A method for actively adjusting the airflow organization of a sterile cleanroom

Abstract

This invention discloses a method for actively adjusting the airflow organization of a sterile cleanroom. Its key feature is the use of variable interference to the airflow direction and volume at the air outlets within the cleanroom to ensure that all risk spaces on each operating panel of the sterile cleanroom maintain a sterile and clean airflow environment under various operating conditions. This effectively regulates the airflow within the cleanroom, particularly on the operating panels that must maintain a safe negative pressure, under different operating conditions. It meets the design requirement of a 1.5-meter distance between air outlets and process equipment such as biosafety cabinets that require wind speed on the operating surface, providing a safe guarantee for the sterile and clean airflow environment of small-scale sterile cleanrooms. It achieves 360-degree omnidirectional airflow direction and volume distribution, adapting to various cleanroom geometries and process equipment layouts, especially for highly integrated Level 2 biosafety experimental units such as gene therapy research and production units.

Description

Technical Field

[0001] This invention relates to sterile cleanroom technology, and in particular to a method for actively adjusting the airflow organization of a sterile cleanroom. Background Technology

[0002] Regardless of whether it is a non-unidirectional flow cleanroom or a unidirectional flow cleanroom, the airflow movement inside is always constrained by factors such as the cleanroom's geometry, the cleanroom's process equipment, the supply airflow and its related parameters, the structural characteristics of the return air vents, and the layout and radiation methods of the supply and return air vents within the cleanroom. Among these, the air supply method is a crucial factor determining the airflow organization within the cleanroom.

[0003] There are two main challenges in designing biosafety cleanrooms: biosafety risks and the cleanliness of the cleanroom.

[0004] To prevent the spillover of biological risks, biosafety cabinets are often installed in cleanrooms. A biosafety cabinet is a box-shaped, negative-pressure air-purifying safety device that prevents the aerosol release of potentially hazardous or unknown biological particles during experimental procedures. However, the "truly safe" operation of a biosafety cabinet depends on its external environment. When the airflow velocity within 0.5 meters of the operating surface of the biosafety cabinet is too high, turbulent vortices will form, making it difficult to create a stable airflow into the cabinet and causing biological risks to spill over. Therefore, in cleanrooms with biosafety cabinets, to avoid the indoor airflow affecting the safety of the biosafety cabinet, it is generally required that the cleanroom's air supply vents maintain a safe distance of at least 1.5 meters from the biosafety cabinet to ensure its safe operation.

[0005] Another challenge is maintaining the cleanliness level of the cleanroom. If the air vents are too dispersed, clean air cannot cover the cleanroom, resulting in the cleanliness level failing to meet standards. Moreover, for some small, compact cleanrooms, even if the air vents are placed at the very edge, the safe distance of 1.5 meters cannot be achieved.

[0006] In existing technologies, cleanroom air outlets are generally square, high-efficiency air outlets. For example, patent publication number CN210875461U describes a mobile scientific experimental platform, with a clean experimental platform inside the casing, including experimental equipment. Another example is patent publication number CN214246781U, which describes a container with a structural layout, where the structural layout takes the form of a cleaning and washing room. These traditional air outlets typically have a perforated plate in the center. Figure 4The diagram shows a traditional air outlet 9, with traditional diffusers 901 serving as diffusers in the four cardinal directions (east, west, south, and north). If this fixed airflow angle and single airflow pattern are used in a small, compact biosafety cleanroom, it will inevitably create disturbing eddies on the biosafety cabinet's operating surface, potentially causing negative impacts and leading to an "unsafety issue" for the biosafety cabinet. Biosafety sterile cleanrooms must ensure clean airflow covers the work area to create a sterile environment while controlling the airflow velocity in high-risk operating areas to prevent negative impacts on the operation of the biosafety cabinet. Therefore, the design of airflow organization is crucial. Summary of the Invention

[0007] The purpose of this invention is to solve the above-mentioned problems and provide a method for actively adjusting the airflow organization of a cleanroom. This method can actively adjust the airflow according to different layouts and working conditions of the cleanroom, so that all operating table risk spaces can meet the aseptic clean environment airflow technical standards for the working conditions of the process.

