Bulk drug freeze-drying front chamber airflow limiting device, airflow control system and preparation method

Abstract

The invention discloses a bulk drug freeze-drying front chamber airflow limiting device, an airflow control system and a preparation method.The airflow limiting device is arranged between a freeze-drying front chamber A-level laminar flow area and a freeze-drying front chamber B-level background area and comprises a partition panel, a main body frame, a supporting rod, a supporting plate and a moving device; the main body frame is clamped at the periphery of the partition panel; one end of each supporting rod is hinged to the lower portion of the main body frame, and the other end of each supporting rod is connected to the supporting plate in a clamped mode; and the moving device is arranged below the supporting plate. The invention aims to optimize the flow pattern of air flow in the chamber before freeze-drying, ensure effective isolation between the A-level laminar flow area and the B-level background area, and eliminate vortexes, so as to ensure sterility and high efficiency of medicine production, and improve operation convenience and space utilization rate at the same time.

Description

Technical Field

[0001] The invention relates to the technical field of freeze-drying of bulk drugs, in particular to an airflow restriction device in an antechamber of freeze-drying of bulk drugs, an airflow control system and a preparation method. Background Art

[0002] In the existing design of the freeze-drying antechamber for raw materials, the freeze dryer needs to open the door and extend the material gun into the freeze dryer to perform the suction operation. However, this operation method has some disadvantages. When the freeze dryer door is opened, the drugs are exposed to the external environment, forming a high-risk operation area. Due to the exposure of drugs, this area must meet Class A environmental standards to ensure the quality and safety of the drugs. To achieve Class A conditions, traditional solutions usually use hard partitions (such as hard glass partitions) or PVC roller curtains to separate the open area of ​​the freeze dryer door from the surrounding Class B background environment.

[0003] However, although the use of hard partitions can form Class A protection, it will affect the operation of personnel, causing the freeze-drying antechamber space to be divided, which has an adverse effect on the operation and appearance of personnel in the clean room. PVC roller curtains are a flexible partition solution, but PVC roller curtains may become a source of pollution and are prone to generate particulate matter during the VHP (steam sterilization) process.

[0004] In addition, since the freeze-drying antechamber is usually equipped with a large laminar flow hood, a large amount of supply air cannot return to the return air outlet in time, resulting in poor air flow pattern in the entire freeze-drying antechamber. For example, vortices will be generated, which will have an adverse effect on the air in the clean room, not only affecting the maintenance of the clean environment, but also posing a threat to the quality and safety of drugs. Summary of the invention

[0005] The object of the present invention is to provide an airflow restriction device, an airflow control system and a preparation method for a freeze-drying antechamber of a raw material drug, so as to achieve effective isolation of the A-level laminar flow area and the B-level background area inside the freeze-drying antechamber and eliminate eddy currents to ensure the sterility and efficiency of drug production.

[0006] To solve the above technical problems, in a first aspect of the present invention, the present invention provides an airflow restriction device for a freeze-drying antechamber of a raw material drug, which is arranged between a Class A laminar flow area and a Class B background area of ​​the freeze-drying antechamber, and comprises: a partition panel, a main frame, a support rod, a support plate and a moving device;

[0007] The main frame is clamped on the four sides of the partition panel; one end of each of the support rods is hinged on the bottom of the main frame, and the other end is clamped on the support plate; the moving device is arranged on the bottom of the support plate.

[0008] Furthermore, in the airflow restriction device, there is a first spacing between adjacent support rods, and the length of the first spacing is greater than the length of the support rod.

[0009] Furthermore, in the airflow restriction device, a handle is provided on one side of the airflow restriction device located at the Class B background area.

[0010] Furthermore, in the airflow restriction device, the moving device includes a small wheel and a sliding track, the small wheel is arranged at the bottom of the support plate, and the small wheel is slidably arranged in the sliding track.

[0011] Furthermore, in the airflow limiting device, the partition panel is made of inorganic glass or corrosion-resistant acrylic board.

[0012] In a second aspect of the present invention, an airflow control system for a freeze-drying antechamber of a bulk drug is also proposed, comprising the airflow restriction device described above, and also comprising a freeze dryer, a Class A laminar flow area in the freeze-drying antechamber, a Class B background area, a suction device, and a pulverizing device;

[0013] The crushing device is located in the Class B background area; one end of the suction device passes through the airflow limiting device and is connected to the crushing device, and the other end passes through the Class A laminar flow area to the freeze dryer for suction; the airflow limiting device is movably arranged between the Class A laminar flow area and the Class B background area.

