Redundant filter with built-in sampling device
The redundant filter with its own sampling device solves the problem of insufficient microbial load in Class C clean environments, effectively monitors the microbial limits of the drug solution and ensures the pass rate after filtration, reducing quality risks and space costs.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- MERRO PHARMA
- Filing Date
- 2025-07-16
- Publication Date
- 2026-06-09
Smart Images
Figure CN224331702U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of liquid preparation and filtration technology, and in particular to a redundant filter with a built-in sampling device used in the liquid preparation process of freeze-dried drugs. Background Technology
[0002] Currently, the requirement for microbial load before sterilization filtration of the drug solution is ≤10CFU / 100ml. After the solution preparation process is completed, the microbial load before sterilization filtration is usually sampled directly from the solution preparation tank. Since the solution preparation process is generally carried out in a Class C clean environment, factors such as environment, temperature and humidity, and raw materials may cause the microbial load to fail to meet the standard, which poses a certain quality risk.
[0003] In view of the problems existing in the above-mentioned prior art, it is necessary to study and design a new type of redundant filter with a built-in sampling device to overcome the problems existing in the prior art. Summary of the Invention
[0004] The existing technology addresses the technical problem that the microbial load may not meet the standards due to factors such as environment, temperature and humidity, and raw materials, which can lead to quality risks when carried out in a Class C clean environment. Therefore, a redundant filter with a built-in sampling device is provided.
[0005] The technical means adopted in this utility model are as follows:
[0006] A redundant filter with a built-in sampling device includes a filter body;
[0007] Furthermore, a filter vent is provided on the top of the filter body to remove air from the liquid medicine;
[0008] Furthermore, the bottom of the filter body is equipped with a liquid inlet pipe and a liquid outlet pipe;
[0009] Furthermore, a sampling port for pre-filtration of the drug solution is set on the drug solution inlet pipe to monitor the microbial status of the drug solution before the load is reduced.
[0010] Furthermore, a sampling port for the filtered drug solution is installed on the drug solution outlet pipe to monitor the microbial status of the drug solution after the load is reduced.
[0011] Furthermore, the filter body includes: a filter housing and a filter element.
[0012] Furthermore, the filter housing is a 10-inch filter housing made of 316L stainless steel;
[0013] Furthermore, a 10-inch 0.45-micron filter element is installed inside the filter housing.
[0014] Furthermore, a pressure detection port is provided at the upper end of the filter housing, and a pressure gauge is assembled inside via a quick-release chuck.
[0015] Furthermore, the filter element is made of polyethersulfone.
[0016] Furthermore, the connection between the filter element base and the filter housing is sealed using quick-connect clips.
[0017] Furthermore, the inlet pipe delivers a solution with a pressure of 0.20-0.25 MPa into the filter, which is then filtered by the filter element and discharged from the outlet pipe.
[0018] Furthermore, the sampling valves installed on the sampling ports before and after drug filtration have the same structure, both using a male and female threaded rotating method for assembly.
[0019] Furthermore, the female end is connected at a 90-degree angle to the inlet or outlet pipe of the liquid medicine. The connection is made using gas pressure shielded welding technology, with 316L stainless steel welding rods used. The weld joint is pickled and passivated, and the inner wall is provided with a 6mm inner wire.
[0020] Furthermore, the male end is a sampling nozzle with a 6mm external thread on its outer wall, which is rotated and tightened with the female end. A 6mm O-ring is used at the connection between the male and female ends to ensure the sealing of the sampling valve.
[0021] The assembly and use process of this utility model is as follows:
[0022] A 10-inch polyethersulfone 0.45-micron filter element is installed in a 10-inch redundant filter. After the solution preparation process is completed, the solution is transported using compressed air at a pressure controlled at 0.20-0.25 MPa. When the solution passes through the redundant filter, air is vented through the vent at the top of the filter element. Once liquid appears, the vent valve is closed, and the filter outlet sampling valve is rotated open to collect the solution into a sampling bottle. By adding sampling devices at the inlet and outlet of the redundant filter, the space cost of adding an additional sampling valve is saved, and the risk of non-compliance of the drug's microbial limit sampling is mitigated. At the same time, the sampling valve before filtration allows for comparison of the difference in microbial limits before and after filtration, more effectively ensuring that the microbial limit is within acceptable limits after 0.45-micron filtration.
[0023] Compared with the prior art, the present invention has the following advantages:
[0024] 1. The redundant filter with built-in sampling device provided by this utility model saves the space cost of adding an additional sampling valve and ensures that the drug microbial limit sampling does not meet the requirements by adding a sampling device to the inlet and outlet of the redundant filter.
[0025] 2. The redundant filter with built-in sampling device provided by this utility model allows for comparison of the difference in microbial limits before and after filtration by the sampling valve before filtration, thus more effectively ensuring that the microbial limits are within acceptable limits after 0.45-micron filtration.
[0026] In summary, the technical solution of this utility model solves the problem in the prior art where the microbial load is not up to standard due to factors such as environment, temperature and humidity, and raw materials when carried out in a Class C clean environment, leading to quality risks. Attached Figure Description
[0027] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0028] Figure 1 This is a schematic diagram of the structure of this utility model.
[0029] In the diagram: 1. Filter housing; 2. Filter element; 3. Filter vent; 4. Liquid inlet pipe; 5. Liquid outlet pipe; 6. Pressure detection port; 7. Quick-connect clip; 8. Sampling port before filtration; 9. Sampling port after filtration. Detailed Implementation
[0030] It should be noted that, where there is no conflict, the embodiments and features in the embodiments of this utility model can be combined with each other. The present utility model will now be described in detail with reference to the accompanying drawings and embodiments.
