Temperature-controlled chute and dust-free sterile operating system

By designing a temperature-controlled chute and dust-free and sterile operating system, the problems of DMSO to cytotoxicity and limited operating space and pollution risks in frozen storage operations in deep and low temperature preservation are solved, and rapid and batch transfer is achieved at predetermined temperatures. Biological samples reduce the risk of DMSO damage and improve the efficiency and safety of frozen storage operations.

WO2025035498A1PCT designated stage expired Publication Date: 2025-02-20JIANGSU PACIFIC MEINUOKE BIOPHARML
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Patent Information

Application Number
PCT/CN2023/115293
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-15
Filing Date
2023-08-28
Publication Date
2025-02-20

AI Technical Summary

Technical Problem

In industries such as biopharmaceuticals and food fermentation, dimethyl sulfoxide (DMSO) is a permeable protective agent as a permeability protector. Although it can avoid cell damage, it is toxic to cells at room temperature and is frozen during operation. The freezing container needs to be transferred quickly to reduce DMSO damage, which has problems with limited operating space and risk of contamination.

Method used

A temperature-controlled slide chute is designed, including a U-shaped slide frame, a temperature control box, a slender slide plate, a slide chute upper cover and a counterweight base through which the biological sample is cleaner from a predetermined temperature. The environment is transferred to a low-cleaning environment, combined with a dust-free and sterile operating system, and realizes rapid and batch transfer of frozen storage containers.

Benefits of technology

It realizes rapid and batch transfer of biological samples from high-cleanness environment to low-cleanness environment without affecting cleanliness, reducing the risk of DMSO to cells, and improving the efficiency and safety of frozen storage operations. sex.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to a temperature-controlled chute and a dust-free sterile operating system. The temperature-controlled chute comprises: a U-shaped chute frame, which comprises an elongated bottom plate and two side walls, the bottom plate and / or the side walls being constructed as a double-layer structure having a sealed cavity, a first longitudinal end of the U-shaped chute frame being open and a second longitudinal end being provided with a baffle extending upward from the bottom plate, external sides of the two side walls being provided with adjustment shafts extending outward in the transverse direction, and inner sides being provided with limiting mechanisms; a temperature control box, which may be embedded in the U-shaped chute frame from below the limiting mechanisms; an elongated sliding plate, wherein the sliding plate may slide into the U-shaped chute frame from a gap between the temperature control box and the limiting mechanisms and is supported by the temperature control box; at least one chute upper cover, which detachably cooperates with top portions of the sides wall of the U-shaped chute frame so as to cover at least a portion of a top opening of the U-shaped chute frame; and a counterweight base, a top portion of which being provided with a pair of fastening fixtures, each fastening fixture being configured to be capable of receiving and gripping a corresponding adjustment shaft of the U-shaped chute frame.
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Description

Temperature-controlled chute and dust-free and sterile operating system Technical Field

[0001] The present invention relates to a temperature-controlled chute for transferring biological samples from an environment with higher cleanliness to an environment with lower cleanliness at a predetermined temperature, and a dust-free and sterile operating system using the temperature-controlled chute. Background Art

[0002] In industries like biopharmaceuticals and food fermentation, cells, bacteria, yeast, and other biological materials and tissue samples are the primary research subjects and raw materials. To ensure research continuity and product stability, cryopreservation of these materials and tissue samples is crucial.

[0003] In cryopreservation, glycerol and dimethyl sulfoxide are generally used as protective agents to prevent damage to the preserved samples during the cryopreservation process. Among them, dimethyl sulfoxide (DMSO) is currently a more popular permeable protective agent.

[0004] During the deep-temperature (minus 196°C) freezing process, DMSO can prevent the formation of ice crystals in cells and prevent cell damage caused by changes in osmotic pressure, cell structure disorder, etc.

[0005] However, relevant studies have shown that DMSO is toxic to cells at room temperature. When the DMSO concentration in the culture medium is 10%, the cell growth inhibition rate is nearly 100%; at a concentration of 1‰, the inhibition rate is 35%; even at a concentration of 0.04‰, DMSO still has an adverse effect on cell growth. Only at deep low temperatures will the toxicity of DMSO to cells be reduced. Therefore, during production operations, especially after adding DMSO during the freezing process, it is necessary to promptly transfer the cells that have been packaged into the freezing container to a low-temperature temporary storage box to reduce the damage caused by DMSO to the cells.

[0006] Because the cryopreservation of biological materials must comply with GMP and other regulatory requirements while minimizing the risk of contamination, actual cryopreservation operations typically involve sample mixing and packaging within a dust-free, sterile operating system, such as a clean bench or biosafety cabinet. Rapidly transferring the packaged cryopreservation containers into low-temperature temporary storage boxes requires the simultaneous collaboration of multiple staff members. However, the operating space within a clean bench or biosafety cabinet is limited, and frequent loading and unloading operations increase the risk of contamination within the cabinet.

[0007] Therefore, there is a need to conveniently and in batches transfer the frozen containers in the clean bench or biosafety cabinet out of the cabinet in a low-temperature environment.

[0008] Summary of the Invention

[0009] One of the purposes of the present application is to provide a temperature-controlled chute for transferring biological samples from an environment with a higher cleanliness level to an environment with a lower cleanliness level at a predetermined temperature.

