WO2022007916A1 - Online testing method for integrity of sterilizing filter element - Google Patents

Online testing method for integrity of sterilizing filter element Download PDF

Info

Publication number
WO2022007916A1
WO2022007916A1 PCT/CN2021/105362 CN2021105362W WO2022007916A1 WO 2022007916 A1 WO2022007916 A1 WO 2022007916A1 CN 2021105362 W CN2021105362 W CN 2021105362W WO 2022007916 A1 WO2022007916 A1 WO 2022007916A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter element
upper chamber
integrity
liquid
sterilization
Prior art date
Application number
PCT/CN2021/105362
Other languages
French (fr)
Chinese (zh)
Inventor
陆健锋
田夫鹏
周卫林
Original Assignee
江苏新美星包装机械股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 江苏新美星包装机械股份有限公司 filed Critical 江苏新美星包装机械股份有限公司
Publication of WO2022007916A1 publication Critical patent/WO2022007916A1/en

Links

Images

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N7/00Analysing materials by measuring the pressure or volume of a gas or vapour
    • G01N7/10Analysing materials by measuring the pressure or volume of a gas or vapour by allowing diffusion of components through a porous wall and measuring a pressure or volume difference

Definitions

  • the invention relates to the field of liquid sterilization and filtration, in particular to an on-line detection method for the integrity of a sterilization filter element.
  • terminal sterilization filter elements are more and more widely used, and the integrity of the terminal sterilization filter element is directly related to product safety. During the use process, the integrity of the sterilization filter element may be damaged, resulting in sterilization efficiency. Drop, integrity testing is an important method to judge the integrity of the sterilization filter.
  • an off-line detection method is generally adopted.
  • the sterilizing filter element is taken out from the filter of the production line, placed in a special filter or holder for laboratory testing, and connected to an integrity detector for detection.
  • an integrity detector for detection or use the online manual connection test, move the integrity tester to the vicinity of the filter of the production line, connect the integrity tester to the filter, and then start the integrity tester for inspection. All of the above methods need to manually connect the integrity detector, the test efficiency is low, and the test cost is relatively high.
  • the purpose of the present invention is to provide an online detection method for the integrity of the sterilization filter element, which can realize the online detection of the integrity of the sterilization filter element, with high detection efficiency and low detection cost.
  • the technical scheme adopted in the present invention is:
  • An on-line detection method for the integrity of a sterilizing filter element comprising the following steps:
  • step (1) the first upper chamber communicating with the outside atmospheric pressure, after 1, the time T on a liquid filled chamber; then the upper chamber with the outside atmospheric pressure is disconnected, after time T 2, the filtering surface of the cartridge attached to a layer of water film.
  • T 1 is 3-5 minutes.
  • T 2 is 20-30 minutes.
  • the waiting time is 10-20 minutes.
  • step (1) the liquid flows into the lower chamber of the filter through the sterilizing filter element, and the liquid in the lower chamber is discharged.
  • the upper chamber is communicated with the external atmospheric pressure, and the sterile gas therein is exhausted.
  • step (1) the liquid flowing from the filter to the sterile water outlet is intercepted, and after step (3), when the integrity of the sterilizing filter element reaches the standard, the liquid output from the filter is allowed to into the sterile water outlet.
  • step (2) the low-pressure gas is passed into the upper chamber after being sterilized and filtered.
  • the present invention has the following advantages compared with the prior art: an on-line detection method for the integrity of a sterilizing filter element of the present invention, by directly feeding liquid into the upper chamber of the working filter in turn and low-pressure gas to conduct on-line detection of the integrity of the sterilization filter element, which not only improves the detection efficiency, but also reduces the detection cost.
  • FIG. 1 is a schematic structural diagram of the detection equipment used in the method of the present invention.
  • the filter 1 to be tested is equipped with a sterilization filter element 2, and the sterilization filter element 2 divides the interior of the filter 1 into an upper chamber and a lower chamber, the upper chamber is used for liquid feeding, and the lower chamber is used for liquid feeding. It is used for effusion.
  • the buffer water tank 3 is communicated with the upper chamber of the filter 1 through the first pipeline 4, the low-pressure gas inlet 5 is communicated with the upper chamber of the filter 1 through the second pipeline 6, and the sterile water outlet 7 is through the third pipeline. 8 communicates with the lower chamber of the filter 1 .
  • the first pipeline 4 is connected with the delivery pump 9 on the side of the buffer water tank 3, the first pneumatic valve 10 on the filter 1 side, and the first drain pipeline between the delivery pump 9 and the first pneumatic valve 10. 11.
  • a second pneumatic valve 12 is provided on the first liquid discharge pipeline 11 .
  • the buffer water tank 3 inputs liquid into the upper chamber of the filter 1 through the first pipeline 4, and the delivery pump is used to provide the delivery power of the liquid.
  • the second pipeline 6 is connected with a gas sterilization filter device 13 , a third pneumatic valve 14 and an electric proportional valve 15 arranged between the gas sterilization filter device 13 and the low-pressure gas inlet 5 , and a third gas sterilization filter device 13 . and the fourth pneumatic valve 16 between the filter 1.
  • the low-pressure gas inlet 5 inputs low-pressure sterile gas into the upper chamber of the filter 1 through the second pipeline 6, and the low-pressure sterile gas is obtained by filtering the low-pressure gas output from the low-pressure gas inlet through the gas sterilization filtering device 13.
  • the electrical proportional valve 15 is used to adjust the flow of low pressure gas.
  • the third pipeline 8 is connected with a second liquid discharge pipeline 17 located between the sterile water outlet 7 and the filter 1 , and a fifth pneumatic valve 18 is provided on the second liquid discharge 17 pipeline.
  • a fifth pneumatic valve 18 is provided on the second liquid discharge 17 pipeline.
  • close the fifth pneumatic valve 18, and the liquid in the lower chamber of the filter 1 enters the sterile water outlet 7 through the third pipeline 8 for use; in the detection state, open the fifth pneumatic valve 18.
  • the liquid in the lower chamber of the filter 1 is discharged through the second liquid discharge pipeline 17 .
  • the upper chamber of the filter 1 is connected with an exhaust pipeline 19 and a pressure sensor 20 , and a sixth pneumatic valve 21 is provided on the exhaust pipeline 19 .
  • a sixth pneumatic valve 21 is provided on the exhaust pipeline 19 .
  • the filter 1 is used to filter the liquid in the buffer water tank 3 and deliver it to the sterile water outlet 7;
  • the communication state between the low-pressure gas inlet 5 and the filter 1 is restored, and there is no need to additionally access other detection equipment, the detection efficiency is high, and the detection cost is low.
  • An on-line detection method for the integrity of a sterilization filter element is realized by the above-mentioned detection equipment, and the integrity is judged according to the diffusion speed of the gas on the surface of the wet sterilization filter element 2, comprising the following steps:
  • T 1 is 3-5 minutes, at this time, the liquid can completely fill the upper chamber;
  • T 2 is 20-30 minutes, at this time, a layer of water film can be attached to the surface of the sterilizing filter element 2;
  • the sterilization filter element 2 can be replaced.
  • the above-mentioned detection equipment further includes an editable logic controller 22 and a data acquisition and calculation system 23, wherein the editable logic controller 22 is used for the control of pumps and valves in the detection process; the data acquisition and calculation system 23 It is used for data acquisition and calculation in the detection process, and to judge the detection result. Before the detection starts, input the set value P 0 into the data acquisition and calculation system 23 .

