CN115290307A - Sterilizing filter integrity testing device - Google Patents

Abstract

The invention relates to a sterilizing filter integrity testing device, which comprises: the integrity tester is used for communicating compressed air; a first filter in communication with the integrity tester via a conduit, the first filter for filtering a gas; a second filter in communication with the first filter through a conduit, the second filter for filtering a liquid; the inlet of the buffer tank is communicated with the second filter through a pipeline, the outlet of the buffer tank is communicated with a sewage discharge pipeline through a pipeline, and the two pipelines communicated with the component are provided with the valves. This degerming filter integrality testing arrangement is favorable to avoiding the risk of secondary pollution of off-line test and the risk that the filter core damaged in the station transfer process, is favorable to improving the reliability of detection efficiency and experimental result.

Description

Sterilizing filter integrity testing device

Technical Field

The invention relates to the technical field of a sterile preparation liquid preparation system, in particular to a sterilizing filter integrity testing device.

Background

With the development of the medicine production technology, an aseptic preparation liquid preparation system appears, in the aseptic preparation liquid preparation system, a sterilizing filter is usually the last guarantee whether the aseptic indexes of medicines reach the standard, whether a filter element of a terminal sterilizing filter is complete and lossless is also an important reference for judging whether the batch of medicines are qualified, so that how to detect the integrity of the filter element by the sterilizing filter is an extremely important one-step detection process, and the existing medicine production quality management practice (GMP) requires that the integrity of the sterilizing filter needs to be tested after the sterilizing filter is used.

In the conventional technology, the existing integrity detection modes in the industry at present are divided into offline integrity detection (the sterilization filter is removed and transferred to a designated station for integrity detection) and sterilization filter in-situ detection (the sterilization filter does not need to be transferred to a position and the integrity detection is carried out at a filtering station), however, the existing offline integrity detection has the defects that the filter element is inconvenient to wet, secondary pollution risks are easily caused before and after detection, and the in-situ detection also has the conditions that the process flow is not complete enough during wetting and detection, the risk control in the detection process is not strict, and the like.

Disclosure of Invention

Therefore, it is necessary to provide a sterilizing filter integrity testing device, which can effectively improve the integrity testing efficiency of the sterilizing filter and avoid secondary pollution.

The technical scheme is as follows: a sterilizing filter integrity testing device comprising: the integrity tester is used for communicating compressed air; a first filter in communication with the integrity tester via a conduit, the first filter for filtering a gas; a second filter in communication with the first filter through a conduit, the second filter for filtering a liquid; an inlet of the buffer tank is communicated with the second filter through a pipeline, and an outlet of the buffer tank is communicated with a sewage discharge pipeline through a pipeline; the valve, the valve is a plurality of, all is equipped with on two pipelines that are linked together the part the valve.

Above-mentioned degerming filter integrality testing arrangement, in the course of the work, when needs join in marriage liquid system to aseptic preparation and carry out the integrality test, insert the integrality tester into the system, open relevant valve, let in the compressed air of test, the compressed air integrality tester that flows through, then flow through first filter, carry out degerming to test gas and filter, be favorable to guaranteeing that the gas after filtering is sanitary-grade compressed air, the secondary pollution appears in the placement system. Then, the gas after filtering gets into the second filter, carries out the integrality test to the second filter, and test data is monitored and is judged whether qualified by the integrality tester, and partial test gas enters into the buffer tank, through the liquid that discharges in the buffer tank to guarantee pressure stability, and guarantee to have liquid existence in the buffer tank all the time, avoid lower pipeline medium reverse pollution to play the separation effect in the system. This degerming filter integrality testing arrangement is favorable to avoiding the risk of secondary pollution risk and the risk that the station transfer process in-process filter core damaged of off-line test, is favorable to improving the reliability of detection efficiency and experimental result.