[0010] According to one aspect of the present application, a temperature-controlled chute is provided for transferring biological samples from a higher cleanliness environment to a lower cleanliness environment at a predetermined temperature. The temperature-controlled chute comprises: a U-shaped chute frame, the U-shaped chute frame comprising a slender bottom plate and two side walls extending upward from the lateral sides of the bottom plate, respectively; the bottom plate and / or the side walls are constructed as a double-layer structure with a closed cavity, the U-shaped chute frame is open at its first longitudinal end, the second longitudinal end of the U-shaped chute frame is provided with a baffle extending upward from the bottom plate, the outer sides of the two side walls of the U-shaped chute frame are respectively provided with laterally outwardly extending adjustment shafts at positions laterally aligned with each other, and the inner sides of the two side walls are respectively provided with corresponding heights. A limiting mechanism arranged longitudinally along the side wall; a temperature control box, the shape and size of the temperature control box being set to be embedded in the U-shaped slide frame from below the limiting mechanism of the U-shaped slide frame; a slender slide, the shape and size of the slide being set to be able to slide into the U-shaped slide frame from the gap between the temperature control box and the limiting mechanism and supported by the temperature control box; at least one slide cover, the slide cover being detachably engaged with the top of the side wall of the U-shaped slide frame to cover at least a portion of the top opening of the U-shaped slide frame; and a counterweight base, the top of the counterweight base being provided with a pair of fastening clamps, the fastening clamps being configured to receive and clamp the corresponding adjustment shafts of the U-shaped slide frame.

[0011] In some embodiments, the limiting mechanism is constructed as a longitudinal protrusion provided on the inner sides of two side walls of the U-shaped chute frame.

[0012] In some embodiments, the limiting mechanism is constructed as a step portion formed on the inner side of the side wall of the U-shaped slide frame, and the cavity thickness of the side wall above the limiting mechanism is greater than the cavity thickness of the side wall below the limiting mechanism.

[0013] In some embodiments, a condensate drain hole is provided on the baffle at the second longitudinal end of the U-shaped chute frame at a position close to the bottom plate and / or on the bottom plate at a position close to the baffle.

[0014] In some embodiments, the condensed water drain hole is configured to have a pipe joint that can be detachably connected to a drain pipe.

[0015] In some embodiments, the temperature control box is constructed in a hollow rectangular parallelepiped shape, and the interior of the temperature control box is filled with heat storage material and is sealed from the outside.

[0016] In some embodiments, the thermal storage material is selected from at least one of the following: water, ethanol solution, sodium polyacrylate, sodium hydroxymethyl cellulose, 25% sodium chloride solution, and 30% calcium chloride solution.

[0017] In some embodiments, the U-shaped chute frame, the temperature control box, the slide plate, and the counterweight base are respectively made of at least one of the following materials: stainless steel, polypropylene plastic, and polycarbonate.

[0018] In some embodiments, the chute cover is formed of at least one of the following materials: tempered glass, polyethylene (PE), polyvinyl chloride (PVC), polyethylene terephthalate (PET), and polypropylene.

[0019] In some embodiments, the upper surface of the slide is polished, or the upper surface of the slide is coated with a coating of polytetrafluoroethylene and / or polyparaxylene.

[0020] In some embodiments, a longitudinal end of the slide is provided with a substantially L-shaped stop plate extending upward from a longitudinal edge and an adjacent side edge of the slide.

[0021] In some embodiments, the fastening fixture includes a lower half and an upper half, the lower half being fixedly coupled to the main body of the counterweight base, and the upper half being configured to be detachably coupled to the lower half to surround and clamp the outer surface of the adjustment shaft.

[0022] In some embodiments, a buffer material is attached to at least one of the following locations: an inner side of the baffle, an inner side of the bottom plate of the U-shaped slide frame, and a contact surface of the fastening clamp for clamping the adjustment shaft.

[0023] In some embodiments, the buffer material is made of at least one of the following materials: silicone, polyvinyl chloride (PVC) and modified PVC.

[0024] In some embodiments, a temperature monitoring device is provided on the inner side of the side wall of the U-shaped chute frame, and the temperature monitoring device is close to the baffle and located above the limiting mechanism. The temperature monitoring device is configured to detect the temperature inside the U-shaped chute frame at intervals or continuously and to issue an alarm when the detected temperature exceeds a predetermined numerical range.

[0025] According to another aspect of the present application, a dust-free and sterile operating system is provided, which comprises: a dust-free and sterile operating cabinet, which comprises a cabinet body with a hollow operating cavity, a workbench arranged in the operating cavity, an operating port is provided on the front side of the cabinet body, and the operator's hand can enter the operating cavity and approach the workbench through the operating port, and the operating port can be partially or completely shielded by a sliding front window, a fan is provided in the cabinet body and above the workbench, the fan blows air to the workbench, and a return air port is provided on the edge of the workbench; and the aforementioned temperature control slide. The U-shaped slide frame is provided across the operating port, the counterweight base of the U-shaped slide frame is placed on the workbench, the first longitudinal end of the U-shaped slide frame is located in the operating cavity of the cabinet body, the second longitudinal end of the U-shaped slide frame is located outside the cabinet body, and the height of the first longitudinal end of the U-shaped slide frame is higher than the second longitudinal end.

[0026] In some embodiments, near the operating port, the flow rate of the airflow blown by the fan to the U-shaped chute frame is at least 0.30 m / s.

[0027] In some embodiments, the cleanliness level in the operating chamber is at least Class A.

[0028] In some embodiments, there is a negative pressure near the operation port with an absolute value greater than or equal to 120 Pa.

[0029] In some embodiments, the concentration of settled bacteria in the operation chamber is less than or equal to 0.5 cfu / dish.

