Sterile dispensing system
By optimizing the design of air pumps, valve plates and filters, the problems of airflow instability and pressure fluctuations caused by unreasonable gas circuits in traditional sterile dispensing systems are solved, and the stability and reliability of the sterile dispensing system are achieved, ensuring the uniformity and stability of the airflow in the sterile environment.
Patent Information
- Application Number
- CN202510810508.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-17
- Publication Date
- 2025-08-12
AI Technical Summary
In the design of the gas circuit structure, traditional sterile dispensing systems have problems such as unreasonable gas circuit pipe diameter, unreasonable air pump power and unstable outlet air pressure, resulting in unstable air flow, large pressure fluctuations, and unsatisfactory filtration effect, which affects the stability and reliability of the system.
A sterile dispensing system is designed, including an air pump, a valve plate and a filter. The air pump outlet diameter is 6-12mm, the valve plate air line diameter is 6-8mm, the filter outlet diameter is 4-6mm, the air pump power is ≤200W, the filter outlet air pressure range is positive pressure 0-0.4Mpa, negative pressure ≤-89Kpa, and the oil-free lubrication design is adopted, and the filter filter pore diameter is 0.2 microns.
It achieves smooth airflow flow, strong system stability and good reliability, meets the requirements of sterile environment, the number of plankton bacteria is less than 2.3CFU/m3, and the airflow uniformity and stability test results are excellent.
Smart Images
Figure CN120459722A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a sterile dispensing system. Background Art
[0002] To ensure safe medication dispensing, a sterile dispensing system is required. Traditional sterile dispensing systems suffer from issues such as irrational gas path diameters, unreasonable air pump power, and unstable outlet pressure due to design estimation errors and inadequate pressure control mechanisms. These issues can lead to unstable airflow, large pressure fluctuations, and suboptimal filtration, impacting system stability and reliability. Summary of the Invention
[0003] The object of the present invention is to provide a sterile dispensing system with strong stability and good reliability.
[0004] To achieve the above-mentioned purpose, the present invention provides an aseptic dispensing system, comprising an air pump, a valve plate and a filter output to an external dissolver connected in sequence on the air path, the air pump suction drives the piston of the external dissolver to retreat to inhale the medicine liquid, and the air pump jet drives the piston of the external dissolver forward to push out the medicine liquid, the air pump outlet pipe diameter is 6~12mm, the valve plate air path pipe diameter is 6~8mm, and the filter outlet pipe diameter is 4~6mm; the air pump power is ≤200W; the filter outlet wind pressure range is positive pressure 0~0.4Mpa and negative pressure ≤-89Kpa.
[0005] Furthermore, it comprises a main unit and a handle connected to the main unit, the air pump and the valve plate are arranged in the main unit, the filter is arranged in the handle, and the handle is connected to the drug dissolver.
[0006] Furthermore, the blowing button and the inhalation button of the air pump are arranged on the handle.
[0007] Furthermore, the air pump adopts an oil-free lubrication design.
[0008] Furthermore, the filter pore size is 0.2 microns.
[0009] Furthermore, the diameter of the air pump outlet pipe is 8-12 mm, the diameter of the valve plate air path pipe is 6-8 mm, and the diameter of the filter outlet pipe is 4-5 mm.
[0010] Furthermore, the diameter of the air pump outlet pipe is 8 mm, the diameter of the valve plate air path pipe is 6 mm, and the diameter of the filter outlet pipe is 4 mm.
[0011] The aseptic dispensing system of the present invention has specially designed dimensions of the air pump outlet pipe diameter, the valve plate air path pipe diameter and the filter outlet pipe diameter. Experimental verification shows that the system has low local resistance, smooth airflow, strong system stability and good reliability. BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Figure 1 It is a schematic diagram of the overall structure of the sterile dispensing system.
[0013] Figure 2 It is a schematic diagram of the gas connection structure of the sterile dispensing system.
[0014] Figure 3 It is a schematic diagram of the exploded structure of the handle connected to the dissolver.