In one embodiment, the buffer tank is provided with a first sensor and a second sensor, the first sensor and the second sensor are arranged at intervals along the height direction of the buffer tank, and the first sensor and the second sensor are both used for detecting the liquid level height in the buffer tank.

In one embodiment, the sterilizing filter integrity testing device further comprises a third filter in communication with the inlet of the buffer tank through a conduit, the third filter for filtering and venting gas.

In one embodiment, a spraying ball is arranged in the buffer tank and is communicated with the inlet of the buffer tank.

In one embodiment, the sterilizing filter integrity testing device further comprises a heat exchanger, wherein an inlet of the heat exchanger is used for communicating water for injection, an outlet of the heat exchanger is communicated with the second filter through a pipeline, and a port of the second filter, which is communicated with the first filter, is also used for communicating with a sewage discharge pipeline through a pipeline.

In one embodiment, the sterilizing filter integrity testing device further comprises a first pressure sensor and a second pressure sensor, wherein the first pressure sensor is communicated with the pipeline between the heat exchanger and the second filter, and the second pressure sensor is communicated with the pipeline between the second filter and the buffer tank.

In one embodiment, the inlet of the heat exchanger is also used for communicating with a compressed air device through a pipeline.

In one embodiment, the heat exchanger is provided with a chilled water inlet and a chilled water outlet, the chilled water inlet is used for introducing chilled water, the chilled water outlet is used for returning the chilled water, a first proportional regulating angle valve is arranged on a pipeline of the chilled water outlet, a first temperature sensor is further arranged on a pipeline between the heat exchanger and the second filter, and the first temperature sensor is electrically connected with the first proportional regulating angle valve.

In one embodiment, the heat exchanger is further provided with a Y-shaped filter, the Y-shaped filter is communicated with the pipeline of the chilled water inlet, and the Y-shaped filter is used for filtering liquid.

In one embodiment, the first filter is provided with a first port, a second port and a third port, the first port is communicated with the second filter, the second port is communicated with the third port through a pipeline and is used for being communicated with a pure steam condensate discharging pipeline, a second temperature sensor is arranged between the second port and the pure steam condensate discharging pipeline, the third filter is provided with a fourth port, a fifth port and a sixth port, the fourth port is communicated with the inlet of the buffer tank, the fifth port and the sixth port are used for being communicated with the pure steam condensate discharging pipeline through a pipeline, a third temperature sensor is arranged between the fourth port and the pure steam condensate discharging pipeline, the outlet of the buffer tank is also used for being communicated with the pure steam condensate discharging pipeline, and a fourth temperature sensor is arranged between the outlet of the buffer tank and the pure steam condensate discharging pipeline.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention.

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic diagram of the sterilizing filter integrity testing apparatus according to one embodiment;

FIG. 2 is a schematic diagram of a CIP online cleaning process according to an embodiment;

FIG. 3 is a schematic diagram of a SIP steam sterilization process according to an embodiment;

FIG. 4 is a schematic diagram of a pre-test wetting procedure as described in one embodiment;

FIG. 5 is a schematic diagram illustrating an integrity test process according to an embodiment;

FIG. 6 is a schematic diagram of a post-test purge drain process according to one embodiment.

Description of reference numerals:

