Aseptic sampler

Abstract

The application provides a sterile sampler, which comprises a sampling container, a sample inputting assembly and a suction assembly, the sample inputting assembly and the suction assembly being fixedly connected to the sampling container, the sample inputting assembly being used for inputting and outputting a liquid sample, and the suction assembly being used for controlling the air inflow and outflow. The sterile sampler is simple and convenient to operate, and can complete sampling by connecting an injector; the sterile and closed sampling can be realized simply. The only interface for air exchange with the outside world is an air filter, and the air filter selects a filter membrane with a sterilization function, so that the outside bacteria are isolated, and the inner cavity of the sampler is prevented from being polluted by the outside bacteria; the sampling container is provided with a scale, and quantitative sampling is realized; the liquid channel and the gas channel are separated, residual samples in the pipeline can be collected back to the sample container by inflating the injector, and waste is avoided; the liquid channel of the bottle cap can be expanded to multiple, and the transfer between different samples can be realized.

Description

Technical Field

[0001] This utility model relates to the field of sampling and testing technology, and in particular to a sterile sampler. Background Technology

[0002] In the biopharmaceutical field, aseptic drug production typically requires aseptic quantitative sampling followed by quality testing. For example, cell culture preparation necessitates periodic sampling and observation of cell culture expansion. At the initial stage of culture, the cell quantity is small; to avoid sample loss due to sampling errors while ensuring aseptic sampling to prevent contamination of the cell samples, this process is crucial.

[0003] Existing technical solutions generally achieve quantitative sampling using syringes. In a Class A environment, the syringe is connected to the sample volume connector, and the sample is drawn into the syringe chamber by pulling the syringe plunger, while simultaneously observing whether the sample volume reaches the corresponding mark on the syringe. Alternatively, a squeeze-type sterile sampler can be used. This sampling method can be implemented in a Class C environment. The sampler's tubing is aseptically connected to the sample volume tubing, and squeezing the sampling capsule creates negative pressure, drawing the sample into the capsule during its rebound. Another option is a capsule-type sterile sampler with a sterile filter. One end of the sampling capsule has tubing for connecting to the sample tubing in a Class C environment. The other end of the sampling capsule is connected to a sterile filter. During operation, a syringe is connected to the sterile filter, and the syringe plunger is pulled outward to create negative pressure in the sampling capsule, allowing the sample to enter.

[0004] The existing sampling techniques mentioned above generally cannot simultaneously meet the requirements of sterility and accurate sampling. Even if they can, the operation process is very complicated and inefficient. Utility Model Content

[0005] The purpose of this invention is to provide a device that can achieve sterile sealing in a Class C environment and accurately quantify samples, while also sterilely transferring excess samples from the sampling channel back to the sample container to avoid waste.

[0006] To achieve this objective, the present invention adopts the following technical solution: 1. A sterile sampler, comprising a sampling container, an injection assembly, and an aspiration assembly, wherein the injection assembly and the aspiration assembly are fixedly connected to the sampling container. The sampling container includes a cavity and a cap, the cavity being hollow and having a volume scale, and the cap covering the opening of the cavity and being detachably connected to the cavity.

[0007] The bottle cap has at least two channels, namely a first channel and a second channel; the sample injection component is connected to the first channel for the input and output of sample liquid; the suction component includes an air conduit and an air filter, the air conduit is connected to the second channel, and the air filter has a filter membrane for controlling the inflow and outflow of air.

[0008] The sample injection assembly includes a sample injection tube, a tube clamp, a Luer connector, and a first protective cap; the suction assembly includes an air conduit, a sleeve, an air filter, and a second protective cap.

[0009] In one embodiment, the channel is configured to be vertically aligned in the same direction, or it can be located on the side of the bottle cap, either on the same side of the bottle cap or on different sides.

[0010] In one embodiment, the first channel is flush with the inner horizontal plane of the bottle cap. This allows for complete sample removal when choosing to retrieve the sample from the sampling container via the channel, minimizing residue. Simultaneously, since the gas channel and liquid are not on the same plane, it effectively prevents liquid from directly entering the gas channel when the sampler is filled with liquid.

[0011] In one embodiment, the air filter is provided with a filter membrane with a pore size of 0.1um-3um. Selecting a filter membrane within this range can effectively isolate external particulate bacteria, ensuring that the sample is not contaminated by the outside world and ensuring the accuracy of sampling.

[0012] In one embodiment, the diameter of the air conduit is matched with the aperture of the second channel to ensure the airtightness between the sample inlet tube and the sampling chamber. The consistency between the air conduit and the channel can effectively ensure the connection between the two, avoiding gaps at the connection that could cause air to mix in and contaminate the sample.