[0014] Furthermore, in the airflow control system of the bulk drug freeze-drying antechamber, it includes a plurality of freeze dryers arranged in parallel, a class A laminar flow area and a class B background area of ​​the freeze-drying antechamber.

[0015] Furthermore, in the airflow control system of the bulk drug freeze-drying antechamber, a return air outlet device is provided in the Class B background area, and the return air outlet device includes a plurality of transversely arranged louver bodies, and the louver bodies include a plurality of blades arranged at intervals and having adjustable angles.

[0016] Furthermore, in the airflow control system of the bulk drug freeze-drying antechamber, the installation position of the return air outlet device is determined according to the wind direction of the vortex generated in the Class B background area.

[0017] In a third aspect of the present invention, a method for preparing a class A laminar flow region and a class B background region is also proposed, which is used between a freeze dryer and an airflow restriction device, and the preparation method comprises:

[0018] Install multiple freeze dryers, and set a sliding track on the floor of the freeze dryer front chamber that does not interfere with the door opening track of the freeze dryer, and set at least one airflow restriction device as described in any one of claims 1 to 5 above on the sliding track;

[0019] Before the material removal operation, the airflow restriction device is first disinfected, and then the airflow restriction device is moved to the freeze dryer door opening area to ensure the formation of Class A conditions; the return air vent device as described in claim 8 is installed in the Class B background area;

[0020] The return air outlet device is adjusted according to the airflow conditions, and the suction operation is performed after a stable airflow of Class A conditions is formed, and the site is cleared as needed after the operation.

[0021] Compared with the prior art, the present invention has at least the following beneficial effects:

[0022] The present invention discloses an airflow restriction device, airflow control system and preparation method for a freeze-drying antechamber of a raw material drug. An airflow restriction device is provided between the A-level laminar flow and the B-level background of the freeze-drying antechamber, wherein a partition panel is used to maintain the cleanliness of the freeze-drying antechamber, one end of a support rod is hinged on the main frame, and the other end is clamped on the support plate. Under normal circumstances, the support rod can support the partition panel. When it needs to be moved, the clamped end can be opened and rotated to a horizontal position to facilitate one end of the suction device to pass through the airflow restriction device, and then it can be put down again and play a supporting role again after clamping. By analogy, the suction device can pass through multiple support rods in sequence, and will not affect the partition effect of the partition panel on the A-level laminar flow area and the B-level background area. The moving device can drive the partition panel to move between different A-level laminar flow areas and B-level background areas. When a freeze dryer needs to suck material, the airflow restriction device can be moved to the corresponding position to isolate and form A-level conditions. The airflow limiting device can optimize the spatial layout of the freeze-drying antechamber. Compared with the traditional fixed hard partition or PVC roller curtain, the airflow limiting device can be moved to one side when not in use, making the space of the freeze-drying antechamber more concise, thereby improving space utilization.

[0023] In addition, the design of the airflow restriction device allows a handle to be set in the Class B background area, so that operators in the Class B background area can easily move the airflow restriction device without entering the Class A laminar flow area, which is convenient for actual production operations and improves the flexibility and convenience of operations.

[0024] Furthermore, the present invention is provided with an air return port device in the Class B background area, which can eliminate the vortex and air flow rising problems caused by the laminar air supply in the Class B background area failing to return to the air-conditioning system in time, and can optimize the air flow pattern in the Class B background area of ​​the freeze-drying antechamber, reduce the generation of vortex and rising air flow, and meet the GMP requirements for clean room air flow. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a front view structural schematic diagram of an airflow restriction device in one embodiment of the present invention;

[0026] Figure 2It is a schematic cross-sectional view of an airflow restriction device in one embodiment of the present invention;

[0027] Figure 3 It is a front view of a high position return air outlet device in one embodiment of the present invention;

[0028] Figure 4 This is a CFD simulation diagram of the airflow pattern before the high-position return air outlet device is installed in one embodiment of the present invention;

[0029] Figure 5 It is a CFD simulation schematic diagram of the airflow pattern after the high-position return air outlet device is installed in one embodiment of the present invention;

[0030] Figure 6 This is a position diagram of the baffle trolley when the freeze dryer A sucks materials in one embodiment of the present invention;

[0031] Figure 7 This is a position diagram of the baffle trolley when the freeze dryer B sucks materials in one embodiment of the present invention;

[0032] Figure 8 This is a diagram showing the position of the baffle trolley when the freeze dryer C is sucking material in one embodiment of the present invention.

