A disposable liquid pre-filter sampling assembly for use in a liquid preparation system

Abstract

The utility model discloses a kind of disposable liquid medicine pre-filtering sampling components for liquid medicine preparation system, belong to liquid medicine preparation sampling equipment technical field, including pre-filtering unit and sampling unit, the sampling unit includes silica gel tube, connecting piece and sampling piece, the pre-filtering unit is communicated with sampling unit by silica gel tube, the input end of the pre-filtering unit is used to butt joint tank bottom liquid medicine's hose, and the sterile sampling of liquid medicine is realized, and need be treated by irradiation sterilization before use, the silica gel tube includes first silica gel tube and second silica gel tube, the connecting piece includes T type tee joint, Y type tee joint, quick -mounting luer joint and quick -mounting conversion joint, the sampling piece includes two liquid storage bags, needleless sampler and luer cap, the utility model has pre-filtering bacteria reduction reduces liquid medicine microorganism load, needleless sterile sampling improves inspection accuracy, without modification existing equipment realizes the technical effect of low-cost process optimization.

Description

Technical Field

[0001] This utility model belongs to the technical field of drug preparation and sampling equipment, and in particular relates to a disposable drug pre-filtration and sampling component used in a drug preparation system. Background Technology

[0002] In existing pharmaceutical preparation systems, the tubing at the bottom of the tank is typically directly connected to the filter piping of a stainless steel product, with the filtration process relying solely on a 0.22μm sterilizing filter at the rear. If the intermediate pharmaceutical solution has a high microbial load, it can easily overload the sterilizing filter, potentially leading to microbial contamination and spoilage. Traditional sampling methods rely on the equipment's built-in sampling port, which is susceptible to environmental or equipment residue contamination, resulting in sampling deviations. Furthermore, optimizing the filtration and sampling processes often requires modifying existing equipment, which is cumbersome and costly. Utility Model Content

[0003] To address the problems existing in the prior art, this utility model provides a disposable drug solution pre-filtration and sampling component for use in a drug solution preparation system. It has the advantages of pre-filtration to reduce the microbial load of the drug solution, needle-free aseptic sampling to improve the accuracy of testing, and low-cost process optimization without modifying existing equipment. It solves the problems in the prior art where excessive microorganisms in intermediate drug solutions lead to drug solution waste, sampling port contamination causes detection deviations, process optimization requires equipment modification, and operation is complicated and costly.

[0004] This invention is implemented as follows: a disposable pre-filtration and sampling component for a drug preparation system includes a pre-filtration unit and a sampling unit. The sampling unit includes a silicone tube, connectors, and a sampling element. The pre-filtration unit and the sampling unit are connected by the silicone tube. The input end of the pre-filtration unit is used to connect to the flexible tube of the drug solution at the bottom of the tank, and the output end of the pre-filtration unit is used to connect to the filter pipeline of a stainless steel product. The pre-filtration unit is a sterilization filter. The pre-filtration unit and the sampling unit are used to pre-filter and sterilize the drug solution output from the bottom of the tank in the drug preparation system, and to achieve aseptic sampling of the drug solution. It needs to be sterilized by irradiation before use. The silicone tube includes a first silicone tube and a second silicone tube. The connectors include a T-type tee connector, a Y-type tee connector, a quick-connect Luer connector, and a quick-connect conversion connector. The sampling element includes two storage bags, a needle-free sampler, and a Luer cap.

[0005] As a preferred embodiment of this invention, the pore size of the sterilization filter is 0.45μm, the material is PVDF, and the model is L05SHLHPVND0045G1P. The exhaust valve of the sterilization filter faces directly upwards, and its orientation is opposite to that of the 1 / 4-inch pagoda interface on the T-type tee connector that is directly connected later.

