A kind of low-loss discharge device and discharge method of freeze-dried powder with multilayer board layer step-by-step expansion

Abstract

This invention belongs to the technical field of pharmaceutical freeze-drying equipment and discloses a low-loss discharge device and method for freeze-dried powder with multi-layer, progressively expanding receiving structure. The device includes a freeze-drying chamber, multiple layers of freeze-dried plates arranged vertically within the chamber, and a vacuum suction and collection mechanism. The multi-layer freeze-dried plates are divided from top to bottom into a standard plate group, a transition receiving plate group, and a bottom receiving plate group. The transition receiving plate group is longer and wider on both sides compared to the standard plate group, while the bottom receiving plate group further increases the expansion range. During discharge, the vacuum suction and collection mechanism is activated to suck up and unload material from each plate layer. Falling material is intercepted step-by-step by the transition receiving plate group and the bottom receiving plate group. Scattered powder gathers along the aggregate slope to the bottom layer, where it is then uniformly collected by the vacuum suction mechanism. This invention achieves near-zero loss in the discharge process of high-value freeze-dried powder through a progressively expanding gradient receiving structure combined with a method of first layered suction and then unified collection.

Description

Technical Field

[0001] This invention relates to the field of freeze-drying equipment technology, specifically to a multi-layer plate-type progressively expanding discharge device and its usage method, which is suitable for preventing material loss during freeze-drying production of high-value-added sterile raw materials such as polypeptide drugs, biopharmaceuticals, and nucleic acids. Background Technology

[0002] Vacuum freeze-drying technology involves pre-freezing water-containing materials to below their eutectic point temperature, then allowing the water to sublimate directly under vacuum conditions to obtain dried products. It is widely used in biopharmaceuticals, food processing, and other fields. In pharmaceutical freeze-drying equipment, the multi-layer vacuum freeze dryer with a tilting plate is the mainstream equipment for producing sterile active pharmaceutical ingredients (APIs). After the freeze-drying process, the material is unloaded via vacuum suction. However, currently available freeze dryers have uniformly sized multi-layer plates with identical planar dimensions. During vacuum suction unloading, powdery materials easily fall from the plate edges, scatter, or spill into the bottom cavity of the chamber or into dead zones between layers. While this problem is acceptable for ordinary raw materials in traditional freeze-drying production, it becomes particularly prominent in today's rapidly developing biopharmaceutical industry.

[0003] With the increasing demand for large-scale production of ultra-high-value pharmaceutical raw materials such as peptide drugs, biological agents, and nucleic acid drugs, these raw materials have extremely high added value, with some high-end raw materials having a market value of several million or even tens of millions of yuan per gram. Traditional plate-like structures of the same size cannot effectively contain scattered powder, and even a small amount of powder loss during production can cause huge economic losses. Taking a typical peptide drug raw material as an example, the raw material loss rate due to material loss during each batch of freeze-drying production can reach 1-3%. Calculated based on the unit price of the raw material, the loss per batch can reach hundreds of thousands or even millions of yuan, significantly increasing the production costs of pharmaceutical companies.

[0004] In addition, loose powder can easily spread throughout the chamber, causing cross-contamination between different batches of materials. At the same time, loose powder adheres to the inner walls of the chamber and the sealing rings, increasing the difficulty of cleaning and sterilization and the cost of equipment maintenance. This directly affects product quality and the level of GMP clean area management, and in severe cases, may lead to the scrapping of the entire batch of products.

[0005] While existing technologies offer improvements to freeze dryer trays, such as converting tray structures to box structures to increase load-bearing capacity and capacity, optimizing refrigerant flow channel design to improve heat transfer uniformity, and adding tray multiplier devices to increase loading capacity, these improvements focus on enhancing the mechanical or thermal properties of the trays themselves, without addressing material loss during discharge. Regarding automated discharge and receiving devices, technologies like vacuum suction guns have been applied to freeze dryer discharge, but none have fundamentally solved the problem of powder loss during tray tipping and unloading. Some improvements incorporate receiving trays or transition plates, but these are mostly auxiliary or temporary additions, failing to form a systematic, gradient receiving layout with the trays.

[0006] A search of existing patent literature revealed no technical solutions that construct an inverted trapezoidal receiving layout through a step-by-step expansion method or achieve full-area bottom protection to prevent falling through a gradient design of plate dimensions. There is an urgent need in this field for a discharge device and method that can fundamentally prevent material falling and wasting from a structural perspective, in order to meet the practical needs of low-loss mass production of high-value pharmaceutical raw materials. Summary of the Invention

[0007] This invention addresses the shortcomings of existing technologies, such as high powder loss due to falling off, serious waste of high-value raw materials, and limited protection range. It provides a low-loss discharge device and method for freeze-dried powder with multi-layer plate-based progressive expansion of the discharge area.

