Closed granulation line structure

Abstract

The utility model relates to a closed granulation line structure which comprises a closed isolator, a wet granulator, a wet straightening granulator, a fluidized bed, a dry straightening granulator, a material buffer tank and a vibration screening machine, the wet granulator, the wet straightening granulator, the fluidized bed, the dry straightening granulator, the material buffer tank, the vibration screening machine and the AB valve are all arranged in the closed isolator; the wet granulator is communicated with the wet straightening granulator, the wet straightening granulator is communicated with the fluidized bed, the fluidized bed is communicated with the dry straightening granulator, the dry straightening granulator is communicated with the material buffer tank, and the material buffer tank is communicated with the vibration screening machine. The utility model aims to provide a closed granulation line structure for overcoming the existing defects, and ensures the high efficiency, the leakproofness and the safety in the production process.

Description

Technical Field

[0001] This utility model relates to a closed granulation line structure. Background Technology

[0002] With the strengthening of drug quality and safety supervision, closed-loop production has become an important mode to ensure drug safety and pollution-free production, and market demand continues to grow. Closed-loop production is considered a key technology for improving product safety and efficiency in the pharmaceutical industry.

[0003] The application of closed granulation line technology in the existing pharmaceutical industry is not yet mature, especially in the production of high-activity pharmaceutical ingredients (HPAPI), where the need for closed technology is particularly urgent. Existing closed technologies cannot strictly meet the closed requirements. Therefore, a closed granulation line structure is proposed to address the above issues. Utility Model Content

[0004] The purpose of this invention is to overcome the existing defects and provide a closed granulation line structure that ensures the efficiency, airtightness and safety of the production process.

[0005] The technical solution to achieve the above objectives is: a closed granulation line structure, including a closed isolator, a wet granulator, a wet granulator, a fluidized bed, a dry granulator, a material buffer tank, and a vibrating screen.

[0006] The wet granulator, the wet sizing machine, the fluidized bed, the dry sizing machine, the material buffer tank, and the vibrating screen are all housed within the sealed isolator.

[0007] The wet granulator is connected to the wet sizing machine, the wet sizing machine is connected to the fluidized bed, the fluidized bed is connected to the dry sizing machine, the dry sizing machine is connected to the material buffer tank, and the material buffer tank is connected to the vibrating screen.

[0008] Preferably, the outlet of the vibrating screen is equipped with an AB valve.

[0009] Preferably, it also includes a BIBO (bag-to-bag-to-filter) transmission port, which is located on the side wall of the sealed isolator.

[0010] Preferably, it also includes a CIP cleaning line (online cleaning); the CIP cleaning line is located inside the sealed isolator.

[0011] Preferably, the bottom of the sealed isolator is connected to multiple isolation support legs.

[0012] The beneficial effects of this utility model are as follows: This closed granulation line structure integrates functions such as isolation and sealing, wet granulation, fluidized bed drying, top spray granulation, sizing, vibrating screening, and material mixing, forming a set of granulation process linkage lines; it adopts modular integrated design and multiple sealing technologies to effectively connect the granulation process flow, realize intelligent, efficient, and safe production; and ensure the efficiency, sealing, and safety of the production process. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the closed granulation line structure of this utility model.

[0014] In the diagram: 1. Sealed isolator; 2. Wet granulator; 3. Wet granulator; 4. Fluidized bed; 5. Dry granulator; 6. Material buffer tank; 7. Vibrating screen; 8. BIBO transfer port; 9. AB valve; 10. CIP cleaning pipeline; 11. PLC and PC control devices. Detailed Implementation

[0015] The technical solution of this utility model will now be clearly and completely described in conjunction with the accompanying drawings. In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0016] The present invention will be further described below with reference to the accompanying drawings.

[0017] like Figure 1 As shown, a closed granulation line structure includes a closed isolator 1, a wet granulator 2, a wet sizing mill 3, a fluidized bed 4, a dry sizing mill 5, a material buffer tank 6, and a vibrating screen 7. The wet granulator 2, wet sizing mill 3, fluidized bed 4, dry sizing mill 5, material buffer tank 6, and vibrating screen 7 are all housed within the closed isolator 1. The wet granulator 2 is connected to the wet sizing mill 3, the wet sizing mill 3 is connected to the fluidized bed 4, the fluidized bed 4 is connected to the dry sizing mill 5, the dry sizing mill 5 is connected to the material buffer tank 6, and the material buffer tank 6 is connected to the vibrating screen 7. An AB valve 9 is installed at the outlet of the vibrating screen 7. Multiple isolation supports are connected to the bottom of the closed isolator 1.