[0015] Explanation of the accompanying symbols: 1. Main unit; 2. Handle; 21. Button; 211. Blowing button; 212. Inhalation button; 3. Dissolver; 31. Front end of cylinder; 32. Rear end of cylinder; 4. Air pump; 5. Valve plate; 6. Filter. DETAILED DESCRIPTION
[0016] The present invention is further described in detail below in conjunction with specific embodiments.
[0017] like Figure 1 As shown, the sterile dispensing system main unit 1 is connected to the handle 2, which is connected to the dissolving container 3. The user presses the button 21 on the handle 2 to drive the rubber piston (omitted in the figure) in the dissolving container 3 to move back and forth. Specifically, the rubber piston of the dissolving container 3 moves backward to absorb the liquid medicine, and then moves forward to push the liquid medicine into the container of the desired medicine, completing the dispensing operation. Figure 3 A high efficiency air filter 6 (HEPA) is provided in the handle 2, and the filter pore size of the filter 6 does not exceed 0.22 microns, preferably 0.2 microns. Figure 2 The main unit 1 is provided with an air pump 4 and a valve plate 5 for adjusting the gas flow and direction. The air pump 4 is connected to the filter 6 in the handle 2 through the valve plate 5. The air pump 4 adopts an oil-free lubrication design and will not pollute the gas during operation.
[0018] The following describes in detail the operation process of the aseptic dispensing system. First, turn on the main unit 1 to start the air pump 4. The air pump 4 sprays gas to the valve plate 5 through the connecting pipeline. The gas enters the filter 6 through the valve plate 5 and becomes sterile gas after filtration. The sterile gas is discharged from the outlet of the filter 6. Next, the dissolver 3 is clipped onto the handle 2 (which belongs to the prior art and will not be described here), so that the opening at the rear end 32 of the dissolver 3 cylinder is aligned with the outlet of the filter 6 in the handle 2. Press the suction button 212 in the button 21 on the handle 2 to reversely inhale the air between the opening at the rear end 32 of the dissolver 3 cylinder and the rear end of the rubber piston, so that a negative pressure is formed between the opening at the rear end 32 of the cylinder and the rear end of the rubber piston, thereby allowing the rubber piston to move backward and reset. Next, pressing the blow button 211 in the button 21 causes the air pump 4 to spray air forward, creating positive air pressure. The air is filtered by the filter 6 into sterile air and blown into the barrel through the opening at the rear end 32. The rubber piston moves forward under the positive air pressure, expelling the air between the front end of the rubber piston and the front end 31 of the barrel. Because the opening at the rear end 32 of the barrel is connected to the sterile air, a sterile environment is created within the barrel. After the air between the front end of the rubber piston and the front end 31 of the barrel is expelled, the barrel draws in the drug solution through the needle 7 and then pushes the solution into the container containing the desired medication, completing the dispensing operation.
[0019] Example 1
[0020] (1) The above-mentioned air path diameter design, air pump 4 power, and filter 6 outlet pressure settings are as follows: air pump 4 outlet diameter is 9 mm, valve plate 5 air path diameter is 7 mm, filter 5 outlet diameter is 5 mm; air pump 4 power is 200 W; filter 6 outlet pressure is 0.2 MPa positive pressure and -89 kPa negative pressure. The capacity specification of dissolving device 3 is 25 ml.
[0021] (2) Sterile environment test
[0022] Airborne bacteria testing: Airborne bacteria refer to microbial particles suspended in the air, whose concentration directly affects environmental cleanliness. At the air outlet of filter 6, a planktonic bacteria sampler was used to collect microorganisms from sterile air. These microorganisms were inoculated into culture medium and the colonies were counted. The entire sampling and counting process was repeated three times under the same conditions, and the average value was calculated. The test results are shown in Table 1.
[0023] The number of planktonic bacteria: The number of planktonic bacteria in a normal environment is usually 100-1000 CFU / m 3 According to the Chinese pharmaceutical industry standard YY 0033-2000 "Management Specifications for the Production of Sterile Medical Devices", the number of floating bacteria in the sterile medical device clean room (required to reach Class 100, equivalent to ISO Class 5) should be ≤ 5 CFU / m 3 .
[0024] (3) Airflow smoothness test
[0025] 1. Flow rate test: Use a laser Doppler velocimeter at the air outlet of filter 6 to measure the flow rate at multiple points and calculate the average flow rate and flow rate standard deviation.
