CN114713036A - Online filter membrane integrity testing device and method and application thereof - Google Patents
Online filter membrane integrity testing device and method and application thereof Download PDFInfo
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- CN114713036A CN114713036A CN202210649808.7A CN202210649808A CN114713036A CN 114713036 A CN114713036 A CN 114713036A CN 202210649808 A CN202210649808 A CN 202210649808A CN 114713036 A CN114713036 A CN 114713036A
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Abstract
The invention provides an online filter membrane integrity testing device, an online filter membrane integrity testing method and application, which are used for online filter membrane integrity testing in radioactive liquid medicine production, and the online filter membrane integrity testing device comprises: an exhaust filter, disposed on a production line of the radioactive liquid medicine, having an inlet and an outlet, comprising: a housing; the liquid filtering membrane is arranged inside the shell and divides the inside of the shell into a first cavity and a second cavity, and the liquid filtering membrane is configured to allow liquid to pass through and remove bacteria in the liquid; the exhaust port is arranged on the shell, so that the first cavity is communicated with the outside; and a gas filtering membrane disposed at the gas outlet configured to allow the passage of gas and to block the passage of liquid; and a plugging device, movable relative to the gas exhaust filter, configured to plug the gas exhaust port when the liquid filtration membrane performs an integrity test.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to an online filter membrane integrity testing device and method and application thereof.
Background
The radioactive liquid medicine has strong radiation, and the production needs to be operated in a shielding isolation box. Due to the short half-life of radionuclides, production is generally carried out fully automatically in dedicated synthesis modules. The method for producing the radioactive liquid medicine by adopting the shielding isolation box comprises the steps of placing the synthesis module in the shielding isolation box, filling raw material consumables such as chemical reagents and the like into the automatic synthesis module, closing the shielding door, injecting radioactive raw materials into the automatic synthesis module through a special shielding pipeline and starting production, and conveying products to product bottles for split charging after full-automatic synthesis. After production is finished, the nuclide decays to the state that the shielding door can be opened (generally, the operation is carried out after 10 half-lives), equipment cleaning is carried out, and the next production is carried out.
Carry the product bottle at the product and carry out the partial shipment before using, need filter the product, when carrying out the test of filter membrane integrality, often need dismantle out its integrality of off-line measuring with filter membrane, influenced production efficiency greatly.
Disclosure of Invention
Some embodiments of the present invention provide an in-line filter membrane integrity testing apparatus for in-line filter membrane integrity testing in the production of radioactive pharmaceutical fluids, the in-line filter membrane integrity testing apparatus comprising:
an exhaust filter, disposed on a production line of the radioactive liquid medicine, having an inlet and an outlet, comprising:
a housing;
the liquid filtering membrane is arranged inside the shell and divides the inside of the shell into a first cavity and a second cavity, and the liquid filtering membrane is configured to allow liquid to pass through and remove bacteria in the liquid;
the exhaust port is arranged on the shell, so that the first cavity is communicated with the outside; and
a gas filtering membrane disposed at the gas outlet configured to allow gas to pass and to block liquid from passing; and
a plugging device, movable relative to the gas vent filter, configured to plug the gas vent when the liquid filtration membrane performs an integrity test.
In some embodiments, the occlusion device comprises:
a support bar;
the first moving rod is connected with the supporting rod in a sliding mode and arranged on one side, far away from the second cavity, of the first cavity; and
a first sealing member provided on a sidewall of the first moving bar facing the first chamber,
when the liquid filtering membrane executes an integrity test, the first moving rod drives the first sealing element to move towards the first cavity until the first sealing element seals the exhaust port.
In some embodiments, the first seal has a protrusion facing the first cavity, the protrusion being inserted into the vent to seal the vent when the liquid filtration membrane performs an integrity test.
In some embodiments, the occlusion device further comprises:
the second moving rod is connected with the supporting rod in a sliding mode and arranged on one side, far away from the first cavity, of the second cavity; and
a second sealing member provided on a sidewall of the second moving bar facing the second chamber,
when the liquid filtering membrane performs an integrity test, the first moving rod and the second moving rod respectively drive the first sealing element and the second sealing element to approach each other, so that the first sealing element and the second sealing element clamp the exhaust filter.
In some embodiments, the inlet of the exhaust gas filter is disposed on a side of the first chamber remote from the second chamber, the inlet being removably coupled to the first conduit,
the plugging device also has a first through hole penetrating the first movable rod and the first sealing member, and the first pipeline is arranged through the first through hole.
In some embodiments, the occlusion device comprises:
a support bar;
the third movable rod is connected with the supporting rod in a sliding or rotating mode and arranged on one side, far away from the second cavity, of the first cavity;
a vent tube supported by the third travel bar, the vent tube having a sealing interface configured to removably sealingly dock to the exhaust port; and
a switch valve arranged on the vent pipe and configured to control the opening or closing of the vent pipe,
wherein, when the liquid filtration membrane performs an integrity test, the sealing interface is sealingly docked to the vent and a switch valve closes the vent tube.
