Aseptic treatment equipment for raw material medicines

Abstract

The utility model relates to the technical field of raw material medicine processing treatment, in particular to raw material medicine sterile treatment equipment which comprises a packaging structure, a housing arranged on the packaging structure in a covering mode and used for sealing and isolation and an air circulation structure installed on the upper portion of the housing. The air circulation structure comprises a filtering structure which is installed on the upper portion of the housing and communicates with the interior of the housing, the end, away from the housing, of the filtering structure communicates with a circulation air pump, and the other end of the circulation air pump communicates with the housing through an air pipe. The air pipe is provided with an air volume damper used for adjusting the air inlet volume in a communicating mode. Therefore, by means of the sterile treatment equipment for the raw material medicine, the technical problems that only single air internal circulation or external circulation can be conducted in the prior art, although the internal circulation can keep the relative closure of the production environment, microorganisms and pollutants in the air are easily accumulated due to long-time internal circulation, and the sterile quality of products is affected can be solved.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of bulk drug processing, in particular to a bulk drug sterile processing equipment. BACKGROUND

[0002] In the production process of sterile bulk drugs, it is crucial to ensure the cleanliness and sterility of the production environment. However, the existing sterile bulk drug production equipment has significant inconvenience in air intake control, which directly affects the stability of the production environment and the quality of the product.

[0003] Specifically, many existing sterile bulk drug production equipment lacks flexible air intake control system in design. The traditional control method often relies on fixed fan speed or manually adjusted valves, which is not only cumbersome to operate, but also difficult to achieve precise air intake control. Since the air intake cannot be adjusted in real time according to the actual needs of the production environment, the air quality in the production environment fluctuates greatly, making it difficult to maintain within the specified sterile standard range.

[0004] In addition, the existing sterile bulk drug production equipment also has limitations in air circulation mode. Many devices can only perform single air internal or external circulation. Internal circulation can maintain the relative closure of the production environment, but long-term internal circulation can easily lead to the accumulation of microorganisms and pollutants in the air, affecting the sterile quality of the product. While external circulation can introduce fresh air, it may also bring external pollution sources into the production environment, also posing a threat to product quality.

[0005] Therefore, in order to solve the deficiencies of existing sterile bulk drug production equipment in air intake control and air circulation mode, a new type of control system and circulation mechanism needs to be developed. This system should be able to achieve precise control of air intake, adjust in real time according to the actual needs of the production environment to maintain the stability of air quality. At the same time, the system should have flexible air circulation mode, which can choose internal circulation, external circulation or their combination according to needs, to minimize microorganisms and pollutants in the air and ensure the sterile state of the production environment. CONTENT OF THE INVENTION

[0006] Based on the above problems, the application provides a bulk drug sterile processing equipment to solve the technical problem that the existing equipment can only perform single air internal or external circulation. Internal circulation can maintain the relative closure of the production environment, but long-term internal circulation can easily lead to the accumulation of microorganisms and pollutants in the air, affecting the sterile quality of the product. While external circulation can introduce fresh air, it may also bring external pollution sources into the production environment, also posing a threat to product quality.

[0007] To solve the above technical problems, the utility model adopts the technical scheme that

[0008] A raw material medicine aseptic processing equipment, including packaging structure, cover for sealing isolation of cover shell of being arranged on the packaging structure and air circulation structure of upper portion of cover shell,

[0009] The air circulation structure includes a filter structure installed on the upper portion of the cover shell and connected with the inside of the cover shell, a circulating air pump is installed at one end of the filter structure away from the cover shell, and the other end of the circulating air pump is connected with the cover shell through an air pipe.

[0010] In a specific implementation scheme, the filter structure includes a shell and a filter core installed in the shell, the filter core is provided with two stages, and a filter screen is arranged at the air inlet of the circulating air pump.

[0011] In a specific implementation scheme, the air volume damper includes a through pipe connected with the air pipe, a handle is arranged on the outer wall of the through pipe, a baffle is arranged in the through pipe, a sealing ring is arranged at the outer edge of the baffle, the baffle is fixedly connected between the handle and the rotating shaft, the rotating shaft is rotatably connected between the side wall of the through pipe, and the handle is provided with a scale plate for observing the opening angle of the baffle.

