Aseptic dispensing system

Abstract

The utility model relates to medical instrument technical field, concretely relates to a sterile dispensing system. The system includes the filter that outputted to the external medicine dispenser connected in proper order on the air path of valve plate and air pump, and the piston of external medicine dispenser is driven to retreat to inhale liquid medicine after air pump suction drive, and the piston of external medicine dispenser is driven to advance to push out liquid medicine after air pump jet drive, the outlet pipe diameter of air pump is 6~12mm, the valve plate air path pipe diameter is 6~8mm, the filter outlet pipe diameter is 4~6mm, and the power of air pump is less than or equal to 200W, and the filter export wind pressure range is positive pressure 0~0.4Mpa, negative pressure less than or equal to -89Kpa. The sterile dispensing system of the utility model, the outlet pipe diameter of air pump, the valve plate air path pipe diameter and the filter outlet pipe diameter three sizes are special design, and experiment verifies that the system local resistance is small, and the airflow flows smoothly, and the system stability is strong, and the reliability is good.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a sterile drug dispensing system. Background Technology

[0002] To ensure medication safety, a sterile medication preparation system is required. Traditional sterile medication preparation systems often suffer from problems due to design estimation errors and insufficient pressure control mechanisms, such as unreasonable gas path diameters, inappropriate pump power, and unstable outlet air pressure. These problems can lead to unstable airflow, large pressure fluctuations, and unsatisfactory filtration effects, affecting the stability and reliability of the system. Utility Model Content

[0003] The purpose of this invention is to provide a sterile dispensing system that is highly stable and reliable.

[0004] To achieve the above objectives, this utility model provides an aseptic drug preparation system, comprising an air pump, a valve plate, and a filter connected in sequence to an external dissolver in the air path. The air pump draws in air, driving the piston of the external dissolver to retract and draw in the drug solution. The air pump also blows air, driving the piston of the external dissolver to advance and expel the drug solution. The air pump outlet pipe diameter is 6–12 mm, the valve plate air path pipe diameter is 6–8 mm, and the filter outlet pipe diameter is 4–6 mm. The air pump power is ≤200W, and the filter outlet air pressure range is positive pressure 0–0.4 MPa and negative pressure ≤-89 kPa.

[0005] Furthermore, it includes a main unit and a handle connected to the main unit, the air pump and valve plate are located inside the main unit, the filter is located inside the handle, and the handle is connected to a dissolving device.

[0006] Furthermore, the blow and inhale buttons of the air pump are located on the handle.

[0007] Furthermore, the air pump adopts an oil-free lubrication design.

[0008] Furthermore, the filter pore size is 0.2 micrometers.

[0009] Furthermore, the air pump outlet pipe diameter is 8–12 mm, the valve plate air passage pipe diameter is 6–8 mm, and the filter outlet pipe diameter is 4–5 mm.

[0010] Furthermore, the air pump outlet pipe diameter is 8mm, the valve plate air passage pipe diameter is 6mm, and the filter outlet pipe diameter is 4mm.

[0011] The aseptic dispensing system of this invention has specially designed dimensions for the air pump outlet pipe diameter, valve plate air passage pipe diameter, and filter outlet pipe diameter. Experimental verification shows that the system has low local resistance, smooth airflow, strong system stability, and good reliability. Attached Figure Description

[0012] Figure 1 This is a schematic diagram of the overall structure of the aseptic dispensing system.

[0013] Figure 2 This is a schematic diagram of the gas path connection structure of an aseptic drug dispensing system.

[0014] Figure 3 This is an exploded view of the handle connecting to the dissolving device.

[0015] Explanation of reference numerals in the attached diagram: 1. Main unit; 2. Handle; 21. Button; 211. Air blowing button; 212. Air inhalation button; 3. Dissolving device; 31. Front end of cylinder; 32. Rear end of cylinder; 4. Air pump; 5. Valve plate; 6. Filter. Detailed Implementation

[0016] The present invention will be further described in detail below with reference to specific embodiments.

[0017] like Figure 1 As shown, the aseptic dispensing system main unit 1 is connected to handle 2, and handle 2 is connected to dissolving tank 3. The user presses button 21 on handle 2 to drive the rubber piston (not shown in the figure) inside dissolving tank 3 to move back and forth. Specifically, the rubber piston of dissolving tank 3 moves backward to draw in the drug solution, and then moves forward to push the drug solution into the container where the required drug is to be prepared, completing the dispensing operation. See Figure 3 The handle 2 contains a high-efficiency particulate air (HEPA) filter 6, the filter 6 having a pore size not exceeding 0.22 micrometers, preferably 0.2 micrometers. See [link / reference]. Figure 2 The main unit 1 is equipped 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 inside the handle 2 via the valve plate 5 in the air circuit. The air pump 4 adopts an oil-free lubrication design, so it will not contaminate the gas during operation.