[0030] The above is a summary of the present application, which may contain simplifications, generalizations, and omissions of details. Therefore, those skilled in the art should recognize that this section is illustrative only and is not intended to limit the scope of the present application in any way. This summary is neither intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The above and other features of the present application will be more fully understood through the following description and the appended claims, taken in conjunction with the accompanying drawings. It should be understood that these drawings only depict several embodiments of the present application and, therefore, should not be construed as limiting the scope of the present application. The present application will be more clearly and fully illustrated by the accompanying drawings.

[0032] 1A-1B are perspective schematic diagrams showing various components of a temperature-controlled chute and the chute as a whole in a disassembled state and an assembled state, respectively, according to an embodiment of the present application.

[0033] FIG1C schematically shows a structural diagram of a temperature control box installed in the U-shaped chute frame shown in FIG1B .

[0034] 2A-2B are perspective schematic diagrams showing various components of a temperature-controlled chute and the chute as a whole in a disassembled state and an assembled state, respectively, according to another embodiment of the present application.

[0035] FIG2C schematically shows a structural diagram of a temperature control box installed in the U-shaped chute frame shown in FIG2B .

[0036] 3A and 3B are schematic diagrams of the inner structure of the side wall and a top view of the bottom plate of the U-shaped chute frame shown in FIG. 2A-2B , respectively.

[0037] FIG. 4 is a schematic diagram showing a slide structure of the temperature control chute shown in FIG. 2A-2B .

[0038] FIG. 5 shows a front view of the inner side of the baffle of the temperature control chute shown in FIG. 2A-2B .

[0039] FIG6 shows a schematic diagram of a dust-free and aseptic operating system according to one embodiment of the present application.

[0040] List of reference numerals: Temperature control chute 100, 200 U-shaped chute frame 110, 210 Frame bottom plate 111, 211 Bottom plate silicone pad 111a, 211a Frame side wall 112, 212 Frame cavity 113 First longitudinal end 114, 214 Second longitudinal end 115, 215 Baffle 116, 216 Baffle buffer material 116a, 216a Dropping port 116b Condensate drain hole 216c Adjusting shaft 117, 217 Limiting mechanism 118, 218 Top opening of U-shaped chute frame 119 Temperature control box 120, 220 Pull buckle 121, 221 Opening 122, 222 Slide plate 130, 230 Stop plate 131, 231 Chute cover 140, 240 Counterweight base 150, 250 Fastening fixture 151 Fastening fixture upper half 151a Fastening fixture lower half 151b Temperature monitoring device 160, 260 Wire clamp 161, 261 Dust-free and sterile operating system 10 Dust-free and sterile operating cabinet 270 Cabinet 271 Operating cavity 272 Workbench 273 Operating port 274 Sliding front window 275 Fan 276 Return air vent 277 DETAILED DESCRIPTION

[0041] In the following detailed description, reference is made to the accompanying drawings which form a part thereof. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be employed and other changes may be made without departing from the spirit or scope of the subject matter of the present application. Before describing the present application in more detail, it should be understood that the present application is not limited to the specific embodiments described and that such embodiments are, of course, subject to change. It should also be understood that the terms used in this application are used only for the purpose of describing specific embodiments and are not intended to be limiting, as the scope of the present application is limited only by the appended claims.

[0042] When providing a numerical range, it should be understood that each intermediate value between the upper and lower limits of the range and any other intermediate values ​​within the range or within the range, to the tenth of the unit of the lower limit, are included in the scope of this application, unless the context clearly indicates otherwise. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges and are also included in the scope of this application, subject to any specifically excluded limits in the range. When the range includes one or two limits, the range excluding one or both of the limits is also included in the scope of this application. References to "about" values ​​or parameters herein include (and describe) variations (including errors and tolerances) for the value or parameter itself. For example, a description of "about X" includes a description of "X". For example, a description of "a value of X" includes values ​​within X ± 10%, X ± 9%, X ± 8%, X ± 7%, X ± 6%, X ± 5%, X ± 4%, X ± 3%, X ± 2% or X ± 1%.

[0043] After reading this application, those skilled in the art will understand that each embodiment described and explained in this application has discrete components and characteristics, which can be easily separated or combined with the characteristics of any other embodiments without departing from the scope or spirit of this application. Any method described can be carried out in the order of events described or in any other order that is logically possible.

[0044] As used herein, the terms "comprise," "include," "contain," and "have" and similar forms are intended to be equivalent in meaning, and the listing of one or more elements following these terms does not imply an exhaustive list or limitation to the listed one or more elements. For example, an article that "comprises" elements A, B, and C may consist of (i.e., comprise only) elements A, B, and C, or may include not only elements A, B, and C but also one or more other elements.

[0045] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. In this specification and the claims that follow, a number of terms will be provided for reference and will be defined to have the following meanings unless a contrary intention is clearly indicated.

[0046] As used herein, for ease of description, spatially relative terms such as "under," "below," "above," "above," "up," "upper," "lower," "left," "right," "vertical," "horizontal," "side," etc. may be used herein to describe the relationship of one element or feature to another element (elements) or feature (features), as illustrated in the figures. In addition to the orientations depicted in the figures, spatially relative terms are intended to cover different orientations of the device in use or operation. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein are likewise interpreted accordingly. It should be understood that when an element is referred to as being "connected to" or "attached to" another element, the element can be directly connected or attached to the other element, or there can be intermediate elements.

[0047] Figure 1A shows a perspective view of the various components of a temperature-controlled chute in an exploded state according to one embodiment of the present application. As shown in Figure 1A , the temperature-controlled chute 100 includes a U-shaped chute frame 110, a temperature control box 120, an elongated slide 130, at least one chute cover 140, and a counterweight base 150.

