Aseptic sampler and use thereof

Abstract

The application discloses a sterile sampler and application thereof, which is composed of a pneumatic valve, a main pipeline, branch pipelines and sampling bottles integrated on a base plate; the pneumatic valve is composed of a diaphragm, a piston rod, a piston pad, a gas chamber and an opening valve gas channel and a closing valve gas channel; during use, the opening and closing of the pneumatic valve are controlled by passing sterile high-pressure gas into the gas channel, so as to complete pipeline cleaning, sterile sampling and pipeline pressure maintaining and other operations; one sampling bottle is used each time, and the bottle is removed after sampling; the remaining sampling bottles are used for the next sampling, so that the sterile sampling in a strict sense is realized.

Description

Technical Field

[0001] This invention relates to a sterile sampler and its application, and more particularly to an automated sterile sampling device for biological processes, belonging to the field of biotechnology. Background Technology

[0002] Currently, there are three common sampling methods for aseptic sampling in bioprocesses: manual quick sampling, three-valve sampling bottles, and welding and cutting machines. The first method requires highly skilled operators and is not conducive to widespread adoption. Three-valve sampling bottles require sterilization for each sampling, which is complex and costly. The third method is also cumbersome and not conducive to widespread adoption because welding and cutting machines are expensive, bulky, and need to be moved to the site each time. Summary of the Invention

[0003] The purpose of this invention is to solve the problem that aseptic sampling devices for biological processes are large in size, high in cost, and unsuitable for large-scale promotion.

[0004] The technical solution of this invention:

[0005] Multiple cavities, a main pipe, and multiple branch pipes are arranged on a glass or plastic substrate using injection molding technology. A pneumatic valve is installed in each cavity. The pneumatic valve consists of a diaphragm, a piston rod, a piston pad, an air chamber, an opening air passage, a closing air passage, and a sterile air passage filter. The air chamber of the pneumatic valve is divided into air chamber 1 and air chamber 2 by a partition with a central hole. Air chamber 1 is further divided into upper and lower air chambers by the piston pad of the pneumatic valve. The opening of the opening air passage is located in the lower air chamber of air chamber 1 near the partition, and the other opening leads to the outside of the substrate. The opening of the closing air passage is located in the upper air chamber of air chamber 1 near the side wall of the substrate, and the other opening leads to the outside of the substrate. During assembly, the diaphragm is oriented inward to place the pneumatic valve into the cavity.

[0006] When high-pressure gas is introduced only into the closed valve passage, the pneumatic valve diaphragm cuts off the pipeline downwards. When high-pressure gas is introduced only into the open valve passage, the pneumatic valve diaphragm is pulled up, opening the pipeline. Sampling is accomplished by controlling the opening and closing of these pneumatic valves to complete pipeline cleaning, sampling, and pressure maintenance of the sampling pipeline, ensuring that the pipeline is not contaminated by environmental microorganisms after sampling. Each time a sample is poured into a sampling bottle, once the sample volume is sufficient, the pneumatic valve on the side of the sampling bottle is closed, and finally the sampling bottle is removed. Attached Figure Description

[0007] Figure 1 , one Schematic diagram of a sterile sampler structure.

[0008] Figure 2 , one A schematic diagram of the pneumatic valve 1 of a sterile sampler.

[0009] Figure 3, one A schematic diagram of the pneumatic valve 2 of a sterile sampler.

[0010] Figure 4 , one Schematic diagram of a sterile sampler structure 2. Detailed Implementation

[0011] The present invention will be further described below with reference to specific embodiments and accompanying drawings, but this does not limit the present invention.