[0006] This setup allows the sterilization filter to precisely intercept microorganisms in the solution, reducing the load on the subsequent 0.22μm sterilization filter from the source and preventing the solution from being wasted due to excessive microorganisms. The upward-facing pagoda-shaped exhaust valve ensures unobstructed exhaust channels, allowing air to be smoothly discharged during the pre-filtration process and improving filtration efficiency. The opposite orientation of the interface to the T-type tee connector effectively avoids spatial interference during pipeline installation, ensuring the stability and standardization of the device installation.

[0007] As a preferred embodiment of this utility model, both the first silicone tube and the second silicone tube are platinum vulcanized silicone tubes. The first silicone tube is model TTH, and the second silicone tube is model TT17. The first silicone tube is used for the main path transmission of the medicine solution between the sterilization filter and the three-way connector, and the second silicone tube is used for the medicine solution transmission of the sampling branch.

[0008] This setup utilizes two types of platinum-cured silicone tubing adapted to different scenarios: the platinum-cured material possesses excellent chemical stability, corrosion resistance, and aseptic compatibility, preventing the tubing from reacting with the medication or releasing contaminants, thus ensuring the purity of the medication; the TTH model first silicone tubing is adapted to the high-flow-rate transmission requirements of the main medication route, while the TT17 model second silicone tubing is adapted to the low-flow-rate transmission requirements of the sampling branch route. The model distinction achieves functional isolation between the main and branch routes, ensuring the orderly and smooth transmission of the medication.

[0009] As a preferred embodiment of this utility model, the T-type tee connector is used to branch off the sampling branch from the main drug solution channel, the Y-type tee connector is used to extend the sampling branch, the quick-connect Luer connector is used to connect the needleless sampler, and the quick-connect adapter is used to connect the device with the stainless steel product filter pipeline.

[0010] With this setup, each connector has a clear division of labor and works in concert: the T-type tee connector enables precise branching from the main line to the first sampling branch, while the Y-type tee connector further expands to form the second sampling branch, meeting the actual needs of multiple sampling or multi-item testing; the quick-connect Luer connector enables a rapid and sealed connection between the needleless sampler and the pipeline, and the quick-connect adapter matches the interface specifications of existing stainless steel filter pipelines, allowing for docking without equipment modification, greatly improving installation convenience.

[0011] As a preferred embodiment of this invention, the needleless sampler is used to achieve needleless and pollution-free sampling of the drug solution, the storage bag is used to contain the sampled drug solution, and the Luer cap is used for sterile sealing before sampling.

[0012] This design avoids contamination caused by contact between the traditional sampling port and the outside environment, enabling contactless sampling and effectively ensuring the sterility of the sample. The Luer cap seals the interface before sampling, further blocking the contamination path. The two storage bags can be used for parallel sample testing or testing of different indicators, improving the practicality and flexibility of sampling.

[0013] In a preferred embodiment of this invention, the output end of the sterilization filter is connected to a T-shaped tee connector via a first silicone tube. One branch of the T-shaped tee connector is connected to a quick-connect Luer connector, a needle-free sampler, and a storage bag via a second silicone tube, forming a first sampling branch. The other branch of the T-shaped tee connector is connected to a Y-shaped tee connector via the first silicone tube. One branch of the Y-shaped tee connector is connected to another set of quick-connect Luer connectors, a needle-free sampler, and a storage bag, forming a second sampling branch. The output end of the Y-shaped tee connector is connected to the filter pipeline of a stainless steel product via a quick-connect adapter, used to transfer the pre-filtered and sterilized drug solution to the subsequent sterilization filtration stage.

[0014] With this setup, after the liquid medicine is sterilized by the pre-filtration unit, it is continuously transported to the subsequent sterilization and filtration stage through the main path without affecting the normal production rhythm. On the other hand, synchronous aseptic sampling is achieved through two independent sampling branches. The sampling process runs parallel to the production process without conflict, and the microbial status of the liquid medicine can be monitored in real time. The dual sampling branch design not only ensures the redundancy of sampling, but also provides adaptability for different testing needs, realizing integrated collaborative operation of filtration and sampling.