[0033] Among them, 1. air flow restriction device; 11. partition panel; 12. main frame; 13. support rod; 14. support plate; 141. buckle; 15. moving device; 151. small wheel; 152. sliding track; 16. baffle trolley; 161. baffle trolley A; 162. baffle trolley B; 163. baffle trolley C; 2. freeze dryer; 21. freeze dryer A; 22. freeze dryer B; 23 freeze dryer C; 3. suction device; 31. automatic suction trolley; 32. material transfer pipeline; 4. crushing device; 51. laminar flow hood; 52. room return air inlet; 53. self-circulating return air inlet; 54. vortex; 55. freeze dryer door opening; 6. return air inlet device; 61. shutter body; 7. shell and tube sterilizer. DETAILED DESCRIPTION

[0034] The following will be described in more detail in conjunction with a schematic diagram of a bulk drug freeze-drying antechamber airflow restriction device, an airflow control system, and a preparation method of the present invention, wherein a preferred embodiment of the present invention is shown, and it should be understood that those skilled in the art can modify the present invention described herein, and still achieve the beneficial effects of the present invention. Therefore, the following description should be understood as being widely known to those skilled in the art, and not as a limitation of the present invention.

[0035] For the sake of clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not described in detail because they would clutter the invention with unnecessary detail. It should be recognized that in the development of any actual embodiment, a large number of implementation details must be made to achieve the developer's specific goals, such as changing from one embodiment to another according to the limitations of the relevant system or the relevant business. In addition, it should be recognized that such development work may be complex and time-consuming, but it is just a routine task for those skilled in the art.

[0036] The present invention is described in more detail in the following paragraphs by way of example with reference to the accompanying drawings. The advantages and features of the present invention will become more apparent from the following description and claims. It should be noted that the drawings are in very simplified form and in non-precise proportions, and are only used to facilitate and clearly assist in illustrating the purpose of the embodiments of the present invention.

[0037] As mentioned in the background technology, there are three existing designs for the freeze-drying antechamber of the API freeze-dried powder workshop:

[0038] (1) A hard partition is set between the A-level laminar flow area and the B-level background area in the freeze-drying antechamber

[0039] Although the hard partition can effectively separate the Class A laminar flow area and the Class B background area, it will seriously affect the spatial layout of the freeze-drying antechamber, resulting in reduced space utilization and inconvenience to actual production operations. Although the hard partition can ensure the Class A condition airflow pattern, the return air system under the partition often cannot efficiently guide the laminar supply air back to the air conditioning system, resulting in the supply air being unable to return in time at the return air outlet side. Part of the supply air will move upward along the wall, forming vortices 54 and upward airflow, which is inconsistent with the GMP (Good Manufacturing Practice) requirement of upward supply and downward return airflow, bringing difficulties to verification.

[0040] (2) PVC roller curtain is used between the A-level laminar flow area and the B-level background area of ​​the freeze-drying antechamber

[0041] PVC roller curtains will be oxidized during VHP disinfection in a Class B environment, causing particles and other pollutants to be produced by the curtains, which has a significant impact on the particle concentration in the B+A environment, and personnel entering and exiting the Class B area will come into contact with the PVC roller curtains. Since PVC roller curtains themselves produce pollutants, the practice of PVC roller curtains is gradually being rejected. In addition, the use of PVC roller curtains will still cause the airflow in the Class B background area to float up along the wall, and the airflow organization effect is not good.

[0042] (3) Freeze-drying antechamber filled with laminar flow solution

[0043] The B+A environment of the freeze-drying antechamber is artificially raised to a full A-level environment. In this case, the initial investment and energy consumption of the freeze-drying antechamber are increased, and a particle concentration alarm will be generated when personnel enter the A-level laminar flow area. Personnel cannot enter during the production process, but the equipment operation screens must be operated by personnel, which is not conducive to normal production. Moreover, the larger the laminar flow area, the greater the air supply volume. Under the premise of ensuring the wind speed and return air effect, the larger the return air outlet area required, and the more stringent the requirements for the clean room.

[0044] It can be seen that the above three schemes have a great impact on the freeze-drying antechamber of the API freeze-dried powder workshop.