In some embodiments, the in-line filter membrane integrity test device further comprises:
a first three-way valve configured to switch between a first state and a second state;
the liquid inlet pipe is connected with the first end of the first three-way valve;
the air inlet pipe is connected with the second end of the first three-way valve;
the first pipeline is connected with the third end of the first three-way valve and the inlet of the exhaust filter;
a second three-way valve configured to switch between a third state and a fourth state;
a second pipe connecting a first end of the second three-way valve and an outlet of the exhaust filter;
the air outlet pipe is connected with the second end of the second three-way valve;
a liquid outlet pipe connected with the third end of the second three-way valve,
when the first three-way valve is switched to a first state and the second three-way valve is switched to a third state, the liquid inlet pipe, the first pipeline, the exhaust filter, the second pipeline and the liquid outlet pipe form a passage, so that bacteria in the liquid medicine are filtered out through the exhaust filter;
when the first three-way valve is switched to the second state and the second three-way valve is switched to the fourth state, the air inlet pipe is communicated with the first pipeline, and the second pipeline is communicated with the air outlet pipe to be used for achieving the integrity test of the online filter membrane.
In some embodiments, at least a portion of the in-line filter membrane integrity testing device is disposed within a shielded isolation box.
Some embodiments of the present invention provide an online filter membrane integrity testing method, using the online filter membrane integrity testing apparatus of the previous embodiments, the online filter membrane integrity testing method comprising:
the first three-way valve is switched to a first state and the second three-way valve is switched to a third state, and the pressurized liquid medicine flows through the liquid inlet pipe and the first pipeline, enters the exhaust filter for filtering, and is discharged through the second pipeline and the liquid outlet pipe; and
and switching the first three-way valve to a second state, switching the second three-way valve to a fourth state, plugging the exhaust port through the plugging device, and allowing the test gas to enter the exhaust filter through the gas inlet pipe and the first pipeline to execute an online filter membrane integrity test.
In some embodiments, prior to switching the first three-way valve to the second state and switching the second three-way valve to the fourth state, the in-line filter membrane integrity test method further comprises:
the air-bleeding filter is flushed with water for injection to infiltrate the liquid filtration membrane.
Some embodiments of the invention provide for the use of an in-line filter membrane integrity test apparatus according to the previous embodiments in an in-line filter membrane integrity test.
Compared with the related art, the invention has at least the following technical effects:
the online filter membrane integrity test in the production of the radioactive liquid medicine is realized by adopting the exhaust filter arranged on the production line of the radioactive liquid medicine and the plugging device which can move relative to the exhaust filter, so that the production and test efficiency is improved. The problem that the pressed gas cannot be discharged in the process of filtering liquid medicine due to the adoption of a conventional sterile filter is solved, the problem that the integrity of the filter membrane of the exhaust filter cannot be tested by adopting a foaming method in the related technology is solved, and the complicated flow caused by the fact that the filter needs to be dismantled from a production line when the integrity of the filter membrane is tested in the related technology is avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and those skilled in the art can also obtain other drawings according to the drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an in-line filter integrity testing apparatus according to some embodiments of the present invention.
FIG. 2 is a schematic diagram of the exploded structure of the in-line filter integrity testing apparatus of FIG. 1.
Fig. 3 is a schematic view of the exhaust gas filter of fig. 1.
FIG. 4 is a schematic structural diagram of an in-line filter membrane integrity testing apparatus according to another embodiment of the present invention.
FIG. 5 is a flow chart of an in-line filter integrity testing method according to some embodiments of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings, and it is apparent that the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The terminology used in the embodiments of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the examples of the present invention and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise, and "a plurality" typically includes at least two.
It should be understood that the term "and/or" as used herein is merely one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.
It is also noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that an article or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such article or apparatus. Without further limitation, the recitation of an element by the phrase "comprising a" does not exclude the presence of additional like elements in a commodity or device comprising the element.
In the related art, radioactive liquid medicine has strong radiation, and production needs to be performed in a shielded isolation box, which is called a hot chamber. Due to the short half-life of radionuclides, production is generally carried out fully automatically in dedicated synthesis modules. The method for producing the radioactive liquid medicine by adopting the hot chamber comprises the steps of placing the synthesis module in the hot chamber, filling raw material consumables such as chemical reagents and the like into the automatic synthesis module, closing the shielding door, injecting radioactive raw materials into the automatic synthesis module through a special shielding pipeline, starting production, conveying the product to a product bottle after full-automatic synthesis, and subpackaging for use.
Production of radioactive pharmaceutical solutions typically involves a sterilization process, typically a sterile filtration process, requiring filter membrane integrity testing of the sterile filter in the hot room immediately after production is complete. Since the inside of the hot chamber and the sterilizing filter still have a strong radioactive dose after the production is finished. In the related art, it is often necessary to take the sterilizing filter out of the production line and perform off-line filter membrane integrity tests, for example, using a foaming process. Thus, a process is complicated, which easily causes leakage of radioactive materials.