100. a sterilizing filter integrity testing device; 110. an integrity tester; 120. a first filter; 130. a second filter; 131. a first pressure sensor; 132. a second pressure sensor; 140. a buffer tank; 141. a first sensor; 142. a second sensor; 143. a third filter; 144. spraying a ball; 150. a heat exchanger; 151. a first temperature sensor; 152. a first proportional regulating angle valve; 153. a Y-type filter; 154. a second temperature sensor; 155. a third temperature sensor; 156. a fourth temperature sensor; 11. a circulating injection water inlet; 12. a circulating injection water outlet; 21. a pure steam inlet; 31. clean compressed air; 41. circulating the chilled water; 42. circulating chilled water is fed; 51. testing the compressed air inlet; 61. material inlet/CIP outlet; 62. material outlet/CIP outlet; 71. discharging pure steam condensate water; 81. a sewage draining pipeline.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless explicitly specified otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In the present invention, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may be directly contacting the second feature or the first and second features may be indirectly contacting each other through intervening media. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Referring to fig. 1 and 5, fig. 1 is a schematic diagram illustrating the operation of a sterilizing filter integrity testing device 100 according to an embodiment of the present invention; fig. 5 is a schematic diagram illustrating an integrity test flow in an embodiment of the present invention, and an embodiment of the present invention provides a sterilizing filter integrity testing apparatus 100, where the sterilizing filter integrity testing apparatus 100 includes: integrity tester 110, first filter 120, second filter 130, surge tank 140, and valves. Integrity tester 110, integrity tester 110 is used to communicate compressed air. The integrity tester 110 is used to perform an integrity test on the first filter 120. The first filter 120 is in communication with the integrity tester 110 via a conduit, the first filter 120 being for filtering the gas. For example, the first filter 120 is a gas filter. The second filter 130 is in communication with the first filter 120 through a pipe, and the second filter 130 is used to filter liquid. The second filter 130 is a liquid filter. An inlet of the buffer tank 140 communicates with the second filter 130 through a pipe, and an outlet of the buffer tank 140 communicates with the drain line 81 through a pipe. The valve is a plurality of, all is equipped with the valve on two pipelines that are linked together the part.

Above-mentioned degerming filter integrality testing arrangement 100, in the course of the work, when needs join in marriage liquid system to aseptic preparation and carry out the integrality test, insert integrality tester 110 into the system, open relevant valve, let in the compressed air of test, compressed air flows through integrality tester 110, then flows through first filter 120, carries out the degerming to test gas and filters, is favorable to guaranteeing that the gas after filtering is sanitary-grade compressed air, places the system and appears secondary pollution. Then, the filtered gas enters the second filter 130, integrity test is carried out on the second filter 130, test data is monitored by the integrity tester 110 and whether the test data is qualified or not is judged, part of the test gas enters the buffer tank 140, and liquid in the buffer tank 140 is discharged, so that stable pressure is ensured, the liquid is always present in the buffer tank 140, reverse pollution of the medium of the lower discharge pipeline to the system is avoided, and a blocking effect is achieved. This bacteria removing filter integrality testing arrangement 100 is favorable to avoiding the risk of the secondary pollution risk of off-line test and the risk that the station shifts in-process filter core and damages, is favorable to improving the reliability of detection efficiency and experimental result.

Since the specific structure and operation of integrity tester 110 are not the improvement of the present invention, the present invention does not specifically limit the structure and operation principle of the integrity test, as long as the integrity test of the filter is satisfied, and refer to the existing integrity tester 110.

Specifically, when the sterilizing filter integrity testing device 100 performs integrity testing on a filter, the complete process flow may sequentially be: CIP online cleaning flow, SIP pure steam sterilization flow, wetting flow before test, integrity test flow and purging and emptying flow after test.

In one embodiment, referring to fig. 1, the buffer tank 140 is provided with a first sensor 141 and a second sensor 142. The first sensor 141 and the second sensor 142 are disposed at intervals along the height direction of the buffer tank 140, and both the first sensor 141 and the second sensor 142 are used for detecting the liquid level height in the buffer tank 140. For example, the first sensor 141 and the second sensor 142 are both liquid level sensors. Can detect the liquid level in buffer tank 140 in the integrality test flow through first sensor 141 and second sensor 142, if during the test, when the liquid level risees to first sensor 141's monitoring position in the buffer tank 140, then corresponding valve is opened in proper order in buffer tank 140's exit and high liquid level is carried out to jar interior liquid and is discharged, when waiting to discharge to liquid level second sensor 142's monitoring, close buffer tank 140's corresponding discharge valve, the discharge is ended, liquid level discharge flow reciprocates according to the interior liquid level condition of jar in buffer tank 140 in proper order, therefore, be favorable to automatic discharge liquid, guarantee buffer tank 140's cushioning effect, avoid the drain down pipeline medium reflux.