[0045] In view of this, if Figure 1 As shown, the present invention provides an airflow limiting device 1 for a freeze-drying antechamber of a raw material drug, which is arranged between a class A laminar flow area and a class B background area of ​​the freeze-drying antechamber, and comprises a partition panel 11, a main frame 12, support rods 13, a support plate 14 and a moving device 15; the main frame 12 is clamped on all sides of the partition panel 11; one end of a plurality of the support rods 14 is hinged at the bottom of the main frame 12, and the other end is clamped on the support plate 14; a moving device 15 is arranged below the support plate 14 for limiting the moving position of the airflow limiting device 1.

[0046] Specifically, one end of the plurality of support rods 13 is hinged at the bottom of the main frame 12, and the other end is clamped on the support plate 14 by a buckle 141, and there is a first spacing between the plurality of support rods 13, and the length of the first spacing is greater than the support rods 13, that is, the length of the first spacing is required to ensure that the support rods 13 can rotate left and right to avoid the material transfer pipe 32 at one end of the suction device, so as to facilitate the material transfer pipe 32 to pass through the airflow restriction device 1.

[0047] like Figure 1 As shown, the number of the support rods 13 is schematically shown as 4. During the movement of the airflow restriction device 1, the operator can manually open the buckle 141 and turn it left and right to pull up one of the support rods 13 (the support rod 13 here refers to the support rod 13 closest to the material transfer pipe 32 in the moving direction of the airflow restriction device 1), thereby avoiding the material transfer pipe 32 during movement.

[0048] In addition, the height of the support rod 13 is determined according to the height of the material transfer pipe 32 of the material suction device 3. That is, the height of the support rod 13 matches the height of the material transfer pipe 32 of the material suction device 3 to ensure smooth material suction. In addition, the appropriate height of the support rod 14 helps to maintain the stability of the airflow in the A-level laminar flow area and reduce the interference with the B-level background area.

[0049] In this embodiment, the mobile device 15 includes a small wheel 151 and a sliding track 152. The small wheel 151 is symmetrically arranged below the support plate 14. There are multiple small wheels 151, and 10 are schematically shown in the figure. The sliding track 152 is made of stainless steel and is in the shape of a long strip protruding from the ground. The small wheel 151 is arranged at the bottom of the support plate 14, and the small wheel 151 is slidably arranged in the sliding track 152. In addition, the sliding track 152 is arranged at a position that does not interfere with the door opening track of the freeze dryer 2, ensuring that the door opening and material suction operations of the freeze dryer 2 can be carried out smoothly without being restricted by the position of the sliding track 152.

[0050] Specifically, the partition panel 11 is made of inorganic glass or corrosion-resistant acrylic plate, both of which have good physical strength and smooth surface, easy to clean and disinfect, which helps to maintain the cleanliness of the freeze-drying front room and meets the requirements of GMP. In addition, both materials have high transparency, which is conducive to the operator observing the operation inside the freeze dryer 2 without destroying the sterile environment, ensuring the accuracy and safety of the operation.

[0051] In this embodiment, the upper and lower heights of the partition panel 11 are determined according to the ceiling height of the freeze-drying antechamber and the minimum operating surface height. The height of the freeze-drying antechamber ceiling refers to the vertical distance from the ceiling to the ground in the freeze-drying antechamber. The height of the partition panel 11 needs to adapt to this space to ensure that it does not exceed the available vertical space, that is, this height determines the position where the upper end of the partition panel 11 should be set; the minimum operating surface height refers to the minimum working height that the operator needs to reach when performing the material taking operation. This height determines the position where the bottom of the partition panel 11 should be set, so that the operator can work comfortably while ensuring the safety and efficiency of the operation.

[0052] In this embodiment, at least one handle is provided in the non-material taking operation area on the side of the Class B background area on the airflow restriction device 1. According to GMP requirements, the Class A laminar flow area needs to maintain a very high cleanliness to prevent the drugs from being contaminated. The handle is provided in the Class B background area, which can reduce the need to enter the Class A laminar flow area, facilitate the movement or adjustment of the airflow restriction device 1, reduce the risk of contamination and the possibility of cross contamination, and thus improve the efficiency of the operation.

[0053] In addition, in the design and operation of the clean room, ensuring good airflow organization is very important because it is directly related to the air quality and particle control in the room. Figure 4As shown, after the air delivered by the air supply system reaches the Class A laminar flow area (Class A area in the figure) through the laminar flow hood 51, part of it is recovered through the room return air vent 52 and the self-circulation return air vent 53, and the other part may form vortex 54 and upward airflow on the wall panels of the Class B background area (Class B area in the figure). The vortex 54 will cause the particles in the air to deposit on the wall panels of the Class B background area, increasing the risk of contamination; it will also interfere with the normal laminar air supply, resulting in uneven airflow distribution, thereby reducing the overall air quality of the clean room and may cause problems during the verification process.