In the related art, the aseptic filtration production process generally employs a conventional filter, whereas in the aseptic filtration production process, sterilization is generally performed by pushing a radioactive liquid medicine to be transferred through a sterile filtration membrane in the filter with a positive gas pressure. In this case, the radioactive liquid medicine is contaminated with gas, and the ordinary aseptic filter cannot discharge the gas that has been pushed in, and cannot effectively filter the radioactive liquid medicine, for example, it is difficult to filter the liquid medicine.
In order to solve the above problems, the present invention provides an in-line filter membrane integrity testing apparatus for in-line filter membrane integrity testing in radioactive liquid medicine production, comprising: an exhaust filter, disposed on a production line of the radioactive liquid medicine, having an inlet and an outlet, comprising: a housing; the liquid filtering membrane is arranged inside the shell and divides the inside of the shell into a first cavity and a second cavity, and the liquid filtering membrane is configured to allow liquid to pass through and remove bacteria in the liquid; the exhaust port is arranged on the shell, so that the first cavity is communicated with the outside; and a gas filtering membrane disposed at the gas outlet configured to allow the passage of gas and to block the passage of liquid; and a plugging device, movable relative to the gas vent filter, configured to plug the gas vent when the liquid filtration membrane performs an integrity test. The exhaust filter arranged on the production line of the radioactive liquid medicine and the plugging device which can move relative to the exhaust filter are adopted to realize the on-line filter membrane integrity test in the production of the radioactive liquid medicine, so that the production and test efficiency is improved.
Alternative embodiments of the present invention are described in detail below with reference to the accompanying drawings.
FIG. 1 is a schematic structural diagram of an in-line filter integrity testing apparatus according to some embodiments of the present invention. FIG. 2 is a schematic diagram of the exploded structure of the in-line filter integrity testing apparatus of FIG. 1. Fig. 3 is a schematic view of the exhaust gas filter of fig. 1.
As shown in fig. 1-3, some embodiments of the present invention provide an in-line filter integrity testing apparatus for in-line filter integrity testing in the production of radiopharmaceutical solutions. At least a portion of the in-line filter integrity test device is disposed, for example, within a shielded isolation box to allow the radioactive medical fluid to be shielded from radiation as much as possible and to avoid radionuclide leakage during the manufacturing process.
As shown in fig. 1 to 3, the in-line filter membrane integrity testing apparatus 100 includes a gas discharge filter 10 and a plugging device 20. The vent filter 10 may be located, for example, removably located, in the manufacturing line of the radiopharmaceutical solution to facilitate replacement of the vent filter 10. in some embodiments, the vent filter 10 may be used to filter one or more batches of the radiopharmaceutical solution, requiring replacement of the vent filter 10 when it reaches a time of use or when a different batch of the radiopharmaceutical solution is manufactured.
The degassing filter 10 is provided on a production line of the radioactive liquid medicine, and has an inlet 15 and an outlet 16, and the radioactive liquid medicine enters the degassing filter 10 through the inlet 15, for example, a bacteria filtering operation is performed on the degassing filter 10, and then the degassing filter 10 is discharged through the outlet 16, so that a sterile radioactive liquid medicine is obtained.
The exhaust gas filter 10 includes a housing 11 and a liquid filtering membrane 12 disposed inside the housing 11. The housing 11 is made of, for example, a polymer material, for example, one or more selected from polyether ether ketone (PEEK), silicone, Polytetrafluoroethylene (PTFE), Polyethylene (PE), polypropylene (PP), Perfluoroalkoxy (PFA), polyvinyl chloride (PVC), Polyimide (PI), and Fluorinated Ethylene Propylene (FEP).
The liquid filtration membrane 12, for example, a sterile filtration membrane, may employ a hydrophilic membrane layer. The interior of the housing is divided into a first cavity a and a second cavity B by a liquid filtering membrane 12, and the liquid filtering membrane 12 is configured to allow liquid to pass through and remove bacteria in the liquid.
The exhaust filter 10 further includes an exhaust port 14 provided on the housing 11, for example, on an upper surface of the housing 11, as shown in fig. 3, so that the first chamber a communicates with the outside for exhausting the gas in the exhaust filter 10. The gas outlet filter 10 further comprises a gas filtering membrane 13, for example a hydrophobic membrane layer, arranged at said gas outlet 14, configured to allow the passage of gas and to block the passage of liquid.