In one embodiment, referring to fig. 1, the sterilizing filter integrity testing device 100 further comprises a third filter 143, the third filter 143 is in communication with the inlet of the buffer tank 140 through a pipe, and the third filter 143 is used for filtering and exhausting gas. For example, the third filter 143 is a gas filter. Thus, during the integrity test, the test gas can be exhausted after being filtered by the third filter 143, which is beneficial to meeting the requirement of gas emission.

In one embodiment, referring to fig. 1, a spray ball 144 is disposed in the buffer tank 140, and the spray ball 144 is communicated with the inlet of the buffer tank 140. Therefore, when CIP is cleaned on line, the injection water enters the buffer tank 140, and then can be cleaned to the buffer tank 140 through the spraying effect of the spraying ball 144, and during the low-temperature wetting process of the test cavity, the low-temperature injection water can be subjected to low-temperature wetting to the buffer tank 140 through the spraying ball 144, so that the improvement of the working efficiency is facilitated.

In one embodiment, referring to fig. 1, the sterilizing filter integrity testing device 100 further comprises a heat exchanger 150, an inlet of the heat exchanger 150 is used for communicating with water for injection, an outlet of the heat exchanger 150 is communicated with the second filter 130 through a pipeline, and a port of the second filter 130 communicated with the first filter 120 is also used for communicating with the sewage drainage pipeline 81 through a pipeline. In this manner, the temperature of the injection water can be varied by the heat exchanger 150 to meet the temperature requirements for CIP online cleaning and SIP pure steam sterilization. And in the pre-test wetting procedure, the heat exchanger 150 can reduce the effluent temperature to meet different wetting requirements.

In one embodiment, referring to FIG. 1, the sterilizing filter integrity testing device 100 further includes a first pressure sensor 131 and a second pressure sensor 132. The first pressure sensor 131 is communicated with a pipe between the heat exchanger 150 and the second filter 130, and the second pressure sensor 132 is communicated with a pipe between the second filter 130 and the buffer tank 140. So, in the pure steam sterilization flow of SIP, when being equipped with the proportional control angle valve between heat exchanger 150 and the second filter 130, the proportional control angle valve can carry out online adjustment valve opening ratio according to the pressure difference between first pressure sensor 131 and the second pressure sensor 132, guarantee the difference between first pressure sensor 131 and the second pressure sensor 132 in predetermineeing the within range, avoid high temperature high pressure to lead to the filter core damage of second filter 130, guarantee bacteria removal filter integrality testing arrangement 100's operational reliability.

In one embodiment, the inlet of the heat exchanger 150 is also used to communicate compressed air equipment through a conduit. So, after the integrality test flow, blow the evacuation flow after can testing all parts in the system through intercommunication compressed air equipment, be in dry state in the guarantee system, avoid remaining risks such as aquatic microorganism breeding.

In one embodiment, the heat exchanger 150 is provided with a chilled water inlet and a chilled water outlet, the chilled water inlet is used for introducing chilled water, the chilled water outlet is used for returning chilled water, a first proportional regulating angle valve 152 is arranged on a pipeline of the chilled water outlet, a first temperature sensor 151 is further arranged on a pipeline between the heat exchanger 150 and the second filter 130, and the first temperature sensor 151 is electrically connected with the first proportional regulating angle valve 152. So, heat exchanger 150 can be through the refrigerated water when wetting the flow before the test to high temperature, first temperature sensor 151 can the injection water heat transfer of cooling down, the in-process first proportional control angle valve 152 of cooling down carries out coordinated control with first temperature sensor 151, accurate control heat exchanger 150 goes out the water temperature and is less than preset temperature, during the heat transfer initial stage, when temperature value is greater than preset temperature, then open relevant valve and carry out the high-temperature water and discharge, when treating that first temperature sensor 151 temperature value is less than or equal to preset temperature, then close relevant valve, filter core in second filter 130 carries out the low temperature and wets.

