CN218853623U

CN218853623U - Multistage filtration degerming equipment

Info

Publication number: CN218853623U
Application number: CN202223412314.1U
Authority: CN
Inventors: 李鑫; 胡怡晨; 潘震
Original assignee: Shanghai Ruining Biotechnology Co ltd
Current assignee: Shanghai Ruining Biotechnology Co ltd
Priority date: 2022-12-20
Filing date: 2022-12-20
Publication date: 2023-04-14
Anticipated expiration: 2032-12-20

Abstract

The utility model relates to a medical equipment technical field specifically provides a multistage filtration degerming equipment, including three-way valve A, three-way valve B, three-way valve E, air sterilization filter (2), air compressor (1), manometer (6), the filter unit of a N series connection, final liquid filter (10), final bubble test structure (13), aseptic stock solution structure (14), through setting up the controllable valve of setting up the multiport at every both ends of crossing the filtering fungus membrane, can realize that multilayer filter membrane normal position integrality detects, provide convenience for the multistage filtration of liquid medicine.

Description

Multistage filtration sterilization equipment

Technical Field

The utility model relates to a medical equipment technical field specifically is a multistage filtration degerming equipment.

Background

Medical devices or medical fluids are currently widely sterilized using radiation or ethylene oxide EO, but for some fluids such as polyethylene glycol hydrogel fluids; if radiation or ethylene oxide is adopted for sterilization, the performance of the liquid medicine can be greatly influenced, and the liquid medicine cannot be normally used. For such medical liquids, sterilization of the medical liquids is generally performed by using a sterilization filtration technology, and the complexity of the sterilization method is mainly that after each sterilization filter is used, the integrity of the filter membrane of the sterilization filter must be tested by using a proper method.

Generally, the aseptic filtration equipment is primary filtration, and related solutions are disclosed in the prior art for performing integrity test of a filter membrane on the basis of the primary aseptic filtration equipment, for example, a patent with the publication number of CN215196355U discloses an aseptic filtration and filter membrane integrity test system, which discloses that after liquid medicine is subjected to aseptic filtration, the function conversion of two systems of filtration and aseptic filter membrane integrity test can be realized only by changing the valve core directions of a three-way valve A and a three-way valve B which are communicated with the front and back of the aseptic filter membrane, the filter membrane is not required to be disassembled to be connected with a commercial integrity tester for integrity test, the filter membrane integrity test time is shortened, and the cost for testing the integrity of the aseptic filter membrane is reduced.

However, the following general phenomena exist in the prior art of adopting a primary filtering device in the sterilization process of liquid medicines: the degerming filter only has one layer of filter membrane, and the filter membrane of the degerming filter directly causes filtration failure after being damaged, and the possibility is much higher than that of the degerming filter with two layers of filter membranes being damaged; in order to reduce the risk, the microbial contamination level of the medium before filtration is generally required to be controlled to be less than or equal to 10cfu/100ml, so that only a sterilizing filter with one filter membrane cannot effectively sterilize the liquid medicine with higher initial contamination bacteria, a series of sterilizing filter devices with at least two filter membranes is required to achieve the sterilizing effect, and then the series of filters must completely pass the integrity test after use. In the prior art, the integrity test of the filter membrane of the multistage filtration sterilization equipment still needs to be carried out after the sterilization filtration is finished, and then the test after the disassembly is carried out, so that the risk of damage of the filter membrane caused by inspection operation due to subsequent operation pollution exists, and the accuracy of the integrity test of the filter membrane cannot be ensured; and because the length of the pipeline of the multistage filtering equipment is long, the tail liquid in the pipeline is excessive after the degerming and filtering is finished, and the filtering loss is large.

SUMMERY OF THE UTILITY MODEL

Not enough to prior art, the utility model provides a multistage filtration degerming equipment can realize the normal position integrality detection of all filter membranes of multistage filtration, provides convenience for the multistage filtration of liquid medicine.