[0008] This invention uses multi-layered plates that gradually lengthen and widen from top to bottom to form a gradient receiving space. Combined with a discharge method that first extracts material in layers and then collects it uniformly, it achieves layer-by-layer interception of falling materials and full-area bottom-up receiving, eliminating material loss and waste from the structural source and meeting the demand for low-loss mass production of high-priced pharmaceutical raw materials.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] The first aspect of the present invention is to provide a low-loss discharge device for freeze-dried powder with multi-layer progressively expanding bearing, the device comprising a freeze-drying chamber arranged in a clean and sealed space, multi-layer freeze-dried plates arranged vertically in the freeze-drying chamber, and a vacuum suction and receiving mechanism.

[0011] The multi-layer freeze-dried board includes, from top to bottom, a standard board layer group, a transition support board layer group, and a bottom support board layer group. Wherein:

[0012] Standard plate sets are conventional plates without expansion processing, mainly used to support the main freeze-dried materials. There can be one or more standard plate sets, which can be flexibly configured according to the total number of plates in the freeze dryer and production needs.

[0013] Compared to the standard plate group, the receiving plate in the transition receiving plate group is longer along the material discharge direction, and its left and right sides are widened outwards simultaneously. The main function of the transition receiving plate group is to receive materials falling from the standard plate group above at close range during unloading.

[0014] Compared to the transitional receiving plate group, the bottom receiving plate group has a further increased length and lateral widening. The main function of the bottom receiving plate group is to receive fine powder that has drifted from higher plates over long distances and to serve as the final collection platform for all scattered materials.

[0015] Through the above structural design, the multi-layer freeze-drying board layer forms a receiving layout that is narrow at the top and wide at the bottom, ensuring that no matter how the material falls during the unloading process, it can be received by the board layer of the corresponding size below.

[0016] In a preferred embodiment, the standard layers in the standard layer group have the same length and width, and the extended lengths and widths of the supporting layers in the transition supporting layer group are the same, all less than the extended lengths and widths of the bottom supporting layer group below. This design, which is consistent within a group and progressively increases between groups, simplifies layer processing and installation while ensuring a gradient support effect.

[0017] Furthermore, the standard plate layer group consists of two groups: one group is located above the transition receiving plate layer group, and the other group is located between the transition receiving plate layer group and the bottom receiving plate layer group. This four-segment layout of upper standard group—transition group—lower standard group—bottom receiving group is particularly suitable for freeze dryers with a large number of plate layers, enabling more refined gradient receiving without increasing the variety of plate layer specifications.

[0018] In another preferred embodiment, each receiving layer in the transition receiving plate group is progressively longer along the material discharge direction compared to the standard receiving plate group, while simultaneously widening outwards layer by layer on both sides; each bottom receiving plate in the bottom receiving plate group is progressively longer along the material discharge direction compared to the transition receiving plate group, while simultaneously widening outwards layer by layer on both sides; and the entire multi-layer freeze-drying plate group forms an inverted trapezoidal receiving layout that is narrower at the top and wider at the bottom. This progressively widening design ensures that each plate layer has a different size, achieving the most refined gradient receiving, suitable for scenarios with extremely high requirements for loss control.

[0019] In the above-described layer-by-layer expansion implementation, preferably, the lengthening increment of each receiving plate layer in the transition receiving plate layer group downwards along the discharge direction is 40-60 mm, more preferably 50 mm; and the lengthening increment of each bottom receiving plate layer in the bottom receiving plate layer group downwards along the discharge direction is 60-100 mm, more preferably 80 mm. This gradient increment takes into account the parabolic trajectory of the material during dumping—a smaller increment is used when the distance is closer, and a larger increment is used when the distance is farther.

[0020] Furthermore, the bottommost receiving plate in the bottom receiving plate assembly is extended by 100-500 mm along the discharge direction, and its lateral widening on one side is extended by 50-200 mm. The selection of these parameter ranges has undergone systematic engineering design optimization: too small an expansion cannot effectively intercept falling powder, while too large an expansion is limited by the internal space constraints of the freeze-drying chamber and may affect the plate flipping operation.

[0021] As a key structural optimization, each layer of the transition receiving plate assembly and the bottom receiving plate assembly is provided with an inwardly tapering material-gathering slope, and low material-retaining edges are integrally provided on both sides of the plate. The material-gathering slope causes powder falling onto the plate to automatically slide and gather towards the center of the plate under the action of gravity, preventing the risk of secondary falling caused by powder accumulating at the edge of the plate. The low material-retaining edges serve as a last line of defense, blocking material that may roll off from the sides of the plate.

[0022] The vacuum suction and collection mechanism has its suction port located at the discharge convergence position of the bottommost bottom support plate of the bottom support plate assembly. It is used to collect all scattered powder materials in a closed negative pressure manner. Since all scattered materials are ultimately guided to this convergence position by the material collection slope, a single fixed suction port can achieve full recovery without the need for manual adjustment of the suction position.