In one embodiment, referring to fig. 1, the heat exchanger 150 further comprises a Y-shaped filter 153, the Y-shaped filter 153 is connected to the pipeline of the chilled water inlet, and the Y-shaped filter 153 is used for filtering the liquid. So, when wetting the flow before the test, Y type filter 153 can filter the refrigerated water, guarantees the refrigeration effect of refrigerated water to guarantee heat exchanger 150's life.

In one embodiment, referring to fig. 1, the first filter 120 has a first port, a second port and a third port, and the first port is communicated with the second filter 130. The second port and the third port are communicated with a pure steam condensate water discharge 71 pipeline through pipelines, and a second temperature sensor 154 is arranged between the second port and the pure steam condensate water discharge 71 pipeline. The third filter 143 is provided with a fourth port, which communicates with the inlet of the buffer tank 140, a fifth port, and a sixth port. The fifth port and the sixth port are communicated with a pure steam condensate water discharge 71 pipeline through pipelines, and a third temperature sensor 155 is arranged between the fourth port and the pure steam condensate water discharge 71 pipeline. The outlet of the buffer tank 140 is also used for being communicated with a pure steam condensate discharge 71 pipeline, and a fourth temperature sensor 156 is arranged between the outlet of the buffer tank 140 and the pure steam condensate discharge 71 pipeline. In this way, in the SIP steam sterilization process, the temperature in the system can be detected simultaneously by the second temperature sensor 154, the third temperature sensor 155 and the fourth temperature sensor 156, when all three groups of temperature sensors exceed the preset temperature, the SIP pure steam sterilization is started in time and continued for a period of time, and then the sterilization is determined to be qualified, and the sterilization process is ended. If the temperature value of any one of the three groups of temperature sensors is lower than the preset temperature in the sterilization process, the whole sterilization process is restarted until the sterilization is qualified. Therefore, the automatic sterilization monitoring device is beneficial to automatically monitoring the sterilization effect and improving the sterilization efficiency.

In one embodiment, the specific workflow of the sterilizing filter integrity testing device 100 is as follows:

first, a CIP (Clean in place) online cleaning process is started, please refer to fig. 2, and fig. 2 shows a schematic diagram of the CIP online cleaning process according to an embodiment of the present invention; wherein, the CIP online cleaning process comprises tangential flow cleaning and vertical flow cleaning. In the tangential flow cleaning, the injection water comes from the injection water circulation pipeline, relevant valves are opened, the injection water passes through the double-tube plate heat exchanger 150, the second filter 130 and the on-way pipeline valves are cleaned in the tangential flow mode, impurities are attached to the surfaces of filter elements, the cleaning is carried out by taking the conductivity detection index of the terminal of the liquid preparation system, which accords with the conductivity index of the injection water (less than or equal to 2.5us/cm @70 ℃), as the final judgment basis, and the vertical flow cleaning program is started if the conductivity detection index is qualified.

Referring to fig. 2, in the vertical flow cleaning, the injection water comes from the injection water circulation pipeline, the valves in the pipeline are opened, the second filter 130, the buffer tank 140, the diaphragm valve are opened by the double-tube plate heat exchanger 150, the diaphragm valve is opened, the proportional control diaphragm valve is opened, the second filter 130, the buffer tank 140 and the valves in the along-route pipeline are cleaned by the vertical flow through the second filter 130, the diaphragm valve, the spraying ball 144, the buffer tank 140 and the valves in the along-route pipeline, the cleaning is finally determined according to the condition that the detection index of the terminal conductivity of the liquid preparation system accords with the conductivity index of the injection water (less than or equal to 2.5us/cm @70 ℃), and the SIP pure steam sterilization process is performed if the water is qualified.

