Ultra-clean sterile packaging workshop
Through the closed workshop design and sterile wind control system, the microbial pollution problems caused by air exchange and personnel entry and exit of the bacterial agent packaging workshop are solved, and an efficient sterile production environment is achieved, which reduces bacterial infection rate and improves production efficiency and reduces costs.
Patent Information
- Application Number
- CN202510648697.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-05-20
- Publication Date
- 2025-08-12
AI Technical Summary
The existing fungal agent packaging workshops have microbial pollution caused by frequent air exchange inside and outside the workshop and frequent personnel entry and exit, which affects the quality of fungal agent products.
The closed workshop is designed and equipped with a sterile air generator. The workshop is divided into multiple areas through closed partitions. The pressure difference acquisition module and control module are used to adjust the sterile air generator power. The sterile module is combined with the sterilization module to ensure the positive pressure environment in the closed workshop and reduce the impact of air exchange and personnel entry and exit.
It effectively reduces the impact of air exchange inside and outside the workshop and personnel entry and exit on the sterile production environment, improves the sterile production environment quality of bacterial agent products, reduces the bacterial infection rate and personnel operation risks, improves production efficiency and reduces costs.
Smart Images
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Abstract
Description
Technical Field
[0001] The present application relates to the field of aseptic production, and in particular to an ultra-clean aseptic packaging workshop. Background Art
[0002] In the production of microbial agents, a sterile production environment is crucial. Microbial agent products are widely used in a variety of industries, including healthcare, food, and agriculture. Their quality is directly related to human health, food safety, and the growth of crops. Contamination of microbial agents can lead to infections and serious health problems in the medical field; in the food industry, it can cause food spoilage and endanger consumer health; and in agriculture, it can affect crop growth, resulting in reduced or even complete crop failure.
[0003] To ensure the quality of microbial products, the sterility requirements for the production environment are extremely high. The production workshop must strictly control the number of microorganisms and maintain it at an extremely low level to prevent microbial contamination of the microbial products. Currently, existing microbial packaging workshops mostly use a combination of ultraviolet sterilization and semi-enclosed clean rooms. However, this seemingly conventional sterilization method has a series of drawbacks that cannot be ignored: The air inside and outside the workshop is continuously exchanged, and the infiltration of bacteria-laden air from the outside causes contamination: During the ventilation process of the workshop, air from the outside containing a large number of microorganisms continuously enters and mixes with the clean air inside the workshop, greatly increasing the risk of contamination of the microbial agent.
[0004] Frequent entry and exit of personnel, introduction of microbial contamination sources during operation: Due to the needs of production operations, staff frequently enter and exit the workshop. If they are not careful during operation, external microorganisms will be brought into the production environment, threatening the quality of microbial products. Summary of the Invention
[0005] The present application provides an ultra-clean sterile workshop, which can reduce the impact of air exchange inside and outside the workshop and the entry and exit of personnel on the production environment, and is conducive to improving the sterile production environment.
[0006] The ultra-clean aseptic packaging workshop provided by this application specifically adopts the following technical solutions: An ultra-clean aseptic packaging workshop comprises a closed workshop and a sterile wind generating device. An openable workshop door is arranged on one side of the closed workshop, and the sterile wind generating device is used to input sterile wind into the closed workshop.
[0007] By adopting the above technical solution, the impact of air exchange inside and outside the workshop and the entry and exit of personnel on the sterile production environment in the closed workshop can be reduced, so as to improve the sterile production environment.
[0008] Furthermore, the closed workshop has a personnel cleaning area, a personnel sterilization area, a first buffer area and a packaging machine area arranged in sequence; The personnel cleaning area is close to the workshop door, and closed partitions and openable workshop doors are arranged between the adjacent areas in the personnel cleaning area, the personnel sterilization area, the first buffer area and the packaging machine area; the sterile air is input into the packaging machine area.
[0009] Furthermore, the closed workshop further comprises a second buffer area, which is arranged on a side of the packaging machine area away from the first buffer area; A closed partition is arranged between the second buffer area and the packaging machine area.