In the aseptic filtration production process of radioactive liquid medicine, the radioactive liquid medicine is generally sterilized by using a gas, such as an inert gas, such as nitrogen, and the like, and moving the radioactive liquid medicine to pass through a sterile filtration membrane in a filter under positive pressure. The pressurized radioactive liquid medicine carrying the gas enters the exhaust filter 10 through the inlet of the exhaust filter 10, for example, enters the first cavity a of the exhaust filter 10, the liquid filtering membrane 12 allows the radioactive liquid medicine to pass through while preventing the gas from passing through due to its hydrophilicity, and the liquid filtering membrane 12 can filter out bacteria of the radioactive liquid medicine. The gas filtering membrane 13 allows gas to pass through but prevents liquid from passing through due to its hydrophobicity. Under the effect of pressure in the first cavity A, the radioactive liquid medicine flows through the liquid filtering membrane 12 to perform sterilization operation, gas in the first cavity A is discharged to the outside from the exhaust port 14, and compared with a common sterile filter, the gas pressed into the filter can be discharged by adopting an exhaust filter, so that effective filtration in the production of the radioactive liquid medicine is realized.
A blocking device 20 is movable relative to the gas vent filter 10 and is configured to block the gas vent 14 when the liquid filtration membrane 12 performs an integrity test. When the vent 14 of the vent filter 10 is plugged, it may be considered a conventional sterile filter and the integrity test may be performed using a conventional filter membrane integrity test method, such as a bubble method. By adopting the mode, the integrity test of the filter membrane of the exhaust filter 10 can be completed without detaching the exhaust filter 10 from the production line, namely, the integrity test of the filter membrane can be completed on line, so that the production efficiency is improved, and the irradiation dose of operators is reduced.
In some embodiments, as shown in fig. 1 to 3, the plugging device 20 includes a support rod 21, a first movable rod 22, and a first sealing member 23. The support bar 21 is, for example, an elongated bar shape and extends in a first direction X, for example, a vertical direction. The first movable rod 22 is slidably connected to the support rod 21 and disposed on a side of the first cavity a away from the second cavity B. The first moving bar 22 extends, for example, in a second direction Y substantially perpendicular to the first direction X, for example, a horizontal direction, and the first moving bar 22 can slide along the support bar 21 in the first direction X. A first sealing element 23 is disposed on a side wall of the first movable rod 22 facing the first chamber a, and is slidable in the first direction X by the first movable rod 22.
When the liquid filtering membrane 12 performs the integrity test, the first moving rod 22 drives the first sealing member 23 to move towards the first cavity a until the first sealing member 23 seals the exhaust port 14.
In some embodiments, a first seal 23, such as a rubber gasket or the like, may substantially completely conform to the upper surface of the housing 11 of the exhaust filter 10 shown in FIG. 3, closing the exhaust port 14. The side of the first sealing element 23 facing away from the first displacement rod 22 has, for example, a surface shape matching the upper surface of the housing 11 of the exhaust gas filter 10, for example, an arc shape, and the first sealing element 23 can be pressed against the upper surface of the housing 11 of the exhaust gas filter 10 by an external force to close the exhaust port 14.
In some embodiments, the first seal 23 has a raised portion facing the first cavity a, which is inserted into the vent 14 to seal the vent 14 when the liquid filtering membrane 12 performs an integrity test. In this case, the convex portion of the first seal member 23 needs to be aligned with the exhaust port 14.
In some embodiments, as shown in fig. 1-3, the occluding device 20 further includes a second travel rod 24 and a second seal 25. The second movable rod 24 is slidably connected to the support rod 21 and disposed on a side of the second cavity B away from the first cavity a. The second moving bar 24 extends, for example, in a second direction Y substantially perpendicular to the first direction X, for example, a horizontal direction, and the second moving bar 24 can slide along the support bar 21 in the first direction X.
A second sealing member 25 is disposed on a side wall of the second moving rod 24 facing the second chamber B, and is slidable in the first direction X by the second moving rod 24.
When the liquid filtering membrane 12 performs the integrity test, the first moving rod 22 and the second moving rod 24 respectively bring the first sealing element 23 and the second sealing element 25 close to each other, so that the first sealing element 23 and the second sealing element 25 clamp the exhaust gas filter 10. The exhaust filter 10 is ensured to be stably arranged when the online filter membrane integrity test is executed, and the smooth implementation of the online filter membrane integrity test is ensured.
In some embodiments, the second seal 25, such as a rubber mat or the like, may substantially completely conform to the lower surface of the housing 11 of the exhaust filter 10 shown in FIG. 3. The side of the second sealing element 25 facing away from the second moving rod 24 has, for example, a surface shape matching the lower surface of the housing 11 of the exhaust gas filter 10, for example, a flat surface, and the first sealing element 23 and the second sealing element 25 clamp the exhaust gas filter 10 under the action of an external force, thereby ensuring the stability of the exhaust gas filter 10 while closing the exhaust port 14.