SIP pure steam sterilization process: pure steam comes from a pure steam distribution system pipe network, a ball valve is opened, a diaphragm valve is opened, the valve passes through the double-pipe plate heat exchanger 150, the diaphragm valve is opened, and a proportion adjusting diaphragm valve is opened, wherein the proportion adjusting diaphragm valve carries out on-line adjustment on the valve opening proportion according to the difference value of the first pressure sensor 131 and the second pressure sensor 132, the difference value of the two pressure sensors is ensured to be less than or equal to 0.3bar, and the filter element damage caused by high temperature and high pressure is avoided. And synchronously opening the branch diaphragm valve, and discharging the non-condensable gas and condensed water before the sterilizing filter through the drain valve. Then the pure steam flows through the second filter 130 synchronously, two diaphragm valves and a ball valve on the route are opened synchronously, and the non-condensable gas and condensed water in the cavity of the first filter 120 are discharged through a drain valve. Then the pure steam synchronously flows through the opened diaphragm valve, passes through the gas sterilization filter, opens the ball valve, and discharges the non-condensable gas and condensed water in the cavity of the first filter 120 through the drain valve. Then the pure steam synchronously flows through the opened diaphragm valve, the spraying ball 144, the buffer tank 140, the opened diaphragm valve, the opened ball valve and the drain valve to discharge the non-condensable gas and condensed water in the buffer tank 140. Then, pure steam synchronously flows through the opened diaphragm valve, passes through the third filter 143, opens the ball valve, and discharges the non-condensable gas & condensed water in the cavity of the third filter 143 through the drain valve.

In conclusion, pure steam sterilization of all accessories in the whole device is carried out, temperature monitoring in the system is carried out through the first temperature sensor 151, the second temperature sensor 154 and the third temperature sensor 155 in the sterilization process, when the temperature values of the three groups of temperature sensors are all equal to or higher than 121 ℃, sterilization timing is started, the temperature values are continuously kept for more than 20min, the sterilization is judged to be qualified, and the sterilization process is ended. If the temperature value of any one of the three groups of temperature sensors is less than 121 ℃ in the sterilization process, the whole sterilization process is restarted until the sterilization is qualified. And after the sterilization process is finished, the next wetting process before testing is carried out.

Referring to fig. 4, fig. 4 is a schematic view of a wetting flow before test according to an embodiment, in the wetting flow before test, the injection water comes from the injection water pipe network, for example, the injection water is about 80 ℃, when the wetting flow before test is used, the diaphragm valve is opened according to the direction indicated by the arrow on the pipe in fig. 4, and the injection water flows through the heat exchanger 150. Meanwhile, the ball valve is opened, the frozen water with the temperature of 7 ℃ is introduced into the shell pass of the heat exchanger 150 by opening the ball valve through the Y-shaped filter 153, the ball valve is opened, the proportional control angle valve is opened, the ball valve is opened, the high-temperature injection water is cooled, the proportional control angle valve and the first temperature sensor 151 are in linkage control in the cooling process, and the temperature of the water outlet of the heat exchanger 150 is accurately controlled to be less than or equal to 40 ℃. In the initial stage of heat exchange, when the temperature value of the first temperature sensor 151 is greater than 40 ℃, the valve is opened to discharge the high-temperature water, so as to prevent the high-temperature water from entering the second filter 130. If the temperature value of the first temperature sensor 151 is less than or equal to 40 ℃, the diaphragm valve is closed, and the diaphragm valve is opened, the proportional control diaphragm valve is opened, the filter element flows through the second filter 130, the diaphragm valve is opened, the filter element flows through the spray ball 144 in sequence, and the filter element in the second filter 130 is wetted at low temperature in the process, and the wetting time can be set in the program. So can ensure the filter core of different dimensions and specifications all can be moistened, injection water after the wetting discharges and carries out jar interior height liquid level monitoring through first sensor 141 and then second sensor 142 in buffer tank 140, when the liquid level reaches first sensor 141 position, then the jar below opens the diaphragm valve in proper order, open the ball valve and carry out the high liquid level and discharge, treat when discharging to the liquid level reaches second sensor 142 position, close jar lower valve, the end of discharging, jar interior liquid level discharge flow is reciprocal in proper order according to jar interior liquid level condition. The purpose is that the integrity test buffer tank 140 is always kept with a water seal, so that the medium in the lower discharge pipeline can be prevented from being reversely polluted into the system, and the barrier effect is achieved; and after the wetting process before the test is finished, the next integrity test process is carried out.