[0048] As shown in the figure, the U-shaped chute frame 110 includes an elongated base plate 111 and side walls 112 extending upward from both lateral sides of the base plate 111. In some embodiments, one of the base plate 111 and the side wall 112 is constructed as a double-layer structure with a closed cavity 113 to enhance thermal insulation performance. In some embodiments, both the base plate 111 and the side wall 112 are constructed as a double-layer structure with a closed cavity 113. The U-shaped chute frame 110 is open at its first longitudinal end 114 to allow the temperature control box 120 and the slide plate 130 to slide into the U-shaped chute frame 110 via the longitudinal opening. A baffle 116 extending upward from the base plate 111 is provided at the second longitudinal end 115 of the U-shaped chute frame 100, and preferably the baffle 116 is also constructed as a double-layer structure with a closed cavity 113.

[0049] Adjustment shafts 117 extending laterally outward from the side walls 112 are respectively provided at positions on the outside of the two side walls 112 of the U-shaped slide frame 110 that are laterally aligned with each other, and limiting mechanisms 118 arranged longitudinally along the side walls 112 are respectively provided at corresponding heights on the inside of the two side walls 112.

[0050] As shown in Figure 1C, the thickness of the cavity 113 of the upper side wall 112 is greater than the thickness of the cavity 113 of the lower side wall 112, thereby forming a step portion on the inner side of the side wall 112 of the U-shaped slide frame 110, and the step portion constitutes a limiting mechanism 118 for limiting the position of the temperature control box 120 and the slide plate in the U-shaped slide frame 110.

[0051] As shown in FIG1A , the temperature control box 120 is constructed in the shape of a hollow rectangular parallelepiped, the interior of which is filled with heat storage material and sealed relative to the outside world. As shown in FIG1C , a pull tab 121 is provided on at least one longitudinal end face of the temperature control box 120 to facilitate the operator to place and remove the temperature control box 120 from the U-shaped chute frame 110. The pull tab 121 can be hinged to the side wall of the temperature control box 120 so that it fits the side wall when not being taken in or out, saving space. Preferably, a recessed portion is formed on the side wall of the temperature control box 120, and the pull tab 121 is hinged in the recessed portion to further save space.

[0052] In some embodiments, the temperature control box 121 is provided with an opening 122 through which an operator can add energy storage material to the temperature control box 121. The opening 122 can be permanently or removably sealed by a seal (for example, by a removable plug being threaded or frictionally fitted into the opening 122). When the opening 122 is removably sealed by the seal, the operator can easily replace the energy storage material in the temperature control box 121 or adjust the amount of energy storage material filled therein.

[0053] In some embodiments, the thermal storage material is selected from at least one of the following: water, an ethanol solution, sodium polyacrylate, sodium hydroxymethyl cellulose, a 25% sodium chloride solution, and a 30% calcium chloride solution. By properly configuring the volume of the temperature control box 120 and the type and amount of thermal storage material stored therein, the temperature control box 120 can be maintained at a low temperature (4°C or below) for a longer period of time (e.g., 2 hours, 3 hours, etc.).

[0054] As shown in Figures 1A-1B, the slide 130 is constructed as an elongated plate-shaped body, with a stopper plate 131 extending upward from a longitudinal edge of the slide 130 body at one longitudinal end. In some embodiments, the stopper plate 131 is substantially perpendicular to the slide 130 body. During sample transport using the temperature-controlled chute 100, the sample is placed on the upper surface of the slide 130 and transported along the surface of the slide 130. Therefore, it is necessary to minimize the frictional resistance of the upper surface of the slide 130. In some embodiments, the upper surface of the slide 130 is polished. In some embodiments, the upper surface of the slide 130 is coated with a friction-reducing coating, such as a coating of polytetrafluoroethylene and / or parylene.

[0055] As shown in FIG. 1A and FIG. 1B , a pair of fastening clamps 151 are provided on the top of the counterweight base 150 . The fastening clamps 151 are configured to receive and clamp the corresponding adjustment shafts 117 of the U-shaped chute frame 110 .

[0056] As shown in FIG1A , the fastening fixture 151 includes an upper portion 151a and a lower portion 151b. The lower portion 151b is fixedly coupled to the main body of the counterweight base 150. One side of the upper portion 151a is pivotally connected to the lower portion 151b, allowing it to rotate relative to the lower portion 151b between an open position and a clamping position, thereby removably engaging the upper portion 151a. In the open position, the free end of the upper portion 151a is spaced away from the top of the lower portion 151b, allowing the adjustment shaft 117 to be placed on the generally semicircular support surface of the lower portion 151b. After placing the adjustment shaft 117, the upper half 151a can be rotated relative to the lower half 151b to a clamping position (Figure 1B). At this time, the upper half 151a and the lower half 151b surround the outer surface of the adjustment shaft 117 with their respective support surfaces. The upper half 151a and the lower half 151b can be further locked to each other by locking elements (such as bolts, snaps, etc.), thereby clamping the outer surface of the adjustment shaft 117, limiting the rotation of the adjustment shaft 117 in the fastening fixture 151, and then locking the angle of the U-shaped slide frame 110 relative to the horizontal plane.

[0057] In some embodiments, the contact surface of the fastening clamp 150 for clamping the adjustment shaft 117 (i.e., the supporting surface of the upper half 151a and the lower half 151b) can be processed to increase the roughness, for example, by attaching a buffer material thereon, and performing mechanical processing such as sandblasting and knurling on the surface.