[0012] Example 1

[0013] A sterile sampler ( Figure 1 and Figure 2 The aseptic sampler's base plate 3 is 180mm long, 100mm wide, and 40mm thick, and is made of PTFE. One main pipe and three branch pipes are arranged on the base plate, each with an inner diameter of 5mm. A sealed cavity is arranged 10mm from the edge of the base plate to the left of the main pipe. The cavity has a cylindrical upper part and a conical lower part. The cylinder has a diameter of 10mm and a height of 20mm, and the cone has a height of 20mm. The cylindrical part of the cavity is divided into two air chambers, air chamber 1 (1-7) and air chamber 2 (1-8), by a partition (1-6) with a hole in the middle. The sample pipe is cut off at the bottom of the cone. The opening diameter on the partition is 5mm. A pneumatic valve 1 is installed in this sealed cavity. The pneumatic valve consists of a diaphragm (1-4) and a piston rod (1-5). The system consists of a diaphragm and piston pads (1-3), wherein the diaphragm and piston pads are made of rubber, and the piston rod is made of polyphenylene sulfide. The diaphragm has a conical structure, the size of which is consistent with the conical bottom of the aforementioned cavity. The piston pad has a cylindrical structure with a diameter of 10mm, and the piston rod has a cylindrical shape with a diameter of 5mm. After passing through the partition hole, its two ends are connected to the diaphragm and piston pad respectively. The piston pad with rod and air chamber 1 form a piston structure. The piston pad divides air chamber 1 into upper and lower spaces, namely the upper air chamber and the lower air chamber. One pneumatic valve corresponds to two control pipes. One is the valve opening air passage 1-2, one end of which is located on the outside of the base plate, and the other end is located near the partition of air chamber 1. The other is the valve closing air passage 1-1, one end of which is located on the outside of the base plate, and the other end is located inside air chamber 1 near the base plate (see...). Figure 2 Both the open and closed valve air passages are equipped with a sterilization filter 1-9 at their external ports. This filter ensures that the high-pressure gas entering the air passage is sterile, preventing the pipeline from being contaminated.

[0014] Reference Figure 1 Install four more pneumatic valves;

[0015] The substrate contains three branch channels 4, one opening on the outside of the substrate and the other opening connecting to the main channel, thus connecting the branch channels to the main channel. Sampling bottles are connected to two of the branch channels.

[0016] The sampling operation is as follows: The PLC of the device to be sampled can output a switch signal, which controls the solenoid valve to distribute high-pressure gas to the open valve passage or the closed valve passage, thereby controlling the opening or closing of the pneumatic valve. Specifically: if high-pressure gas is only introduced into the open valve passage of the pneumatic valve, the upward air pressure pulls up the diaphragm of the pneumatic valve, connecting the two pipe sections; if high-pressure gas is only introduced into the closed valve passage of the pneumatic valve, the air pressure will press down the diaphragm of the pneumatic valve, closing the two pipe sections.

[0017] Before sampling, connect the left opening of the main pipe of the sterile sampler to the sampling port of the equipment. Connect a sterilizing filter head to the branch pipe on the lower left side that is not connected to the sampling bottle. Then, perform off-site steam sterilization simultaneously with the equipment. After sterilization, connect high-pressure air to the sterilizing filters on the openings of the open and closed valve passages. The air entering the valve body at this time is sterile air. Connect the high-pressure air to the sterilizing filter head on the lower left branch pipe. This air is used to blow away sample residue in the pipe. Before sampling, supply air to the closed valve passage and close all pneumatic valves. After preparation, open the sampling port switch on the equipment, then open the pneumatic valve on the left side of the main pipe, and then open the pneumatic valve of the branch pipe with the sampling bottle. The material will then flow into the sampling bottle. After the sample volume is sufficient, close the pneumatic valve on the left side of the main pipe, and then open the pneumatic valve on the lower left side. Air will then enter the pipe and fill the sampling bottle with the residual material in the pipe. After cleaning, close the pneumatic valve on the sampling bottle side. The air will then maintain pressure in the pipe. Finally, remove the sampling bottle, and the sampling is complete.

[0018] Furthermore, multiple sterile samplers can be stacked together for use.

[0019] Example 2

[0020] A sterile sampler ( Figure 3 The main pipe or branch pipe has a gap at the top of its wall. The pipe wall on the opposite side of the gap bulges upward, dividing the gap into two parts, which become the inlet and outlet of the two pipe sections.

[0021] The diaphragm of the pneumatic valve is disc-shaped, similar to a red blood cell. The diaphragm is aligned with the notch, and the sides of the diaphragm are welded to the pipe. The purpose of welding is to strictly separate the gas in the pneumatic valve from the pipe, which can effectively prevent the gas in the airway from contaminating the pipe. When the pneumatic valve diaphragm is pressed against the notch, the two sections of the pipe are disconnected, and vice versa.

[0022] Following the above-described piping and pneumatic valve design, it is also possible to achieve [the desired result]. Figure 1 Same effect.

[0023] Example 3

[0024] A sterile sampler ( Figure 4To prevent pipeline contamination in case of pneumatic valve seal failure, check valves are added to all pipelines to ensure unidirectional liquid flow.

