A cleaning and sterilization method and device for a continuous blow-fill-seal apparatus

Abstract

The application discloses a cleaning and sterilizing method of a continuous blow-filling-sealing device. A sterilizing cup is connected with an extrusion die head and seals a gap at the connecting position. A filling needle is lowered and connected with a medium channel of the sterilizing cup and seals a gap at the connecting position. Cleaning medium flows into the medium channel from the filling needle. The filling needle is raised to connect the medium channel with a first channel in the extrusion die head. Sterilizing medium flows into the medium channel and the first channel from the filling needle. The sterilizing device of the continuous blow-filling-sealing device comprises an extrusion die head, a sterilizing cup detachably connected with the extrusion die head, and a filling needle arranged in the extrusion die head. A gap is formed between the filling needle and the extrusion die head to form a first channel. A first sealing element is arranged between the sterilizing cup and the extrusion die head. A medium outlet is arranged on the sterilizing cup. A medium channel is arranged on the sterilizing cup for the lower end of the filling needle to extend into. A fifth sealing element is arranged on the sterilizing cup to separate the first channel and the medium channel. The application is simple in operation and can avoid backflow of the cleaning medium into the inner cavity of the extrusion die head.

Description

Technical Field

[0001] This invention relates to food and pharmaceutical packaging equipment and methods of use, and more particularly to a cleaning and sterilization method and apparatus for a continuous blow-fill-seal equipment. Background Technology

[0002] Before production in a continuous blow-fill-seal equipment, the channels for the filling solution (including the connecting pipes between the solution tank and the filling needle, and components such as the filling needle itself) and the gas channel supporting the tube preform need to be sterilized and cleaned to ensure aseptic performance of the product. Traditional reciprocating blow-fill-seal equipment only sterilizes the channels for the filling solution, leaving unsterilized areas that fail to meet requirements. Therefore, current sterilization methods primarily employ multiple channels to sterilize both the filling solution channels and the tube preform support gas channel separately. This method is complex, costly, and requires precise needle placement: the needle must rise to avoid obstruction before the sterilization cup is in place, and then descend to insert into the cup afterward, making the process quite complex. To address this, patent document CN 115259051 A discloses a sterilization device for a continuous blow-fill-seal equipment. This device comprehensively sterilizes the filling liquid channel, the outer wall of the filling needle, the inner cavity of the extrusion die, the inner cavity of the filling needle sealing seat, the inner cavity of the filling needle seat, and the gas channel supporting the tube blank, providing aseptic protection. It eliminates the need for multiple channels, and the filling needle does not need to descend again after rising, resulting in a simple structure and low cost. However, when cleaning the filling needle, the cleaning medium is prone to backflow and erosion of the extrusion die's inner cavity, causing residue. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a cleaning and sterilization method for a continuous blow-fill-seal equipment that is simple to operate and can prevent the cleaning medium from flowing back into the inner cavity of the extrusion die.

[0004] The present invention further provides a cleaning and sterilization device for a continuous blow-fill-seal equipment that is simple in structure, low in cost, and can prevent the cleaning medium from flowing back into the inner cavity of the extrusion die.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0006] A cleaning and sterilization method for a continuous blow-fill-seal equipment includes S1, a cleaning process: the sterilization cup is connected to the extrusion die and the gap at the connection is sealed; the filling needle descends and connects with the medium channel of the sterilization cup and the gap at the connection is sealed; the cleaning medium flows from the filling needle into the medium channel.

[0007] S2. Sterilization process: The filling needle rises to connect the medium channel with the first channel inside the extrusion die, and the sterilization medium enters the medium channel and the first channel from the filling needle.

[0008] A cleaning and sterilization device for a continuous blow-fill-seal equipment includes an extrusion die, a sterilization cup detachably connected to the extrusion die, and a filling needle inserted into the extrusion die. The filling needle and the extrusion die have a gap to form a first channel. A first seal is provided between the sterilization cup and the extrusion die. The sterilization cup has a medium outlet. The sterilization cup also has a medium channel for the lower end of the filling needle to extend into and a fifth seal for separating the first channel from the medium channel.

[0009] As a further improvement to the above technical solution: both the lower end of the filling needle and the medium channel are conical structures, and the fifth sealing element is located at the conical structure of the medium channel.