Referring to fig. 5, fig. 5 is a schematic diagram illustrating an integrity test flow according to an embodiment of the invention; in the integrity test process, the integrity tester 110 is connected into the system, the ball valve is sequentially opened to introduce compressed air for testing according to the arrow direction of the pipeline in fig. 5, the compressed air flows through the integrity tester 110, then the ball valve is opened, the compressed air flows through the third filter 143, the third filter 143 is used for performing terminal sterilization and filtration on the compressed air for testing, the compressed air entering the module is guaranteed to be sanitary-grade compressed air, and secondary pollution of the system is prevented. And then, the diaphragm valve is opened, test gas enters the second filter 130 to carry out integrity test on the second filter 130, test data is monitored by the integrity tester 110 and is judged whether to be qualified or not, the diaphragm valve is synchronously opened, the diaphragm valve is opened, the ball valve is opened, the gas is exhausted through the third filter 143 during the test, if the liquid level in the integrity test buffer tank 140 is raised to the position of the first sensor 141 during the test process, the diaphragm valve is sequentially opened and the ball valve is opened under the tank to carry out high liquid level discharge, when the liquid level reaches the position of the second sensor 142 after the liquid level is discharged, the lower valve of the tank is closed, the discharge is finished, and the liquid level discharge process in the tank sequentially reciprocates according to the liquid level condition in the tank. The integrity test buffer tank 140 is always kept with a water seal, so that reverse pollution of a medium in a lower pipeline into a system can be avoided, and a barrier effect is achieved; and after the integrity test flow is finished, entering a next test and then purging and emptying flow.

Referring to fig. 6, fig. 6 is a schematic diagram illustrating a post-test purging and evacuating flow according to an embodiment of the present invention, after an integrity test, residual water for injection may exist inevitably in a system, and the post-test purging and evacuating flow is designed to solve such problems in order to avoid breeding of microorganisms in the residual water and influence on the content of active ingredients in a liquid medicine at an initial stage. The specific purging process is that 3bar of clean compressed air 31 comes from a clean compressed air 31 distribution system pipe network, the ball valves are sequentially opened according to the arrow direction of the pipeline in fig. 6, the diaphragm valves are opened, the heat exchanger 150 is used for opening the diaphragm valves, the diaphragm valves are opened for proportional adjustment, the second filter 130 is used for opening the diaphragm valves, the spraying ball 144 is used for opening the diaphragm valves and the ball valves are opened, in sum, the valves are opened to realize the positive pressure purging and emptying process of clean pressure air, the inside of the system is in a dry state after purging, and risks such as breeding of microorganisms in residual water are avoided.