[0018] Specifically, the wet granulator 2, wet sizing machine 3, fluidized bed dryer and top spray granulator 5, dry sizing machine 6, material buffer tank 6, and vibrating screen 7 are arranged in the same isolator, which has a modular integrated structure and meets the needs of space saving and high-efficiency production.

[0019] Specifically, it also includes BIBO transmission port 8, which is located on the side wall of the sealed isolator 1.

[0020] Specifically, it also includes CIP cleaning line 10; CIP cleaning line 10 is installed inside the sealed isolator 1.

[0021] Specifically, the entire process is sealed through isolators, vacuum conveying of materials, BIBO transfer sampling, AB valve docking for material transfer, and CIP online cleaning, which greatly reduces the risk of dust leakage and meets the dust leakage requirements of OEB4 and OEB5.

[0022] Specifically, the material is continuously placed into the settling chamber of the sealed isolator 1 through a continuous bag; after settling, the material is placed into the granulation chamber through a transfer window using operating gloves; the bag is broken and the material is fed into the wet granulator 2 for mixing and wet granulation; after wet granulation, the material is discharged through vacuum into the wet granulator 3 for granulation, and the granulated material is then pumped into the fluidized bed 4 through vacuum conveying; after top spray granulation and fluidized drying, the material is discharged through vacuum into the dry granulator 5 for granulation, and the granulated material is then pumped into the material buffer tank 6 through vacuum conveying; the material is screened by the vibrating screen 7 and connected through the AB valve 9 for transfer to the next process flow; during production, sampled materials or waste can be removed through the BIBO transfer port 8.

[0023] Specifically, the cleaning valve on the CIP cleaning line 10 is opened to enable in-situ CIP cleaning.

[0024] This closed granulation line integrates functions such as isolation and sealing, wet granulation, fluidized bed drying, top-spray granulation, sizing, vibrating sieving, and material mixing, forming a complete granulation process linkage line. Intelligent production is achieved through equipment interconnection, PLC control, and PC terminal operation. System functions include equipment management, process formulation management, production operation monitoring, production operation, alarm management, batch reports, and audit trails, significantly improving production efficiency, ensuring the uniformity of drug quality, reducing risks, and saving costs.

[0025] In another embodiment, after production is completed, the PLC and PC control device 11 can be used for PC-side operation to realize PLC control and control the opening and closing of the cleaning valves on the CIP cleaning pipeline 10, thereby realizing the CIP in-situ cleaning function. The PLC and PC control device 11 are commonly used existing devices, and their working principle, size, and model are irrelevant to the function of this application, so they will not be described in detail.

[0026] This closed granulation line integrates functions such as isolation and sealing, wet granulation, fluidized bed drying, top spray granulation, sizing, vibrating screening, and material mixing, forming a complete granulation process linkage line. It adopts a modular integrated design and multiple sealing technologies to effectively connect the granulation process flow, realizing intelligent, efficient, and safe production, and ensuring the efficiency, sealing, and safety of the production process.

[0027] The above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. A closed granulation line structure, characterized in that, It includes a sealed isolator (1), a wet granulator (2), a wet granulator (3), a fluidized bed (4), a dry granulator (5), a material buffer tank (6), and a vibrating screen (7); The wet granulator (2), the wet granulator (3), the fluidized bed (4), the dry granulator (5), the material buffer tank (6), and the vibrating screen (7) are all located inside the sealed isolator (1); The wet granulator (2) is connected to the wet granulator (3), the wet granulator (3) is connected to the fluidized bed (4), the fluidized bed (4) is connected to the dry granulator (5), the dry granulator (5) is connected to the material buffer tank (6), and the material buffer tank (6) is connected to the vibrating screen (7).

2. The closed granulation line structure according to claim 1, characterized in that, The outlet of the vibrating screen (7) is equipped with an AB valve (9).

3. The closed granulation line structure according to claim 1, characterized in that, It also includes a BIBO transmission port (8), which is located on the side wall of the sealed isolator (1).

4. The closed granulation line structure according to claim 1, characterized in that, It also includes a CIP cleaning line (10); the CIP cleaning line (10) is located inside the sealed isolator (1).

5. The closed granulation line structure according to claim 1, characterized in that, The bottom of the sealed isolator (1) is connected to multiple isolation support legs.

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