[0025] Additionally, the upper left pneumatic valve does not have a shut-off air passage. Figure 4 A spring 7 is installed in the upper air chamber of its air chamber 1. When no high-pressure gas is introduced into the valve opening air passage, the diaphragm of the pneumatic valve is pressed by the downward force generated by this spring, and the pneumatic valve is in the closed state at this time. When high-pressure gas is introduced into the valve opening air passage, the lifting force generated by the upward air pressure is greater than the downward force of the spring. At this time, the diaphragm of the pneumatic valve is pulled up, and the pneumatic valve is in the open state, thereby connecting the pipeline.

[0026] Example 4

[0027] Similar to Example 3, the pneumatic valve does not have an opening air passage, but a spring is installed in the lower air chamber of its air chamber 1. When no high-pressure gas is introduced into the closing air passage, the pneumatic valve diaphragm is pulled up by the upward force generated by this spring, and the pipeline is in the open state. When high-pressure gas is introduced into the closing air passage, the pressure generated by the downward air pressure is greater than the upward force of the spring, and the pneumatic valve diaphragm is compressed.

[0028] In summary, the present invention arranges sampling channels, cleaning channels, and pneumatic valves on a substrate. The cleaning of the pipeline, sampling of the equipment, re-cleaning of the pipeline, and pressure maintenance of the pipeline can be completed by operating the pneumatic valves, thereby realizing the automatic and strict aseptic sampling function of biological processes.

[0029] The above description is merely an example of the embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the technical principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A sterile sampler, characterized in that: The sterile sampler consists of a pneumatic valve, a main pipe, and branch pipes integrated on a substrate; the number of pneumatic valves is greater than or equal to 3; the two ends of the main pipe are on the side of the substrate, the outer end of the branch pipe is on the side of the substrate, and the inner end is connected to the middle part of the main pipe; the pneumatic valve consists of a diaphragm, a piston rod, a piston pad, an air chamber, an opening valve passage, a closing valve passage, and an air passage filter; the air passage filter is installed on the opening valve passage and the closing valve passage; the diaphragm of the pneumatic valve is located at the middle opening of the main pipe and the middle opening of the branch pipe; there are 3 branch pipes inside the substrate, one opening of each branch pipe is on the outside of the substrate, and one opening merges into the main pipe, so that the branch pipe is connected to the main pipe, and sampling bottles are connected to 2 of the branch pipes; each branch pipe is further divided into 2 sections by the pneumatic valve, and the diaphragm of the pneumatic valve is installed at this middle opening position; before sampling, a sterilization filter head is connected to the branch pipe on the lower left side of the substrate that does not have a sampling bottle connected; high-pressure air is connected to the sterilization filter head of the lower left branch pipe to blow away the sample residue in the pipe.

2. The aseptic sampler as described in claim 1, characterized in that, The air chamber of the pneumatic valve is divided into air chamber 1 and air chamber 2 by a partition with a hole in the middle; air chamber 1 is located outside air chamber 2; the piston pad of the pneumatic valve divides air chamber 1 into upper air chamber and lower air chamber, and the piston rod passes through the partition through the partition hole, with one end connected to the piston pad and the other end connected to the diaphragm.

3. The aseptic sampler as described in claim 2, characterized in that, The opening air passage of the pneumatic valve has an opening position inside the substrate located in the lower air chamber of air chamber 1 near the partition side, and another opening leading to the outside of the substrate; the closing air passage of the pneumatic valve has an opening position inside the substrate located in the upper air chamber of air chamber 1 near the side wall of the substrate, and another opening leading to the outside of the substrate.

4. The aseptic sampler as described in claim 1, characterized in that, The main pipeline is divided into three sections by two pneumatic valves.

5. A sterile sampler as described in claim 2, characterized in that, The piston pad of the pneumatic valve and the air chamber 1 form a piston structure.

6. A sterile sampler as described in claim 2, characterized in that, The outer diameter of the piston rod of the pneumatic valve is consistent with the size of the opening between air chamber 1 and air chamber 2.

7. A sterile sampler as described in claim 1, characterized in that, The sides of the diaphragm are fixed to the pipe wall.

8. A sterile sampler as described in claim 1, characterized in that, The main pipeline and branch pipelines are equipped with check valves near the pneumatic valves.

9. A sterile sampler as described in claim 2, characterized in that, The pneumatic valve has no opening air passage, and there is a section of elastic material in the lower air chamber of air chamber 1; or, the pneumatic valve has no closing air passage, and there is a section of elastic material in the upper air chamber of air chamber 1.

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