[0012] In a specific implementation scheme, the packaging structure includes a first film winding roller and a second film winding roller, the first film winding roller is located at the front end of the second film winding roller, a feeding port is arranged between the first film winding roller and the second film winding roller, and the packaging film led out by the first film winding roller is located below the packaging film led out by the second film winding roller.

[0013] In a specific implementation scheme, two longitudinal sealers are arranged in front of the second film winding roller, and a transverse sealer is arranged between the two longitudinal sealers.

[0014] In a specific implementation scheme, the transverse sealer is provided with two groups, each group of the transverse sealer is provided with four rollers, the four rollers are arranged in pairs and symmetrically arranged in up and down, and a compaction roller is arranged between the two groups of transverse sealers.

[0015] In a specific implementation scheme, a collection roller for packaging the packaged raw material medicine into a roll is arranged in front of the frontmost longitudinal sealer.

[0016] The utility model has the advantages of:

[0017] An air circulation structure is introduced into the device, which includes a filtering structure, a circulating air pump, an air pipe, and an air volume damper for adjusting the air intake. This design enables the device to accurately adjust the air intake through the air volume damper according to the actual needs of the production environment, thereby maintaining the stability of air quality.

[0018] The filtering structure includes an outer shell and a two-stage filter cartridge, as well as a filter screen at the air intake of the circulating air pump. This multi-stage filtering design can more effectively remove microorganisms and pollutants from the air, ensuring the sterile state of the production environment.

[0019] The air volume damper achieves precise adjustment of the air intake through the cooperation of the handle and the air baffle. The scale plate on the handle allows the operator to intuitively understand the opening angle of the air baffle, thereby more accurately controlling the air intake.

[0020] The packaging structure includes a first film winding roller and a second film winding roller, as well as a feed inlet, a longitudinal sealing device, and a transverse sealing device. This design enables the bulk drug to be effectively packaged and packed during the production process, further ensuring the sterile quality of the product. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or prior art description. Obviously, the drawings in the following description are only embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of the provided drawings.

[0022] Figure 1 Structure diagram of the utility model without part of the shell;

[0023] Figure 2 Structure diagram of the filtering structure of the utility model;

[0024] Figure 3 Structure diagram of the air volume damper of the utility model;

[0025] Figure 4 Structure diagram of part of the structure of the utility model;

[0026] BRIEF DESCRIPTION OF DRAWINGS

[0027] 1, shell; 2, outer shell; 3, circulating air pump; 4, air pipe; 5, filter cartridge; 6, through pipe; 7, handle; 8, air baffle; 9, sealing ring; 10, scale plate; 11, shaft; 12, first film winding roller; 13, second film winding roller; 14, feed inlet; 15, longitudinal sealing device; 16, transverse sealing device; 17, roller; 18, compaction roller; 19, collection roller. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0029] Example 1

[0030] like Figures 1-3 As shown, a drug substance aseptic processing device includes a packaging structure, a cover 1 for sealing and isolating the packaging structure, and an air circulation structure installed on the upper part of the cover 1.

[0031] The cover 1 adopts a sealed design, which can effectively isolate pollutants in the external environment, provide a relatively closed and clean production environment for the production of raw materials, and further ensure the sterility quality of the product.

[0032] The air circulation structure includes a filtering structure installed on the upper part of the cover 1 and connected to the interior of the cover 1. The filtering structure includes a shell 2 and a filter element 5 installed in the shell 2. The filter element 5 is provided with two stages. The first-stage filter element 5 is HEPA grade. The material of the filter element 5 is usually selected from glass fiber, polytetrafluoroethylene (PTFE), polypropylene (PP), etc. It has extremely high filtering efficiency and can remove most of the tiny particles in the air. The second-stage filter element 5 is ULPA grade. The material of the filter element 5 is usually selected from ultrafine glass fiber. The filtering structure includes two-stage filter elements 5, the first stage is HEPA grade, and the second stage is ULPA grade, with high filtering efficiency. It can effectively remove microorganisms and pollutants in the air, ensuring the cleanliness and sterility of the production environment.