[0058] Figure 1B shows a perspective view of the temperature-controlled chute 100 in its assembled state. In this assembled state, the temperature control box 120 and the slide 130 slide into the U-shaped chute frame 110 from the first longitudinal end 114 of the U-shaped chute frame 110. The chute cover 140 removably engages with and is supported by the top of the sidewall 112 of the U-shaped chute frame 110, thereby covering at least a portion of the top opening 119 of the U-shaped chute frame 110. Optionally, a sealing strip made of a cushioning material is provided at the mating location of at least one of the chute cover 140 and the sidewall 112 to ensure a sealed fit between the chute cover 140 and the U-shaped chute frame 110.

[0059] In some embodiments, the width of the chute cover 140 can also be set to be slightly smaller than the distance between the two side walls 112 so that it can be received between the two side walls 112. Accordingly, a support bar is provided on the inner side of the side wall 112 of the U-shaped chute frame 110 near the top opening 119 to support the chute cover 140. Optionally, a buffer material is provided on the support bar to reduce the impact of the chute cover 140 on the support bar when the chute cover 140 is installed.

[0060] As shown in FIG1C , when the temperature control box 120 is installed in the U-shaped chute frame 110 , the temperature control box 120 is located below the limiting mechanism 118 with a gap therebetween. The slide plate 130 can slide into the U-shaped chute frame 110 through the gap and be supported by the temperature control box 120 .

[0061] As previously mentioned, a stop plate 131 is provided at one longitudinal end of the slide 130, extending upward from the longitudinal edge of the slide 130. The height of the stop plate 131 is set to be higher than the height of the limiting mechanism 118 of the U-shaped chute frame 110 relative to the bottom plate 111 thereof. Therefore, in the assembled state, the abutment between the limiting mechanism 118 and the stop plate 131 can limit the depth of the slide 130 sliding into the U-shaped chute frame 110, and the stop plate 131 of the slide 130 can cover at least a portion of the opening at the first longitudinal end 114 of the U-shaped chute frame 110, and preferably cover the entire opening.

[0062] In some embodiments, a cushioning material is attached to the inner side of the stopper plate 131 of the slide 130 (i.e., the side facing the first longitudinal end 114 of the U-shaped chute frame 110) to reduce the impact of the slide 130 on the first longitudinal end 114 of the U-shaped chute frame 110 and the limiting mechanism 118 during the sliding process. In some embodiments, a cushioning material is provided at the location where the inner side of the U-shaped chute frame 110 and the stopper plate 131 meet (e.g., the edge portion of the bottom plate 111 and the side wall 112 near the first longitudinal end 114), thereby making the connection between the two closer, thereby further improving the thermal insulation performance of the interior of the assembled U-shaped chute frame 110.

[0063] In order to avoid the contamination of the operating environment by the temperature control chute 100, its components must be sterilized before use. In certain embodiments, before use, components such as the U-shaped chute frame 110, the slide plate 130, and the counterweight base 140 are subjected to high-temperature steam sterilization and / or irradiation sterilization, while the temperature control box 120 and the chute cover 140 are sterilized using irradiation or a sterilizing agent (e.g., alcohol, iodine tin, etc.). Therefore, these components need to be made of materials that can withstand high temperatures and / or irradiation / sterilizing agents without deformation or property changes. In certain embodiments, the U-shaped chute frame 110, the temperature control box 120, the slide plate 130, and the counterweight base 140 are made of at least one of the following materials: stainless steel, polypropylene plastic, and polycarbonate. In certain embodiments, the chute cover 140 is formed of at least one of the following materials: tempered glass, polyethylene (PE), polyvinyl chloride (PVC), polyethylene terephthalate (PET), and polypropylene.

[0064] As shown in FIG1A , a cushioning material 116 a is attached to the inner side of the baffle 116. This cushioning material 116 a can absorb the kinetic energy of the sample transferred from the first longitudinal end 114, protecting the sample from damage caused by the transfer shock. In some embodiments, a cushioning material can also be attached to the inner side of the bottom plate 111 of the U-shaped chute frame 110. This cushioning material can elastically deform, thereby providing thermal insulation while also pressing the temperature control box 120 and the slide plate 130 toward the limiting mechanism 118.

[0065] In some embodiments, the buffer material is a material with good elasticity and low thermal conductivity, such as at least one of the following materials: silicone, polyvinyl chloride (PVC), and modified PVC.

[0066] In order to ensure that the sample conveyed by the temperature-controlled chute 100 always maintains a low temperature, it is necessary to monitor the temperature inside the temperature-controlled chute 100, particularly the temperature near the second longitudinal end 115 of the U-shaped chute frame 110. To this end, as shown in FIG1C , a temperature monitoring device 160, such as a digital temperature sensor, a logic output temperature sensor, etc., is provided on the inner side of the sidewall 112 of the U-shaped chute frame 110. The temperature monitoring device 160 is capable of intermittently or continuously detecting the temperature inside the temperature-controlled chute 100. In some embodiments, the temperature monitoring device 160 is positioned near the baffle 116 and above the limiting mechanism 118. Preferably, the temperature monitoring device 160 is configured to issue an alarm, such as a visual alarm, an audible alarm, or a combination thereof, when the detected temperature exceeds a predetermined value range.

[0067] In some embodiments, the bottom plate 111 of the U-shaped chute frame 110 is provided with a drop opening near the baffle 116. This drop opening is connected to the sample dispensing mechanism, allowing the sample to automatically drop into the sample dispensing mechanism when it reaches the baffle 116, thereby enabling automatic sample dispensing. In some embodiments, the sample dispensing mechanism is a low-temperature temporary storage box.