[0023] As a preferred option in terms of materials, each plate in the standard plate group, transition support plate group and bottom support plate group is made of 316L medical-grade stainless steel. The plate surface is mirror polished, with no powder accumulation dead corners, and fully meets the cleanliness requirements of GMP aseptic pharmaceutical production environment.

[0024] The second aspect of the present invention is to provide a low-loss discharge method based on the high-value biopharmaceutical freeze-dried powder low-loss discharge device described in any of the above claims. This method differs from the traditional method of first unloading by tilting and then collecting the material, but instead adopts an innovative process of first vacuum suction and layered unloading, and then uniformly collecting the scattered materials. Specifically, it includes the following steps:

[0025] S1. After the freeze-drying process is completed, the vacuum suction and collection mechanism is activated to suction and unload the multi-layer freeze-dried sheets one by one. That is, the vacuum suction head is aligned with each sheet in turn, directly suctioning and collecting the main freeze-dried powder material on the sheet. Unlike the traditional flipping unloading method, this step completes the main material discharge through active suction, which greatly reduces the material scattering caused by the flipping of the sheets.

[0026] S2. During the unloading process, a small amount of material may still fall or scatter due to the vacuum suction operation. Material falling at close range is intercepted and collected by the transition receiving plate group, while fine powder scattered at long distance is fully received by the bottom receiving plate group, ensuring that no material falls into the dead corner of the bottom cavity of the freeze-drying chamber. The expanded plate layer acts as a "safety net" here, ensuring that any accidentally fallen material is received.

[0027] S3. Relying on the material-gathering inclined surfaces set on each receiving plate, the scattered powder is automatically slid under the action of gravity and uniformly gathered to the bottom plate outlet position.

[0028] S4. Reactivate the vacuum material collection mechanism to collect all the material scattered to the bottom layer, achieving low-loss discharge of high-value freeze-dried powder. This step enables secondary recycling of scattered materials, ensuring that all materials are collected and utilized.

[0029] The core advantage of this discharge method lies in the following: by first completing the main discharge through vacuum suction, the operation of flipping the plates and the resulting material scattering are minimized; the gradient receiving system composed of expanded plates provides a "safety net" for accidentally dropped materials; and then, a secondary vacuum recovery achieves complete collection of the materials. The process design that separates the main discharge from the bulk material recovery reduces the overall discharge loss rate to an extremely low level.

[0030] The present invention adopts the above technical solution and has the following technical effects compared with the prior art:

[0031] (1) Comprehensive material receiving coverage, completely eliminating the risk of material leakage during unloading: This invention forms an inverted trapezoidal receiving layout by gradually lengthening and widening the layers from top to bottom, strictly matching the falling trajectory of powder from top to bottom and at varying distances during unloading. The standard layer group ensures standard load-bearing function, the transition layer group intercepts materials falling at close range, and the bottom layer group receives fine powder scattered at long distances. Each layer has a clear division of labor and works in coordination. This structure can achieve layered interception and full-area bottom-feeding of freeze-dried powder falling, scattering, and splashing during unloading, effectively sealing the dead corners of material accumulation in the cavity at the bottom of the box, and preventing irregular material leakage from the structural level.

[0032] (2) Innovative discharge method, significantly reducing the loss of high-value raw materials: The discharge method adopted in this invention, which involves first vacuum suction and layered discharge, followed by unified collection of scattered materials, is fundamentally different from the traditional method of first flipping and then collecting materials. Active vacuum suction completes the main discharge, significantly reducing the flipping operation of the plates and the resulting material scattering; the gradient receiving system composed of expanded plates provides a safety net for accidentally dropped materials; secondary vacuum collection achieves complete collection of scattered materials. This triple protection mechanism reduces the overall discharge loss rate to below 0.05%. For special raw materials with a unit price of several million yuan / gram, the economic loss reduced per batch production can reach hundreds of thousands to millions of yuan, resulting in extremely significant economic benefits.

[0033] (3) Effectively avoids production pollution risks and improves product qualification rate: The present invention adopts a fully enclosed negative pressure material receiving mode, eliminating open dust phenomena. Combined with the structural characteristics of the 316L mirror-polished plate layer without powder accumulation dead corners, it can not only prevent scattered powder from spreading around the box and causing cross-contamination between different batches of materials, but also facilitate equipment cleaning and sterilization, strictly complying with GMP aseptic pharmaceutical production standards. At the same time, since the inverted trapezoidal layout collects all the fallen materials on the plate surface, it greatly reduces the difficulty of online cleaning (CIP) and online sterilization (SIP) of the freeze dryer.

[0034] (4) Flexible layout, adaptable to various equipment specifications: This invention provides multiple layer layout options. It can adopt a simplified design with consistent layers within a group and incremental layers between groups, suitable for situations with a large number of layers and sensitive processing costs; or it can adopt a refined design with progressively expanding layers, suitable for high-end raw material production scenarios with extremely high requirements for loss control. Neither layout option requires modification of the original core system of the freeze dryer and can be directly adapted to mainstream flip-plate and sheet-type multi-layer freeze dryers on the market.