The utility model discloses a multistage filtration sterilization equipment, as shown in figure 1, comprising a three-way valve A, a three-way valve B, a three-way valve E, an air sterilization filter (2), an air compressor (1), a pressure gauge (6), N series-connected filter units, a final liquid filter (10), a final foaming test structure (13) and an aseptic liquid storage structure (14);

three ports of the three-way valve A are respectively marked as A-a, A-b and A-c;

three ports of the three-way valve B are respectively marked as B-a, B-B and B-c;

three ports of the three-way valve E are respectively marked as E-a, E-b and E-c;

a port A-a of the three-way valve A is connected with a first pipeline (3), the first pipeline (3) is used as an inlet of liquid medicine or water for injection, and a port A-B is connected with a port B-a of the three-way valve B through a pipeline; the through port A-c is connected with an outlet of the air sterilizing filter (2) through a pipeline, and an inlet of the air sterilizing filter (2) is connected with the air compressor (1) through a pipeline;

a port B-B of the three-way valve B is connected with the inlet ends of N filtering units connected in series through a pipeline, and a port B-c is connected with the pressure gauge (6);

the outlet ends of the N filtering units connected in series are connected with the inlet of a final liquid filter (10) through a pipeline; the outlet of the final liquid filter (10) is connected with a port E-a of the three-way valve E, a port E-c is connected with a final foaming test structure (13), and a port E-b is connected with a sterile liquid storage structure (14).

As shown in fig. 2, the filter unit includes: the device comprises a three-way valve C, a unit liquid filter (80), a four-way valve D and a unit foaming test structure (120); the port C-a of the three-way valve C is an inlet of a filtering unit, the port C-b of the three-way valve C is connected with an inlet of a unit liquid filter (80) through a pipeline, the port C-C is connected with the port D-D of a four-way valve D through a pipeline, and an outlet of the unit liquid filter (80) is connected with the port D-a of the four-way valve D and the port D-b to be connected with a unit foaming test structure (120).

Compared with the prior art, the beneficial effects of the utility model are as follows:

1. the multi-stage filtration sterilization equipment of the utility model can be provided with two or more stages of sterilization filtration links, so as to meet the sterilization filtration requirements of various liquid medicines, especially the liquid medicine with higher initial bacteria content;

2. the utility model discloses a multistage filtration degerming equipment, immediately there is not the transfer and does not have the split, carries out the test of filter membrane integrality more than two-stage or two-stage respectively, prevents that inspection operation pollution filter from causing the interference to test itself, and the test result is more accurate.

3. The utility model discloses a multistage filtration degerming equipment can use the compressed air through the degerming to carry out the tail liquid evacuation, reduces filtration loss, and can regulate and control and monitor pressure, prevents that the filter membrane from damaging.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a schematic structural view of the multi-stage filtration sterilization apparatus of the present invention;

FIG. 2 is a schematic structural view of the filtering unit of the present invention;

FIG. 3 is a schematic structural view of the two-stage filtration sterilization apparatus according to the embodiment of the present invention.

In the figure: 1. an air compressor; 2. an air sterilizing filter; 3. a first conduit; 6. a pressure gauge; 80. a unit liquid filter; 8. a first liquid filter; 10. a final liquid filter; 120. a unit blister test structure; 12. a first blister test structure; 13. a final blister test structure; 14. aseptic stock solution structure.

Detailed Description

In the following description, numerous implementation details are set forth in order to provide a more thorough understanding of the present invention. It should be understood, however, that these implementation details should not be used to limit the invention. That is, in some embodiments of the invention, details of these implementations are not necessary. In addition, some conventional structures and components are shown in simplified schematic form in the drawings.

In addition, the descriptions related to "first", "second", etc. in the present invention are only for description purposes, not specifically referring to the order or sequence, and are not intended to limit the present invention, but only to distinguish the components or operations described in the same technical terms, and are not to be construed as indicating or implying any relative importance or implicit indication of 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 addition, the technical solutions in the embodiments may be combined with each other, but it must be based on the realization of those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should not be considered to exist, and is not within the protection scope of the present invention.