[0068] Figures 2A-2B show perspective views of the various components of a temperature-controlled chute 200 according to another embodiment of the present application, in both disassembled and assembled states. Compared to the temperature-controlled chute 100 shown in Figures 1A-1C , the primary difference between the temperature-controlled chute 200 and the temperature-controlled chute 100 lies in the specific structure of the slide plate and the U-shaped chute frame. The following will focus on these differences; for components not described in detail, reference can be made to the description of the temperature-controlled chute 100.

[0069] As shown in Figure 2C, the bottom plate 211 and the side wall 212 of the U-shaped chute frame 210 are both constructed as a double-layer structure with a closed cavity to increase the thermal insulation performance of the U-shaped chute frame 210. The thickness of the closed cavity of the side wall 212 of the U-shaped chute frame 210 is consistent from top to bottom. In some embodiments, the bottom plate 211 of the U-shaped chute frame 210 is also constructed as a double-layer structure with a closed cavity, and the thickness of its closed cavity is the same as the thickness of the closed cavity of the side wall 212. The limiting mechanism 218 is constructed as a longitudinal protrusion fixedly provided on the inner side of the two side walls 212 of the U-shaped chute frame 210. The protrusion can be fixed to the side wall 212 by, for example, integral molding or welding.

[0070] As shown in Figure 2A, a longitudinal end of the slide plate 230 is provided with a substantially L-shaped stop plate 231 extending upward from the longitudinal edge and an adjacent side of the slide plate 230. The structure of the slide plate 230 and the L-shaped stop plate 231 is shown in Figure 4.

[0071] As shown in Figures 3A-3B, cushioning material is attached to the edges of the bottom plate 211 and sidewall 212 at the opening at the first longitudinal end 214 of the U-shaped chute frame 210, allowing the L-shaped baffle 231 to fit tightly against the U-shaped chute frame 210 to improve thermal insulation performance. In some embodiments, a notch is provided near the first longitudinal edge 214 of the sidewall 212 of the U-shaped chute frame 210 that engages with the L-shaped stop plate 231. The notch is slightly smaller than the area of ​​the portion of the L-shaped stop plate 231 that extends along the longitudinal direction of the slide 230, thereby reducing friction between the stop plate 231 and the sidewall 212 as the slide 230 slides into the U-shaped chute frame 210.

[0072] In some embodiments, the stop plate 231 is higher than the top of the side wall 212 of the U-shaped chute frame 210 to ensure that when the operator places a sample into the temperature-controlled chute 200, the sample does not bounce off the outside of the temperature-controlled chute 200. In some embodiments, a cushioning material is attached to the inner side of the U-shaped chute frame 210 where it meets the stop plate 231 of the slide plate 230, thereby improving the thermal insulation performance of the assembled U-shaped chute frame 210.

[0073] 3A and 3B respectively illustrate a schematic diagram of the inner side structure of the U-shaped chute frame shown in FIG2A-2B and a top view of the bottom plate. As shown in FIG3A , a temperature monitoring device 260 is mounted on the side wall 212 of the U-shaped chute frame 210. In some embodiments, a hook or bolt is provided on the side wall 212 of the U-shaped chute frame 210 for mounting the temperature monitoring device 260. In some embodiments, a notch is provided on the side wall 212 of the U-shaped chute frame 210 near the baffle 216 to allow the cable of the temperature monitoring device 260 to extend through the notch to the outside of the U-shaped chute frame 210 and to be inserted into the wire slot 261 provided on the outside of the side wall 212, thereby facilitating connection to a power source (not shown) or other devices.

[0074] As shown in Figure 3B, the bottom plate 211 of the temperature control slide 200 is attached with a buffer material constructed as a silicone pad 211a. The thickness of the silicone pad 211a is set to be able to undergo elastic deformation in the combined state, thereby pressing the temperature control box 220 and the slide 230 toward the limiting mechanism 218, making the contact between the temperature control box 220 and the slide 230 closer, and then allowing the low temperature of the temperature control box 220 to be quickly transferred to the slide 230, thereby improving the heat conduction efficiency.

[0075] FIG5 shows a front view of the inner side of the baffle of the U-shaped chute frame shown in FIG2A-2B . A cushioning material 216a is attached to the inner side of the baffle 216 of the U-shaped chute frame 210 to absorb the kinetic energy of the sample and protect the sample from impact damage. Preferably, the cushioning material 216a covers the entire surface of the baffle 216 above the stopper 218.

[0076] As shown in the figure, the baffle 216 is provided with a condensation drain hole 216c at a position close to the bottom plate 211 of the U-shaped chute frame 210, which is used to discharge the condensation generated when the temperature control box 220 absorbs heat in the U-shaped chute frame 210. The condensation drain hole 216c is constructed with a pipe joint that can be detachably connected to a drain pipe, thereby collecting and discharging condensation through the drain pipe to prevent condensation from leaking. Obviously, the condensation drain hole 216c can also be constructed as an opening that passes through the baffle 216, and a condensation collection device (such as a container such as a measuring cup) can be optionally provided below the opening. In some embodiments, a condensation drain hole can also be provided on the bottom plate 211 near the baffle 216.

[0077] FIG6 shows a schematic diagram of a dust-free and sterile operating system 10 according to one embodiment of the present application. As shown in FIG6 , the dust-free and sterile operating system 10 includes a dust-free and sterile operating cabinet 270 and a temperature-controlled chute 200. However, it is apparent that the temperature-controlled chute 100 can also be used in the dust-free and sterile operating system 10.

