steam buffer device (1) arranged on the inner chamber steam pipe at an end of the inner chamber steam inlet valve (4) away from the sterilizer, and a buffer device steam inlet valve (2) is arranged on the inner chamber steam pipe between the steam buffer device (1) and the steam source.

5. A sterilization device according to claim 4, characterized in that: The steam buffer device (1) comprises a steam temporary storage tank, a first pressure transmitter (3) arranged on the steam temporary storage tank, and a steam temporary storage tank drain device (8) arranged on the steam temporary storage tank, wherein the steam temporary storage tank drain device (8) is used to prevent condensed water from being generated and entering the inner chamber (10).

6. A sterilization device according to claim 1, characterized in that: The inner chamber drain assembly comprises an inner chamber drain pipe arranged on the inner chamber (10) and an inner chamber drain flow limiting control device (21) arranged on the inner chamber drain pipe.

7. A sterilization device according to claim 1, characterized in that: The inner chamber evacuation assembly comprises an inner chamber evacuation pipe arranged on the inner chamber (10), an inner chamber evacuation valve (22) arranged on the inner chamber evacuation pipe, and an inner chamber evacuation flow limiting control device (19) arranged on the inner chamber evacuation pipe and connected in parallel with the inner chamber evacuation valve (22); a vacuum pump (20) is arranged on the inner chamber evacuation pipe, and the vacuum pump (20) is connected in series with the inner chamber evacuation flow limiting control device (19) and the inner chamber evacuation valve (22).

8. A sterilization device according to claim 1, characterized in that: The inner chamber air intake assembly comprises an inner chamber return valve (23) and an air valve (25) arranged on the inner chamber air intake pipe, and a compressed air intake valve (28) is arranged on the inner chamber air intake pipe, and the compressed air intake valve (28) is connected in parallel with the air valve (25).

9. A sterilization device according to claim 8, characterized in that: A filter (24) is provided on the inner chamber air inlet pipe. The filter (24) is located between the inner chamber return valve (23) and the air valve (25) as well as the compressed air inlet valve (28). The inner chamber return valve (23) is connected in series with the air valve (25) and the compressed air inlet valve (28).

10. A sterilization control method, characterized in that: Applied to the sterilization device according to any one of claims 1 to 9, the control method comprises: In the preheating stage, the interlayer steam inlet control component and the interlayer steam exhaust and drainage component are controlled to rapidly heat the interlayer (11) and the inner chamber (10), and the interlayer steam inlet control component and the interlayer steam exhaust and drainage component are controlled to adjust the pressure in the interlayer (11) according to the temperature of the inner chamber (10). During this period, the inner chamber evacuation component and the inner chamber drainage component are controlled to keep the inner chamber (10) in a slightly negative pressure state; In the replacement phase, the inner chamber steam inlet buffer component and the inner chamber evacuation component are controlled to use steam to purge and replace the inner chamber (10); During the pulsation stage, the inner chamber evacuation component is controlled to evacuate the inner chamber (10) until the pressure in the inner chamber (10) reaches a minimum value of a specified pressure and is maintained for one minute, the inner chamber steam inlet buffer component is controlled to introduce steam into the inner chamber (10) so that the pressure in the inner chamber (10) reaches a maximum value of a specified pressure and is maintained for twenty minutes, and after repeating the above evacuation and steam inlet operation three times, the inner chamber evacuation component is controlled to evacuate the inner chamber (10) for the fourth time until the pressure in the inner chamber (10) reaches a minimum value of a specified pressure and is maintained for one minute; In the heating stage, the inner chamber steam inlet buffer component and the inner chamber hydrophobic component are controlled to heat the inner chamber (10), wherein the heating rate of the inner chamber (10) is 0.5-1°C / min, and the pressure change rate of the inner chamber (10) is 2 kPa / min, until the temperature and pressure in the inner chamber (10) reach the sterilization set value; During the sterilization stage, the inner chamber steam inlet buffer component and the inner chamber hydrophobic component are controlled so that the temperature and pressure in the inner chamber (10) are maintained within the sterilization specified range, and the sterilization lasts for sixty minutes; During the steam exhaust cooling stage, the inner chamber drain component is controlled to reduce the pressure of the inner chamber (10) to a specified pressure, during which the inner chamber steam inlet buffer component is controlled to periodically inlet steam into the inner chamber (10) to control the cooling rate of the inner chamber (10) to 0.5-1°C / min and the pressure change rate to 2kPa / min; In the air slight cooling stage, the inner chamber air inlet assembly is periodically controlled to introduce air into the inner chamber (10) when the pressure in the inner chamber (10) reaches a minimum pressure value so that the pressure in the inner chamber (10) reaches normal pressure and then stops, and this process is repeated until the temperature in the inner chamber (10) is lower than 90° C.; The sterilizer side door seal is removed to allow the inner chamber (19) to communicate with the outside world until the temperature of the inner chamber (10) is lower than 40°C.

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