The multistage filtration sterilization apparatus of the present invention, using two-stage sterilization filtration as an example to illustrate the function implementation process, as shown in fig. 3, the unit liquid filter 80 in the filtration unit of the multistage filtration sterilization apparatus is the first liquid filter 8, and the final liquid filter 10 is the second liquid filter 10; final blister test structure 13 is second blister test structure 13;

the multistage filtration sterilization device comprises a three-way valve A, a three-way valve B, a three-way valve E, an air sterilization filter, an air compressor 1, a pressure gauge 6, a first liquid filter 8, a first foaming test structure 12, a second liquid filter 10, a second foaming test structure 13 and a sterile liquid storage structure 14; the first blister test structure 12 and the second blister test structure 13 may be constituted by glass beakers loaded with clean water; the first liquid filter 8 and the second liquid filter 10 are needle filters, for example, when the first liquid filter and the second liquid filter are used for sterilization filtration of polyethylene glycol hydrogel liquid medicine;

the sterile liquid storage structure 14 may be a sterile liquid storage tank; all the three-way valves and the four-way valves are injection molding parts preferably made of polypropylene PP materials; the joints of all the three-way valves and the four-way valves are sealed by raw material belts and are fixed by binding belts; the three-way valve, the four-way valve, the silicone tube, the raw material belt and the ribbon assembly are all dried after being subjected to damp-heat sterilization.

Taking the prepared polyethylene glycol hydrogel intermediate water solution with a bacteria content of 50cfu/mL as an example, and the specific first liquid filter (8) and the second liquid filter both adopt a merck phi 33mm needle filter, a PES hydrophilic filter membrane with a pore size of 0.22um; the sterile liquid storage structure 14 adopts a 1000mL sterile bottle of New medical materials Co., ltd. Of Diruil, changzhou; the air compressor 1 is a model ZY-550-30 air compressor of Zhejiang Shengyuan air compressor manufacturing Limited; the air sterilizing filter 2 is a merck air sterilizing filter; all connecting pipelines including the first pipeline 3 adopt 16# silicone tubes of Fumeis instruments (Shanghai) limited; the pressure gauge 6 is a Y-60BF pressure gauge of Shanghai instrument cloud instrument factory; the functions are adjusted and realized as follows:

and (3) a degerming and filtering link: adjusting the three-way valve A to enable the ports A-a and A-b of the three-way valve A to form a passage, and closing the ports A-c; the three-way valve B is a holding passage of three ports; adjusting the three-way valve C to enable the C-a and the C-b to form a passage and close the C-C; regulating the four-way valve D to enable D-a and D-c to form a passage and D-b and D-D to be closed; adjusting the three-way valve E to enable the E-a and the E-b to form a passage, and closing the E-c; the sterilization and filtration can be performed by introducing the chemical solution from the first pipe 3. When degerming filtration is carried out, the process monitoring filtration pressure is 0.10MPa, the pressure gradually rises to 0.15MPa with the increase of filtrate, and the filtration is finished;

and (3) tail liquid emptying link: after the degerming and filtering link is finished, adjusting the three-way valve A to enable the A-b and the A-c to form a channel, closing the A-a and keeping the rest valves unchanged; and opening the air compressor 1, and after the compressed air with certain power passes through the air sterilizing filter 2, performing tail liquid flushing and discharging of subsequent pipelines and liquid filters at all stages by using the sterilized compressed air. Regulating a pressure regulating valve of an air compressor to set the pressure to be 0.1MPa, and flushing and discharging tail liquid by using sterilized compressed air;

and (3) a preparation link of filter membrane integrity checking: after the tail-page emptying link is finished, firstly adjusting a three-way valve A to enable A-a and A-b to form a channel, A-c to be closed, adjusting a three-way valve E to enable E-a and E-c to form a channel, E-b to be closed, then replacing the liquid medicine with water for injection, and flushing a filter membrane;

a membrane integrity checking stage of the first liquid filter (8): and adjusting the three-way valve C to enable the C-a and the C-b to form a passage, closing the C-C, adjusting the four-way valve D to enable the D-a and the D-b to form a passage, and closing the D-C and the D-D, so that a filter membrane integrity test, namely a bubble point test, of the first liquid filter 8 can be carried out. Adjusting the pressure setting of a pressure regulating valve of an air compressor to be 0.5MPa, reading the pressure of a bubbling point from a pressure gauge (6) to be 0.38MPa, and judging that the integrity test of the filter membrane passes;

filter membrane integrity checking procedure for the second liquid filter 10: after the integrity test of the filter membrane of the first liquid filter 8 is finished, the three-way valve C is adjusted to enable the C-a and the C-C to form a passage, the C-b is closed, the four-way valve D is adjusted to enable the D-C and the D-D to form a passage, and the D-a and the D-b are closed, so that the filter membrane integrity test, namely the bubble point test, of the second liquid filter (10) can be carried out. Adjusting the pressure setting of the pressure regulating valve of the air compressor to be 0.5MPa, and the pressure of the bubble point to be 0.39MPa, and judging that the integrity test of the filter membrane passes.