[0015] Compared with existing technologies, the beneficial effects of this utility model are as follows: It realizes the integrated function of pre-filtration and sterilization of drug solution and aseptic sampling, solving the core problems of high filtration load and sampling contamination in existing technologies from the source. The device adopts a disposable design and is sterilized by irradiation before use, which completely avoids the risk of cross-contamination and ensures the compliance of drug solution generation. Through the standardized quick-connect connector design, there is no need to modify the existing drug solution equipment. Installation can be completed simply by connecting the two ends, which is convenient and cost-effective. At the same time, the combination of needle-free sampling technology and dual sampling branches not only greatly improves the accuracy of sampling results, but also adapts to the needs of multiple sampling and multi-item testing in actual production, effectively reducing the waste rate of drug solution and improving production efficiency and product quality stability. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the overall structure provided in an embodiment of the present utility model;

[0017] Figure 2 This is a schematic diagram of the liquid storage bag structure provided in an embodiment of the present invention.

[0018] In the diagram: 1. Quick-connect Luer connector; 2. Needleless sampler; 3. Luer cap; 4. Quick-connect adapter; 5. T-type tee connector; 6. Y-type tee connector; 7. Liquid storage bag; 8. Sterilization filter; 9. First silicone tube; 10. Second silicone tube. Detailed Implementation

[0019] To further understand the utility model content, features and effects of this utility model, the following embodiments are provided, and detailed descriptions are given in conjunction with the accompanying drawings.

[0020] The structure of this utility model will now be described in detail with reference to the accompanying drawings.

[0021] refer to Figures 1 to 2 As shown in the figure, a disposable pre-filtration and sampling component for a drug preparation system provided by this utility model includes a pre-filtration unit and a sampling unit. The sampling unit includes a silicone tube, a connector, and a sampling component. The pre-filtration unit and the sampling unit are connected by a silicone tube. The input end of the pre-filtration unit is used to connect to the flexible tube of the drug solution at the bottom of the tank, and the output end of the pre-filtration unit is used to connect to the filter pipeline of a stainless steel product. The pre-filtration unit is a sterilization filter 8. The pre-filtration unit and the sampling unit are used to pre-filter and sterilize the drug solution output from the bottom of the tank in the drug preparation system and to achieve sterile sampling of the drug solution. It needs to be sterilized by irradiation before use. The silicone tube includes a first silicone tube 9 and a second silicone tube 10. The connector includes a T-type tee connector 5, a Y-type tee connector 6, a quick-connect Luer connector 1, and a quick-connect conversion connector 4. The sampling component includes two storage bags 7, a needleless sampler 2, and a Luer cap 3.

[0022] Specifically, the pore size of the sterilization filter 8 is 0.45μm, the material is PVDF, and the model is L05SHLHPVND0045G1P. The exhaust valve of the sterilization filter 8 faces directly upwards, and its orientation is opposite to that of the 1 / 4-inch pagoda interface on the T-type tee connector 5 that is directly connected later.

[0023] Using the above scheme, the sterilization filter 8 can accurately intercept microorganisms in the drug solution, reducing the load on the subsequent 0.22μm sterilization filter from the source and preventing the drug solution from being scrapped due to excessive microorganisms; the upward-facing design of the exhaust valve pagoda head ensures unobstructed exhaust channels, ensuring smooth air discharge during the pre-filtration process and improving filtration efficiency; the design with the interface facing the opposite direction to the T-type tee connector 5 can effectively avoid spatial interference during pipeline installation, ensuring the stability and standardization of the device installation.

[0024] Specifically, both the first silicone tube 9 and the second silicone tube 10 are platinum vulcanized silicone tubes. The first silicone tube 9 is model TTH, and the second silicone tube 10 is model TT17. The first silicone tube 9 is used for the main path transmission of the medicine solution between the sterilization filter 8 and the three-way connector, and the second silicone tube 10 is used for the medicine solution transmission of the sampling branch.