In some embodiments, as shown in fig. 1 to 3, the inlet 15 of the exhaust filter 10 is disposed on a side of the first cavity a away from the second cavity B, and the inlet 15 is detachably connected to the first pipe 30. The first pipe 30 is used to transfer an object, such as a medical liquid or gas, etc., which enters the exhaust filter 10. For example, the inlet 15 is hermetically connected to the first conduit 30, for example, by a luer fitting, which facilitates installation and removal, and prevents leakage at the interface. The plugging device 20 further has a first through hole H1 penetrating the first movable rod 22 and the first sealing member 23, and the first pipeline 30 is disposed through the first through hole H1, in this arrangement, the first sealing member 23 is, for example, a circular rubber gasket. When the integrity test of the liquid filtering membrane 12 is performed, the first moving rod 22 drives the first sealing element 23 to move towards the first cavity a, so that the first sealing element 23 is attached to the upper surface of the housing 11 of the exhaust gas filter 10, and the protrusion of the inlet 15 of the exhaust gas filter 10 penetrates into the first through hole H1.
In some embodiments, as shown in fig. 1 to 3, the outlet 16 of the exhaust gas filter 10 is disposed on a side of the second cavity B away from the first cavity a, and the outlet 16 is detachably connected to the second pipeline 40. The second pipe 40 is used to transfer objects, such as medical liquid, etc., discharged from the exhaust filter 10. For example, the outlet 16 is hermetically connected to the second conduit 40, for example, by a luer fitting, which facilitates installation and removal, and prevents leakage at the interface. The plugging device 20 further has a second through hole H2 penetrating the second moving rod 24 and the second sealing member 25, and the second pipeline 40 is disposed through the second through hole H2. When the integrity test of the liquid filtering membrane 12 is performed, the second moving rod 24 drives the second sealing element 25 to move towards the second cavity B, so that the second sealing element 25 is attached to the lower surface of the housing 11 of the exhaust filter 10, and the protrusion of the outlet 16 of the exhaust filter 10 penetrates into the second through hole H2.
In some embodiments, as shown in fig. 1 to 3, the online membrane integrity testing apparatus 100 further includes a first three-way valve 50, a second three-way valve 60, a liquid inlet pipe 71, a liquid outlet pipe 72, a gas inlet pipe 81, and a gas outlet pipe 82.
The first three-way valve 50 comprises a first end 51, a second end 52 and a third end 53, the first three-way valve 50 can be switched between a first state and a second state, when the first three-way valve 50 is in the first state, a passage is formed between the first end 51 and the third end 53 in the first three-way valve 50, and the second end 52 is not communicated with the first end 51 and the third end 53; when the first three-way valve 50 is in the second state, a passage is formed between the second end 52 and the third end 53 inside the first three-way valve 50, and the first end 51 is not communicated with the second end 52 and the third end 53.
The liquid inlet pipe 71 is connected to the first end 51 of the first three-way valve 50, and specifically, one end of the liquid inlet pipe 71 is connected to the radioactive liquid pressurizing device, and the other end is connected to the first end 51 of the first three-way valve 50. The radiopharmaceutical pressurizing apparatus may provide a high-pressure radiopharmaceutical, such as pressurization with a gas. The radioactive liquid medicine pressurizing device can be placed in the shielding isolation box or outside the shielding isolation box, when the radioactive liquid medicine pressurizing device is placed in the shielding isolation box, the liquid inlet pipe 71 is completely positioned in the shielding isolation box, when the radioactive liquid medicine pressurizing device is placed outside the shielding isolation box, the liquid inlet pipe 71 penetrates through the wall of the shielding isolation box and is connected with the radioactive liquid medicine pressurizing device, and a sealing piece is arranged at the penetrating position to ensure the airtightness of the shielding isolation box.
And the air inlet pipe 81 is connected with the second end 52 of the first three-way valve 50, specifically, one end of the air inlet pipe 81 is connected with an air source, and the other end is connected with the second end 52 of the first three-way valve 50. The gas source may provide a gas for testing the integrity of the filter membrane, such as nitrogen, and may regulate the gas pressure. The air supply can be placed in the shielding isolation box, also can place outside the shielding isolation box, and when the air supply was placed in the shielding isolation box, intake pipe 81 was located the shielding isolation box completely, and when the air supply was placed outside the shielding isolation box, intake pipe 81 penetrated the wall of shielding isolation box and was connected with the air supply, set up the leakproofness that the sealing member guaranteed the shielding isolation box in the department of penetrating through.
The first pipe 30 connects the third end 53 of the first three-way valve 50 and the inlet 15 of the exhaust filter 10 for transferring an object, such as a liquid medicine or gas, entering the exhaust filter 10.
The second three-way valve 60 includes a first end 61, a second end 62 and a third end 63, the second three-way valve 60 can be switched between a third state and a fourth state, when the second three-way valve 60 is in the third state, a passage is formed between the first end 61 and the third end 63 inside the second three-way valve 60, and the second end 62 is not communicated with the first end 61 and the third end 63; when the second three-way valve 60 is in the fourth state, a passage is formed between the second end 62 and the first end 61 inside the second three-way valve 60, and the third end 63 is not communicated with the second end 62 and the first end 61.