[0013] In one embodiment, the air filter may include one or more sterile filters that can filter the air to ensure that the inside of the sampling chamber is sterilely isolated from the external environment, to ensure that the sampled sample is not contaminated during the sampling process, and to ensure the consistency of the sample input and output.

[0014] In one embodiment, the cavity has a volume scale for marking the amount of sample taken, and the cavity volume can be expanded from 1mL to 100mL, allowing for different volume selections based on different needs.

[0015] The above technical solution is simple and convenient to operate; sampling can be completed with just an external syringe. It enables easy and sterile, closed-loop sampling. The only interface with outside air is the air filter. Because the air filter uses a sterilizing membrane, it isolates external bacteria, thus ensuring that the sampler's internal cavity is not contaminated. The sampling container has graduations, making the sample volume readily apparent and enabling quantitative sampling. The liquid and gas channels are separate; by inflating the syringe, residual sample in the tubing can be easily collected back into the sample container, avoiding waste. The liquid channel on the cap can be expanded to multiple channels, allowing for liquid transfer between different samples, such as transferring a sample from sample A to the sampling container and then transferring the sample from the sampling container to sample B. Sample removal is quick and convenient; simply unscrew the cap. Attached Figure Description

[0016] Figure 1 A schematic diagram of the cap structure of a sterile sampler provided in one embodiment of this application; Figure 2 A schematic diagram of another structure of the bottle cap of the aseptic sampler provided in one embodiment of this application; Figure 3 A schematic diagram of the structure of a sterile sampler provided in one embodiment of this application; Figure 4 A schematic diagram of another sterile sampler provided in one embodiment of this application; Attached image symbols: 1. Chamber, 2. Bottle cap, 3. Sample inlet tube, 4. Tube clamp, 5. Luer connector, 6. First protective cap, 7. Second protective cap, 8. Air filter, 9. Air conduit, 10. Tube; Detailed Implementation

[0017] like Figure 3 , Figure 4 As shown, a sterile sampler according to this embodiment includes a sampling container, a sample injection component, and an aspiration component.

[0018] The sampling container includes a cavity 1 and a cap 2. The volume of the cavity 1 can be selected from 1mL to 100mL and can be adjusted according to actual needs; this application does not impose any limitations. The cavity 1 has graduations with a resolution of 0.1mL to 1mL. The cavity 1 is a hollow cavity with an opening, which is covered by the cap 2. The cap 2 is detachably connected to the cavity 1.

[0019] The sample introduction assembly includes a sample introduction tube 3, a tube clamp 4, a Luer connector 5, and a first protective cap 6. The sample introduction tube 3 can be made of polyvinyl chloride (PVC), or a material with equivalent function can be used instead; this application does not impose any limitations. The sample introduction tube 3 is made of PVC and can be aseptically connected using a high-frequency or high-temperature heat-sealing aseptic connection machine, thereby ensuring the airtightness of the sample introduction tube 3 and ensuring that the sample obtained in the sampling chamber 1 is not contaminated.

[0020] The bottle cap 2 has two or more independent channels, namely a first channel and a second channel. The first channel connects to the sample inlet tube 3 for liquid delivery; the second channel connects to the air conduit 9 and is connected to the suction assembly for controlling airflow. The air conduit 9 can be made of polyvinyl chloride (PVC), or a material with equivalent functionality can be used instead; this application does not impose any restrictions.

[0021] The structure of bottle cap 2 can be adopted as follows Figure 1 , Figure 2 The example illustrates two methods, but is not limited to these two. The two channels can be set vertically, or they can be located on the side of the bottle cap 2, on the same side, or on different sides. The second channel (channel 2) is primarily used as the gas channel. The first channel (channel 1) is primarily used as the liquid channel and should ideally be flush with the inner plane of the bottle cap 2. This has the advantage that when selecting to remove the sample from the sampling container through the first channel, the entire sample can be removed, reducing residue. Simultaneously, since the gas channel and liquid channel are not on the same plane, it effectively prevents liquid from directly entering the gas channel when the sampler is filled with liquid.

[0022] The suction assembly includes an air conduit 9, a sleeve 10, an air filter 8, and a second protective cap 7. The air conduit 9 is connected to the sampling chamber 1 via a second channel. The diameter of the air conduit 9 is matched to the pore size of the channel to ensure airtightness between the air conduit 9 and the sampling chamber 1. The air filter 8 can be configured to contain one or more sterile filters. The air filter 8 contains a filter membrane with a pore size of 0.1µm-3µm. The filter membrane can filter out impurities or microorganisms with a particle size greater than 3µm. The thickness of the filter membrane is not limited in this application. The filter membrane can filter the air, ensuring sterile isolation between the inside of the sampling chamber 1 and the external environment, ensuring that the sampled sample is not contaminated during the sampling process, and also blocking the sample inside the sampling chamber 1 to prevent sample spillage. There can be two filter membranes, which can be spaced apart inside the air filter 8. Due to the bacterial filtration effect of the air filter 8, the inside of the sampler is guaranteed not to be contaminated by bacteria.