[0033] A filter is provided at the air inlet of the circulating air pump 3. When the external wind enters the filter structure, the large particles of impurities in the air are first removed through the filter.

[0034] The end of the filtering structure away from the cover shell 1 is connected to a circulating air pump 3, and the other end of the circulating air pump 3 is connected to the cover shell 1 through an air duct 4. The air duct 4 is connected to an air volume damper for adjusting the air intake volume. One end of the air volume damper is connected to the air duct 4, and the other end is connected to the external environment.

[0035] The air volume damper includes a through pipe 6 connected to the air duct 4, a turning handle 7 is provided on the outer wall of the through pipe 6, a wind shield 8 is provided inside the through pipe 6, and a sealing ring 9 is provided at the outer edge of the wind shield 8, the wind shield 8 is fixedly connected to the turning handle 7 through a rotating shaft 11, and the rotating shaft 11 is rotatably connected to the side wall of the through pipe 6, and the turning handle 7 is provided with a scale plate 10 for observing the opening and closing angle of the wind shield 8. The scale plate 10 is provided with scale numbers of 0-90. The rotation of the wind shield 8 is achieved by rotating the turning handle 7 to control the air intake. When the turning handle 7 is rotated to 0, the air intake of the external air is at the maximum state. When the turning handle 7 is rotated to 90, the air volume damper is in a closed state, and the air circulation structure is in an internal circulation mode.

[0036] The air volume damper features a flexible design, allowing easy adjustment of air volume by turning the knob 7. Operators can precisely adjust the air volume to meet the actual needs of the production environment to maintain stable air quality. Furthermore, the air volume damper's closed position enables the air circulation structure to maintain an internal circulation mode, further ensuring a sterile production environment.

[0037] Example 2

[0038] like Figures 1-3 As shown, the difference between this embodiment and the above embodiment lies in a more detailed description of the packaging structure, which includes a first film roll 12 and a second film roll 13. The first film roll 12 is located at the front end of the second film roll 13. A feed port 14 is provided between the first film roll 12 and the second film roll 13. The feed port 14 evenly lays the raw material between the packaging film output from the first film roll 12 and the second film roll 13 through an external feed pipeline. The packaging film output from the first film roll 12 is located below the packaging film output from the second film roll. The design of the first film roll 12 and the second film roll 13 enables a continuous and stable supply of packaging film, ensuring the packaging requirements of the API during the production process.

[0039] Two longitudinal sealers 15 are provided in front of the second film roll 13, and a transverse sealer 16 is provided between the two longitudinal sealers 15. A collecting roller 19 for packaging the encapsulated API into rolls is provided in front of the front longitudinal sealer 15. The encapsulating film passes through the middle position of each sealer and between each group of rollers 17 (refer to FIG. Figure 4 ) is finally wound on the collecting roller 19.

[0040] The transverse sealer 16 is provided with two groups, each group of the transverse sealer 16 is provided with four roller wheels 17, and the four roller wheels 17 are arranged in pairs and symmetrically up and down, and a compaction roller 18 is arranged between the two groups of the transverse sealer 16, and the compaction roller 18 is arranged symmetrically up and down, and the arrangement of the compaction roller 18 can ensure the close fit between the packaging film and the raw material, and improve the firmness of packaging. The up and down spacing between the roller wheels 17 of the two transverse sealers 16 can be adjusted up and down, and the prior art adopted will not be described in more detail.

[0041] The following are the comparative experimental results of the laboratory measured equipment prototype, and the actual mass production equipment has undergone a large number of debugging, and the optimal air intake and circulation mode are obtained through experiments, and the performance will be improved.

[0042] Control group (without air circulation structure): microbial contamination level 100 CFU / m 3 (colony forming units per cubic meter), particulate contamination level: 500,000 particles per cubic meter (0.5 μm and above), and 50 kg of raw material is processed per hour.