[0010] Furthermore, it also includes a pressure difference acquisition module and a control module; The pressure difference acquisition module is used to collect pressure difference data inside and outside the closed workshop; The control module is connected to the pressure difference acquisition module and the sterile wind generating device, and is used to receive the pressure difference data, and control the sterile wind generating power of the sterile wind generating device according to the pressure difference data and a pre-acquired target pressure difference range.
[0011] Furthermore, it also includes an influencing factor collection module; The influencing factor collection module is used to collect influencing factor information, wherein the influencing factor information includes one or more of external environmental factors, personnel entry and exit frequency, and equipment load parameters; The control module is connected to the influencing factor acquisition module, receives the influencing factor information, and determines the target pressure difference range according to the influencing factor information.
[0012] Furthermore, the control module is configured to: Acquire the influencing factor information, wherein the influencing factor information includes external environmental factors, personnel entry and exit frequency, and equipment load parameters, and the external environmental factors include environmental pollution parameters, environmental temperature data, environmental humidity data, and environmental wind speed parameters; Calculating a factor influence score based on the influencing factor information, the factor influence score is positively correlated with the personnel entry and exit frequency, the equipment load parameter, the environmental pollution parameter, and the environmental wind speed parameter, and the factor influence score is positively correlated with the temperature difference data between the ambient temperature data and the preset temperature data, and the humidity difference data between the ambient humidity data and the preset humidity data; The target pressure difference range is calculated according to the factor influence score and a preset reference pressure difference range, and an upper limit and a lower limit of the target pressure difference range are both positively correlated with the factor influence score.
[0013] Furthermore, if the closed workshop has a personnel cleaning area, a personnel sterilization area, a first buffer area, and a packaging machine area arranged in sequence; the personnel cleaning area is close to the workshop door, and closed partitions and openable workshop doors are arranged between adjacent areas among the personnel cleaning area, the personnel sterilization area, the first buffer area, and the packaging machine area; An entry and exit attention coefficient is also configured for the personnel entry and exit frequency corresponding to each workshop door. The closer the workshop door is to the packaging machine area, the greater the entry and exit attention coefficient is.
[0014] Furthermore, the sterile air generating device includes a main fan and a backup fan.
[0015] Furthermore, the control module is configured to: If the pressure difference data exceeds the target pressure difference range for a preset period of time, an abnormal warning signal is generated.
[0016] Furthermore, it also includes a sterilization module configured in the closed workshop, the sterilization module is connected to the control module, and responds to the triggering of the abnormal warning signal.
[0017] In summary, this application has at least the following beneficial effects: An ultra-clean aseptic packaging workshop is provided, which can provide positive pressure aseptic air for the closed workshop, reduce the impact of air exchange inside and outside the workshop and personnel entry and exit on the aseptic production environment in the closed workshop, so as to improve the aseptic production environment; The personnel cleaning area, personnel sterilization area, first buffer area, packaging machine area and second buffer area are configured to isolate the packaging machine area from the external environment as much as possible, and clean and sterilize personnel entering and leaving, which is conducive to further improving the sterile production environment in the closed workshop; Controlling the sterile air generating power according to the internal and external pressure difference and influencing factor information is conducive to enabling the positive pressure sterile air to cope with the disturbance of various influencing factor information, and then further improving the sterile production environment of the closed workshop.
[0018] It should be understood that the contents described in the Summary of the Invention are not intended to limit the key or important features of the embodiments of the present application, nor are they intended to limit the scope of the present application. Other features of the present application will become readily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The above and other features, advantages and aspects of the embodiments of the present application will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings. In the accompanying drawings, the same or similar reference numerals represent the same or similar elements, wherein: Figure 1A schematic diagram of an ultra-clean aseptic packaging workshop in an embodiment of the present application is shown. DETAILED DESCRIPTION
[0020] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are 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.
[0021] In this document, the term "and / or" simply describes a relationship between related objects, indicating that three possible relationships exist. For example, "A and / or B" can represent: A exists alone, A and B exist simultaneously, or B exists alone. Furthermore, the character " / " in this document generally indicates that the related objects are in an "or" relationship.