[0035] (5) Regulate the material collection process and simplify the unloading operation: The material gathering slope and side retaining edge of the board can automatically complete the directional collection of scattered materials without the need for manual assistance in sorting and collecting. The vacuum suction port is fixedly set at the bottom collection position without the need for manual adjustment, which can realize automated and unified material collection, significantly simplify the unloading operation process, reduce the intensity of manual operation and the risk of pollution caused by personnel intervention in the clean area.

[0036] (6) Promote industry development and achieve dual benefits for industry and people's livelihood: This invention effectively breaks the development constraints of high loss in the mass production of high-end biopharmaceutical raw materials, accelerates the mass production and production speed of innovative high-priced drugs, helps reduce the comprehensive cost of high-end drug research and development and mass production, promotes the rational reduction of the price of clinical high-end treatment drugs, helps the biopharmaceutical industry reduce costs, increase efficiency and transform and upgrade, and effectively reduces the burden of medical drugs for the public. Attached Figure Description

[0037] Figure 1This is a side view of a low-loss discharging device for high-value biopharmaceutical freeze-dried powder according to the present invention, showing a four-section layout of standard plate layer group (multiple layers), transition receiving plate layer group (one layer), standard plate layer group (multiple layers), and bottom receiving plate layer group (one layer).

[0038] Figure 2 For the present invention Figure 1 The diagram shows a front view of a device for discharging high-value biopharmaceutical freeze-dried powder with low loss.

[0039] Figure 3 This is a side view of a low-loss discharging device for high-value biopharmaceutical freeze-dried powder according to the present invention, showing a progressively expanding inverted trapezoidal layout of a standard plate layer group (one layer), a transition receiving plate layer group (multiple layers, with increasing length and width), and a bottom receiving plate layer group (multiple layers, with increasing length and width).

[0040] Figure 4 This is a schematic diagram of the main structure of the receiving plate layer in a low-loss discharging device for high-value biopharmaceutical freeze-dried powder according to the present invention.

[0041] Figure 5 This is a partially enlarged structural diagram of the front end of the receiving plate layer in a low-loss discharging device for high-value biopharmaceutical freeze-dried powder according to the present invention, showing the material-gathering inclined surface located at the front discharge port and the low material-blocking edges located on both sides.

[0042] The attached diagrams are labeled as follows: 001-clean and enclosed space; 100-freeze-drying chamber; 200-freeze-drying plate layer; 201-material-gathering slope; 202-low material-blocking edge; 210-standard plate layer group; 220-transition receiving plate layer group; 230-bottom receiving plate layer group; 300-vacuum suction and material collection mechanism. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are merely some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0044] Example 1

[0045] This embodiment provides a low-loss discharge device and method for freeze-dried powder with multi-layer progressively expanding bearing. It adopts a four-section layout of upper standard group - transition group - lower standard group - bottom support group, which is suitable for large-scale production freeze dryers with 8-20 layers. This embodiment takes 14 layers as an example.

[0046] like Figure 1 and Figure 2 As shown, the device includes a freeze-drying chamber 100 arranged in a clean and sealed space 001, a multi-layer freeze-drying plate layer 200 arranged vertically in the freeze-drying chamber 100, and a vacuum suction and receiving mechanism 300.

[0047] The multi-layer freeze-dried board 200 includes, from top to bottom, a standard board layer group 210, a transition receiving board layer group 220, and a bottom receiving board layer group 230. In this embodiment, the standard board layer group 210 consists of two groups: the first group of standard board layer groups 210 is located above the transition receiving board layer group 220 and includes layers 1 to 6; the second group of standard board layer groups 210 is located between the transition receiving board layer group 220 and the bottom receiving board layer group 230 and includes layers 8 to 13. The transition receiving board layer group 220 includes layer 7, and the bottom receiving board layer group 230 includes layers 9 and 10 (the bottom layer is layer 14).

[0048] Each standard plate in the standard plate group 210 has the same length and width. In this embodiment, the length L0 = 1200 mm and the width W0 = 800 mm are set.

[0049] Compared to the standard plate group 210, the receiving plate (7th layer) in the transition receiving plate group 220 is 150 mm longer along the material discharge direction, with a length L7=1350 mm, and is widened by 75 mm on each side, with a width W7=950 mm.

[0050] Compared to the transition support plate group 220, the bottom support plate layer (layer 14) in the bottom support plate layer group 230 has a further increased length and lateral widening. Specifically, the 14th layer is 200mm longer along the discharge direction than the 7th layer (transition plate layer), with a length L. 14 =1550 mm, widening outwards by 100 mm on each side, width W 14 =1150 mm.