[0054] Therefore, to solve the above problems, please refer to Figure 2 In another aspect of the present embodiment, an airflow control system for the freeze-drying antechamber of a raw material drug is proposed, comprising the airflow limiting device 1 as described above, and also comprising a freeze dryer 2, a class A laminar flow area in the freeze-drying antechamber, a class B background area, a suction device 3 and a crushing device 4; the crushing device 4 is located in the class B background area; a material transfer pipe 32 at one end of the suction device 3 passes through the airflow limiting device 1 and is connected to the crushing device 4, and a suction gun at the other end passes through the class A laminar flow area to the freeze dryer 2 for suction; the airflow limiting device 1 is movably arranged between the class A laminar flow area and the class B background area.

[0055] In this embodiment, there are multiple freeze dryers, freeze drying antechamber A-level laminar flow area and B-level background area arranged in parallel. Figure 6 As shown, the airflow control system of the API freeze-drying antechamber includes freeze dryers A21, B22, and C23 arranged in parallel, and also includes a Class A laminar flow area and a Class B background area arranged in parallel.

[0056] like Figure 5 As shown, in the Class B background area in the freeze-drying antechamber, a return air outlet device 6 is added. At this time, the return air outlet device 6 can effectively capture and guide the rising airflow back to the air conditioning system, ensuring that the air flows from top to bottom, which is in line with the airflow organization principle of the clean room, that is, "upward delivery and downward return". Thereby reducing or eliminating the vortex 54 that may be generated due to the interaction between the air supply and the room structure, forming a more uniform and orderly airflow pattern, reducing the retention and deposition of particles in the room, improving the air quality in the room, and meeting the GMP requirements for cleanliness.

[0057] Specifically, a return air outlet device 6 is provided in the Class B background area, such as Figure 3 As shown, the return air outlet device 6 includes a plurality of louver bodies 61 arranged transversely, and the louver bodies 61 include a plurality of blades arranged at intervals and having adjustable angles. The return air outlet device 6 shown can be a complete rectangle, or can be composed of a plurality of small rectangles arranged in parallel, such as Figure 36-1, 6-2, 6-3. The return air outlet device 6 is made of plastic-sprayed aluminum alloy, which not only meets the functional requirements but also provides good durability and maintenance convenience. The louver body 61 is also surrounded by a return air outlet frame, and the nylon filter is installed on the return air outlet frame to capture and filter dust, particulate matter and other impurities in the air to improve the air purification efficiency and protect the interior of the air conditioning system from damage by pollutants.

[0058] In this embodiment, the installation position of the return air vent device 6 can be determined according to the wind direction of the vortex 54, and the rotation wind direction of the vortex 54 can be determined according to the air flow simulation results of the freeze-drying front chamber, thereby determining the optimal installation position of the return air vent device 6. The size of the return air vent device 6 is calculated based on the actual laminar flow area, wind speed, and recommended wind speed of the return air vent. Among them, air flow simulation can help predict and visualize the air flow conditions in the freeze-drying front chamber, find the location where the vortex 54 is generated, and thus accurately determine the optimal installation position of the return air vent device 6, which helps to reduce or eliminate the vortex 54 and upward airflow caused by the laminar flow hood 51. In addition, if the air flow simulation data of the freeze-drying front chamber is not available, it is also possible to refer to empirical data to provide a reasonable preliminary setting plan for the return air vent device 6. Subsequently, the performance of the return air vent device 6 can be optimized through actual monitoring and adjustment to ensure that the air flow pattern of the freeze-drying front chamber reaches the optimal state.

[0059] In this embodiment, the size of the airflow restriction device 1 is larger than the size of the freeze dryer 2. Specifically, the size of the airflow restriction device 1 is determined based on the size of the freeze dryer 2 and the size of the laminar flow buffer zone. The size of the airflow restriction device 1 needs to take into account the size of the freeze dryer 2 because one of the main functions of the airflow restriction device 1 is to provide Class A protection for the freeze dryer 2 when the door is open, ensuring that the drugs are not exposed to a potentially contaminated environment during operation. Therefore, the size of the airflow restriction device 1 must be sufficient to cover the range when the freeze dryer 2 is opened, as well as possible movement and operation space. The size of the airflow restriction device 1 also needs to take into account the size of the laminar flow buffer zone because the laminar flow buffer zone is designed to maintain the cleanliness of a certain area to protect the drugs from contaminated areas. The laminar flow buffer zone can ensure that the airflow restriction device 1 effectively isolates the Class A laminar flow area from the Class B background environment, while allowing sufficient space for laminar flow stabilization and buffering.