[0022] The present application provides an ultra-clean aseptic packaging workshop, which can reduce the impact of air exchange inside and outside the workshop and the entry and exit of personnel on the production environment, and is conducive to improving the aseptic production environment.
[0023] Figure 1 A schematic diagram of an ultra-clean aseptic packaging workshop in an embodiment of the present application is shown.
[0024] Reference Figure 1 The ultra-clean aseptic packaging workshop includes a closed workshop and a sterile air generating device. An openable workshop door is provided on one side of the closed workshop. The sterile air generating device is used to input sterile air into the closed workshop.
[0025] Specifically, the closed workshop is a rectangular block as a whole, which is represented by a rectangular area in the figure. An openable workshop door is provided on the left side of the closed workshop. The sterile air generating device is used to input sterile air into the right side of the closed workshop. The packaging machine used for production is also arranged on the right side of the closed workshop.
[0026] Closed workshops must be as airtight as possible. When the sterile air generating device is activated, it can provide positive pressure sterile air for the closed workshop. When the closed workshop is closed, the positive pressure sterile air is mainly output to the external environment through the tiny gas exchange gaps in the closed workshop, which is conducive to avoiding the impact of gas exchange between the external environment and the closed workshop on the sterile production environment. When people enter and exit the closed workshop, the positive pressure sterile air can also be output to the external environment through the workshop door to overcome the airflow disturbance caused by the opening and closing of the workshop door and the entry and exit of people, which is conducive to avoiding the impact of the entry and exit of people on the sterile production environment.
[0027] To further improve the aseptic production environment, the closed workshop is divided into several areas via enclosed partitions. From left to right, these are the personnel clean area, the personnel sterilization area, the first buffer area, the packaging machine area, and the second buffer area. The personnel clean area is connected to the outside environment via a removable door. Furthermore, removable doors are also installed on the enclosed partitions between the personnel clean area and the personnel sterilization area, the personnel sterilization area and the first buffer area, and the first buffer area and the packaging machine area. Sterile air is supplied to the first buffer area, the packaging machine area, and the second buffer area.
[0028] During specific work, all workshop doors need to be closed. When entering a closed workshop, personnel must first open the outermost workshop door, and then open the next workshop door after closing the outermost workshop door. The same applies when continuing to enter or exit the closed workshop. Try to avoid opening multiple workshop doors at the same time to ensure that the packaging machine area in the closed workshop is relatively isolated from the external environment. The configuration of the personnel cleaning area and the personnel sterilization area is conducive to more comprehensive sterilization treatment for personnel entering the closed workshop, so as to improve the sterile production environment; the setting of the first buffer area can avoid the impact of the personnel sterilization area to a certain extent, and the second buffer area is conducive to avoiding the impact of the external environment on the packaging machine area, which is conducive to further improving the sterile production environment of the packaging machine area.
[0029] To ensure the proper speed of the positive pressure sterile air, the ultra-clean aseptic packaging workshop also includes a pressure differential acquisition module and a control module. The pressure differential acquisition module collects pressure differential data between the interior and exterior of the enclosed workshop. The control module connects the pressure differential acquisition module and the sterile air generator, controlling the sterile air generation power of the generator based on the pressure differential data to ensure the proper pressure differential between the interior and exterior of the enclosed workshop.
[0030] In a specific example, the control module can use PID control logic to control the sterile air generating power. Specifically, a target pressure difference range can be configured in the control module. When the pressure difference data exceeds the target pressure difference range, the sterile air generating power is adjusted so that the pressure difference data is adjusted to within the target pressure difference range.
[0031] Furthermore, the control module can use intelligent algorithms to control the sterile air generation power. The ultra-clean aseptic packaging workshop is equipped with an influencing factor collection module, which collects information on factors that affect the target pressure differential range, such as external environmental factors, personnel entry and exit frequency, and equipment load parameters. The control module connects to the influencing factor collection module, receives the influencing factor information, and determines the target pressure differential range based on the influencing factor information, thereby ensuring that the target pressure differential range can cope with various influencing factors.