Landscapes

  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)

Abstract

Disclosed in the present invention is an online testing method for integrity of a sterilizing filter element. The method comprises the following steps: (1) introducing liquid into an upper chamber of a filter that is provided with a sterilizing filter element therein until a water film is adhered to the surface of the sterilizing filter element, and discharging the excess liquid in the upper chamber; (2) introducing sterile gas into the upper chamber until the air pressure in the upper chamber is stabilized at P 1; (3) after a period of time, measuring to obtain the air pressure value P 2 in the upper chamber, and comparing the difference ΔP between P1 and P 2 and a set value P 0: if ΔP < P 0, the integrity of the sterilizing filter element meets the standard; if ΔP ≧ P 0, the integrity of the sterilizing filter element does not meet the standard. The online testing method for integrity of a sterilizing filter element of the present invention can realize the online testing for integrity of a sterilizing filter element, and the test is highly efficient and low-cost.

Description

一种除菌滤芯的完整性在线检测方法A kind of online detection method for the integrity of sterilization filter element 技术领域technical field
本发明涉及液体除菌过滤领域,特别涉及一种除菌滤芯的完整性在线检测方法。The invention relates to the field of liquid sterilization and filtration, in particular to an on-line detection method for the integrity of a sterilization filter element.
背景技术Background technique
无论在饮料行业还是在医疗行业,终端除菌滤芯使用越来越广泛,终端除菌滤芯的完整性直接关系产品安全,在使用过程中,除菌滤芯的完整性可能受到破坏,导致除菌效率下降,完整性检测是判断除菌滤芯完整性的重要方法。Whether in the beverage industry or in the medical industry, terminal sterilization filter elements are more and more widely used, and the integrity of the terminal sterilization filter element is directly related to product safety. During the use process, the integrity of the sterilization filter element may be damaged, resulting in sterilization efficiency. Drop, integrity testing is an important method to judge the integrity of the sterilization filter.
现有技术中,一般是采用离线式检测方法,从生产线过滤器中取出除菌滤芯,放置于实验室测试专用过滤器或夹持器中,连接完整性检测仪进行检测。或者采用在线式手动连接检测,将完整性检测仪搬运到生产线过滤器附近,将完整性检测仪与过滤器连接,然后启动完整性检测仪进行检查。上述方法均需要手动连接完整性检测仪,测试效率较低,测试成本相对较高。In the prior art, an off-line detection method is generally adopted. The sterilizing filter element is taken out from the filter of the production line, placed in a special filter or holder for laboratory testing, and connected to an integrity detector for detection. Or use the online manual connection test, move the integrity tester to the vicinity of the filter of the production line, connect the integrity tester to the filter, and then start the integrity tester for inspection. All of the above methods need to manually connect the integrity detector, the test efficiency is low, and the test cost is relatively high.
发明内容SUMMARY OF THE INVENTION
本发明的目的是提供一种除菌滤芯的完整性在线检测方法,能够实现对除菌滤芯的完整性在线检测,检测效率较高,检测成本较低。The purpose of the present invention is to provide an online detection method for the integrity of the sterilization filter element, which can realize the online detection of the integrity of the sterilization filter element, with high detection efficiency and low detection cost.
为达到上述目的,本发明采用的技术方案是:To achieve the above object, the technical scheme adopted in the present invention is:
一种除菌滤芯的完整性在线检测方法,包括以下步骤:An on-line detection method for the integrity of a sterilizing filter element, comprising the following steps:
(1)向内部装有除菌滤芯的过滤器的上腔室中通入液体,直至所述除菌滤芯的表面附着一层水膜后,停止通入液体,并将所述上腔室中多余的液体排出;(1) Pour liquid into the upper chamber of the filter with the sterilization filter element inside, until a layer of water film is attached to the surface of the sterilization filter element, stop the introduction of the liquid, and put the upper chamber into the upper chamber. Excess fluid drains;
(2)向所述上腔室中通入无菌气,待所述上腔室中的气压稳定在P 1后,停止通入无菌气; (2) introduce sterile gas into the upper chamber, stop the sterile gas from being introduced after the air pressure in the upper chamber is stabilized at P 1;
(3)等待一段时间后,测量得到所述上腔室中的气压值为P 2,将P 1和P 2的差值△P与设定值P 0进行比较: (3) After waiting for a period of time, the air pressure in the upper chamber is measured to be P 2 , and the difference ΔP between P 1 and P 2 is compared with the set value P 0 :
当△P<P 0时,所述除菌滤芯的完整性达标; When ΔP<P 0 , the integrity of the sterilization filter element reaches the standard;
当△P≥P 0时,所述除菌滤芯的完整性不达标。 When ΔP≥P 0 , the integrity of the sterilizing filter element is not up to standard.