[0060] In a specific example, the moving position of the airflow limiting device 1 needs to be determined according to the number and layout of the freeze dryers 2 to ensure that each freeze dryer 2 can be properly protected under Class A conditions when performing the suction operation. In addition, considering the efficiency and convenience of the operation, the airflow limiting device 1 can be selected as a baffle trolley 16, and the baffle trolley 16 still has a partition panel 11, a main frame 12, a support rod 13, a support plate 14 and a moving device 15. The moving device 15 also includes a small wheel 151 and a sliding track 152. The small wheel 151 allows the baffle trolley 16 to slide in the sliding track 152. The number of baffle trolleys 16 can be one or more, and multiple baffle trolleys 16 can be placed side by side to quickly switch between different freeze dryers 2 and reduce preparation and conversion time. The following is an example of the baffle trolley 16.

[0061] In addition, the return air inlet device 6 is defined as a cyclone-extinguishing air inlet, the suction device 3 is defined as an automatic suction trolley 31, and the crushing device 4 is defined as a crusher. The implementation process of the airflow restriction device in the front chamber of the freeze-drying of the raw material drug is as follows:

[0062] 1. Implementation environment preparation

[0063] Assume that in a cephalosporin API freeze-dried powder workshop, the workshop is equipped with 6 freeze dryers 2 for freeze drying of APIs. Before implementing the freeze drying antechamber airflow restriction device 1, ensure that the workshop has been designed and constructed in accordance with GMP standards and has a basic clean environment.

[0064] 2. Design and layout of baffle trolley 163

[0065] The design of the baffle trolley 163 needs to be based on the specific requirements of the freeze-drying front room. First, according to the height of the ceiling of the freeze-drying front room (assuming it is 3.2 meters) and the height of the operating surface (assuming it is 2.5 meters), the height of the baffle trolley 163 is determined to be 0.7 meters to ensure that it will not affect the work of the operator. Secondly, according to the size of the freeze dryer 2 (assuming the width is 1.5 meters) and the need for the laminar flow buffer zone (assuming that an additional 0.5-meter buffer zone is required), the length of the baffle trolley 163 is determined to be at least 2 meters. Ten small wheels 151 are welded on both sides of the bottom of the baffle trolley 163. According to the number and layout of the freeze dryer 2, three baffle trolleys 16 are provided, namely baffle trolley A161, baffle trolley B162, and baffle trolley C163. The corresponding positions of the movement of different baffle trolleys 16 are marked on the sliding track 152 in front of each freeze dryer 2 in advance.

[0066] 3. Installation of sliding rail 152

[0067] On the floor of the freeze-drying front room, a stainless steel sliding track 152 is installed. The sliding track 152 is long and protrudes 2 to 3 mm from the floor to guide the movement of the baffle trolley 16. The position of the sliding track 152 is designed to ensure that it does not interfere with the track of the freeze dryer 2 door opening.

[0068] 4. Setting of cyclone vents

[0069] According to the airflow simulation results of the freeze-drying front chamber, determine the best installation position of the anti-cyclone air outlet. According to the actual laminar flow area, wind speed, and recommended wind speed of the return air outlet, the size and number of the anti-cyclone air outlet are obtained. If the simulation data is not available, refer to the empirical data and install the anti-cyclone air outlet at a height of 1.6 to 1.8 meters below the ceiling of the freeze-drying front chamber. The angle of the blades of the louver body 61 can be adjusted to change the angle of the anti-cyclone air outlet as needed.

[0070] 5. Movement and positioning of baffle trolley 16

[0071] Before preparing for the freeze-drying suction operation, the surface of the baffle trolley 16 is first wiped with disinfectant to ensure the sterile conditions of the Class A environment. Then, when the freeze dryer A21 is ready to discharge, the operator moves the baffle trolley A161, baffle trolley B162 and baffle trolley C163 to the Class B background area by the handle. Figure 6 The baffle trolley 16 is moved to the door opening area of ​​the freeze dryer A21 to ensure that the area is under Class A conditions. At the same time, the movement trajectory of the automatic suction trolley 31 after it comes out of the shell and tube sterilizer 7 is also protected under Class A conditions. Since the remaining freeze dryers B22 and C23 are in a closed state and there is no risk of drug exposure, the area in front of them can maintain Class B conditions.