The liquid outlet pipe 72 is connected to the third end 63 of the second three-way valve 60, specifically, one end of the liquid outlet pipe 72 is connected to a degerming liquid medicine collecting container, and the other end is connected to the third end 63 of the second three-way valve 60. The degerming liquid medicine collecting container can collect the radioactive liquid medicine with bacteria filtered out. Degerming liquid medicine collection container can place in the shielding isolation box, also can place outside the shielding isolation box, when degerming liquid medicine collection container placed in the shielding isolation box, drain pipe 72 is located the shielding isolation box completely, when degerming liquid medicine collection container placed outside the shielding isolation box, drain pipe 72 pierces through the wall of shielding isolation box and is connected with degerming liquid medicine collection container, sets up the leakproofness that the sealing member guaranteed the shielding isolation box in the department that pierces through.
And an outlet pipe 82 connected to the second end 62 of the second three-way valve 60, specifically, one end of the outlet pipe 82 is connected to a gas detection device, and the other end is connected to the second end 62 of the second three-way valve 60. The gas detection means may detect a change in gas pressure. Gaseous detection device can place in the shielding shielded box, also can place outside the shielding shielded box, and when gaseous detection device placed in the shielding shielded box, outlet duct 82 was located the shielding shielded box completely, and when gaseous detection device placed outside the shielding shielded box, outlet duct 82 penetrated the wall of shielding shielded box and was connected with gaseous detection device, set up the leakproofness that the sealing member guaranteed the shielding shielded box in penetrating department.
A second pipe 40 connects the first end 61 of the second three-way valve 60 and the outlet 16 of the exhaust filter 10 for transferring objects, such as liquid medicine or gas, discharged from the exhaust filter 10.
The connection of above-mentioned each part adopts luer to connect for example, and convenient the dismantlement just avoids revealing.
When the first three-way valve 50 is switched to the first state and the second three-way valve 60 is switched to the third state, the liquid inlet pipe 71, the first pipeline 30, the exhaust filter 10, the second pipeline 40 and the liquid outlet pipe 72 form a passage so that the liquid medicine passes through the exhaust filter 10 to filter bacteria. At this time, the high-pressure radioactive drug solution from the radioactive drug solution pressurizing device flows through the exhaust filter 10, bacteria are filtered, and the high-pressure radioactive drug solution is collected into the sterilized drug solution collecting container through the liquid outlet pipe 72, so that the production of sterile drug solution is realized.
When the first three-way valve 50 is switched to the second state and the second three-way valve 60 is switched to the fourth state, the air inlet pipe 81 is communicated with the first pipeline 30, and the second pipeline 40 is communicated with the air outlet pipe 82 for realizing the integrity test of the online filter membrane. For example, by using the bubbling method, a gas source is used to supply a gas, such as nitrogen, to the exhaust filter 10 for closing the exhaust port 14 through the inlet pipe 81 and the first pipeline 30, and the pressure of the gas is gradually increased until the gas detection device detects a change in the gas pressure. At this time, if the pressure of the gas provided by the gas source is greater than or equal to the preset value, the liquid filtering membrane in the exhaust filter is intact, and the radioactive liquid medicine collected into the degerming liquid medicine collecting container is satisfactory. If the pressure of the gas provided by the gas source is less than the preset value, the liquid filtering membrane in the exhaust filter is broken, and the radioactive liquid medicine collected into the sterilizing liquid medicine collecting container is not satisfactory.
FIG. 4 is a schematic structural diagram of an in-line filter membrane integrity testing apparatus according to another embodiment of the present invention. The online filter membrane integrity testing device shown in fig. 4 has substantially the same structure as the online filter membrane integrity testing device shown in fig. 1, and the same parts are not repeated, and the differences are mainly described below.
As shown in fig. 4, the in-line filter integrity testing apparatus 100' has a different structure of the plugging device 20 compared to the in-line filter integrity testing apparatus 100 shown in fig. 1, and specifically, the plugging device 20 includes a support rod 21, a third movable rod 26, a vent pipe 27, and an on-off valve 28. The support bar 21 is, for example, an elongated bar shape and extends in a first direction X, for example, a vertical direction. The third movable rod 26 is connected with the support rod 21 in a sliding or rotating manner and is arranged on one side of the first cavity far away from the second cavity. The third moving bar 26 extends, for example, in a second direction Y substantially perpendicular to the first direction X, for example, in a horizontal direction. In some embodiments, the third moving bar 26 may slide along the support bar 21 in the first direction X. In another embodiment, the third movable bar 26 can rotate around the support bar 21 in a plane perpendicular to the first direction X.