And (3) degerming filter membrane breakage demonstration: after the filter membrane integrality of second filter 8 is checked, adjust each valve to the state of above-mentioned "filter membrane integrality check preparation link", use the water for injection, continuously increase discharge, wash the filter membrane, the 6 readings of manometer continuously rise, continue to increase discharge, reduce suddenly until the 6 readings of manometer reduce, the filter membrane has been damaged this moment. And (3) adjusting each valve to a filter membrane integrity checking link of the first liquid filter (8), adjusting the pressure setting of a pressure regulating valve of an air compressor to be 0.5MPa, and performing a filter membrane integrity test of the first liquid filter (8) again, wherein a pressure gauge 6 basically has no indication, the bubble point pressure is about 0.02MPa, and the filter membrane integrity test fails.

The above description is only an embodiment of the present invention, and is not intended to limit the present invention. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A multi-stage filtration sterilization device is characterized by comprising a three-way valve A, a three-way valve B, a three-way valve E, an air sterilization filter (2), an air compressor (1), a pressure gauge (6), N filter units connected in series, a final liquid filter (10), a final foaming test structure (13) and an aseptic liquid storage structure (14);

the port A-a of the three-way valve A is connected with a first pipeline (3), the first pipeline (3) is used as an inlet of liquid medicine or water for injection, and the port A-B is connected with the port B-a of the three-way valve B through a pipeline; the port A-c is connected with the outlet of the air sterilizing filter (2) through a pipeline, and the inlet of the air sterilizing filter (2) is connected with the air compressor (1) through a pipeline;

the port B-B of the three-way valve B is connected with the inlet ends of N filtering units connected in series through a pipeline, and the port B-c is connected with the pressure gauge (6);

the outlet ends of the N filtering units connected in series are connected with the inlet of a final liquid filter (10) through a pipeline; the outlet of the final liquid filter is connected with a port E-a of the three-way valve E, a port E-c is connected with a final foaming test structure (13), and a port E-b is connected with a sterile liquid storage structure;

the filter unit includes: the device comprises a three-way valve C, a unit liquid filter (80), a four-way valve D and a unit foaming test structure (120); the device comprises a three-way valve C, a unit liquid filter, a unit foaming test structure (120), a unit liquid filter D, a unit foaming test structure (120), a filter unit and a unit foaming test system, wherein a port C-a of the three-way valve C is an inlet of the filter unit, a port C-b of the three-way valve C is connected with an inlet of the unit liquid filter through a pipeline, a port C-C is connected with a port D-D of the four-way valve D through a pipeline, and an outlet of the unit liquid filter (80) is connected with a port D-a and a port D-b of the four-way valve D.

2. The multi-stage filtration sterilization apparatus according to claim 1, wherein the multi-stage filtration sterilization apparatus is a two-stage sterilization filtration apparatus, a unit liquid filter in the filtration unit is a first liquid filter, and a final liquid filter is a second liquid filter; the final blister test structure is the second blister test structure.

3. The multistage filter sterilization apparatus according to claim 1 or 2, wherein the unit foaming test structure and the final foaming test structure are constituted by glass beakers loaded with clean water.

4. The multi-stage filtration sterilization apparatus according to claim 1 or 2, wherein when the multi-stage filtration sterilization apparatus is used for polyethylene glycol hydrogel liquid sterilization filtration, the unit liquid filter and the final liquid filter are both needle filters.

5. The multistage filtration sterilization apparatus according to claim 4, wherein the needle filter is a PES hydrophilic filter having a pore size of 0.22um.

6. The multistage filtration sterilization apparatus according to claim 1 or 2, wherein the three-way valve a, the three-way valve B, the three-way valve C, the four-way valve D, and the three-way valve E are injection molded parts made of polypropylene.

7. The multi-stage filtration sterilization apparatus of claim 1, wherein all of the connecting lines including the first line are silicone tubing.