优选地,在步骤(1)中,先将所述上腔室与外界大气压连通,经过时间T 1后,液体布满所述上腔室;再将所述上腔室与外界大气压断开,经过时间T 2后,所述除菌滤芯的表面附着一层所述水膜。 Preferably, in step (1), the first upper chamber communicating with the outside atmospheric pressure, after 1, the time T on a liquid filled chamber; then the upper chamber with the outside atmospheric pressure is disconnected, after time T 2, the filtering surface of the cartridge attached to a layer of water film.
更优选地,在步骤(1)中,T 1为3-5分钟。 More preferably, in step (1), T 1 is 3-5 minutes.
更优选地,在步骤(1)中,T 2为20-30分钟。 More preferably, in step (1), T 2 is 20-30 minutes.
优选地,在步骤(3)中,等待的时间为10-20分钟。Preferably, in step (3), the waiting time is 10-20 minutes.
优选地,在步骤(1)中,液体通过所述除菌滤芯流入所述过滤器的下腔室中,排出所述下腔室中的液体。Preferably, in step (1), the liquid flows into the lower chamber of the filter through the sterilizing filter element, and the liquid in the lower chamber is discharged.
优选地,在步骤(3)之后,将所述上腔室与外界大气压连通,排出其中的无菌气。Preferably, after step (3), the upper chamber is communicated with the external atmospheric pressure, and the sterile gas therein is exhausted.
优选地,在步骤(1)中,截留所述过滤器流向无菌水出口的液体,在步骤(3)之后,当所述除菌滤芯的完整性达标时,使所述过滤器输出的液体进入所述无菌水出口。Preferably, in step (1), the liquid flowing from the filter to the sterile water outlet is intercepted, and after step (3), when the integrity of the sterilizing filter element reaches the standard, the liquid output from the filter is allowed to into the sterile water outlet.
优选地,在步骤(2)中,将低压气经过除菌过滤后通入所述上腔室中。Preferably, in step (2), the low-pressure gas is passed into the upper chamber after being sterilized and filtered.
由于上述技术方案的运用,本发明与现有技术相比具有下列优点:本发明一种除菌滤芯的完整性在线检测方法,通过直接向工作中的过滤器的上腔室中依次通入液体和低压气,来对除菌滤芯的完整性进行在线检测,不仅提高了检测效率,同时降低了检测成本。Due to the application of the above-mentioned technical solutions, the present invention has the following advantages compared with the prior art: an on-line detection method for the integrity of a sterilizing filter element of the present invention, by directly feeding liquid into the upper chamber of the working filter in turn and low-pressure gas to conduct on-line detection of the integrity of the sterilization filter element, which not only improves the detection efficiency, but also reduces the detection cost.
附图说明Description of drawings
附图1为本发明方法采用的检测设备结构示意图。FIG. 1 is a schematic structural diagram of the detection equipment used in the method of the present invention.
其中:1、过滤器;2、除菌滤芯;3、缓存水罐;4、第一管路; 5、低压气进口;6、第二管路;7、无菌水出口;8、第三管路;9、输送泵;10、第一气动阀;11、第一排液管路;12、第二气动阀;13、气体除菌过滤装置;14、第三气动阀;15、电气比例阀;16、第四气动阀;17、第二排液管路;18、第五气动阀;19、排气管路;20、压力传感器;21、第六气动阀;22、可编辑逻辑控制器;23、数据采集及计算系统。Among them: 1. Filter; 2. Sterilizing filter element; 3. Buffer water tank; 4. First pipeline; 5. Low-pressure gas inlet; 6. Second pipeline; 7. Sterile water outlet; 8. Third Pipeline; 9. Delivery pump; 10. The first pneumatic valve; 11. The first liquid discharge pipeline; 12. The second pneumatic valve; 13. The gas sterilization filter device; 14. The third pneumatic valve; Valve; 16, the fourth pneumatic valve; 17, the second liquid discharge pipeline; 18, the fifth pneumatic valve; 19, the exhaust pipeline; 20, the pressure sensor; 21, the sixth pneumatic valve; 22, the programmable logic control 23. Data acquisition and computing system.
具体实施方式detailed description
下面结合附图来对本发明的技术方案作进一步的阐述。The technical solutions of the present invention will be further elaborated below in conjunction with the accompanying drawings.
参见图1所示,待检测的过滤器1中装有除菌滤芯2,除菌滤芯2将过滤器1内部分隔成上腔室和下腔室,上腔室用于进液,下腔室则用于出液。缓存水罐3通过第一管路4与过滤器1的上腔室连通,低压气进口5通过第二管路6与过滤器1的上腔室连通,无菌水出口7通过第三管路8与过滤器1的下腔室连通。Referring to Fig. 1, the filter 1 to be tested is equipped with a sterilization filter element 2, and the sterilization filter element 2 divides the interior of the filter 1 into an upper chamber and a lower chamber, the upper chamber is used for liquid feeding, and the lower chamber is used for liquid feeding. It is used for effusion. The buffer water tank 3 is communicated with the upper chamber of the filter 1 through the first pipeline 4, the low-pressure gas inlet 5 is communicated with the upper chamber of the filter 1 through the second pipeline 6, and the sterile water outlet 7 is through the third pipeline. 8 communicates with the lower chamber of the filter 1 .