[0008] The above-mentioned technical problems of the present invention are mainly solved by the following technical solution: a method for actively adjusting the airflow organization of a sterile clean chamber, characterized in that, by interfering with the airflow direction and directional airflow volume of the air outlet in the clean chamber, all risk spaces of each operating panel of the sterile clean chamber meet the sterile clean airflow environment of the working condition under various working conditions.

[0009] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the air outlet is arranged at the top of the clean chamber, the air outlet is provided with a vertical air supply plate and a diffuser plate arranged around the vertical air supply plate, and a movable wind deflector plate is provided on one side of the diffuser plate to cooperate with the diffuser plate. The movable wind deflector plate can change the direction and directional airflow of the airflow guided by the diffuser plate of the air outlet.

[0010] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the movable wind deflector can completely or partially block the diffuser plate.

[0011] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the vertical air supply orifice plate of the air supply port has a circular structure, a number of diffuser plates are provided, the number of diffuser plates are spaced apart around the vertical air supply orifice plate, a slide rail is provided concentrically with the diffuser plates, and a number of movable wind deflectors are positioned on the slide rail.

[0012] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the width of the diffuser plate is A, the interval between two adjacent diffusers plate is B, and the width of the movable wind deflector is C, then B > C > A.

[0013] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the air outlets and each control panel are located in a non-vertical spatial position.

[0014] The aforementioned method for actively adjusting the airflow organization of a sterile cleanroom is characterized by using commercial CFD software to perform numerical simulation of the cleanroom, establishing a physical model to simulate the impact of different air supply directions on each control panel, and evaluating the wind speed within 0.5 meters of all risk spaces from the control panel.

[0015] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the 0.5-meter range of all risk spaces on the control panel includes five directions: front, top, bottom, left, and right of the control panel; and the obtained data is compared with the actual measurement data, and the adjustment positions for different working conditions are marked on the movable windshield deflector.

[0016] The aforementioned method for actively adjusting the airflow organization of a sterile clean chamber is characterized in that the control panel is a biosafety cabinet, a fume hood, or a workbench.

[0017] The aforementioned method for actively adjusting the airflow organization of a sterile cleanroom is characterized in that the variation interference of the airflow direction and directional airflow volume at the air outlet is controlled manually, automatically, or remotely.

[0018] In cleanrooms with compact layouts and limited space, the location of air supply outlets often cannot meet the requirement of being 1.5 meters away from process equipment such as biosafety cabinets and fume hoods that require wind speed at the operating surface. This technical solution addresses this issue by studying and designing the influence range of airflow movement and airflow organization within the cleanroom, starting from the air supply airflow and its related parameters, such as the geometric shape and structural characteristics of the air supply outlet, air supply airflow parameters, etc.

[0019] This solution primarily achieves its goal of maintaining a sterile clean environment across all control panels and risk spaces under varying operating conditions by manipulating two key elements of the air supply outlets within the cleanroom: airflow direction and directional airflow rate. This sterile clean environment fully complies with standards for biomedicine, precision medicine, gene research / dynamic drug production management, and effectively ensures high-tech standards for airflow patterns in experimental / research and development, and production integration / production units.

[0020] In this design, the air supply outlets are positioned at the top of the cleanroom within a limited space. The vertical air supply perforation plate directs the main airflow, while the diffuser plate surrounding it directs the diffused airflow. After defining the positional relationship between the air supply outlets and the control panels, since the vertical air supply perforation plate has minimal impact on the control panels, adjusting the diffuser plate through movable dampers effectively regulates the diffused airflow direction and volume.