[0018] The following details the operation of the aseptic drug preparation system. First, turn on the main unit 1 to start the air pump 4. The air pump 4 injects gas into the valve plate 5 through the connecting pipe. The gas passes through the valve plate 5 and enters the filter 6, where it is filtered to become sterile gas. The sterile gas is discharged from the outlet of the filter 6. Next, attach the dissolving device 3 to the handle 2 (this is existing technology and will not be described in detail here), aligning the opening 32 at the rear end of the dissolving device 3 with the outlet of the filter 6 inside the handle 2. Press the suction button 212 on the handle 2, causing the air pump 4 to draw in air in the reverse direction between the opening 32 at the rear end of the dissolving device 3 and the rear end of the rubber piston. This creates a negative pressure between the opening 32 at the rear end of the dissolving device and the rear end of the rubber piston, causing the rubber piston to move backward and reset. Then, press the air blowing button 211 on button 21 to cause the air pump 4 to spray gas in a positive direction, creating positive air pressure. The gas is filtered into sterile gas by filter 6 and blown into the cylinder from the opening 32 at the rear end of the cylinder. Under the action of positive air pressure, the rubber piston moves forward, expelling the air located between the front end of the rubber piston and the front end 31 of the cylinder. Since the opening 32 at the rear end of the cylinder is connected to the sterile gas, a sterile environment is formed inside the cylinder. After the air between the front end of the rubber piston and the front end 31 of the cylinder is completely expelled, the cylinder draws in the drug solution through the needle 7, and then pushes the drug solution into the container for the required drug preparation, completing the drug preparation operation.

[0019] Example 1

[0020] (1) The above-mentioned air path diameter design, air pump 4 power and filter 6 outlet air pressure settings are as follows: air pump 4 outlet pipe diameter is 9mm, valve plate 5 air path pipe diameter is 7mm, filter 5 outlet pipe diameter is 5mm; air pump 4 power is 200W; filter 6 outlet air pressure is positive pressure 0.2Mpa, negative pressure -89Kpa. The capacity specification of the dissolving device 3 is 25ml.

[0021] (2) Sterile environment test

[0022] Airborne bacteria testing was used: Airborne bacteria refer to microbial particles suspended in the air, and their concentration directly affects the cleanliness of the environment. At the air outlet of filter 6, airborne bacteria samplers were used to collect microorganisms in sterile gas, inoculated into culture medium, and colony counts were performed. The entire sampling and counting process was repeated 3 times under the same conditions, and the average value was taken. The test results are shown in Table 1.

[0023] Planktonic bacteria count: The number of planktonic bacteria in a normal environment is usually 100-1000 CFU / m³. 3 According to the Chinese pharmaceutical industry standard YY 0033-2000 "Management Standard for the Production of Sterile Medical Devices", the airborne bacteria count in a sterile medical device cleanroom (requiring a Class 100 standard, equivalent to ISO Class 5) should be ≤5 CFU / m³. 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 the standard deviation of the flow rate.

[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. Check for any obvious fluctuations or 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 drug preparation system in this embodiment is basically the same as that in Embodiment 1, except for the design of the gas path diameter and the capacity of the dissolving device 3: specifically, the outlet diameter of the air pump 4 is 8mm, the gas path diameter of the valve plate 5 is 6mm, the outlet diameter of the filter 6 is 4mm, and the capacity of the dissolving device 3 is 20ml.

[0031] Example 3

[0032] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the design of the gas path diameter and the capacity of the dissolving device 3: specifically, the outlet diameter of the air pump 4 is 6mm, the gas path diameter of the valve plate 5 is 6mm, the outlet diameter of the filter 6 is 6mm, and the capacity of the dissolving device 3 is 30ml.

[0033] Example 4

[0034] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the design of the gas path diameter and the capacity of the dissolving device 3: specifically, the outlet diameter of the air pump 4 is 12mm, the gas path diameter of the valve plate 5 is 8mm, the outlet diameter of the filter 6 is 6mm, and the capacity of the dissolving device 3 is 50ml.

[0035] Example 5

[0036] The aseptic dispensing system in this embodiment is basically the same as that in Embodiment 1, except that the power of the air pump 4 is 150W.

[0037] Example 6

[0038] The aseptic drug preparation system in this embodiment is basically the same as that in Embodiment 1, except for the power of the air pump 4 and the capacity of the dissolving device 3: specifically, the power of the air pump 4 is 50W and the capacity of the dissolving device 3 is 60ml.

[0039] Example 7

[0040] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the positive pressure of the outlet air pressure of filter 6 and the capacity of the dissolving device 3: specifically, the positive pressure is 0 MPa and the capacity of the dissolving device 3 is 30 ml.

[0041] Example 8

[0042] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the positive pressure of the outlet air pressure of filter 6 and the capacity of the dissolving tank 3: specifically, the positive pressure is 0.4 MPa and the capacity of the dissolving tank 3 is 50 ml.

[0043] Example 9

[0044] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the negative pressure of the outlet air pressure of filter 6 and the capacity of the dissolving device 3: specifically, the negative pressure is -120Kpa and the capacity of the dissolving device 3 is 20ml.

[0045] Example 10

[0046] The aseptic drug preparation system in this embodiment is basically the same as that in embodiment 1, except for the negative pressure of the outlet air pressure of filter 6 and the capacity of the dissolving device 3: specifically, the negative pressure is -100Kpa and the capacity of the dissolving device 3 is 60ml.