[0032] In one example, the influencing factor information includes external environmental factors, personnel entry and exit frequency, and equipment load parameters. The external environmental factors include environmental pollution parameters, ambient temperature data, ambient humidity data, and ambient wind speed parameters. The control module calculates the factor impact score based on the influencing factor information. The factor impact score is positively correlated with the personnel entry and exit frequency, equipment load parameters, environmental pollution parameters, and ambient wind speed parameters. The factor impact score is positively correlated with the temperature difference data between the ambient temperature data and the preset temperature data, and the humidity difference data between the ambient humidity data and the preset humidity data. Finally, the target pressure difference range is calculated based on the factor impact score and the preset reference pressure difference range. The upper and lower limits of the target pressure difference range are both positively correlated with the factor impact score. Considering that known public technologies can realize the collection of the aforementioned external environmental factors, personnel entry and exit frequency, and equipment load parameters, for example, temperature and humidity sensors and anemometers are used to collect external environmental factors, environmental pollution parameters are evaluated according to public air quality information, and various equipment in a closed workshop (such as a packaging machine) are connected to collect their equipment load parameters. Human body sensors or cameras are used in conjunction with image recognition technology to determine the personnel entry and exit frequency of each workshop door, etc. The specific implementation method of the factor collection module will not be described here.
[0033] A specific method for calculating the factor impact score is to respectively determine the quantified frequency of personnel entry and exit, equipment load parameters, environmental pollution parameters and environmental wind speed parameters, and determine the temperature difference value between the ambient temperature data and the preset temperature data, where the temperature difference value is specifically equal to the absolute value of the ambient temperature data minus the preset temperature data, and determine the humidity difference value between the ambient humidity data and the preset humidity data, where the humidity difference value is specifically equal to the absolute value of the ambient humidity value minus the preset humidity data. Finally, the factor impact score is calculated by combining the frequency of personnel entry and exit, equipment load parameters, environmental pollution parameters, environmental wind speed parameters, temperature difference value and humidity difference value, and then the target pressure difference range is determined in combination with the reference pressure difference range.
[0034] For example, suppose the personnel entry and exit frequency, equipment load parameter, environmental pollution parameter, environmental wind speed parameter, temperature difference value, and humidity difference value are F, L, P, W, T, and H respectively, and the factor influence score is S. Assign a corresponding weight to each influencing factor. Suppose the personnel entry and exit frequency weight is , the equipment load parameter weight is , the environmental pollution parameter weight is , the weight of the ambient wind speed parameter is , the temperature difference value weight is , the humidity difference value weight is ,and ,but .
[0035] At this time, the target pressure difference range is determined in combination with the reference pressure difference range. The reference pressure difference range is set to , then the target pressure difference range The calculation formula is:
[0036] in It is an adjustment coefficient, which can be determined through experiments or experience according to actual workshop conditions. It is used to control the adjustment range of the impact score of the control factors on the target pressure difference range.
[0037] In the above example, an entry and exit attention coefficient can be configured for the frequency of personnel entry and exit of each workshop door. The closer the workshop door is to the packaging machine area, the larger the corresponding entry and exit attention coefficient. The overall personnel entry and exit frequency is expressed as the weighted sum of the personnel entry and exit frequencies at all workshop doors based on the entry and exit attention coefficients. The sum of the entry and exit attention coefficients of all workshop doors is equal to 1.
[0038] Of course, other methods can also be used to determine the target pressure differential range, such as pre-training a neural network model to determine the relationship between each influencing factor information and the target pressure differential range. These methods will not be listed here.
[0039] In order to further increase the reliability of the sterile air generating device, a main fan and a backup fan are configured for the sterile air generating device. The main fan works under normal circumstances. If the main fan has an abnormality, the backup fan is started. This is conducive to ensuring the reliability of the sterile air generating device.
[0040] When the pressure difference data continues to exceed the target pressure difference range for a preset period of time, it indicates that the pressure difference regulation has failed. At this time, the control module generates an abnormal warning signal, prompting relevant personnel to pay attention in time and perform inspection and maintenance on the ultra-clean aseptic packaging workshop.