[0010] As a further improvement to the above technical solution: the cleaning and sterilization device of the continuous blow-fill-seal equipment also includes a filling needle sealing seat located above the extrusion die head and a filling needle seat passing through the filling needle sealing seat. The filling needle seat is provided with a tube blank support gas channel and multiple filling needles. There is a gap between the filling needle sealing seat and the filling needle to form a second channel. There is a gap between the filling needle seat and the filling needle sealing seat to form a third channel. There is a gap between the filling needle and the filling needle seat to form a fourth channel.

[0011] As a further improvement to the above technical solution: a first temperature measuring component is provided at the medium outlet.

[0012] As a further improvement to the above technical solution: a second temperature measuring component is provided at one end of the tube blank support gas channel connected to the second channel, and a third temperature measuring component is provided at the other end of the tube blank support gas channel.

[0013] As a further improvement to the above technical solution: an air filter is provided between the second temperature measuring component and the third temperature measuring component.

[0014] As a further improvement to the above technical solution: a second sealing element is provided between the extrusion die head and the filling needle sealing seat, a third sealing element for sealing the filling needle seat is provided on the upper part of the filling needle sealing seat, and a fourth sealing element is provided between the upper part of the filling needle seat and the filling needle.

[0015] Compared with the prior art, the advantages of the present invention are as follows: In the sterilization method of the continuous blow-fill-seal equipment disclosed in this invention, during cleaning, the sterilization cup first connects with the extrusion die head and seals the seam. Then, the filling needle descends and connects with the medium channel of the sterilization cup and seals the seam, thereby isolating the medium channel from the first channel inside the extrusion die head. The cleaning medium enters the medium channel through the filling needle, completing the cleaning of the filling needle and the upstream connecting pipeline, while preventing the cleaning medium from flowing back into the first channel. During sterilization, the filling needle rises, connecting the medium channel with the first channel inside the extrusion die head. The cleaning medium can enter the medium channel and the first channel through the filling needle, ensuring complete and comprehensive sterilization. This provides excellent aseptic protection for the continuous blow-fill-seal equipment and helps improve product quality stability.

[0016] The sterilization device of the sterilization apparatus of the continuous blow-fill-seal equipment disclosed in this invention has the following features: during the cleaning process, the medium channel can accommodate the filling needle so that the filling needle can descend; the fifth sealing element can seal the gap between the filling needle and the medium channel, thereby isolating the medium channel from the first channel and preventing the cleaning medium from flowing back into the inner cavity of the extrusion die. The structure is simple and effective. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the sterilization device of the continuous blow-fill-seal equipment of the present invention.

[0018] Figure 2 This is a partially enlarged view of the sterilization device of the continuous blow-fill-seal equipment of the present invention in the cleaning state.

[0019] Figure 3 This is a partially enlarged view of the sterilization state of the sterilization device in the continuous blow-fill-seal equipment of the present invention.

[0020] Figure 4 yes Figure 2 Enlarged view of point A in the middle.

[0021] Figure 5 yes Figure 3 Enlarged view of point B in the middle.

[0022] Figure 6 This is a schematic diagram illustrating the principle of the cleaning process of this invention.

[0023] Figure 7 This is a schematic diagram illustrating the principle of the sterilization process of this invention.

[0024] Figure 8 yes Figure 7 A magnified view of a portion of the image.

[0025] The labels in the diagram represent:

[0026] 1. Filling needle sealing seat; 2. Extrusion die head; 3. Sterilization cup; 31. Media outlet; 32. Media channel; 4. Filling needle seat; 41. Tube blank support gas channel; 5. Filling needle; 61. First channel; 62. Second channel; 63. Third channel; 64. Fourth channel; 71. First temperature measuring component; 72. Second temperature measuring component; 73. Third temperature measuring component; 74. Air filter; 81. First seal; 82. Second seal; 83. Third seal; 84. Fourth seal; 85. Fifth seal; 9. Drug solution buffer tank. Detailed Implementation