第一管路4上连接有位于缓存水罐3侧的输送泵9、位于过滤器1侧的第一气动阀10、位于输送泵9和第一气动阀10之间的第一排液管路11,第一排液管路11上设有第二气动阀12。缓存水罐3通过第一管路4向过滤器1的上腔室中输入液体,输送泵用于提供液体的输送动力。The first pipeline 4 is connected with the delivery pump 9 on the side of the buffer water tank 3, the first pneumatic valve 10 on the filter 1 side, and the first drain pipeline between the delivery pump 9 and the first pneumatic valve 10. 11. A second pneumatic valve 12 is provided on the first liquid discharge pipeline 11 . The buffer water tank 3 inputs liquid into the upper chamber of the filter 1 through the first pipeline 4, and the delivery pump is used to provide the delivery power of the liquid.
第二管路6上连接有气体除菌过滤装置13、设于气体除菌过滤装置13和低压气进口5之间的第三气动阀14和电气比例阀15、设于气体除菌过滤装置13和过滤器1之间的第四气动阀16。低压气进口5通过第二管路6向过滤器1的上腔室中输入低压无菌气,低压无菌气由低压气进口输出的低压气经过气体除菌过滤装置13过滤后得到。电气比例阀15用于调节低压气的流量。The second pipeline 6 is connected with a gas sterilization filter device 13 , a third pneumatic valve 14 and an electric proportional valve 15 arranged between the gas sterilization filter device 13 and the low-pressure gas inlet 5 , and a third gas sterilization filter device 13 . and the fourth pneumatic valve 16 between the filter 1. The low-pressure gas inlet 5 inputs low-pressure sterile gas into the upper chamber of the filter 1 through the second pipeline 6, and the low-pressure sterile gas is obtained by filtering the low-pressure gas output from the low-pressure gas inlet through the gas sterilization filtering device 13. The electrical proportional valve 15 is used to adjust the flow of low pressure gas.
第三管路8上连接有位于无菌水出口7和过滤器1之间的第二排液管路17,第二排液17管路上设有第五气动阀18。在非检测状态时,关闭第五气动阀18,过滤器1下腔室中的液体通过第三管路8进入无菌水出口7中,以供使用;在检测状态时,打开第五气动阀18, 过滤器1下腔室中的液体通过第二排液管路17排出。The third pipeline 8 is connected with a second liquid discharge pipeline 17 located between the sterile water outlet 7 and the filter 1 , and a fifth pneumatic valve 18 is provided on the second liquid discharge 17 pipeline. In the non-detection state, close the fifth pneumatic valve 18, and the liquid in the lower chamber of the filter 1 enters the sterile water outlet 7 through the third pipeline 8 for use; in the detection state, open the fifth pneumatic valve 18. The liquid in the lower chamber of the filter 1 is discharged through the second liquid discharge pipeline 17 .
过滤器1的上腔室连接有排气管路19和压力传感器20,排气管路19上设有第六气动阀21。通过第二管路6向上腔室中通入无菌气时,根据压力传感器20的数值调节电气比例阀15,使上腔室中的压力缓慢上升,以避免除菌滤芯2表面的水膜由于升压过快而破裂。The upper chamber of the filter 1 is connected with an exhaust pipeline 19 and a pressure sensor 20 , and a sixth pneumatic valve 21 is provided on the exhaust pipeline 19 . When sterile gas is introduced into the upper chamber through the second pipeline 6, the electrical proportional valve 15 is adjusted according to the value of the pressure sensor 20, so that the pressure in the upper chamber rises slowly, so as to avoid the water film on the surface of the sterilization filter element 2 due to Boost too fast and burst.
正常工作时,过滤器1用于过滤缓存水罐3中的液体,并输送至无菌水出口7中;且断开低压气进口5与过滤器1的连通状态。检测时,恢复低压气进口5与过滤器1的连通状态,无需额外接入其他检测设备,检测效率较高,检测成本较低。During normal operation, the filter 1 is used to filter the liquid in the buffer water tank 3 and deliver it to the sterile water outlet 7; During detection, the communication state between the low-pressure gas inlet 5 and the filter 1 is restored, and there is no need to additionally access other detection equipment, the detection efficiency is high, and the detection cost is low.
一种除菌滤芯的完整性在线检测方法,通过上述检测设备实现,具体根据气体在已润湿的除菌滤芯2表面的扩散速度来判断其完整性,包括以下步骤:An on-line detection method for the integrity of a sterilization filter element is realized by the above-mentioned detection equipment, and the integrity is judged according to the diffusion speed of the gas on the surface of the wet sterilization filter element 2, comprising the following steps:
(1)打开第五气动阀18,使过滤器1的下腔室与第二排液管路17连通,以截留通往无菌水出口7的液体。(1) Open the fifth pneumatic valve 18 to make the lower chamber of the filter 1 communicate with the second drainage pipeline 17 , so as to intercept the liquid leading to the sterile water outlet 7 .
(2)打开输送泵9和第一气动阀10,关闭第二气动阀12,通过缓存水罐3向过滤器1的上腔室中通入液体;同时先打开第六气动阀21,将上腔室与外界大气压连通,使通入的液体能够将上腔室中的气体通过排气管路19向外完全排出,以避免对除菌滤芯2的润湿不完全,经过时间T 1后,液体布满上腔室;再关闭第六气动阀21,将上腔室与外界大气压断开,经过时间T 2后,除菌滤芯2的表面附着一层水膜;关闭输送泵9,打开第二气动阀12,将上腔室中多余的液体从第一排液管路11中排出; (2) Open the delivery pump 9 and the first pneumatic valve 10, close the second pneumatic valve 12, and pass liquid into the upper chamber of the filter 1 through the buffer water tank 3; atmospheric pressure chamber in communication with the outside, so that the liquid can be introduced into the upper chamber via the gas exhaust line 19 is completely discharged outward, to avoid wetting sterilization filter 2 is not complete, the elapsed time T 1, the liquid filled chamber; then close the pneumatic valve 21 the sixth, the upper chamber with the outside atmospheric pressure is disconnected after 2, surface sterilized water film cartridge 2 is attached to a layer of time T; closed delivery pump 9, a first open Two pneumatic valves 12, to discharge the excess liquid in the upper chamber from the first liquid discharge pipeline 11;