A vent tube 27 is supported by the third travel bar 26 and has a sealing interface configured to removably sealingly interface to the exhaust port 14 of the exhaust filter 10. Specifically, the third moving rod 26 is connected to, for example, an end of the vent pipe 27 having a sealing interface to support the vent pipe 27, and the third moving rod 26 can move the vent pipe 27 together during the moving process. An on-off valve 28 is provided on the vent pipe 27 and configured to control the opening and closing of the vent pipe 27. When the liquid filtration membrane performs an integrity test, the sealing interface is sealingly docked to the vent 14 and an on-off valve 28 closes the vent tube 27.
In some embodiments, the plugging device 20 of the in-line filter integrity testing device 100' shown in fig. 4 may further include a second movable rod 24 and a second sealing member 25, the specific structure and function of which can be described with reference to the corresponding structure of the in-line filter integrity testing device 100 shown in fig. 1, and will not be described herein again. The online filter membrane integrity testing device 100' shown in fig. 4 further includes a first three-way valve 50, a second three-way valve 60, a liquid inlet pipe 71, a liquid outlet pipe 72, a gas inlet pipe 81, and a gas outlet pipe 82, and the specific structure and function thereof can refer to the description of the structure corresponding to the online filter membrane integrity testing device 100 in fig. 1, and will not be described again.
In some embodiments, when the in-line filter membrane integrity test device 100' shown in fig. 4 is used to perform an in-line filter membrane integrity test, the vent filter 10 may be supported by the second sealing member 25, the vent pipe 27 abuts on the vent filter 10 under the driving of the third movable rod 26, so that the sealing interface of the vent pipe 27 is in sealing contact with the vent opening 14 of the vent filter 10, and the vent pipe 27 is closed by the on-off valve 28 so that the blocking device 20 blocks the vent opening 14. In some embodiments, with the in-line filter membrane integrity testing apparatus 100' shown in fig. 4, during the production process of the normal radioactive liquid medicine, the vent tube 27 can abut against the exhaust filter 10 so that the sealing interface of the vent tube 27 is in sealing abutment with the exhaust port 14 of the exhaust filter 10, the on-off valve 28 is used to control the conduction of the vent tube 27, and when the in-line filter membrane integrity test needs to be performed, the on-off valve 28 is used to close the vent tube 27.
Fig. 5 is a flow chart of an in-line filter membrane integrity testing method according to some embodiments of the present invention, and as shown in fig. 5, some embodiments of the present invention provide an in-line filter membrane integrity testing method, which may include the following steps using the in-line filter membrane integrity testing apparatus according to the previous embodiments:
s501: and the first three-way valve is switched to a first state and the second three-way valve is switched to a third state, and the pressurized liquid medicine flows through the liquid inlet pipe and the first pipeline, enters the exhaust filter for filtering and is discharged through the second pipeline and the liquid outlet pipe.
S503: and switching the first three-way valve to a second state, switching the second three-way valve to a fourth state, plugging the exhaust port through the plugging device, and allowing the test gas to enter the exhaust filter through the gas inlet pipe and the first pipeline to execute an online filter membrane integrity test.
Specifically, the switching control of the first three-way valve and the second three-way valve may be electronically controlled or mechanically controlled, as long as the two are switched at substantially the same time. The control of the blocking device to block the exhaust port may be performed automatically or manually, for example, such that the first sealing member 23 and the second sealing member 25 clamp the exhaust filter 10, thereby blocking the exhaust port 14 of the exhaust filter 10 and ensuring a stable arrangement of the exhaust filter 10.
In some embodiments, as shown in fig. 5, prior to switching the first three-way valve to the second state and the second three-way valve to the fourth state, the in-line filter membrane integrity test method further comprises:
s502: the air-bleeding filter is flushed with water for injection to infiltrate the liquid filtration membrane.
Specifically, the flow path of the radioactive liquid medicine is flushed by using the injection water, the radioactive liquid medicine in the exhaust filter is flushed completely when the exhaust filter performs online filter membrane detection, and the liquid filter membrane 12 of the exhaust filter 10 is soaked by using the injection water, so that a more accurate test result can be obtained when a filter membrane integrity test is performed by using a bubbling method.
Some embodiments of the invention also provide for the use of an in-line filter membrane integrity test apparatus according to the preceding embodiments in an in-line filter membrane integrity test.
Finally, it should be noted that: the embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The system or the device disclosed by the embodiment corresponds to the method disclosed by the embodiment, so that the description is simple, and the relevant points can be referred to the method part for description.
The above examples are only intended to illustrate the technical solution of the present invention, and not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (11)
1. An in-line filter membrane integrity testing apparatus for in-line filter membrane integrity testing in the production of radioactive pharmaceutical fluids, said in-line filter membrane integrity testing apparatus comprising:
an exhaust filter, disposed on a production line of the radioactive liquid medicine, having an inlet and an outlet, comprising:
a housing;
the liquid filtering membrane is arranged inside the shell and divides the inside of the shell into a first cavity and a second cavity, and the liquid filtering membrane is configured to allow liquid to pass through and remove bacteria in the liquid;
the exhaust port is arranged on the shell, so that the first cavity is communicated with the outside; and
a gas filtering membrane disposed at the gas outlet configured to allow gas to pass and to block liquid from passing; and
a plugging device, movable relative to the gas vent filter, configured to plug the gas vent when the liquid filtration membrane performs an integrity test.