[0027] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0028] Example 1

[0029] Figures 1 to 5 This invention illustrates an embodiment of the cleaning and sterilization device for a continuous blow-fill-seal equipment. The cleaning and sterilization device of this embodiment includes a needle sealing seat 1, an extrusion die 2 located below the needle sealing seat 1, a sterilization cup 3 detachably connected to the extrusion die 2, and a needle seat 4 inserted into the needle sealing seat 1. The needle seat 4 is provided with a tube blank support gas channel 41 and multiple needles 5. A gap exists between the needles 5 and the extrusion die 2 to form a first channel 61; a gap exists between the needle sealing seat 1 and the needles 5 to form a second channel 62; a gap exists between the needle seat 4 and the needle sealing seat 1 to form a third channel 63; and a gap exists between the needles 5 and the needle seat 4 to form a fourth channel 64. The sterilization cup 3 is provided with a medium channel 32 into which the lower end of the needles 5 extends, a fifth seal 85 for separating the medium channel 32 from the first channel 61, and a medium outlet 31 for discharging cleaning medium (e.g., cleaning water) and sterilization medium (e.g., sterilization steam) from the sterilization cup 3.

[0030] In this continuous blow-fill-seal equipment's cleaning and sterilization device, during cleaning, the sterilization cup 3 first aligns with the extrusion die 2 and seals the joint. Then, the filling needle 5 descends and aligns with the medium channel 32 of the sterilization cup 3, sealing the joint. This isolates the medium channel 32 from the first channel 61 inside the extrusion die 2. The cleaning medium enters the medium channel 32 through the filling needle 5, completing the cleaning of the filling needle 5 and the upstream connecting pipeline, while preventing the cleaning medium from flowing back into the first channel 61. During sterilization, the filling needle seat 4 drives each filling needle 5 to rise until the lower end of the filling needle 5 does not exceed the lower part of the extrusion die 2. The sterilization medium passes through the inner cavity of each filling needle 5 to reach the sterilization cup 3, and then flows back into the tube blank support gas channel 41 through the first channel 61, second channel 62, third channel 63, and fourth channel 64. This allows for the cleaning of channels for filling liquids (such as...). Figure 7As shown, the entire structure, including the drug buffer tank 9, the connecting pipeline between the drug buffer tank 9 and the filling needle seat 4, the inner cavity of the filling needle 5, the outer wall of the filling needle 5, the inner cavity of the extrusion die 2, the inner cavity of the filling needle sealing seat 1, the inner cavity of the filling needle seat 4, and the tube blank support gas channel 41, is thoroughly sterilized to provide aseptic protection. There is no need to set up multiple channels, and the filling needle 5 does not need to be lowered again after rising. Moreover, the structure is simple and the cost is low.

[0031] Furthermore, in this embodiment, the lower end of the filling needle 5 and the upper part of the medium channel 32 are both conical structures. The fifth sealing element 85 is located at the conical structure of the medium channel 32. After the filling needle 5 descends, it helps to ensure the sealing between the filling needle 5 and the medium channel 32. The structure is simple and reliable.

[0032] Furthermore, in this embodiment, a first temperature measuring component 71 (e.g., a temperature sensor) is provided at the medium outlet 31 of the sterilization cup 3. The sterilization medium flows out from the inner cavity of the filling needle 5 and into the sterilization cup 3. The first temperature measuring component 71 can measure the temperature of the sterilization medium entering the sterilization cup 3, thereby determining the sterilization effect on the channel for filling the medicine liquid.

[0033] Furthermore, in this embodiment, a second temperature measuring component 72 is provided at one end of the tube preform support gas channel 41 connected to the second channel 62, and a third temperature measuring component 73 is provided at the other end of the tube preform support gas channel 41. The second temperature measuring component 72 and the third temperature measuring component 73 can be, for example, temperature sensors. The temperature of the sterilization medium at both ends of the tube preform support gas channel 41 can be measured by the second temperature measuring component 72 and the third temperature measuring component 73, thereby determining the sterilization effect on the tube preform support gas channel 41. The structure is simple and has good reliability.

[0034] Furthermore, in this embodiment, an air filter 74 is provided between the second temperature measuring component 72 and the third temperature measuring component 73. During the production process of the continuous blow-fill-seal equipment, the external gas passes through the air filter 74 to ensure cleanliness. The clean gas enters the tube blank support gas channel 41, and then flows out from the lower part of the extrusion die 2 through the fourth channel 64, the third channel 63, the second channel 62 and the first channel 61, which helps to improve the tube blank forming quality.