在本实施例中,T 1为3-5分钟,此时液体能够完全布满上腔室;T 2则为20-30分钟,此时除菌滤芯2表面能够附着一层水膜; In this embodiment, T 1 is 3-5 minutes, at this time, the liquid can completely fill the upper chamber; T 2 is 20-30 minutes, at this time, a layer of water film can be attached to the surface of the sterilizing filter element 2;
在润湿过程中,由于液体通过除菌滤芯2流入过滤器1的下腔室中,下腔室中的液体则排入第二排液管路17中。During the wetting process, since the liquid flows into the lower chamber of the filter 1 through the sterilizing filter element 2 , the liquid in the lower chamber is discharged into the second liquid discharge pipeline 17 .
(3)打开第三气动阀14和第四气动阀16,向上腔室中通入低 压无菌气(由低压气经过气体除菌过滤装置13后得到,能够避免污染除菌滤芯2),根据压力传感器20的数值调节电气比例阀15,使上腔室中的压力缓慢上升,待上腔室中的气压稳定在P 1(通过压力传感器20测得)后,关闭第三气动阀14和第四气动阀16,停止通入低压无菌气。 (3) Open the third pneumatic valve 14 and the fourth pneumatic valve 16, and introduce low-pressure sterile gas into the upper chamber (obtained by the low-pressure gas after passing through the gas sterilizing filter device 13, which can avoid contamination of the sterilizing filter element 2), according to Numerical electrical pressure sensor 20 is proportional regulating valve 15, the pressure in the upper chamber rises slowly until the pressure in the chamber stabilized at P 1 (measured by the pressure sensor 20), closing the third pneumatic valve 14 and Four pneumatic valves 16, stop the introduction of low-pressure sterile gas.
(4)在P 1压力下,无菌气在除菌滤芯2表面的水膜上自由扩散,等待10-20分钟后,通过压力传感器20测量得到上腔室中的气压值为P 2,将P 1和P 2的差值△P与设定值P 0进行比较: (4) Under the pressure of P 1 , the sterile gas diffuses freely on the water film on the surface of the sterilizing filter element 2. After waiting for 10-20 minutes, the pressure value in the upper chamber is measured by the pressure sensor 20 to obtain the value of P 2 . The difference ΔP between P 1 and P 2 is compared with the set value P 0 :
当△P<P 0时,说明上腔室中气压下降较慢,除菌滤芯2的完整性达标; When △ P <P 0, the instructions on the chamber pressure decreases slowly, the integrity of the standard sterilization filter 2;
当△P≥P 0时,说明上腔室中气压下降较快,除菌滤芯2的完整性不达标。 When △P≥P 0 , it means that the air pressure in the upper chamber drops rapidly, and the integrity of the sterilization filter element 2 is not up to the standard.
(5)测试完成后,打开第六气动阀21,将上腔室与外界大气压连通,排出其中的无菌气,接着关闭第六气动阀21。(5) After the test is completed, open the sixth pneumatic valve 21, connect the upper chamber to the outside atmospheric pressure, discharge the sterile gas therein, and then close the sixth pneumatic valve 21.
(6)当除菌滤芯2的完整性达标时,关闭第五气动阀18,使过滤器1下腔室中输出的液体能够通过无菌水出口7输出,保持正常工作状态;(6) when the integrity of the sterilizing filter element 2 is up to standard, the fifth pneumatic valve 18 is closed, so that the liquid output in the lower chamber of the filter 1 can be output through the sterile water outlet 7 to maintain a normal working state;
当除菌滤芯2的完整性不达标时,更换除菌滤芯2即可。When the integrity of the sterilization filter element 2 is not up to standard, the sterilization filter element 2 can be replaced.
参见图1所示,上述检测设备还包括可编辑逻辑控制器22和数据采集及计算系统23,其中,可编辑逻辑控制器22用于检测过程中泵和阀的控制;数据采集及计算系统23用于检测过程中数据采集及计算,并判断检测结果,检测开始前,向数据采集及计算系统23中输入设定值P 0Referring to Fig. 1 , the above-mentioned detection equipment further includes an editable logic controller 22 and a data acquisition and calculation system 23, wherein the editable logic controller 22 is used for the control of pumps and valves in the detection process; the data acquisition and calculation system 23 It is used for data acquisition and calculation in the detection process, and to judge the detection result. Before the detection starts, input the set value P 0 into the data acquisition and calculation system 23 .
上述实施例只为说明本发明的技术构思及特点,其目的在于让熟悉此项技术的人士能够了解本发明的内容并加以实施,并不能以此限制本发明的保护范围,凡根据本发明精神实质所作的等效变化或修饰,都应涵盖在本发明的保护范围内。The above-mentioned embodiments are only to illustrate the technical concept and characteristics of the present invention, and their purpose is to enable those who are familiar with the art to understand the content of the present invention and implement it, and cannot limit the scope of protection of the present invention with this, all according to the spirit of the present invention Substantially equivalent changes or modifications should be included within the protection scope of the present invention.