[0043] Experimental group (with air circulation structure): microbial contamination level 1 CFU / m 3 , particulate contamination level: 10,000 particles per cubic meter (0.5 μm and above), and 60 kg of raw material is processed per hour.

[0044] Result analysis:

[0045] Microbial contamination level reduction: The microbial contamination level of the experimental group is significantly lower than that of the control group, indicating that the HEPA and ULPA filters in the air circulation structure effectively remove the microorganisms in the air.

[0046] Particulate contamination level reduction: The particulate contamination level of the experimental group is also significantly lower than that of the control group, indicating that the air circulation structure improves the cleanliness of the production environment.

[0047] Finally, it should be noted that in this document, relational terms such as first and second and the like can only be used to distinguish one entity or action from another entity or action, without necessarily requiring or implying that there is any such actual relationship or order between these entities or actions. Moreover, the terms "comprising", "including" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus including a series of elements includes not only those elements, but also other elements not explicitly listed or inherent to such a process, method, article or apparatus. Without more limitations, the element defined by the statement "comprising a" does not exclude the presence of additional identical elements in the process, method, article or apparatus including the element.

[0048] The foregoing description of the disclosed embodiments enables a person skilled in the art to make or use the application. Modifications of these embodiments will occur to persons of skill in the art, and that the generic principles defined herein can be applied to other embodiments without departing from the spirit or scope of the application. Therefore, the present application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A bulk drug aseptic processing apparatus, characterized in that, The air circulation structure comprises a filter structure installed on the upper part of the cover shell (1) and connected with the inside of the cover shell (1), one end of the filter structure away from the cover shell (1) is connected and communicated with a circulating air pump (3), the other end of the circulating air pump (3) is connected and communicated with the cover shell (1) through an air pipe (4), and an air volume damper for adjusting the air inlet amount is arranged on the air pipe (4). The filter structure comprises an outer shell (2) and a filter core (5) installed in the outer shell (2), the filter core (5) is provided with two stages, and a filter screen is arranged at the air inlet of the circulating air pump (3).

2. A bulk drug aseptic processing apparatus as defined in claim 1, wherein, The air volume damper comprises a through pipe (6) connected with the air pipe (4), a handle (7) is arranged on the outer wall of the through pipe (6), a wind baffle (8) is arranged in the through pipe (6), a sealing ring (9) is arranged at the outer edge of the wind baffle (8), the wind baffle (8) is fixedly connected between the handle (7) and the rotating shaft (11), the rotating shaft (11) is rotatably connected between the side wall of the through pipe (6) and the handle (7), and the handle (7) is provided with a scale plate (10) for observing the opening angle of the wind baffle (8).

3. A bulk drug aseptic processing apparatus as defined in claim 1, wherein, The packaging structure comprises a first film winding roller (12) and a second film winding roller (13), the first film winding roller (12) is located at the front end of the second film winding roller (13), a feeding port (14) is arranged between the first film winding roller (12) and the second film winding roller (13), and the packaging film led out by the first film winding roller (12) is located below the packaging film led out by the second film winding roller.

4. The bulk drug aseptic processing apparatus of claim 1, wherein, Two longitudinal sealers (15) are arranged in front of the second film winding roller (13), and a transverse sealer (16) is arranged between the two longitudinal sealers (15).

5. A bulk pharmaceutical aseptic processing apparatus as defined in claim 4, wherein, The transverse sealer (16) is provided with two groups, each group of the transverse sealer (16) is provided with four roller wheels (17), the four roller wheels (17) are arranged in pairs and symmetrically above and below, and a compaction roller (18) is arranged between the two groups of the transverse sealer (16).

6. A bulk pharmaceutical aseptic processing apparatus as defined in claim 5, wherein, The front end of the longitudinal sealer (15) is provided with a collection roller (19) for packaging the packaged raw medicinal materials into a roll.

7. A bulk pharmaceutical aseptic processing apparatus as defined in claim 5, wherein, ​

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