[0035] Furthermore, in this embodiment, a first sealing element 81 is provided between the upper part of the sterilization cup 3 and the lower part of the extrusion die 2; a second sealing element 82 is provided between the upper part of the extrusion die 2 and the lower part of the filling needle sealing seat 1; a third sealing element 83 for sealing the filling needle seat 4 is provided on the upper part of the filling needle sealing seat 1; and a fourth sealing element 84 is provided between the upper part of the filling needle seat 4 and the filling needle 5. By providing the first sealing element 81, the second sealing element 82, the third sealing element 83, and the fourth sealing element 84, it is beneficial to ensure the sealing performance at the joints between components, allowing the sterilization medium and clean gas to flow along the set path and avoiding leakage.

[0036] In a preferred embodiment, the third sealing element 83 is an inflatable sealing ring. When the filling needle seat 4 is raised or lowered (during the filling process, the filling needle seat 4 needs to drive the filling needle 5 to rise or fall; during cleaning, the filling needle seat 4 needs to drive the filling needle 5 to fall and press the fifth sealing element 85; during sterilization, the filling needle seat 4 needs to drive the filling needle 5 to rise and avoid the sterilization cup 3), the inflatable sealing ring deflates and contracts, creating a gap between it and the filling needle seat 4 to prevent friction from generating particles; when the filling needle seat 4 does not need to be raised or lowered (during sterilization, after the filling needle seat 4 drives the filling needle 5 to rise to the position, it stops moving), the inflatable sealing ring inflates and expands, fitting tightly against the filling needle seat 4, which helps to ensure a static seal.

[0037] In a preferred embodiment, the fourth seal 84 is a sealing sleeve.

[0038] In a preferred embodiment, the first seal 81, the second seal 82, and the fifth seal 85 are O-rings.

[0039] Example 2

[0040] Figures 6 to 8 An embodiment of the cleaning and sterilization method of the continuous blow-fill-seal equipment of the present invention is shown. The cleaning and sterilization method of the continuous blow-fill-seal equipment of this embodiment includes S1, cleaning process: the sterilization cup 3 is connected to the extrusion die head 2 and the gap at the connection is sealed, the filling needle 5 is lowered and connected to the medium channel 32 of the sterilization cup 3 and the gap at the connection is sealed, and the cleaning medium flows from the filling needle 5 into the medium channel 32.

[0041] S2. Sterilization process: The filling needle 5 rises to connect the medium channel 32 with the first channel 61 in the extrusion die 2, and the sterilization medium enters the medium channel 32 and the first channel 61 from the filling needle 5.

[0042] The specific steps of the cleaning process are as follows:

[0043] The sterilization cup 3 rises and docks with the extrusion die 2, pressing the first seal 81 on the upper part of the sterilization cup 3 (in other embodiments, the first seal 81 may also be located at the lower part of the extrusion die 2), thereby sealing the gap at the docking point. Then, the filling needle 5 descends and extends into the medium channel 32 of the sterilization cup 3, pressing the fifth seal 85 on the upper part of the sterilization cup 3, thereby sealing the gap between the medium channel 32 and the filling needle 5, separating the medium channel 32 from the first channel 61. The cleaning medium flows from the filling needle 5 into the medium channel 32, and the cleaning medium in the sterilization cup 3 can be discharged through the medium outlet 31.

[0044] The specific steps of the sterilization process are as follows:

[0045] After cleaning is completed, the injection needle seat 4 drives each injection needle 5 to rise until the lower end of the injection needle 5 does not exceed the lower part of the extrusion die 2.

[0046] In the sterilization method of the continuous blow-fill-seal equipment of this embodiment, during cleaning, the sterilization cup 3 first mates with the extrusion die 2 and seals the joint. Then, the filling needle 5 descends and mates with the medium channel 32 of the sterilization cup 3 and seals the joint, thereby isolating the medium channel 32 from the first channel 61 inside the extrusion die 2. The cleaning medium enters the medium channel 32 through the filling needle 5, completing the cleaning of the filling needle 5 and the upstream connecting pipeline, while preventing the cleaning medium from flowing back into the first channel 61. The sterilization medium reaches the sterilization cup 3 through the inner cavity of each filling needle 5, and then flows in reverse through the first channel 61, the second channel 62, the third channel 63, and the fourth channel 64 into the tube blank support gas channel 41. The process is simple and convenient to operate. During the flow of the sterilization medium, the channels for filling the medicine liquid (such as...) can be cleaned. Figure 6 and Figure 7 As shown, the entire system, including the drug buffer tank 9, the connecting pipeline between the drug buffer tank 9 and the filling needle seat 4, the inner cavity of the filling needle 5, the outer wall of the filling needle 5, the inner cavity of the extrusion die 2, the inner cavity of the filling needle sealing seat 1, the inner cavity of the filling needle seat 4, and the tube blank support gas channel 41, undergoes comprehensive sterilization. This provides excellent aseptic protection for continuous blow-fill-seal equipment, which is beneficial to improving product quality stability. After the filling needle 5 rises, it does not need to descend again to its final position, simplifying the operation process.