Claims (10)

  1. 一种除菌滤芯的完整性在线检测方法,其特征在于:包括以下步骤:An on-line detection method for the integrity of a sterilizing filter element, comprising the following steps:
    (1)向内部装有除菌滤芯的过滤器的上腔室中通入液体,直至所述除菌滤芯的表面附着一层水膜后,停止通入液体,并将所述上腔室中多余的液体排出;(1) Pour liquid into the upper chamber of the filter with the sterilization filter element inside, until a layer of water film is attached to the surface of the sterilization filter element, stop the introduction of the liquid, and put the upper chamber into the upper chamber. Excess fluid drains;
    (2)向所述上腔室中通入无菌气,待所述上腔室中的气压稳定在P 1后,停止通入无菌气; (2) introduce sterile gas into the upper chamber, stop the sterile gas from being introduced after the air pressure in the upper chamber is stabilized at P 1;
    (3)等待一段时间后,测量得到所述上腔室中的气压值为P 2,将P 1和P 2的差值△P与设定值P 0进行比较: (3) After waiting for a period of time, the air pressure in the upper chamber is measured to be P 2 , and the difference ΔP between P 1 and P 2 is compared with the set value P 0 :
    当△P<P 0时,所述除菌滤芯的完整性达标; When ΔP<P 0 , the integrity of the sterilization filter element reaches the standard;
    当△P≥P 0时,所述除菌滤芯的完整性不达标; When ΔP≥P 0 , the integrity of the sterilization filter element is not up to standard;
    在步骤(1)中,先将所述上腔室与外界大气压连通,经过时间T 1后,液体布满所述上腔室;再将所述上腔室与外界大气压断开,经过时间T 2后,所述除菌滤芯的表面附着一层所述水膜;其中,T 1为3-5分钟,T 2为20-30分钟; In step (1), the first upper chamber communicating with the outside atmospheric pressure, after 1, the time T on a liquid filled chamber; then the upper chamber with the outside atmospheric pressure is disconnected, the elapsed time T After 2 , a layer of the water film is attached to the surface of the sterilization filter element; wherein, T 1 is 3-5 minutes, and T 2 is 20-30 minutes;
    在步骤(1)中,液体通过所述除菌滤芯流入所述过滤器的下腔室中,排出所述下腔室中的液体;In step (1), the liquid flows into the lower chamber of the filter through the sterilization filter element, and the liquid in the lower chamber is discharged;
    在步骤(2)中,将低压气经过除菌过滤后通入所述上腔室中;In step (2), the low-pressure gas is passed into the upper chamber after sterile filtration;
    在步骤(3)中,等待的时间为10-20分钟;In step (3), the waiting time is 10-20 minutes;
    在步骤(3)之后,将所述上腔室与外界大气压连通,排出其中的无菌气;After step (3), the upper chamber is communicated with the outside atmospheric pressure, and the sterile gas therein is discharged;
    在步骤(1)中,截留所述过滤器流向无菌水出口的液体,在步骤(3)之后,当所述除菌滤芯的完整性达标时,使所述过滤器输出的液体进入所述无菌水出口。In step (1), the liquid flowing from the filter to the sterile water outlet is intercepted, and after step (3), when the integrity of the sterilizing filter element reaches the standard, the liquid output by the filter is allowed to enter the Sterile water outlet.
  2. 一种除菌滤芯的完整性在线检测方法,其特征在于:包括以下步骤:An on-line detection method for the integrity of a sterilizing filter element, comprising the following steps:
    (1)向内部装有除菌滤芯的过滤器的上腔室中通入液体,直至所述除菌滤芯的表面附着一层水膜后,停止通入液体,并将所述上腔室中多余的液体排出;(1) Pour liquid into the upper chamber of the filter with the sterilization filter element inside, until a layer of water film is attached to the surface of the sterilization filter element, stop the introduction of the liquid, and put the upper chamber into the upper chamber. Excess fluid drains;
    (2)向所述上腔室中通入无菌气,待所述上腔室中的气压稳定在P 1后,停止通入无菌气; (2) introduce sterile gas into the upper chamber, stop the sterile gas from being introduced after the air pressure in the upper chamber is stabilized at P 1;
    (3)等待一段时间后,测量得到所述上腔室中的气压值为P 2,将P 1和P 2的差值△P与设定值P 0进行比较: (3) After waiting for a period of time, the air pressure in the upper chamber is measured to be P 2 , and the difference ΔP between P 1 and P 2 is compared with the set value P 0 :