[0078] The dust-free and sterile operating cabinet 270 includes a cabinet body 271 with a hollow operating chamber 272, a workbench 273 disposed within the operating chamber 272, an operating port 274 disposed on the front side of the cabinet body, a sliding front window 275, a fan 276, and a return air vent 277. The operator's hand can enter the operating chamber 272 and approach the workbench 273 through the operating port 274, which can be partially or completely shielded by the sliding front window 275. When the operator is working, the opening height of the operating port 274 is, for example, 150 mm to 300 mm. In some embodiments, the opening height of the operating port 274 is 200 mm to 300 mm. The fan 276 is disposed above the workbench 273 and blows air toward the workbench 273. A portion of the air flows to the return air vent 277 disposed at the edge of the workbench 273, while another portion of the air flows through the operating chamber 272, passes through a filter, and is then circulated by the fan 276 back into the operating chamber 272.

[0079] As shown in Figure 6, the U-shaped slide frame 110 is set across the operating opening 274, the counterweight base 250 of the U-shaped slide frame is placed on the workbench 273, the first longitudinal end 214 of the U-shaped slide frame 210 is located in the operating cavity 272 of the cabinet 271, and the second longitudinal end 215 of the U-shaped slide frame 210 is located outside the cabinet 271, and the height of the first longitudinal end 214 of the U-shaped slide frame 210 is higher than the second longitudinal end 215.

[0080] The operator can adjust the position of the counterweight base 250 relative to the sliding front window 275 based on their height and the height of the workbench 273 (i.e., move the counterweight base 250 closer to or further away from the sliding front window 275). The operator can also adjust the angle between the temperature-controlled chute 200 and the workbench 273 and the height of the first longitudinal end 214 of the U-shaped chute frame relative to the workbench 273 by adjusting the rotation of the adjustment shaft 217 within the fastening fixture. By adjusting the angle between the temperature-controlled chute 200 and the workbench 273, the conveying speed of the sample within the temperature-controlled chute 200 can also be controlled. In some embodiments, the counterweight base 250 is positioned near the return air vent 277 at the edge of the workbench 273. In some embodiments, the second longitudinal end 115 of the U-shaped chute frame 110 is located 30 cm from the outer edge of the workbench 273.

[0081] In some embodiments, near the operating port 274, the flow rate of the air flow blown by the blower 276 to the U-shaped chute frame 210 is large enough so that the part of the U-shaped chute frame 210 in the cabinet is in a dust-free and sterile environment. In some embodiments, near the operating port 274, the flow rate of the air flow blown by the blower 276 to the U-shaped chute frame 210 is at least 0.30m / s, 0.33m / s, 0.36m / s, 0.40m / s or 0.50m / s. In some embodiments, the sedimentation bacteria concentration in the operating chamber is less than or equal to 0.5cfu / dish. Therefore, when there is no need to frequently expand the operating port 274 height to pass the sample out of the operating chamber 272, the dust-free and sterile operating system 10 described in the present application can transfer the sample from the dust-free and sterile operating cabinet 270 with a higher cleanliness level to an external environment with a lower cleanliness level through the temperature control chute 200 without affecting the cleanliness in the operating chamber 272. In some embodiments, the cleanliness level in the operating chamber 272 is at least Class A as specified in the Good Manufacturing Practice for Pharmaceuticals (revised in 2010) (new version of GMP), i.e., the air cleanliness level is required to reach a concentration of 35 particles / m3 of 0.1-0.5 μm particles. 3 the following.

[0082] In some embodiments, the dust-free and aseptic operation cabinet is a clean bench. In some embodiments, the dust-free and aseptic operation cabinet is a biological safety cabinet. In some embodiments, there is a negative pressure of not less than 120 Pa near the operation port 272, thereby providing effective protection for the operator.

[0083] Although the principles of the present invention have been described in conjunction with the embodiments, it should be understood that these descriptions are for illustrative purposes only and are not intended to limit the scope of the invention. The contents of this disclosure are for illustrative and descriptive purposes only and are not intended to be exhaustive or to limit the scope of the disclosure in a particular form. For those skilled in the art, many adjustments and changes are obvious. The selection basis of the contents of this disclosure is to better explain the principles and practical applications of the embodiments, so that those skilled in the art can understand the various different embodiments and adjustments made for specific applications. The scope of the contents of this disclosure is defined by the following claims or their equivalents.

Claims

1. A temperature-controlled slide for transferring biological samples from a clean environment with a higher degree of cleanliness to a clean environment with a lower degree of cleanliness at a predetermined temperature, characterized in that: The temperature control chute comprises: The U-shaped slide groove frame comprises an elongated bottom plate and two side walls extending upward from the two lateral sides of the bottom plate, respectively, the bottom plate and / or the side walls are constructed as a double-layer structure with a closed cavity, the U-shaped slide groove frame is open at its first longitudinal end, a baffle extending upward from the bottom plate is provided at the second longitudinal end of the U-shaped slide groove frame, and adjustment shafts extending laterally outward are respectively provided at positions of the outer sides of the two side walls of the U-shaped slide groove frame that are laterally aligned with each other, and limiting mechanisms arranged longitudinally along the side walls are respectively provided at corresponding heights on the inner sides of the two side walls; A temperature control box, wherein the shape and size of the temperature control box are configured to be embedded in the U-shaped chute frame from below the limiting mechanism of the U-shaped chute frame; An elongated slide plate, wherein the shape and size of the slide plate are configured to be able to slide into the U-shaped slide groove frame from the gap between the temperature control box and the limiting mechanism and be supported by the temperature control box; At least one slide slot upper cover, the slide slot upper cover is detachably matched with the top of the side wall of the U-shaped slide slot frame to cover at least a portion of the top opening of the U-shaped slide slot frame; and A counterweight base, a pair of fastening clamps are provided on the top of the counterweight base, and the fastening clamps are configured to receive and clamp the corresponding adjustment shafts of the U-shaped slide groove frame.