[0021] The main airflow direction of the air outlet is designed as a circular structure. The diffuser is evenly arranged around the outer circle of the vertical air outlet plate with the center as the center. The movable wind deflector can block all or part of the airflow surface of the diffuser plate, forming a 360-degree ring-shaped all-round control range. The direction and volume of the airflow from the diffuser plate can be selected and used without level or dead angle, forming a safe space that meets the specifications, ensuring the positive pressure requirements of the control panel, and preventing instantaneous backflow at the exhaust outlet under certain special working conditions.

[0022] The reasonable data on how the movable windshield deflectors affect airflow organization can be obtained through numerical simulation using commercial CFD software, combined with actual measurement data. In practical applications, the identification symbols for the different adjustment positions of the movable windshield deflectors under different operating conditions serve as a reference for manual interference. Furthermore, this solution can also achieve automatic and remote-controlled interference operation.

[0023] Compared with existing technologies, the beneficial effects of this invention are: it effectively regulates the risk range of the operating panel in the cleanroom, especially the operating panel which must maintain a safe negative pressure, and the airflow under different operating conditions; it meets the design requirement of a 1.5-meter distance between the air supply outlet and process equipment such as biosafety cabinets that require wind speed on the operating surface; it provides a safety guarantee for the sterile and clean airflow environment of small-scale sterile cleanrooms; it achieves 360-degree all-round airflow direction and volume distribution, adapting to various cleanroom geometries and process equipment layouts, especially for highly integrated Level 2 biosafety experimental units such as gene therapy research and development and production functions; and the air supply window structure is reasonable and the operation is simple. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of an application site structure of the present invention.

[0025] Figure 2 This is a schematic diagram of the top planar arrangement of an air outlet according to the present invention.

[0026] Figure 3 This is a schematic diagram of an air outlet structure according to the present invention.

[0027] Figure 4 This is a schematic diagram of a traditional air outlet structure.

[0028] Figure 5This is a lower velocity cloud map (planar) of an unmanned working condition according to the present invention.

[0029] Figure 6 This is a lower velocity vector diagram (plane) of an unmanned working condition according to the present invention.

[0030] Figure 7 This invention provides a lower velocity cloud map (planar) for a manned (2-person) situation.

[0031] Figure 8 This invention provides a frontal velocity cloud map (planar) for a manned (2-person) situation.

[0032] In the diagram: 1. Main laboratory, 2. Auxiliary room for the machine room, 3. Preparation room, 4. Incubator, 5. Workbench, 6. Centrifuge, 7. Biosafety cabinet, 8. Air outlet, 801. Vertical air supply perforated plate, 802. Slide rail, 803. Diffuser, 804. Movable wind deflector, 9. Traditional air outlet, 901. Traditional air diffuser, 10. Staff. Detailed Implementation

[0033] The technical solution of the present invention will be further described in detail below through embodiments and in conjunction with the accompanying drawings.

[0034] This embodiment describes a method for actively adjusting the airflow organization of a sterile clean chamber, taking a mobile sterile experimental chamber as an example. Figure 1 As shown, the central area is the main laboratory 1. To one side of the main laboratory 1 is the auxiliary room 2, and to the other side is the preparation room 3. On one side of the floor of the main laboratory 1, incubators 4 and workbenches 5 are arranged, while centrifuges 6 and biosafety cabinets 7 are arranged on the other side. Figure 2 As shown, the air supply vent 8 is located on the top of the cleanroom between the workbench 5 and the biosafety cabinet 7, in a non-vertical spatial position relative to each control panel.

[0035] The airflow organization of the sterile clean chamber is adjusted with the main laboratory 1 (clean chamber) as the target. The basic principle is: by interfering with the airflow direction and directional airflow (vector air volume formed by the diffuser plate) of the air supply outlet 8 in the clean chamber, all risk spaces (potential leakage points) of each operating panel in the sterile clean chamber meet the sterile clean airflow environment of the working condition under various working conditions.