[0025] The above solution employs two types of platinum-cured silicone tubing adapted to different scenarios: the platinum-cured material possesses excellent chemical stability, corrosion resistance, and aseptic compatibility, preventing the tubing from reacting with the drug solution or releasing contaminants, thus ensuring the purity of the drug solution; the first silicone tubing 9 of the TTH model is adapted to the high-flow transmission requirements of the main drug solution route, while the second silicone tubing 10 of the TT17 model is adapted to the low-flow transmission requirements of the sampling branch route. The differentiation between the models achieves functional isolation between the main and branch routes, ensuring the orderly and smooth transmission of the drug solution.

[0026] Specifically, the T-type tee connector 5 is used to branch off the sampling branch from the main drug solution line, the Y-type tee connector 6 is used to extend the sampling branch, the quick-connect Luer connector 1 is used to connect the needleless sampler 2, and the quick-connect adapter 4 is used to connect the device to the stainless steel product filter pipeline.

[0027] Using the above scheme, each connector has a clear division of labor and works in concert: the T-type tee connector 5 enables precise branching of the main line to the first sampling branch, and the Y-type tee connector 6 further expands to form the second sampling branch, meeting the actual needs of multiple sampling or multi-item testing; the quick-connect Luer connector 1 enables quick and sealed connection between the needleless sampler 2 and the pipeline, and the quick-connect conversion connector 4 matches the interface specifications of existing stainless steel product filter pipelines, allowing for docking without equipment modification, greatly improving installation convenience.

[0028] Specifically, the needleless sampler 2 is used to achieve needleless and contamination-free sampling of the drug solution, the storage bag 7 is used to contain the sampled drug solution, and the Luer cap 3 is used for sterile sealing before sampling.

[0029] Using the above scheme, the needleless sampler 2 avoids contamination caused by the traditional sampling port coming into contact with the outside world, achieving contactless sampling and effectively ensuring the sterility of the sample; the Luer cap 3 seals and protects the interface before sampling, further blocking the contamination path; the two liquid storage bags 7 can be used for parallel sample testing or different index testing respectively, improving the practicality and flexibility of sampling.

[0030] Specifically, the output end of the sterilization filter 8 is connected to a T-shaped tee connector 5 via a first silicone tube 9. One branch of the T-shaped tee connector 5 is connected to a quick-connect Luer connector 1, a needleless sampler 2, and a storage bag 7 via a second silicone tube 10, forming a first sampling branch. The other branch of the T-shaped tee connector 5 is connected to a Y-shaped tee connector 6 via the first silicone tube 9. One branch of the Y-shaped tee connector 6 is connected to another set of quick-connect Luer connectors 1, needleless samplers 2, and a storage bag 7, forming a second sampling branch. The output end of the Y-shaped tee connector 6 is connected to the filter pipeline of the stainless steel product via a quick-connect conversion connector 4, which is used to transfer the pre-filtered and sterilized drug solution to the subsequent sterilization filtration stage.

[0031] Using the above scheme, after the drug solution is sterilized by the pre-filtration unit, it is continuously transported to the subsequent sterilization and filtration stage through the main path without affecting the normal production rhythm. On the other hand, synchronous aseptic sampling is achieved through two independent sampling branches. The sampling process runs parallel to the production process without conflict, and the microbial status of the drug solution can be monitored in real time. The dual sampling branch design not only ensures the redundancy of sampling, but also provides adaptability for different testing needs, realizing the integrated collaborative operation of filtration and sampling.

[0032] The working principle of this utility model:

[0033] In use, the quick-connect interface at the input end of the sterilization filter 8 is directly connected to the liquid tubing at the bottom of the tank. The quick-connect adapter 4 is connected to the filter pipeline of the stainless steel product. The liquid output from the bottom of the tank is first pre-filtered and sterilized by the sterilization filter 8 to reduce the microbial load and reduce the load on the subsequent sterilization filter. The pre-filtered liquid is then diverted to the main transmission route and the sampling branch route via a T-type tee connector. The main liquid is continuously transported to the filter pipeline of the stainless steel product through a Y-type tee connector 6 and a quick-connect adapter 4 to enter the subsequent stage. The two independent sampling branches are connected by a platinum vulcanized silicone tube, a quick-connect Luer connector 1, a needleless sampler 2, and a storage bag 7. Under the aseptic sealing of the Luer cap 3, non-contact aseptic sampling is achieved. The device is for single use only, which does not interfere with the original production process and simultaneously achieves the process optimization goals of reducing the risk of liquid waste and improving sampling accuracy.