[0072] 6. Optimization of airflow pattern

[0073] According to the airflow conditions in the freeze-drying antechamber, Figure 5 As shown, an anti-cyclone air outlet is added in the Class B background area, and the shutter angle of the anti-cyclone air outlet is adjusted to optimize the airflow pattern, maintain the upward and downward flow of the airflow, and reduce vortex 54 and upward airflow.

[0074] 7. Freeze-drying suction operation

[0075] After a stable Class A airflow is formed in the door opening area of ​​the freeze dryer A21, the operator opens the door of the freeze dryer A21, and the suction gun at one end of the automatic suction trolley 31 enters the interior of the freeze dryer A21. At this time, the material transfer pipe 32 at the other end passes through the baffle trolley 16 to transfer the freeze-dried cephalosporin raw materials to the pulverizer, and the cephalosporin raw materials are lyophilized and pulverized in the pulverizer to obtain the freeze-dried powder.

[0076] 8. Subsequent Operations

[0077] After the suction and crushing operation of freeze dryer A21 is completed, the cleaning operation is selected according to whether the drugs in the remaining freeze dryers 2 are from the same batch as the drugs in freeze dryer A21. If the drugs in the remaining freeze dryers 2 are not from the same batch as the drugs in freeze dryer A21, the cleaning operation is required, that is, the recovery work after the operation is performed. At this time, the operator should move the baffle trolley A161, baffle trolley B162, and baffle trolley C163 back to their original positions along the sliding track 152, and ensure that the airflow pattern of the freeze drying front chamber returns to normal.

[0078] If the medicines in the remaining freeze dryers 2 and the medicines in the freeze dryer A21 are from the same batch, the above steps 5-7 can be performed on the remaining freeze dryers 2 in sequence.

[0079] Specifically, when the freeze dryer B22 is discharging, the operator pushes the baffle trolley 16 to move to the level B background area. Figure 7 The position shown forms a Class A condition protection area, ensuring that the door opening area of ​​the freeze dryer B22 and the moving track of the automatic suction trolley 31 are both under Class A conditions. According to the airflow conditions in the freeze-drying front chamber, adjust the blade angle of the shutter body 61 of the cyclone extinguishing outlet to optimize the airflow pattern. After a stable Class A condition airflow is formed in the door opening area of ​​the freeze dryer B22, the operator opens the door of the freeze dryer B22 to perform suction and subsequent crushing operations inside the freeze dryer B22.

[0080] Similarly, when the freeze dryer C23 is discharging, the operator moves the baffle trolley 16 to the level B background area. Figure 8 At the position shown, a Class A condition protection area is formed to ensure that the freeze dryer C23 door opening area and the moving track of the automatic suction trolley 31 are both under Class A conditions. According to the airflow conditions in the freeze-drying front chamber, the blade angle of the shutter body 61 of the cyclone extinguishing outlet is adjusted to optimize the airflow pattern. After a stable Class A condition airflow is formed in the freeze dryer C23 door opening area, the operator opens the freeze dryer C23 door to perform suction and subsequent crushing operations inside the freeze dryer C23.

[0081] 9. Recording and Verification

[0082] During the entire operation, the adjustment parameters, operation time, airflow status and other information of the baffle trolley 16 and the cyclone-extinguishing air outlet are recorded in detail for reference in subsequent production and quality control.

[0083] In summary, in the airflow restriction device and airflow control system for the freeze-drying antechamber of the raw material medicine provided in this embodiment, the freeze-drying antechamber of the raw material medicine is provided with an airflow restriction device 1 between the A-level laminar flow and the B-level background of the freeze-drying antechamber, wherein the partition panel 11 is used to maintain the cleanliness of the freeze-drying antechamber, one end of the support rod 13 is hinged on the main frame 12, and the other end is clamped on the support plate 14. Under normal circumstances, the support rod 13 can support the partition panel 11. When it needs to be moved, the clamped end can be opened and rotated to a horizontal position, so that one end of the suction device 3 can pass through the airflow restriction device 1, and then it will be put down again, and it will play a supporting role again after clamping. By analogy, the suction device 3 can pass through multiple support rods in sequence, and will not affect the partition effect of the partition panel 11 on the A-level laminar flow area and the B-level background area. The moving device 15 can drive the partition panel 11 to move between different A-level laminar flow areas and B-level background areas. When a freeze dryer needs to suck material, the airflow restriction device 1 can be moved to the corresponding position to isolate and form the A-level condition. The airflow limiting device 1 can optimize the spatial layout of the freeze-drying antechamber. Compared with the traditional fixed hard partition or PVC roller curtain, the airflow limiting device 1 can be moved to one side when not in use, making the space of the freeze-drying antechamber more concise, thereby improving space utilization.