[0031] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit this utility model or its application or use. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.
[0032] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to the present invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.
[0033] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values of the components and steps described in these embodiments do not limit the scope of this invention. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following figures denote similar items; therefore, once an item is defined in one figure, it need not be further discussed in subsequent figures.
[0034] In the description of this utility model, it should be understood that the orientation or positional relationship indicated by directional terms such as "front, back, up, down, left, right", "horizontal, vertical, horizontal" and "top, bottom" is usually based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing this utility model and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the scope of protection of this utility model. The directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.
[0035] For ease of description, spatial relative terms such as "above," "over," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation besides the orientation of the device as described in the figures. For example, if the device in the figures is inverted, a device described as "above" or "above" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.
[0036] Furthermore, it should be noted that the use of terms such as "first" and "second" to define components is merely for the purpose of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be construed as limiting the scope of protection of this utility model.
[0037] like Figure 1 As shown, this utility model provides a redundant filter with a built-in sampling device, including a filter body; a filter exhaust port 3 is provided on the top of the filter body to remove air from the liquid medicine; a liquid medicine inlet pipe 4 and a liquid medicine outlet pipe 5 are assembled at the bottom of the filter body; a pre-filtration sampling port 8 is provided on the liquid medicine inlet pipe 4 to monitor the microbial status of the liquid medicine before de-loading; a post-filtration sampling port 9 is provided on the liquid medicine outlet pipe 5 to monitor the microbial status of the liquid medicine after de-loading.
[0038] The filter body includes: filter housing 1 and filter element 2. Filter housing 1 is a 10-inch filter housing made of 316L stainless steel; a 10-inch 0.45 micron filter element 2 is installed inside filter housing 1.
[0039] The upper end of the filter housing 1 is provided with a pressure detection port 6, and a pressure gauge is assembled inside via a quick chuck.
[0040] Filter element 2 is made of polyethersulfone.
[0041] The base of filter element 2 is sealed to the filter housing 1 using quick-connect clips 7.
[0042] The inlet pipe 4 delivers a liquid medicine with a pressure of 0.20-0.25 MPa into the filter, which is then filtered by the filter element 2 and discharged from the outlet pipe 5.
[0043] The sampling valves installed on the sampling port 8 before and the sampling port 9 after the drug solution filtration have the same structure, and are assembled by rotating the male and female threads. The female end is connected to the drug solution inlet pipe 4 or the drug solution outlet pipe 5 at a 90-degree angle. The connection is made by gas pressure protected welding technology, using stainless steel 316L welding rods. The weld joint is pickled and passivated, and the inner wall is provided with a 6mm internal thread. The male end is the sampling nozzle, with a 6mm external thread on the outer wall, which is rotated and tightened with the female end. The connection between the male and female ends is ensured by a 6mm O-ring to ensure the sealing of the sampling valve.
[0044] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.
Claims
1. A redundant filter with a built-in sampling device, comprising a filter body; characterized in that: The filter body is provided with a filter exhaust port (3) at the top, which serves to expel air from the liquid medicine; The bottom of the filter body is equipped with a liquid inlet pipe (4) and a liquid outlet pipe (5); The inlet pipe (4) of the liquid medicine is provided with a sampling port (8) before the liquid medicine is filtered, which can monitor the microbial status of the liquid medicine before the load is reduced; The drug outlet pipe (5) is equipped with a sampling port (9) for drug filtration, which can monitor the microbial status of the drug after the load is reduced.
2. The redundant filter with integrated sampling device according to claim 1, characterized in that: The filter body includes: a filter housing (1) and a filter element (2). The filter housing (1) is a 10-inch filter housing made of 316L stainless steel; The filter housing (1) is fitted with a 10-inch 0.45-micron filter element (2).
3. The redundant filter with integrated sampling device according to claim 2, characterized in that: The filter housing (1) is provided with a pressure detection port (6) at the upper end, and a pressure gauge is assembled inside via a quick chuck.
4. The redundant filter with integrated sampling device according to claim 2, characterized in that: The filter element (2) is made of polyethersulfone.
5. The redundant filter with integrated sampling device according to claim 2, characterized in that: The connection between the base of the filter element (2) and the filter housing (1) is sealed using a quick-connect clip (7).
6. The redundant filter with integrated sampling device according to claim 1, characterized in that: The inlet pipe (4) delivers a liquid medicine with a pressure of 0.20-0.25 MPa into the filter, and after being filtered by the filter element (2), it is discharged from the outlet pipe (5).
7. The redundant filter with integrated sampling device according to claim 1, characterized in that: The sampling valves installed on the sampling port (8) before drug filtration and the sampling port (9) after drug filtration have the same structure, and are assembled by rotating male and female threaded heads. The female end is perpendicularly connected to the inlet pipe (4) or outlet pipe (5) of the liquid medicine at a 90-degree angle. The connection is made by gas pressure protection welding technology. The welding rod is made of stainless steel 316L welding rod. The weld joint is pickled and passivated. The inner wall is provided with a 6mm inner wire. The male end is a sampling nozzle with a 6mm external thread on its outer wall, which is rotated and tightened with the female end. A 6mm O-ring is used at the connection between the male and female ends to ensure the sealing of the sampling valve.