[0041] To further increase the reliability of the ultra-clean aseptic packaging workshop, a sterilization module, such as an ultraviolet sterilization lamp, can also be configured in the closed workshop. When the pressure difference adjustment fails and an abnormal warning signal is generated, the control module can also automatically control the start-up of the sterilization module, or it can be combined with the strategy of regularly starting the ultraviolet sterilization lamp to further ensure the reliability of the sterile production environment.
[0042] In summary, this application has at least the following beneficial effects: An ultra-clean aseptic packaging workshop is provided, which can provide positive pressure aseptic air for the closed workshop, reduce the impact of air exchange inside and outside the workshop and personnel entry and exit on the aseptic production environment in the closed workshop, so as to improve the aseptic production environment; The personnel cleaning area, personnel sterilization area, first buffer area, packaging machine area and second buffer area are configured to isolate the packaging machine area from the external environment as much as possible, and clean and sterilize personnel entering and leaving, which is conducive to further improving the sterile production environment in the closed workshop; Controlling the sterile air generating power according to the internal and external pressure difference and influencing factor information is conducive to enabling the positive pressure sterile air to cope with the disturbance of various influencing factor information, and then further improving the sterile production environment of the closed workshop.
[0043] During normal operation of the sterile packaging workshop, the effectiveness of the sterile packaging workshop of this application was tested in accordance with national standards for the packaging machine area (or the first and second buffer areas). Specifically, according to the national standard GB / T16924, the test method for the detection of settling bacteria in pharmaceutical clean rooms, a 90mm diameter plate was tested within 30 minutes per unit space, with a count of ≤15 bacteria per plate. Compared to a conventional workshop (using the same test method, the test result was 30-300 bacteria per plate), the sterile environment of the sterile packaging workshop of this application was significantly improved.
[0044] Rhizobia are a product with a commercial value far exceeding that of spore-forming bacteria, reaching 300,000 to 500,000 yuan per ton. During shelf-life quality tracking of rhizobia products, it was discovered that equipment and environmental factors caused contamination during the packaging process. After contamination, the shelf life of the rhizobia bacteria did not exceed 35 days (the normal shelf life for products is at least 6 months), resulting in significant production losses.
[0045] To address the above-mentioned problem of bacterial contamination during the production and packaging of rhizobia, this application has renovated the packaging workshop space to provide an ultra-clean and sterile packaging workshop. The application of this ultra-clean and sterile packaging workshop in the production and filling of rhizobia products has the following advantages: (1) Reduce the infection rate Before the transformation, the contamination rate of finished filling products exceeded 90%; after the transformation, the contamination rate was below 5%, greatly reducing the packaging contamination rate from over 90% to below 5%, and increasing the product qualification rate to over 95%.
[0046] (2) Improve packaging efficiency Before the transformation, each batch was packaged within 12 hours; after the transformation, each batch was packaged within 10 hours, shortening the packaging time by 2 hours per batch, thus improving the packaging efficiency by 16.7%.
[0047] (3) Reduce labor costs Before the transformation, there were 3 operators in the entire packaging process; after the transformation, the number of operators in the entire packaging process was reduced to 1, reducing labor input by 66.7%.
[0048] (4) Reduce costs Before the transformation, the packaging contamination rate of each batch was over 90%, and the products could not be shipped out of the factory, resulting in a loss of 80,000 yuan in culture medium costs and 50,000 yuan in manufacturing costs, with a total loss of 130,000 yuan per batch. After the transformation, the contamination rate of each batch was below 5%, and the products could be shipped out normally. The total loss was controlled below 6,000 yuan per batch, and the loss was reduced by 124,000 yuan per batch, which is equivalent to a cost reduction of 124,000 yuan per batch.
[0049] The above description is merely an illustration of the preferred embodiments of the present application and the technical principles employed. Those skilled in the art should understand that the scope of disclosure in this application is not limited to the technical solutions formed by the specific combination of the above-mentioned technical features, but also encompasses other technical solutions formed by any combination of the above-mentioned technical features or their equivalents without departing from the aforementioned disclosed concepts. For example, a technical solution formed by replacing the above-mentioned features with (but not limited to) technical features with similar functions disclosed in this application.