    当△P<P 0时,所述除菌滤芯的完整性达标; When ΔP<P 0 , the integrity of the sterilization filter element reaches the standard;
    当△P≥P 0时,所述除菌滤芯的完整性不达标。 When ΔP≥P 0 , the integrity of the sterilizing filter element is not up to standard.
  3. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(1)中,先将所述上腔室与外界大气压连通,经过时间T 1后,液体布满所述上腔室;再将所述上腔室与外界大气压断开,经过时间T 2后,所述除菌滤芯的表面附着一层所述水膜。 The method for detecting the integrity of the line sterilization filter element according to claim 2, wherein: in step (1), the first upper chamber communicating with the outside atmospheric pressure, the elapsed time T 1, the liquid fabric the upper chamber is full; then the upper chamber with the outside atmospheric pressure is disconnected after the time T 2, the sterilization filter attached to the surface layer of the water film.
  4. 根据权利要求3所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(1)中,T 1为3-5分钟。 The on-line detection method for the integrity of a sterilizing filter element according to claim 3, characterized in that: in step (1), T 1 is 3-5 minutes.
  5. 根据权利要求3所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(1)中,T 2为20-30分钟。 The on-line detection method for the integrity of a sterilizing filter element according to claim 3, characterized in that: in step (1), T 2 is 20-30 minutes.
  6. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(3)中,等待的时间为10-20分钟。The on-line detection method for the integrity of a sterilizing filter element according to claim 2, characterized in that: in step (3), the waiting time is 10-20 minutes.
  7. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(1)中,液体通过所述除菌滤芯流入所述过滤器的下腔室中,排出所述下腔室中的液体。The on-line detection method for the integrity of a sterilizing filter element according to claim 2, characterized in that: in step (1), the liquid flows into the lower chamber of the filter through the sterilizing filter element, and the liquid is discharged into the lower chamber of the filter. liquid in the lower chamber.
  8. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(3)之后,将所述上腔室与外界大气压连通,排出其中的无菌气。The on-line detection method for the integrity of a sterilizing filter element according to claim 2, characterized in that: after step (3), the upper chamber is communicated with the outside atmospheric pressure, and the sterile gas therein is discharged.
  9. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(1)中,截留所述过滤器流向无菌水出口的液体,在步骤(3)之后,当所述除菌滤芯的完整性达标时,使所述过 滤器输出的液体进入所述无菌水出口。The on-line detection method for the integrity of a sterilizing filter element according to claim 2, characterized in that: in step (1), the liquid flowing to the sterile water outlet of the filter is intercepted, and after step (3), When the integrity of the sterilizing filter element reaches the standard, the liquid output from the filter is allowed to enter the sterile water outlet.
  10. 根据权利要求2所述的一种除菌滤芯的完整性在线检测方法,其特征在于:在步骤(2)中,将低压气经过除菌过滤后通入所述上腔室中。The on-line detection method for the integrity of a sterilization filter element according to claim 2, characterized in that: in step (2), the low-pressure gas is passed into the upper chamber after sterilization and filtration.
PCT/CN2021/105362 2020-07-09 2021-07-09 Online testing method for integrity of sterilizing filter element WO2022007916A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010654675.3A CN111896422A (en) 2020-07-09 2020-07-09 Online integrity detection method for sterilizing filter element
CN202010654675.3 2020-07-09