[0026] 2. Pressure measurement: Install pressure sensors before and after the air outlet of filter 6 to record the positive pressure fluctuation range over a period of time.
[0027] 3. Smoke test: Use a smoke generator to release visible smoke and observe its flow path at the air outlet of filter 6 to check for obvious fluctuations and stagnant areas to verify the uniformity and stability of the airflow.
[0028] The results of the above three tests are detailed in Table 2.
[0029] Example 2
[0030] The aseptic dispensing system of this embodiment is basically the same as that of Example 1, with the only difference being the design of the air path diameter and the capacity specification of the dissolver 3: specifically, the outlet diameter of the air pump 4 is 8 mm, the air path diameter of the valve plate 5 is 6 mm, the outlet diameter of the filter 6 is 4 mm, and the capacity specification of the dissolver 3 is 20 ml.
[0031] Example 3
[0032] The aseptic dispensing system of this embodiment is basically the same as that of Example 1, with the only difference being the design of the air path diameter and the capacity specification of the dissolver 3: specifically, the outlet diameter of the air pump 4 is 6 mm, the air path diameter of the valve plate 5 is 6 mm, the air outlet diameter of the filter 6 is 6 mm, and the capacity specification of the dissolver 3 is 30 ml.
[0033] Example 4
[0034] The aseptic dispensing system of this embodiment is basically the same as that of Example 1, with the only difference being the design of the air path diameter and the capacity specification of the dissolver 3: specifically, the outlet diameter of the air pump 4 is 12 mm, the air path diameter of the valve plate 5 is 8 mm, the outlet diameter of the filter 6 is 6 mm, and the capacity specification of the dissolver 3 is 50 ml.
[0035] Example 5
[0036] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the power of the air pump 4 . The power of the air pump 4 of this embodiment is 150W.
[0037] Example 6
[0038] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the power of the air pump 4 and the capacity specification of the dissolver 3: specifically, the power of the air pump 4 is 50W, and the capacity specification of the dissolver 3 is 60ml.
[0039] Example 7
[0040] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the positive pressure of the outlet air pressure of the filter 6 and the capacity specification of the dissolver 3: specifically, the positive pressure is 0 MPa, and the capacity specification of the dissolver 3 is 30 ml.
[0041] Example 8
[0042] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the positive pressure of the outlet air pressure of the filter 6 and the capacity specification of the dissolver 3: specifically, the positive pressure is 0.4 MPa, and the capacity specification of the dissolver 3 is 50 ml.
[0043] Example 9
[0044] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the negative pressure at the outlet of the filter 6 and the capacity specification of the dissolver 3: specifically, the negative pressure is -120Kpa, and the capacity specification of the dissolver 3 is 20ml.
[0045] Example 10
[0046] The aseptic dispensing system of this embodiment is basically the same as that of embodiment 1, with the only difference being the negative pressure of the air pressure at the outlet of the filter 6 and the capacity specification of the dissolver 3: specifically, the negative pressure is -100Kpa, and the capacity specification of the dissolver 3 is 60ml.
[0047] Comparative Example 1
[0048] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the outlet diameter of the air pump 4 , which is 5 mm.
[0049] Comparative Example 2
[0050] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the outlet diameter of the air pump 4 , which is 13 mm.
[0051] Comparative Example 3
[0052] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the gas path of the valve plate 5 . The diameter of the gas path of the valve plate 5 of this comparative example is 5 mm.
[0053] Comparative Example 4
[0054] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the gas path of the valve plate 5 . The diameter of the gas path of the valve plate 5 of this comparative example is 9 mm.
[0055] Comparative Example 5
[0056] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the air outlet pipe of the filter 6 , which is 7 mm in this comparative example.
[0057] Comparative Example 6
[0058] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the air outlet pipe of the filter 6 , which is 3 mm in this comparative example.
[0059] Comparative Example 7
[0060] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the air path: specifically, the outlet diameter of the air pump 4 is 5 mm, the air path diameter of the valve plate 5 is 5 mm, and the outlet diameter of the filter 6 is 3 mm.