Claims
1. An ultra-clean aseptic packaging workshop, characterized in that: It includes a closed workshop and a sterile air generating device. An openable workshop door is provided on one side of the closed workshop. The sterile air generating device is used to input sterile air into the closed workshop.
2. The ultra-clean aseptic packaging workshop according to claim 1, characterized in that: The closed workshop has a personnel cleaning area, a personnel sterilization area, a first buffer area and a packaging machine area arranged in sequence; The personnel cleaning area is close to the workshop door, and closed partitions and openable workshop doors are arranged between the adjacent areas in the personnel cleaning area, the personnel sterilization area, the first buffer area and the packaging machine area; the sterile air is input into the packaging machine area.
3. The ultra-clean aseptic packaging workshop according to claim 2, characterized in that: The closed workshop further comprises a second buffer area, which is arranged on a side of the packaging machine area away from the first buffer area; A closed partition is arranged between the second buffer area and the packaging machine area.
4. The ultra-clean aseptic packaging workshop according to any one of claims 1 to 3, characterized in that: It also includes a pressure difference acquisition module and a control module; The pressure difference acquisition module is used to collect pressure difference data inside and outside the closed workshop; The control module is connected to the pressure difference acquisition module and the sterile wind generating device, and is used to receive the pressure difference data, and control the sterile wind generating power of the sterile wind generating device according to the pressure difference data and a pre-acquired target pressure difference range.
5. The ultra-clean aseptic packaging workshop according to claim 4, characterized in that: It also includes an influencing factor collection module; The influencing factor collection module is used to collect influencing factor information, wherein the influencing factor information includes one or more of external environmental factors, personnel entry and exit frequency, and equipment load parameters; The control module is connected to the influencing factor acquisition module, receives the influencing factor information, and determines the target pressure difference range according to the influencing factor information.
6. The ultra-clean aseptic packaging workshop according to claim 5, characterized in that: The control module is configured to: Acquire the influencing factor information, wherein the influencing factor information includes external environmental factors, personnel entry and exit frequency, and equipment load parameters, and the external environmental factors include environmental pollution parameters, environmental temperature data, environmental humidity data, and environmental wind speed parameters; Calculating a factor influence score based on the influencing factor information, the factor influence score is positively correlated with the personnel entry and exit frequency, the equipment load parameter, the environmental pollution parameter, and the environmental wind speed parameter, and the factor influence score is positively correlated with the temperature difference data between the ambient temperature data and the preset temperature data, and the humidity difference data between the ambient humidity data and the preset humidity data; The target pressure difference range is calculated according to the factor influence score and a preset reference pressure difference range, and an upper limit and a lower limit of the target pressure difference range are both positively correlated with the factor influence score.
7. The ultra-clean aseptic packaging workshop according to claim 6, characterized in that: If the closed workshop has a personnel cleaning area, a personnel sterilization area, a first buffer area, and a packaging machine area arranged in sequence; the personnel cleaning area is close to the workshop door, and closed partitions and openable workshop doors are arranged between adjacent areas among the personnel cleaning area, the personnel sterilization area, the first buffer area, and the packaging machine area; An entry and exit attention coefficient is also configured for the personnel entry and exit frequency corresponding to each workshop door. The closer the workshop door is to the packaging machine area, the greater the entry and exit attention coefficient is.
8. The ultra-clean aseptic packaging workshop according to any one of claims 1 to 3, characterized in that: The sterile air generating device includes a main fan and a backup fan.
9. The ultra-clean aseptic packaging workshop according to claim 4, characterized in that: The control module is configured to: If the pressure difference data exceeds the target pressure difference range for a preset period of time, an abnormal warning signal is generated.
10. The ultra-clean aseptic packaging workshop according to claim 4, characterized in that: It also includes a sterilization module configured in the closed workshop, which is connected to the control module and operates in response to the triggering of the abnormal warning signal.