[0036] The air supply outlet 8, which has an operating panel on the cleanroom floor, is designed with a variable interference device. The structure of air supply outlet 8 is as follows: Figure 3 As shown, it includes a vertical air supply perforated plate 801 with a circular structure. Eight diffuser plates 803 are arranged around the vertical air supply perforated plate 801 with the center of the vertical air supply perforated plate 801 as the center. The shape of the diffuser plates 803 is consistent with the arc of the part where they are located.

[0037] Eight diffuser plates 803 are spaced apart, with a spacing of B between adjacent diffuser plates 803 [Note: In this embodiment, all measurements are in radians], where B is set to 25 degrees. The width (arc length) of each diffuser plate 803 is A, where A is 20 degrees. A slide rail frame 802 is concentrically mounted with the diffuser plates 803, and eight movable wind deflectors 804 are mounted on it. These wind deflectors are positioned and distributed around the diffuser plates 803 via the slide rail frame 802. The width of each movable wind deflector 804 is C, where C is set to 22 degrees.

[0038] Therefore, the movable wind deflector 804 can completely or partially block the diffuser plate, that is, the movable wind deflector 804 can change the direction and directional airflow of the airflow guided by the diffuser plate 803 at the air outlet 8.

[0039] In this embodiment, the data for each setting of the movable wind deflector 804 were obtained through two comparison methods. First, a cleanroom numerical simulation was performed using commercial CFD software such as Fluent. A physical model was established to simulate the impact of different airflow directions on each control panel, with the evaluation index being the wind speed within a 0.5-meter radius of all risk spaces from the control panels. Second, actual measurements were taken. The 0.5-meter radius of all risk spaces from the control panels (biosafety cabinet 7, fume hood, workbench 5) included the five directions: front, top, bottom, left, and right. The obtained data was then compared with the actual measurement data, and the adjustment positions for different operating conditions were marked on the movable wind deflector 804 to achieve manual interference. Automatic or remote control interference can also be easily implemented.

[0040] Combining CFD software numerical simulation and actual sample measurement data, the comprehensive experimental analysis under two working conditions—unmanned and manned (2 people)—is as follows:

[0041] Main Laboratory 1 (cleanroom) has a positive biological laboratory environment (cleanliness level: B). The laboratory dimensions are 3.55m × 2.9m × 2.7m (length × width × height), with a mezzanine height of 0.55m. The cleanroom is equipped with one biosafety cabinet (Thermo Scientific 1500 series B2 type Class II biosafety cabinet), centrifuge, incubator, stainless steel workbench, and other equipment and facilities.

[0042] The evaluation metric is the wind speed within 0.5 meters of each direction (front, top, bottom, left, and right, a total of five planes) from the operating surface of the biosafety cabinet. The results for each plane are displayed in two forms: a velocity contour map and a velocity vector map.

[0043] like Figure 5 The image shows a top-down velocity cloud map of the unmanned working condition. The image shows the area 500mm below the biosafety cabinet 7. The darker areas of the centrifuge 6 represent areas with higher wind speeds, while the white areas represent the objects being captured. Figure 6 This is a vector diagram of the velocity under unmanned working conditions. The wireframe represents the outline of the object above the cross-section. It is also a top view, showing the data for the position 500mm below the biosafety cabinet 7.

[0044] Figure 7 It is a bottom velocity cloud map (top view) with two people in the manned condition. The blank part is the object being cut off. Number 10 is the staff member. The line frame is the outline of the object above the cross section. It is the position data of 500mm below the biosafety cabinet 7. Figure 8 This is a top-down view of the front velocity contour map of a manned vehicle (2 people).

[0045] This embodiment also experimentally measures the particulate matter concentration in the main laboratory 1 (cleanroom): under dynamic conditions, i.e., under manned working conditions; and under static conditions, including self-inspection conditions and on-duty conditions. The particulate matter standard is a particle size of 0.5 μm (the volume of each particle sphere is 6.545 × 10⁻⁶). -20 m 3 ), with a density of 1000 kg / m³ 3 The unit particulate matter mass is 6.545 × 10⁻⁶. -17 kg / particle.