The sterilizing filter integrity testing device 100 is beneficial to solving the secondary pollution risks of the filter in the operation processes of low-temperature injection water wetting (less than or equal to 40 ℃), compressed air pipeline connection of more than 6bar, secondary connection of a filtering station after the test is finished and the like in the traditional off-line integrity test and the false detection risks caused by accidental damage of a filter element in the station transfer process. And, be favorable to solving in situ integrality test in the past, the secondary risk that the wetting water in the filter core wetting process remains, reverse secondary pollution risk in the test process and the secondary pollution risk that the sanitary quality problem of high pressure compressed air leads to in the test. In addition, the design of the sterilizing filter integrity testing device 100 is a modularized flexible design, the sterilizing filter can be matched with sterilizing filters with various sizes and specifications according to the requirement of liquid medicine filling flow, the volume of the buffer tank 140 can be provided by matching different volumes according to the requirement of filter element wetting water quantity, the module can be suitable for filling filtration and integrity testing of any sterile preparation liquid preparation system, the modularized design is compact in structure and small in occupied space, the air conditioner energy consumption of a pharmaceutical factory purification area can be reduced, and the module is convenient to transport, install and operate and maintain.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. A sterilizing filter integrity testing device, comprising:

the integrity tester is used for communicating compressed air;

a first filter in communication with the integrity tester via a conduit, the first filter for filtering a gas;

a second filter in communication with the first filter through a conduit, the second filter for filtering a liquid;

an inlet of the buffer tank is communicated with the second filter through a pipeline, and an outlet of the buffer tank is communicated with a sewage discharge pipeline through a pipeline;

the valve, the valve is a plurality of, all is equipped with on two pipelines that are linked together the part the valve.

2. A sterilising filter integrity test apparatus according to claim 1, wherein the buffer tank is provided with a first sensor and a second sensor, the first sensor and the second sensor being spaced apart along the height of the buffer tank, both the first sensor and the second sensor being adapted to detect the level of liquid within the buffer tank.

3. The sterilizing filter integrity testing device of claim 1 further comprising a third filter in communication with the inlet of the surge tank through a conduit, the third filter for filtering and venting gases.

4. The sterilizing filter integrity testing device of claim 1 wherein a spray ball is disposed within the surge tank, the spray ball communicating with an inlet of the surge tank.

5. The sterilizing filter integrity testing device of claim 3 further comprising a heat exchanger having an inlet for communicating water for injection, an outlet for communicating with the second filter via a conduit, and a port of the second filter in communication with the first filter for further communicating with a blowdown line via a conduit.

6. The sterilizing filter integrity testing device of claim 5 further comprising a first pressure sensor in communication with the conduit between the heat exchanger and the second filter and a second pressure sensor in communication with the conduit between the second filter and the buffer tank.

7. The sterilizing filter integrity testing device of claim 5 wherein the inlet of the heat exchanger is also used to communicate compressed air equipment through a conduit.

8. The sterilization filter integrity testing device according to claim 5, wherein the heat exchanger is provided with a chilled water inlet and a chilled water outlet, the chilled water inlet is used for introducing chilled water, the chilled water outlet is used for returning chilled water, a first proportional regulating angle valve is arranged on a pipeline of the chilled water outlet, a first temperature sensor is further arranged on a pipeline between the heat exchanger and the second filter, and the first temperature sensor is electrically connected with the first proportional regulating angle valve.

9. The sterilizing filter integrity testing device of claim 8, wherein the heat exchanger is further provided with a Y-filter, the Y-filter is communicated with the pipeline of the chilled water inlet, and the Y-filter is used for filtering liquid.

10. The sterilizing filter integrity testing device of claim 8, wherein the first filter is provided with a first port, a second port and a third port, the first port is in communication with the second filter, the second port and the third port are in communication with a pure steam condensate drain conduit through a conduit, a second temperature sensor is provided between the second port and the pure steam condensate drain conduit, the third filter is provided with a fourth port, a fifth port and a sixth port, the fourth port is in communication with the inlet of the buffer tank, the fifth port and the sixth port are in communication with the pure steam condensate drain conduit through a conduit, a third temperature sensor is provided between the fourth port and the pure steam condensate drain conduit, the outlet of the buffer tank is also in communication with the pure steam condensate drain conduit, and a fourth temperature sensor is provided between the outlet of the buffer tank and the pure steam condensate drain conduit.

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