[0051] If necessary, a bottom support plate layer (the bottommost layer, the 15th layer) can be added to the bottom support plate layer group 230. This bottommost layer is 100 mm longer than the 14th layer along the discharge direction, with a length L. 15 =1650 mm, widening outwards by 50 mm on each side, width W 15 =1250 mm. The bottommost bottom plate layer (15th layer) is extended by a total of 450 mm along the discharge direction, and the total lateral width on one side is increased by 225 mm.

[0052] like Figure 4 and Figure 5As shown, each layer of the transition receiving plate group 220 and the bottom receiving plate group 230 has an inwardly tapering aggregate slope 201 on its surface. The inclination angle of the aggregate slope relative to the horizontal plane is 5-30°, preferably 15-25°, so that the powder falling on the plate surface automatically slides towards the center of the plate under the action of gravity. A low baffle edge 202 with a height of 30mm is integrally provided on both sides of the plate to prevent powder from falling from the sides of the plate.

[0053] The suction port of the vacuum suction and collection mechanism 300 can be set at the discharge collection position of the bottommost bottom plate (14th layer) of the bottom receiving plate group 230, for collecting all scattered powder materials in a closed negative pressure manner. The suction port is connected to the vacuum pump and the collection container through a flexible hose.

[0054] All panels are made of 316L medical-grade stainless steel, and the surface is mirror-polished with a surface roughness Ra≤0.4 μm, eliminating powder accumulation dead corners.

[0055] Based on the discharge method of the freeze-dried powder low-loss discharge device with multi-layer progressive expansion receiving in this embodiment, after the freeze-drying process is completed, the following steps are performed for low-loss discharge:

[0056] S1. Start the vacuum material collection mechanism 300, align the vacuum suction head with the 1st to 14th layers of the board in sequence, and perform suction and unloading one by one. The main material is directly sucked and collected in this step, without the need for board flipping operation.

[0057] S2. During the suction and unloading process, a small amount of material may fall or scatter from the edge of the plate. Material falling at close range is intercepted and collected by the 5th transition receiving plate group; fine powder scattering from higher layers is fully collected by the 14th and 15th bottom receiving plate groups. It has been verified that no material falls into the dead corner of the bottom cavity of the freeze-drying chamber.

[0058] S3. Relying on the material-gathering inclined surface 201 set on each receiving plate, the scattered powder automatically slides under the action of gravity and gathers to the convergence point at the discharge position of the 15th plate.

[0059] S4. Restart the vacuum suction and collection mechanism 300 to uniformly collect all the materials scattered to the bottom layer of the bottom plate, so as to achieve low loss of high-value freeze-dried powder.

[0060] Performance Verification: A follow-up statistical analysis of 50 batches of freeze-drying production showed that the average material loss rate using the method described in this embodiment was 0.042%. Because the main discharge method uses vacuum suction instead of plate flipping, material scattering is significantly reduced, and the overall loss rate is reduced by 97.7% compared to the traditional flipping discharge method (loss rate of about 1.8%).

[0061] Example 2

[0062] This embodiment provides a low-loss discharge device and method for freeze-dried powder with multi-layer progressively expanding bearing. It adopts a refined inverted trapezoidal layout with progressively expanding bearing and is suitable for high-end raw material freeze dryers with 8-20 layer configurations. This embodiment takes an 8-layer configuration as an example.

[0063] like Figure 3 As shown, the device includes a freeze-drying chamber 100 arranged in a clean and sealed space 001, eight freeze-drying plates 200 arranged vertically in the freeze-drying chamber 100, and a vacuum suction and receiving mechanism 300.

[0064] The multi-layer freeze-drying board 200 includes, from top to bottom, a standard board layer group 210, a transition support board layer group 220, and a bottom support board layer group 230. In this embodiment, the standard board layer group 210 is a single group containing the first board layer; the transition support board layer group 220 contains the second to fifth board layers; and the bottom support board layer group 230 contains the sixth to eighth board layers.

[0065] Compared to the standard layer group 210, each layer in the transition receiving plate group 220 is progressively longer along the material discharge direction, while simultaneously widening outwards on both sides. Similarly, each bottom receiving plate in the bottom receiving plate group 230 is progressively longer along the material discharge direction, while simultaneously widening outwards on both sides. The entire multi-layer freeze-drying plate group 200 forms an inverted trapezoidal receiving layout that is narrower at the top and wider at the bottom.

[0066] The specific dimensions are as follows:

[0067] Standard panel group 210 (layer 1): length L1=1000 mm, width W1=600 mm.

[0068] Transition receiving plate layer group 220: For each lower layer, the length increases by 50 mm along the discharge direction, and the width expands outward by 25 mm on each side. That is: 2nd layer: length L2=1050 mm, width W2=650 mm; 3rd layer: length L3=1100 mm, width W3=700 mm; 4th layer: length L4=1150 mm, width W4=750 mm; 5th layer: length L5=1200 mm, width W5=800 mm.