[0046] The continuous phase was tested using steady-state methods, while the discrete phase was tested using unsteady-state methods. The standard requirement for the concentration in a Class B cleanroom is: 3520 particles / m³ (static). 3 (Self-inspection condition), dynamic 3,520,000 particles / m 3 (Working conditions and on-duty conditions).

[0047] Test results:

[0048] Manned working conditions (dynamic): The test point was a longitudinal section of the cleanroom at a height of 1m, in the area with a high concentration of particulate matter on the face of the workers. The particulate matter concentration in the cleanroom was 16085 particles / m³. 3 Less than the standard of 352,000 particles / m 3 .

[0049] Self-test condition (static): Test location is a 1m high plane, longitudinal section of the room. Particulate matter concentration in the room is 1066 particles / m³. 3 Less than the standard of 3520 particles / m 3 .

[0050] Operating conditions (static): The test location is a 1m high plane, longitudinal section of the room. The particulate matter concentration in the room is 3318 particles / m³. 3 Less than the required 352,000 particles / m 3 .

[0051] The above test and inspection results show that by interfering with the airflow direction and directional airflow volume of the air supply outlet 8 in the clean chamber, the airflow environment requirements of all risk spaces of each operating panel in the sterile clean chamber are fully met under various working conditions.

[0052] The above embodiments are illustrative of the present invention and are not intended to limit the present invention. In the field of sterile cleanrooms without departing from the principles of the present invention, any simple modifications to the structure or method of the present invention are within the protection scope of the present invention.

Claims

1. A method for actively adjusting the airflow organization of a sterile clean room, characterized in that, The air flow direction and directional air flow of the air supply port (8) in the clean cabin are interfered in a variable manner, so that all risk spaces of the operation panel of the sterile clean cabin meet the air flow environment of the sterile clean cabin under various working conditions. The air supply port (8) is arranged at the top of the clean cabin, and the air supply port is provided with a vertical air supply hole plate (801) and a diffusion plate (803) arranged around the vertical air supply hole plate. The diffusion plate (803) is provided with a movable wind deflector (804) matched with the diffusion plate. The movable wind deflector (804) can interfere with the air flow direction and directional air flow of the diffusion plate of the air supply port. The movable wind deflector (804) can fully or partially shield the diffusion plate. The vertical air supply hole plate (801) of the air supply port (8) is in a circular structure. The diffusion plate (803) is provided with a plurality of diffusion plates. The plurality of diffusion plates are distributed at intervals around the vertical air supply hole plate. The diffusion plate is provided with a slide rail frame (802) concentrically. The plurality of movable wind deflectors (804) are positioned on the slide rail frame. The numerical simulation of the clean cabin is carried out by using a commercial CFD software. The influence of different air supply directions on the operation panel is simulated by establishing a physical model. The evaluation index is the wind speed within 0.5 meters of the all risk space of the operation panel.

2. The method for actively adjusting the airflow organization of a sterile clean cabin according to claim 1, characterized in that, The width of the diffusion plate (803) is A, the interval distance between the adjacent two diffusion plates is B, and the width of the movable wind deflector (804) is C, then B>C>A.

3. The method for actively adjusting the airflow organization of a sterile cleanroom according to claim 1, characterized in that, The air supply port (8) and the operation panel are located in a non-vertical space position.

4. The method for adjusting the air flow organization of a sterile clean cabin according to claim 1, characterized in that, The all risk space of the operation panel within 0.5 meters includes five directions of front, top, bottom, left and right of the operation panel. The obtained data is compared with the actual measured data, and the identification of the adjustment position of the movable wind deflector (804) under different working conditions is carried out.

5. The method for adjusting the airflow organization of a sterile clean cabin actively as claimed in claim 1, wherein, The variable interference of the air flow direction and directional air flow of the air supply port (8) is controlled manually or automatically or remotely.

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