[0034] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0035] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A disposable pre-filtration and sampling component for a drug solution preparation system, characterized in that: It includes a pre-filtration unit and a sampling unit. The sampling unit includes a silicone tube, a connector and a sampling component. The pre-filtration unit and the sampling unit are connected by a silicone tube. The input end of the pre-filtration unit is used to connect to the hose of the medicine liquid at the bottom of the tank. The output end of the pre-filtration unit is used to connect to the filter pipeline of the stainless steel product. The pre-filtration unit is a sterilization filter (8). The pre-filtration unit and the sampling unit are used to pre-filter and sterilize the medicine liquid output from the bottom of the tank in the medicine preparation system and to achieve sterile sampling of the medicine liquid. It needs to be irradiated and sterilized before use. The silicone tube includes a first silicone tube (9) and a second silicone tube (10). The connector includes a T-type tee connector (5), a Y-type tee connector (6), a quick-connect Luer connector (1) and a quick-connect conversion connector (4). The sampling component includes two liquid storage bags (7), a needleless sampler (2) and a Luer cap (3).

2. The disposable drug solution pre-filtration and sampling component used in the drug solution preparation system as described in claim 1, characterized in that: The filter pore size of the sterilization filter (8) is 0.45μm, the material is PVDF, and the model is L05SHLHPVND0045G1P. The exhaust valve pagoda head of the sterilization filter (8) faces directly upwards and is opposite to the 1 / 4-inch pagoda interface on the T-type tee connector (5) that is directly connected later.

3. The disposable drug solution pre-filtration and sampling component used in the drug solution preparation system as described in claim 1, characterized in that: The first silicone tube (9) and the second silicone tube (10) are both platinum vulcanized silicone tubes. The first silicone tube (9) is model TTH and the second silicone tube (10) is model TT17. The first silicone tube (9) is used for the main path transmission of medicine between the sterilization filter (8) and the three-way connector, and the second silicone tube (10) is used for the medicine transmission of the sampling branch.

4. The disposable drug solution pre-filtration and sampling component used in the drug solution preparation system as described in claim 1, characterized in that: The T-type tee connector (5) is used to branch off the sampling branch from the main drug solution route, the Y-type tee connector (6) is used to extend the sampling branch, the quick-connect Luer connector (1) is used to connect the needleless sampler (2), and the quick-connect conversion connector (4) is used to connect the device with the stainless steel product filter pipeline.

5. The disposable drug solution pre-filtration and sampling component used in the drug solution preparation system as described in claim 1, characterized in that: The needleless sampler (2) is used to achieve needleless and pollution-free sampling of the drug solution, the storage bag (7) is used to contain the sampled drug solution, and the Luer cap (3) is used for sterile sealing before sampling.

6. The disposable drug solution pre-filtration and sampling component used in a drug solution preparation system as described in claim 1, characterized in that: The output end of the sterilization filter (8) is connected to a T-type tee connector (5) via a first silicone tube (9). One branch of the T-type tee connector (5) is connected to a quick-connect Luer connector (1), a needleless sampler (2), and a storage bag (7) via a second silicone tube (10) to form a first sampling branch. The other branch of the T-type tee connector (5) is connected to a Y-type tee connector (6) via the first silicone tube (9). One branch of the Y-type tee connector (6) is connected to another set of quick-connect Luer connectors (1), a needleless sampler (2), and a storage bag (7) to form a second sampling branch. The output end of the Y-type tee connector (6) is connected to the filter pipeline of the stainless steel product via a quick-connect conversion connector (4) to transfer the pre-filtered sterilized medicine to the subsequent sterilization filtration stage.

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