[0069] Bottom support plate layer 230: Each subsequent layer extends 80 mm in length along the discharge direction and widens 40 mm outward on both sides. That is: 6th layer: length L6=1280 mm, width W6=880 mm; 7th layer: length L7=1360 mm, width W7=960 mm; 8th layer (bottom layer): length L8=1440 mm, width W8=1040 mm.

[0070] The bottommost bottom plate layer (8th layer) is extended by 440 mm along the discharge direction and widened by 220 mm on one side.

[0071] The length of the support plate layer in the transition support plate layer group 220 increases by 50 mm for each layer below it, and the length of the bottom support plate layer in the bottom support plate layer group 230 increases by 80 mm for each layer below it, which strictly conforms to the preferred parameter range.

[0072] like Figure 4 and Figure 5 As shown, each receiving plate layer is provided with an inwardly tapering material-gathering inclined surface 201, with an angle of 20° (suitable for powdery materials with general flowability). Both sides of the plate layer are integrally provided with a low material-blocking edge 202 with a height of 30 mm.

[0073] The suction port of the vacuum suction and receiving mechanism 300 is fixedly located at the convergence position of the discharge direction of the 8th layer.

[0074] All panels are made of 316L medical-grade stainless steel, and the surface is mirror-polished.

[0075] Based on the discharge method of the low-loss discharge device for freeze-dried powder with multi-layer progressive expansion receiving in this embodiment, after the freeze-drying process is completed, the following steps are performed:

[0076] S1. Start the vacuum material receiving mechanism 300, align the vacuum suction head with the 1st to 8th layers of the board in sequence, and perform suction and unloading one by one.

[0077] S2. During the suction and unloading process, the progressively expanding dimensions of each layer create a complete gradient receiving system. Material falling from the first layer at close range is intercepted by the transition receiving plates in layers 2-5; fine powder drifting from layers 2-5 is fully received by the bottom receiving plates in layers 6-8. Verification has shown that no material falls into the dead corners of the freeze-drying chamber's bottom cavity.

[0078] S3. Relying on the material-gathering inclined surface 201 of each receiving plate, the scattered powder automatically slides and gathers to the discharge point of the 8th plate.

[0079] S4. Restart the vacuum material collection mechanism 300 to collect all scattered materials under a negative pressure of -85kPa.

[0080] Performance Verification: The proposed solution has been validated through pilot production at a biopharmaceutical company. For the freeze-drying production of a nucleic acid drug raw material (market price approximately 15 million RMB / kg), the adoption of this solution reduced the raw material loss rate at the discharge stage from 2.1% to 0.028%, a reduction of 98.7%. A single batch (5 kg of raw material) can reduce raw material loss by approximately 103.6 grams, saving approximately 1.55 million RMB in costs. The refined design with progressively expanding coverage achieves a near 100% acceptance rate, outperforming the intra-group consistency design of Example 1.

[0081] Example 3

[0082] This embodiment provides a low-loss discharge device and method for freeze-dried powder with multi-layer progressive expansion, which combines a double-layer standard plate layout with progressive expansion design, and is suitable for large-scale production freeze dryers with 12-layer plate configuration.

[0083] The device includes a freeze-drying chamber 100 arranged in a clean and sealed space 001, 12 freeze-drying plates 200 arranged vertically inside the freeze-drying chamber 100, and a vacuum suction and receiving mechanism 300.

[0084] The multi-layer freeze-dried board 200 is divided into three groups from top to bottom: a standard board group 210, a transition support board group 220, and a bottom support board group 230. The standard board group 210 consists of two groups: the first group contains layers 1 to 3, and the second group contains layers 7 to 8. The transition support board group 220 contains layers 4 to 6. The bottom support board group 230 contains layers 9 to 12.

[0085] Compared to the standard plate group (layers 1-3) above, each receiving plate in the transition receiving plate group 220 is progressively longer along the material discharge direction, while simultaneously widening outwards layer by layer on both sides. Compared to the transition receiving plate group 220, each bottom receiving plate in the bottom receiving plate group 230 is progressively longer along the material discharge direction, while simultaneously widening outwards layer by layer on both sides.

[0086] Specific dimensions:

[0087] The first standard panel group (layers 1-3): length L=1100 mm, width W=700 mm.

[0088] Transition support plate layers (layers 4-6): Each layer below increases in length by 55 mm and widens on both sides by 27.5 mm. Layer 4: 1155 mm × 755 mm; Layer 5: 1210 mm × 810 mm; Layer 6: 1265 mm × 865 mm.

[0089] The second set of standard plate layers (layers 7-8): maintains the same dimensions as the first set of standard plate layers, i.e., 1100 mm × 700 mm. These two standard plate layers are placed between the transition support plate layer group and the bottom support plate layer group, serving to support materials while being protected by the bottom support plate layer group below.

[0090] Bottom support layer (layers 9-12): Each subsequent layer increases in length by 90 mm and widens on both sides by 45 mm. Layer 9: 1355 mm × 955 mm; Layer 10: 1445 mm × 1045 mm; Layer 11: 1535 mm × 1135 mm; Layer 12 (bottom layer): 1625 mm × 1225 mm.