[0061] Comparative Example 8
[0062] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the diameter of the air path: specifically, the outlet diameter of the air pump 4 is 13 mm, the air path diameter of the valve plate 5 is 9 mm, and the outlet diameter of the filter 6 is 7 mm.
[0063] Comparative Example 9
[0064] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the power of the air pump 4 . The power of the air pump 4 of this comparative example is 220W.
[0065] Comparative Example 10
[0066] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being that the outlet air pressure of the filter 6 is positive pressure, and the outlet air pressure of the filter 6 of this comparative example is 0.5 MPa.
[0067] Comparative Example 11
[0068] The aseptic dispensing system of this comparative example is basically the same as that of Example 1, with the only difference being the negative pressure at the outlet of the filter 6 . In this comparative example, the negative pressure at the outlet of the filter 6 is -88 KPa.
[0069] Table 1 Planktonic bacteria test results
[0070]
[0071]
[0072] In the experimental data in Table 1, the average number of planktonic bacteria in Examples 1 to 10 was less than 2.3 CFU / m 3 The average number of planktonic bacteria in Comparative Examples 1 to 11 is higher than 4.7 CFU / m 3It can be seen that the diameter of the outlet pipe of the air pump 4, the diameter of the air path pipe of the valve plate 5 and the diameter of the air outlet pipe of the filter 6 are well matched, and the filtering effect is good.
[0073] Table 2 Airflow uniformity and stability test results
[0074]
[0075] In the experimental results in Table 2, Examples 1 through 10 exhibit moderate average flow rates, with standard deviations within 0.1 m / s, pressure fluctuations within ±9 kPa, and no significant smoke flow fluctuations or stagnant areas. In contrast, Comparative Examples 1 through 11 exhibit standard deviations exceeding 0.15 m / s, pressure fluctuations exceeding ±10 kPa, and smoke flow fluctuations and localized stagnation. This demonstrates the coordinated design of the outlet pipe diameter of the air pump 4, the air path diameter of the valve plate 5, and the outlet pipe diameter of the filter 6, resulting in low local system resistance, smooth airflow, and excellent system stability and reliability.
[0076] The above is only an embodiment of the present invention and does not limit the scope of patent protection. Those skilled in the art can make non-substantial changes or substitutions based on the present invention and still fall within the scope of patent protection.
Claims
1. A sterile dispensing system, comprising an air pump (4), a valve plate (5) and a filter (6) connected in sequence on an air path to an external dissolving device (3), wherein the air pump (4) drives the piston of the external dissolving device (3) to retreat to inhale the liquid medicine, and the air pump (4) drives the piston of the external dissolving device (3) to advance to push out the liquid medicine, characterized in that: The outlet pipe diameter of the air pump (4) is 6-12 mm, the air path pipe diameter of the valve plate (5) is 6-8 mm, and the outlet pipe diameter of the filter (6) is 4-6 mm; the power of the air pump (4) is ≤200 W; the outlet air pressure range of the filter (6) is 0-0.4 MPa for positive pressure and ≤-89 KPa for negative pressure.
2. The aseptic dispensing system according to claim 1, characterized in that: The invention comprises a main unit (1) and a handle (2) connected to the main unit (1); the air pump (4) and the valve plate (5) are arranged in the main unit (1); the filter (6) is arranged in the handle (2); and the handle (2) is connected to the drug dissolving device (3).
3. The aseptic dispensing system according to claim 2, characterized in that: The blowing key (211) and the suction key (212) of the air pump (4) are arranged on the handle (2).
4. The aseptic dispensing system according to claim 1, characterized in that: The air pump (4) adopts an oil-free lubrication design.
5. The aseptic dispensing system according to claim 1, characterized in that: The filtration pore size of the filter (6) is 0.2 microns.
6. The aseptic dispensing system according to claim 1, characterized in that: The outlet pipe diameter of the air pump (4) is 8-12 mm, the air path pipe diameter of the valve plate (5) is 6-8 mm, and the outlet pipe diameter of the filter (6) is 4-5 mm.
7. The aseptic dispensing system according to claim 1, characterized in that: The outlet pipe diameter of the air pump (4) is 8 mm, the air path pipe diameter of the valve plate (5) is 6 mm, and the outlet pipe diameter of the filter (6) is 4 mm.