[0047] Comparative Example 1

[0048] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet pipe diameter of the air pump 4 is 5 mm.

[0049] Comparative Example 2

[0050] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet pipe diameter of the air pump 4 is 13 mm.

[0051] Comparative Example 3

[0052] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the diameter of the gas passage of valve plate 5 is 5 mm.

[0053] Comparative Example 4

[0054] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the diameter of the gas passage of valve plate 5 is 9 mm.

[0055] Comparative Example 5

[0056] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet diameter of filter 6 is 7 mm.

[0057] Comparative Example 6

[0058] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet diameter of filter 6 is 3 mm.

[0059] Comparative Example 7

[0060] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except for the gas pipe diameter: specifically, the outlet pipe diameter of the air pump 4 is 5mm, the gas pipe diameter of the valve plate 5 is 5mm, and the outlet pipe diameter of the filter 6 is 3mm.

[0061] Comparative Example 8

[0062] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except for the gas pipe diameter: specifically, the outlet pipe diameter of the air pump 4 is 13mm, the gas pipe diameter of the valve plate 5 is 9mm, and the outlet pipe diameter of the filter 6 is 7mm.

[0063] Comparative Example 9

[0064] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the power of the air pump 4 is 220W.

[0065] Comparative Example 10

[0066] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet air pressure of filter 6 is positive, which is 0.5 MPa.

[0067] Comparative Example 11

[0068] The aseptic dispensing system in this comparative example is basically the same as that in Example 1, except that the outlet air pressure of filter 6 is negative, which is -88 kPa.

[0069] Table 1. Results of the airborne bacteria test

[0070]

[0071]

[0072] In Table 1, the average number of airborne bacteria in Examples 1 through 10 was less than 2.3 CFU / m³. 3 The average number of airborne bacteria in Comparative Examples 1-11 was higher than 4.7 CFU / m³. 3It is evident that the dimensions of the air pump 4 outlet pipe diameter, the valve plate 5 air passage pipe diameter, and the filter 6 outlet pipe diameter of this utility model are well-matched, resulting in excellent filtration performance.

[0073] Table 2 Results of Airflow Uniformity and Stability Tests

[0074]

[0075] In Table 2, the experimental results show that the average flow rate of Examples 1 to 10 was moderate, with a standard deviation within 0.1 m / s and pressure fluctuations within ±9 kPa. Furthermore, the smoke flow exhibited no significant fluctuations or stagnation areas. In contrast, the standard deviations of the flow rates in Comparative Examples 1 to 11 exceeded 0.15 m / s, and the pressure fluctuations exceeded ±10 kPa. Moreover, the smoke flow showed fluctuations and localized stagnation. It is evident that the well-matched dimensions of the outlet pipe diameter of the air pump 4, the air passage diameter of the valve plate 5, and the outlet pipe diameter of the filter 6 in this invention result in low local resistance, smooth airflow, and strong system stability and reliability.

[0076] The above description is merely an embodiment of the present invention and does not limit the scope of patent protection. Any non-substantial changes or substitutions made by those skilled in the art based on the present invention will still fall within the scope of patent protection.

Claims

1. A sterile dispensing system comprising a gas pump (4), a valve plate (5) and a filter (6) connected in sequence on a gas path, the gas pump (4) driving a piston of an external medicine container (3) to retreat to suck in medicine liquid when the gas pump (4) sucks in gas, and the gas pump (4) driving the piston of the external medicine container (3) to advance to push out the medicine liquid when the gas pump (4) spouts out gas, characterized in that: The outlet pipe diameter of the air pump (4) is 6-12mm, the air pipe diameter of the valve plate (5) is 6-8mm, and the outlet pipe diameter of the filter (6) is 4-6mm; the power of the air pump (4) is ≤200W; the outlet air pressure range of the filter (6) is positive pressure 0-0.4Mpa and negative pressure ≤-89Kpa. ​ 2. A system as claimed in claim 1, characterised in that: Includes a main unit (1) and a handle (2) connected to the main unit (1), the air pump (4) and valve plate (5) are located inside the main unit (1), the filter (6) is located inside the handle (2), and the handle (2) is connected to a dissolving device (3).

3. A system as claimed in claim 2, wherein: The blow button (211) and the suction button (212) of the air pump (4) are located on the handle (2).

4. The aseptic dispensing system of claim 1, wherein: The air pump (4) adopts an oil-free lubrication design.

5. The aseptic dispensing system of claim 1, wherein: The filter (6) has a pore size of 0.2 micrometers.

6. The aseptic dispensing system of claim 1, wherein: The outlet pipe diameter of the air pump (4) is 8-12mm, the air pipe diameter of the valve plate (5) is 6-8mm, and the outlet pipe diameter of the filter (6) is 4-5mm.

7. The aseptic dispensing system of claim 1, wherein: The outlet pipe diameter of the air pump (4) is 8mm, the air pipe diameter of the valve plate (5) is 6mm, and the outlet pipe diameter of the filter (6) is 4mm.

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