[0091] The bottommost bottom plate layer (12th layer) is extended by 525 mm along the discharge direction and widened by 262.5 mm on one side (actually 250 mm due to space limitations of the box).

[0092] Each receiving plate layer is equipped with a material-gathering inclined surface 201 (angle 20°) and a low material-stopping edge 202 (height 30 mm). All plates are made of 316L stainless steel with a mirror polished finish. The vacuum suction port is fixedly located at the material discharge convergence position on the 12th layer.

[0093] The discharge method of the freeze-dried powder low-loss discharge device based on the multi-layer progressively expanding receiving method of this embodiment specifically includes the following steps:

[0094] S1. Start the vacuum material collection mechanism 300 to suck up and unload the material from the 1st to the 12th layer of the board one by one.

[0095] S2. During the suction process, materials falling from the first set of standard plate layers (layers 1-3) are intercepted by the transition receiving plate layer group (layers 4-6); materials falling from the transition receiving plate layer group and the second set of standard plate layers (layers 4-8) are fully received by the bottom receiving plate layer group (layers 9-12). The bottom receiving plate layer group provides unified support between the two sets of standard plate layers, forming a dual protection system of upper transition support and lower bottom protection.

[0096] S3. The scattered powder from each plate layer is gathered along the aggregate slope 201 to the discharge point of the 12th layer.

[0097] S4. Restart the vacuum material collection mechanism 300 to collect all scattered materials.

[0098] Performance Verification: This embodiment achieved low-loss output on a 12-layer large-scale freeze dryer, with a measured loss rate of 0.035%. The design of the double-layer standard plate group, while ensuring the gradient bearing effect, reduces the number of expansion plates requiring special processing (only the 4th-6th and 9th-12th layers, a total of 7 expansion plates, need to be processed). The expansion plates account for approximately 58% of the total 12 layers. Compared with the full layer-by-layer expansion scheme of Embodiment 2 (expansion plates account for 87.5%), it effectively reduces manufacturing costs while maintaining excellent bearing effect.

[0099] The core innovation of this invention lies in its graded, expanding structural design, which constructs a gradient receiving system highly matched to the trajectory of falling powder. In traditional plate-flipping unloading processes, when material falls from the upper plate, its trajectory is influenced by multiple factors such as initial velocity, gravity, and airflow disturbance, exhibiting a complex parabolic shape. Material falling from higher layers has a longer fall time, a greater horizontal displacement distance, and a wider dispersion range. Because traditional fixed-size plates have fixed dimensions, when the dispersion range exceeds the coverage area of ​​the lower plate, the material will directly fall into the bottom cavity of the box, causing loss.

[0100] The progressively widening structure of this invention precisely matches this physical law: the transition receiving plate group 220 is moderately widened compared to the standard plate group 210, used to receive materials falling from above at a close distance; the bottom receiving plate group 230 is further widened, used to receive fine powder drifting from a greater distance; the overall structure forms an inverted trapezoidal layout that is narrower at the top and wider at the bottom (e.g., Figure 3 As shown in the figure, this ensures that the material falls within the coverage area of ​​a certain receiving plate layer at any drop height and scattering angle.

[0101] like Figure 4 and Figure 5 As shown, the aggregated slope 201 is set on the surface of the plate layer, forming an inwardly converging slope. When powder falls onto the plate layer, it automatically slides towards the center of the plate layer under the action of gravity. This design solves two key problems: first, it prevents the risk of secondary falling caused by powder accumulating at the edge of the plate layer; second, it guides all scattered materials to a unified discharge and collection point, enabling the fixed vacuum suction port to achieve full recovery. Low-profile baffles 202 are set on both sides of the plate layer, forming a physical barrier. When materials slide on the plate layer or are disturbed by airflow, the baffles can effectively prevent materials from overflowing from both sides. The synergistic effect of the aggregated slope 201 and the low-profile baffles 202 realizes a complete material control path of dispersed reception—active aggregation—directional flow guidance—comprehensive blocking.

[0102] The material discharge method of this invention differs fundamentally from existing technologies. Existing technologies typically employ a passive process of plate-layer flipping unloading—material falling—manual or mechanical collection. This invention, however, employs an active process of active vacuum suction to complete the main material discharge—an expanded plate layer to catch accidentally dropped material—and secondary vacuum recovery of scattered material. The core advantages of this method are: In step S1, vacuum suction directly collects the main material from each plate layer, avoiding the large-scale material scattering that occurs in traditional flipping unloading methods; in step S2, the expanded plate layer acts as a safety net, only needing to catch a very small amount of accidentally dropped material during vacuum suction, significantly reducing the extreme requirements on the load-bearing capacity; in step S4, secondary vacuum recovery collects all scattered material caught by the expanded plate layer, completing the complete recovery of all material.