2. The temperature control chute according to claim 1, characterized in that: The limiting mechanism is constructed as a longitudinal protrusion arranged on the inner sides of the two side walls of the U-shaped sliding groove frame.

3. The temperature control chute according to claim 1, characterized in that: The limiting mechanism is constructed as a step portion formed on the inner side of the side wall of the U-shaped slide groove frame, and the cavity thickness of the side wall above the limiting mechanism is greater than the cavity thickness of the side wall below the limiting mechanism.

4. The temperature control chute according to any one of claims 1 to 3, characterized in that: A condensation water drain hole is provided on the baffle plate at the second longitudinal end of the U-shaped chute frame at a position close to the bottom plate and / or on the bottom plate at a position close to the baffle plate.

5. The temperature control chute according to claim 4, characterized in that: The condensed water drain hole is configured to have a pipe joint that can be detachably connected to a drain pipe.

6. The temperature control chute according to any one of claims 1 to 5, characterized in that: The temperature control box is constructed in a hollow rectangular parallelepiped shape. The interior of the temperature control box is filled with heat storage material and is sealed relative to the outside.

7. The temperature control chute according to claim 6, characterized in that: The heat storage material is selected from at least one of the following: water, ethanol solution, sodium polyacrylate, sodium hydroxymethyl cellulose, 25% sodium chloride solution and 30% calcium chloride solution.

8. The temperature control chute according to any one of claims 1 to 7, characterized in that: The U-shaped chute frame, the temperature control box, the slide plate, and the counterweight base are respectively made of at least one of the following materials: stainless steel, polypropylene plastic, and polycarbonate.

9. The temperature control chute according to any one of claims 1 to 8, characterized in that: The slide slot upper cover is formed of at least one of the following materials: tempered glass, polyethylene (PE), polyvinyl chloride (PVC), polyethylene terephthalate (polyester) (PET) and polypropylene.

10. The temperature control chute according to any one of claims 1 to 9, characterized in that: The upper surface of the slide plate is polished, or the upper surface of the slide plate is coated with a coating of polytetrafluoroethylene and / or polyparaxylene.

11. The temperature control chute according to any one of claims 1 to 10, characterized in that: A substantially L-shaped stop plate extending upward from a longitudinal edge and an adjacent side edge of the slide plate is provided at one longitudinal end of the slide plate.

12. The temperature control chute according to any one of claims 1 to 11, characterized in that: The fastening fixture includes a lower half and an upper half, the lower half is fixedly coupled to the main body of the counterweight base, and the upper half is configured to be detachably coupled to the lower half to surround and clamp the outer surface of the adjustment shaft.

13. The temperature control chute according to any one of claims 1 to 12, characterized in that: A buffer material is attached to at least one of the following locations: an inner side (G) of the baffle plate, an inner side of a bottom plate of the U-shaped slideway frame, and a contact surface of the fastening clamp for clamping the adjustment shaft.

14. The temperature control chute according to claim 13, characterized in that: The buffer material is made of at least one of the following materials: silica gel, polyvinyl chloride (PVC) and modified PVC.

15. The temperature control chute according to any one of claims 1 to 14, characterized in that: A temperature monitoring device is provided on the inner side of the side wall of the U-shaped chute frame, and the temperature monitoring device is close to the baffle and located above the limiting mechanism. The temperature monitoring device is configured to detect the temperature inside the U-shaped chute frame at intervals or continuously and to issue an alarm when the detected temperature exceeds a predetermined value range.

16. A dust-free and sterile operating system, characterized in that: The dust-free and sterile operating system comprises: A dust-free and aseptic operating cabinet, comprising a cabinet having a hollow operating cavity, and a workbench arranged in the operating cavity, wherein an operating port is arranged on the front side of the cabinet, and an operator's hand can enter the operating cavity and approach the workbench through the operating port, and the operating port can be partially or completely shielded by a sliding front window, a fan is arranged in the cabinet and above the workbench, and the fan blows air to the workbench, and an air return port is arranged at the edge of the workbench; and A temperature controlled chute as described in any one of claims 1 to 15; Wherein, the U-shaped chute frame is arranged across the operation port, and the counterweight base of the U-shaped chute frame is placed Placed on the workbench, the first longitudinal end of the U-shaped slide groove frame is located in the operating cavity of the cabinet, the second longitudinal end of the U-shaped slide groove frame is located outside the cabinet, and the height of the first longitudinal end of the U-shaped slide groove frame is higher than that of the second longitudinal end.

17. The dust-free and aseptic operating system according to claim 16, characterized in that: Near the operating port, the velocity of the airflow blown by the fan toward the U-shaped chute frame is at least 0.30 m / s.

18. The dust-free and aseptic operating system according to claim 16 or 17, characterized in that: The cleanliness level in the operating chamber is at least Class A.

19. The dust-free and aseptic operating system according to claim 18, characterized in that: There is a negative pressure near the operation port with an absolute value greater than or equal to 120 Pa.

20. The dust-free and aseptic operating system according to any one of claims 16 to 19, characterized in that: The concentration of settled bacteria in the operation chamber is less than or equal to 0.5 cfu / dish.

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