[0047] In this embodiment, in step S2, the first temperature measuring component 71 measures the temperature of the sterilization medium at the sterilization medium outlet 31, and the second temperature measuring component 72 and the third temperature measuring component 73 measure the temperature of the sterilization medium at both ends of the tube blank support gas channel 41, respectively.

[0048] While the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the invention. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention, or modify them into equivalent embodiments, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the scope of the present invention, should fall within the protection scope of the present invention.

Claims

1. A cleaning and sterilization method for a continuous blow-fill-seal equipment, characterized in that: Including S1, cleaning process: the sterilization cup (3) is connected to the extrusion die (2) and the gap at the connection is sealed. The filling needle (5) descends and connects with the medium channel (32) of the sterilization cup (3) and the gap at the connection is sealed. The cleaning medium flows from the filling needle (5) into the medium channel (32). S2. Sterilization process: The filling needle (5) rises to connect the medium channel (32) with the first channel (61) in the extrusion die (2). The filling needle (5) passes through the extrusion die (2) and has a gap between it and the extrusion die (2) to form the first channel (61). The sterilization medium enters the medium channel (32) and the first channel (61) from the filling needle (5).

2. A cleaning and sterilization device for a continuous blow-fill-seal equipment, comprising an extrusion die (2), a sterilization cup (3) detachably connected to the extrusion die (2), and a filling needle (5) inserted into the extrusion die (2), wherein a gap exists between the filling needle (5) and the extrusion die (2) to form a first channel (61), a first sealing element (81) is provided between the sterilization cup (3) and the extrusion die (2), and a media outlet (31) is provided on the sterilization cup (3), characterized in that: The sterilization cup (3) is also provided with a medium channel (32) into which the lower end of the filling needle (5) extends, and a fifth sealing element (85) for separating the first channel (61) from the medium channel (32).

3. The cleaning and sterilization device for the continuous blow-fill-seal equipment according to claim 2, characterized in that: The lower end of the filling needle (5) and the medium channel (32) are both conical structures, and the fifth sealing element (85) is located at the conical structure of the medium channel (32).

4. The cleaning and sterilization device for the continuous blow-fill-seal equipment according to claim 2, characterized in that: It also includes a filling needle sealing seat (1) located above the extrusion die (2) and a filling needle seat (4) passing through the filling needle sealing seat (1). The filling needle seat (4) is provided with a tube blank support gas channel (41) and multiple filling needles (5). There is a gap between the filling needle sealing seat (1) and the filling needles (5) to form a second channel (62). There is a gap between the filling needle seat (4) and the filling needle sealing seat (1) to form a third channel (63). There is a gap between the filling needles (5) and the filling needle seat (4) to form a fourth channel (64).

5. The cleaning and sterilization device for the continuous blow-fill-seal equipment according to claim 4, characterized in that: The medium outlet (31) is provided with a first temperature measuring component (71).

6. The cleaning and sterilization device for the continuous blow-fill-seal equipment according to claim 5, characterized in that: The tube blank support gas channel (41) is connected to the second channel (62) at one end with a second temperature measuring component (72), and the tube blank support gas channel (41) is connected to a third temperature measuring component (73) at the other end.

7. The cleaning and sterilization device for the continuous blow-fill-seal equipment according to claim 6, characterized in that: An air filter (74) is provided between the second temperature measuring component (72) and the third temperature measuring component (73).

8. The cleaning and sterilization apparatus for a continuous blow-fill-seal equipment according to any one of claims 4 to 7, characterized in that: A second sealing element (82) is provided between the extrusion die (2) and the filling needle sealing seat (1), a third sealing element (83) for sealing the filling needle seat (4) is provided on the upper part of the filling needle sealing seat (1), and a fourth sealing element (84) is provided between the upper part of the filling needle seat (4) and the filling needle (5).

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