[0103] In this invention, the expanded plate structure and the vacuum suction and collection mechanism are not independent units, but form a close system integration relationship: the expanded plate guides the scattered materials to the bottom fixed position convergence point through the material gathering slope; the vacuum suction port is fixedly set at the convergence point, without the need for manual adjustment or movement; the first suction (step S1) is for the main material of each plate, and the second suction (step S4) is for the scattered materials gathered at the bottom. The two suctions use the same set of vacuum suction mechanism, and the suction position is automatically switched by program control.

[0104] The system integration design of the low-loss discharge device and discharge method of this invention realizes a fully automated low-loss discharge process without manual intervention, and fully meets the cleanliness requirements of the aseptic pharmaceutical production environment.

[0105] The specific embodiments of the present invention have been described in detail above, but they are merely examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, all equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

1. A low-loss discharge device for freeze-dried powder with multi-layer progressively expanding receiving, comprising a freeze-drying chamber (100), multi-layer freeze-dried plates (200) arranged vertically within the freeze-drying chamber (100), and a vacuum suction and receiving mechanism (300), characterized in that, The multi-layer freeze-dried board (200) includes, from top to bottom, a standard board group (210), a transition support board group (220), and a bottom support board group (230); wherein: Compared to the standard plate group, the receiving plate in the transition receiving plate group (220) is longer along the material discharge direction, and its left and right sides are simultaneously widened outwards; compared to the transition receiving plate group (220), the bottom receiving plate in the bottom receiving plate group (230) is further lengthened and widened laterally.

2. The freeze-dried powder low-loss discharge device according to claim 1, characterized in that, The standard plate layers in the standard plate layer group (210) have the same length and width, and the extended length and width of the support plate layers in the transition support plate layer group (220) are the same, both less than the extended length and width of the bottom support plate layer group (230) below.

3. The freeze-dried powder low-loss discharge device according to claim 2, characterized in that, The standard plate layer group (210) consists of two groups, one group located above the transition support plate layer group (220) and the other group located between the transition support plate layer group (220) and the bottom support plate layer group (230).

4. The low-loss discharge device for freeze-dried powder according to claim 1, characterized in that, Compared to the standard plate group (210), each receiving plate in the transition receiving plate group (220) is gradually lengthened along the material discharge direction, while the left and right sides are gradually widened outwards. Compared to the transition support plate group (220), each bottom support plate in the bottom support plate group (230) is gradually lengthened along the material discharge direction, while the left and right sides are gradually widened outwards. Furthermore, each layer of the multi-layer freeze-dried board (200) forms an inverted trapezoidal support layout that is narrower at the top and wider at the bottom.

5. The freeze-dried powder low-loss discharge device according to claim 4, characterized in that, The length of each receiving plate layer in the transition receiving plate layer group (220) increases by 40-60 mm along the discharge direction for each layer below it; the length of each bottom receiving plate layer in the bottom receiving plate layer group (230) increases by 60-100 mm along the discharge direction for each layer below it.

6. The freeze-dried powder low-loss discharge device according to claim 1, characterized in that, The bottommost bottom support plate in the bottom support plate group (230) is extended in the discharge direction by 100~500 mm, and the lateral expansion on one side is 50~200 mm.

7. The freeze-dried powder low-loss discharge device according to claim 1, characterized in that, Each layer of the transition receiving plate group (220) and the bottom receiving plate group (230) is provided with an inwardly converging material-gathering slope (201), and a low material-blocking edge (202) is integrally provided on both sides of the plate.

8. The low-loss discharge device for freeze-dried powder according to claim 1, characterized in that, The suction port of the vacuum suction and collection mechanism (300) is located at the discharge convergence position of the bottom bottom plate of the bottom receiving plate group (230), and is used to draw and collect all scattered powder in a closed negative pressure manner.

9. The freeze-dried powder low-loss discharge device according to claim 1, characterized in that, Each plate in the standard plate group (210), the transition support plate group (220) and the bottom support plate group (230) is made of 316L medical grade stainless steel, and the plate surface is mirror polished to eliminate powder accumulation dead corners.

10. A low-loss discharge method for freeze-dried powder based on any one of claims 1 to 9, characterized in that, Includes the following steps: S1. After the freeze-drying process is completed, start the vacuum suction and unloading mechanism to suck up and unload the multi-layer freeze-dried plates one by one. S2. During the unloading process, materials falling at close range are intercepted and collected by the transition receiving plate layer group, and fine powder drifting at long distance is fully received by the bottom receiving plate layer group, with no material falling into the dead corner of the bottom cavity of the freeze-drying box. S3. Relying on the material-gathering slopes set on the surface of each receiving plate, the scattered powder is uniformly gathered to the bottom plate outlet position. S4. Restart the vacuum suction and collection mechanism to uniformly collect all the materials scattered to the bottom layer of the bottom plate, so as to achieve low loss of high-value freeze-dried powder.

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