[0023] During sampling, there are two possible connection methods to the sample: First, in a Class C environment, clamp 4 is closed, and a sterile connector is used to aseptically connect the injection tube 3 to the sample container. Second, in a Class A environment, clamp 4 is closed, the first protective cap 6 is unscrewed, and the Luer connector is connected to the sample container. During sampling, the second protective cap 7 is unscrewed, the syringe is connected to the air filter 8, and clamp 4 is opened. Air is drawn from the syringe, creating a passage between the cavity 1, the air conduit 9, the air filter 8, and the syringe. A negative pressure is created inside the sampling container, allowing the sample to enter the sampling container cavity 1 through the injection tube 3 and the first channel. When the sampling volume corresponds to the graduation on the sampling container cavity 1, the air pressure inside the sampling cavity 1 becomes negative, and the sample enters the sampling cavity 1 through the injection tube 3. The operator can determine the final required sampling volume based on the graduation on the sampling container cavity 1. Then, by pushing the syringe back, a positive pressure is formed in the sampling container cavity 1, which pushes the remaining sample in the tube, the first channel, and the injection tube 3 back into the original sample container to avoid residue.

[0024] Close clamp 4, screw on the second protective cap 7, and disconnect the injection tube 3 from the sample container, which can be done by heat sealing. To remove the sample from the sampling container cavity 1, simply unscrew cap 2. Alternatively, invert the sampling container and use a syringe to pump air into the sampling container cavity 1 through air filter 8 and air conduit 9; the sample will then flow out and be collected through the first channel and injection tube 3. Because the outlet of the first channel is flush with the inner bottom of cap 2, almost no sample remains in the sampling container cavity 1. This method can also be applied to scenarios where samples are added to another sample container.

[0025] The sterile sampler of this application is simple and convenient to operate; sampling can be completed by connecting an external syringe. It can easily achieve sterile and closed sampling. The only interface with the outside air is the air filter 8. Since the air filter uses a filter membrane with antibacterial function, it isolates external bacteria, thus ensuring that the inner cavity of the sampler is not contaminated by external bacteria. The sampling container has graduations, making the sampling volume clear at a glance, enabling quantitative sampling. The liquid channel and gas channel are separated. By inflating the syringe, residual sample in the tubing can be easily collected back into the sample container, avoiding waste. The liquid channel of the cap 2 can be expanded to multiple (e.g., Figure 4 The liquid channel can be expanded into multiple channels through the branch connector 11, or it can be achieved directly by adding channels on the bottle cap. This allows for the transfer between different samples, such as taking a sample from sample A into a sampling container and then transferring the sample from the sampling container into sample B. Taking out the sample is quick and convenient; simply unscrew the bottle cap 2.

[0026] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these features, they should be considered to be within the scope of this specification.

Claims

1. A sterile sampler, characterized in that, The device includes a sampling container, a sampling assembly, and a suction assembly. The sampling assembly and the suction assembly are fixedly connected to the sampling container. The sampling container includes a cavity (1) and a cap (2). The cavity (1) is hollow and has a volume scale. The cap (2) covers the opening of the cavity (1) and is detachably connected to the cavity (1). The cap (2) has at least two channels, including a first channel and a second channel. The sampling assembly is connected to the first channel for the input and output of the sampled liquid. The suction assembly includes an air conduit (9) and an air filter (8). The air conduit (9) is connected to the second channel. The air filter (8) has a filter membrane for controlling the airflow.

2. The aseptic sampler as described in claim 1, characterized in that, The channel is set to be vertical and in the same direction, or it can be set on the side of the bottle cap (2).

3. The aseptic sampler as described in claim 1, characterized in that, The first channel is level with the horizontal plane inside the bottle cap.

4. The aseptic sampler as described in claim 1, characterized in that, The sample injection assembly includes a sample injection tube (3), a tube clamp (4), a Luer connector (5), and a first protective cap (6); the suction assembly includes an air conduit (9), a sleeve (10), an air filter (8), and a second protective cap (7); the sample injection tube (3) is fixedly connected to the first channel, and the air conduit (9) is fixedly connected to the second channel.

5. The aseptic sampler as described in claim 4, characterized in that, The air filter (8) is provided with a filter membrane, and the pore size of the filter membrane can be 0.1um-3um.

6. The aseptic sampler as described in claim 4, characterized in that, The diameter of the air duct (9) is matched with the aperture of the second channel.

7. The aseptic sampler as described in claim 5, characterized in that, The air filter (8) may contain one or more sterile filters.

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