2. The in-line filter membrane integrity testing device of claim 1, wherein the plugging device comprises:
a support bar;
the first moving rod is connected with the supporting rod in a sliding mode and arranged on one side, far away from the second cavity, of the first cavity; and
a first sealing member provided on a sidewall of the first moving bar facing the first chamber,
when the liquid filtering membrane executes an integrity test, the first moving rod drives the first sealing element to move towards the first cavity until the first sealing element seals the exhaust port.
3. The in-line filtration membrane integrity testing apparatus of claim 2, wherein the first seal has a raised portion facing the first cavity, the raised portion being inserted into the vent to seal the vent when the liquid filtration membrane performs an integrity test.
4. The in-line filter membrane integrity testing device of claim 2, wherein the plugging device further comprises:
the second movable rod is connected with the supporting rod in a sliding mode and arranged on one side, far away from the first cavity, of the second cavity; and
a second sealing member provided on a sidewall of the second moving bar facing the second chamber,
when the liquid filtering membrane performs an integrity test, the first moving rod and the second moving rod respectively drive the first sealing element and the second sealing element to approach each other, so that the first sealing element and the second sealing element clamp the exhaust filter.
5. The in-line filtration membrane integrity testing apparatus of any one of claims 2-4, wherein an inlet of the vent filter is disposed on a side of the first chamber remote from the second chamber, the inlet being removably connected to a first conduit,
the plugging device also has a first through hole penetrating the first movable rod and the first sealing member, and the first pipeline is arranged through the first through hole.
6. The in-line filter membrane integrity testing device of claim 1, wherein the plugging device comprises:
a support bar;
the third movable rod is connected with the supporting rod in a sliding or rotating mode and arranged on one side, far away from the second cavity, of the first cavity;
a vent tube supported by the third travel bar, the vent tube having a sealing interface configured to removably sealingly dock to the exhaust port; and
a switch valve arranged on the vent pipe and configured to control the opening or closing of the vent pipe,
wherein, when the liquid filtration membrane performs an integrity test, the sealing interface is sealingly docked to the vent and a switch valve closes the vent tube.
7. The in-line filter membrane integrity testing apparatus of any of claims 1-4 and 6, further comprising:
a first three-way valve configured to switch between a first state and a second state;
the liquid inlet pipe is connected with the first end of the first three-way valve;
the air inlet pipe is connected with the second end of the first three-way valve;
the first pipeline is connected with the third end of the first three-way valve and the inlet of the exhaust filter;
a second three-way valve configured to switch between a third state and a fourth state;
a second pipe connecting a first end of the second three-way valve and an outlet of the exhaust filter;
the air outlet pipe is connected with the second end of the second three-way valve;
a liquid outlet pipe connected with the third end of the second three-way valve,
when the first three-way valve is switched to a first state and the second three-way valve is switched to a third state, the liquid inlet pipe, the first pipeline, the exhaust filter, the second pipeline and the liquid outlet pipe form a passage, so that bacteria in the liquid medicine are filtered out through the exhaust filter;
when the first three-way valve is switched to the second state and the second three-way valve is switched to the fourth state, the air inlet pipe is communicated with the first pipeline, and the second pipeline is communicated with the air outlet pipe to be used for achieving the integrity test of the online filter membrane.
8. The in-line filter membrane integrity testing apparatus of claim 7, wherein at least a portion of the in-line filter membrane integrity testing apparatus is disposed within a shielded isolation box.
9. An in-line filter membrane integrity test method using the in-line filter membrane integrity test apparatus of claim 7 or 8, the in-line filter membrane integrity test method comprising:
the first three-way valve is switched to a first state and the second three-way valve is switched to a third state, and the pressurized liquid medicine flows through the liquid inlet pipe and the first pipeline, enters the exhaust filter for filtering, and is discharged through the second pipeline and the liquid outlet pipe; and
and switching the first three-way valve to a second state and switching the second three-way valve to a fourth state, plugging the exhaust port by the plugging device, and allowing the test gas to enter the exhaust filter through the gas inlet pipe and the first pipeline to execute an online filter membrane integrity test.
10. The in-line filter membrane integrity test method of claim 9, wherein prior to switching the first three-way valve to the second state and the second three-way valve to the fourth state, the in-line filter membrane integrity test method further comprises:
flushing the gas removal filter with water for injection to infiltrate the liquid filtration membrane.
11. Use of an in-line filtration membrane integrity test apparatus according to any one of claims 1 to 8 in an in-line filtration membrane integrity test.
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| CN114713036B (en) | 2022-08-26 |
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