Publications (1)

Publication Number Publication Date
WO2022007916A1 true WO2022007916A1 (en) 2022-01-13

Family

ID=73193030

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/105362 WO2022007916A1 (en) 2020-07-09 2021-07-09 Online testing method for integrity of sterilizing filter element

Country Status (2)

Country Link
CN (1) CN111896422A (en)
WO (1) WO2022007916A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114235666A (en) * 2022-02-25 2022-03-25 徐州百艾电子科技有限公司 System and method for detecting performance of filter element of purifier

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111896422A (en) * 2020-07-09 2020-11-06 江苏新美星包装机械股份有限公司 Online integrity detection method for sterilizing filter element
CN115868570A (en) * 2022-10-18 2023-03-31 黑龙江飞鹤乳业有限公司 Lactoferrin treatment method and device

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008246482A (en) * 2008-06-04 2008-10-16 L'air Liquide-Sa Pour L'etude & L'exploitation Des Procedes Georges Claude Filter module for cryostatic temperature liquid and its integrity test method
CN203965099U (en) * 2014-07-07 2014-11-26 海南通用康力制药有限公司 Integral filter integrity detection instrument
CN107289984A (en) * 2016-04-13 2017-10-24 上海东全生物科技有限公司 One kind is used for sterilizing cabinet filter integrity online verification system and its detection method
CN209416624U (en) * 2019-01-18 2019-09-20 楚天科技股份有限公司 A kind of integrity detection system and freeze dryer of freeze dryer filter
CN210322727U (en) * 2019-08-08 2020-04-14 上海青赛生物科技有限公司 Filter core integrality detecting system
CN111896422A (en) * 2020-07-09 2020-11-06 江苏新美星包装机械股份有限公司 Online integrity detection method for sterilizing filter element

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4209519C3 (en) * 1992-03-24 2000-06-15 Pall Corp Method and device for quickly testing the integrity of filter elements
CN201732014U (en) * 2010-08-20 2011-02-02 伊马莱富(北京)制药系统有限公司 Online integrity test system of sterile filter
CN104949808B (en) * 2014-03-24 2017-10-13 北京北方华创微电子装备有限公司 A kind of leak rate detection method and system
CN107362692A (en) * 2017-08-21 2017-11-21 叶军 A kind of aseptic filtration filter core integrality detection method
CN109395588A (en) * 2018-11-13 2019-03-01 重庆本善医疗设备有限公司 Peritoneal dialysis liquid online generating means dialysate filter device integrity testing system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008246482A (en) * 2008-06-04 2008-10-16 L'air Liquide-Sa Pour L'etude & L'exploitation Des Procedes Georges Claude Filter module for cryostatic temperature liquid and its integrity test method
CN203965099U (en) * 2014-07-07 2014-11-26 海南通用康力制药有限公司 Integral filter integrity detection instrument
CN107289984A (en) * 2016-04-13 2017-10-24 上海东全生物科技有限公司 One kind is used for sterilizing cabinet filter integrity online verification system and its detection method
CN209416624U (en) * 2019-01-18 2019-09-20 楚天科技股份有限公司 A kind of integrity detection system and freeze dryer of freeze dryer filter
CN210322727U (en) * 2019-08-08 2020-04-14 上海青赛生物科技有限公司 Filter core integrality detecting system
CN111896422A (en) * 2020-07-09 2020-11-06 江苏新美星包装机械股份有限公司 Online integrity detection method for sterilizing filter element

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114235666A (en) * 2022-02-25 2022-03-25 徐州百艾电子科技有限公司 System and method for detecting performance of filter element of purifier

Also Published As

Publication number Publication date
CN111896422A (en) 2020-11-06

Similar Documents

Publication Publication Date Title
WO2022007916A1 (en) Online testing method for integrity of sterilizing filter element
RU2113706C1 (en) Method checking integrity of filtration element and filtration unit
JP4566262B2 (en) Apparatus and method for inspecting filters
JP4221156B2 (en) Method and apparatus for detecting the presence of a leak in a system in which fluid is flowing
JP2001190938A (en) Method of detecting breakage of water treating membrane
US11846566B2 (en) System and method for detecting a possible loss of integrity of a flexible bag for biopharmaceutical product
CN207816538U (en) A kind of air-distributor vacuum actuator leakage test device
CN105758599A (en) Automatic leakage detecting device of water heater or wall-hung stove and operating method thereof
CN114062219A (en) Breathable film performance test integrated device and operation method thereof
CN207301061U (en) Glue-making tank-reactor glue acidity and viscosity on-line monitoring system
CN114509395B (en) Online monitoring device and method for gas in transformer oil
CN206996308U (en) Dry filter membrane cartridge test equipment
JPH0523551A (en) Perfection testing apparatus
CN114235660B (en) Filter element integrality and air permeability performance testing device
CN211697762U (en) Oil field production water on-line monitoring device
KR102388967B1 (en) aircraft hydraulic pump test device
JP2003210949A (en) Method and apparatus for detecting breakage of membrane of membrane filtration apparatus
CN210114983U (en) Testing arrangement of dull and stereotyped membrane
CN206960292U (en) Concrete soak test device
CN1255683C (en) Automatic on line detecting device of hollow fiber separating membrane
JP2005315784A (en) Leak detecting method, and detector therefor
CN115773776B (en) Blocking test method for negative pressure vacuum pipeline
JP4267197B2 (en) Method for testing sterilization filter of hemodialysis machine
CN206906899U (en) A kind of CODcr water routes quantitative system
JPH1137889A (en) Device for testing leakage and flow rate

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21837704

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21837704

Country of ref document: EP

Kind code of ref document: A1