[0084] Furthermore, the present invention is provided with a return air outlet device 6 in the Class B background area, which can eliminate the vortex 54 and air flow floating problems caused by the laminar air supply in the Class B background area failing to return to the air-conditioning system in time, and can optimize the air flow pattern in the Class B background area of ​​the freeze-drying antechamber, reduce the generation of vortex 54 and floating airflow, and meet the GMP requirements for clean room airflow.

[0085] The above is only a preferred embodiment of the present invention and does not limit the present invention in any way. Any technician in the relevant technical field, without departing from the scope of the technical solution of the present invention, makes any form of equivalent replacement or modification to the technical solution and technical content disclosed in the present invention, which does not depart from the content of the technical solution of the present invention and still falls within the protection scope of the present invention.

Claims

1. A bulk drug freeze-drying antechamber airflow restriction device, arranged between the A-level laminar flow area and the B-level background area of ​​the freeze-drying antechamber, characterized in that: include: Partition panels, main frames, support rods, support plates and moving devices; The main frame is clamped on the four sides of the partition panel; one end of each of the support rods is hinged at the bottom of the main frame, and the other end is clamped on the support plate; the moving device is arranged at the bottom of the support plate.

2. The airflow restriction device according to claim 1, characterized in that: There is a first spacing between adjacent support rods, and the length of the first spacing is greater than the length of the support rod.

3. The airflow restriction device according to claim 1, characterized in that: The airflow restriction device is provided with a handle on one side of the Class B background area.

4. The airflow restriction device according to claim 1, characterized in that: The moving device comprises a small wheel and a sliding track. The small wheel is arranged at the bottom of the supporting plate, and the small wheel is slidably arranged in the sliding track.

5. The airflow restriction device according to claim 1, characterized in that: The partition panel is made of inorganic glass or corrosion-resistant acrylic board.

6. A bulk drug freeze-drying antechamber airflow control system, characterized in that: The device comprises an airflow restriction device as described in any one of claims 1 to 5 above, and further comprises a freeze dryer, a freeze drying antechamber A-level laminar flow area, a B-level background area, a suction device and a pulverizing device; The pulverizing device is located in the Class B background area; One end of the suction device passes through the airflow limiting device and is connected to the crushing device, and the other end passes through the Class A laminar flow area to the freeze dryer for suction; the airflow limiting device is movably arranged between the Class A laminar flow area and the Class B background area.

7. The airflow control system for the bulk drug freeze-drying antechamber according to claim 6, characterized in that: It includes a plurality of freeze dryers arranged in parallel, a freeze drying antechamber A-level laminar flow area and a B-level background area.

8. The airflow control system for the bulk drug freeze-drying antechamber according to claim 6, characterized in that: An air return port device is provided in the Class B background area. The air return port device includes a plurality of transversely arranged louver bodies. The louver bodies include a plurality of blades arranged at intervals and having adjustable angles.

9. The airflow control system for the bulk drug freeze-drying antechamber according to claim 8, characterized in that: The installation position of the return air outlet device is determined according to the wind direction in which the vortex is generated in the Class B background area.

10. A method for preparing a Class A laminar flow region and a Class B background region, used between a freeze dryer and an airflow restriction device, characterized in that: The preparation method comprises: Install multiple freeze dryers, and set a sliding track on the floor of the freeze dryer front chamber that does not interfere with the door opening track of the freeze dryer, and set at least one airflow restriction device as described in any one of claims 1 to 5 above on the sliding track; Before the material removal operation, the airflow restriction device is first disinfected, and then the airflow restriction device is moved to the freeze dryer door opening area to ensure the formation of Class A conditions; the return air vent device as described in claim 8 is installed in the Class B background area; The return air outlet device is adjusted according to the airflow conditions, and the suction operation is performed after a stable airflow of Class A conditions is formed, and the site is cleared as needed after the operation.

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