A sterilization detection system for a BFS aseptic filling plant

Abstract

This invention discloses a sterilization detection system for a BFS aseptic filling equipment, comprising a filling mechanism, a forming mold, a sterilization cup, and an air supply mechanism. The sterilization cup is connected below the forming mold. Liquid in the filling mechanism passes through the forming mold to reach the sterilization cup. The air supply mechanism is connected to the forming mold via an air inlet pipe and is used to provide supporting gas to the sterilization cup. The sterilization cup discharges gas through an air outlet pipe. The sterilization detection system also includes a particle detection mechanism, which is installed on the air inlet pipe and / or the air outlet pipe and is used to detect the content of dust particles in the gas inside the sterilization cup. The sterilization detection system of this invention for the BFS aseptic filling equipment, by setting a particle detection mechanism on the air outlet pipe, can perform online detection of the dust particle content of the supporting air inside the sterilization detection system before production, during production intervals, and after production. The supporting air sampled for detection follows the same path as the supporting air during actual production, resulting in sampling results closer to the true value.

Description

Technical Field

[0001] This invention relates to the field of food and pharmaceutical packaging machinery and equipment technology, specifically to a sterilization detection system for BFS aseptic filling equipment. Background Technology

[0002] Continuous BFS aseptic filling systems perform filling inside a closed preform, with the filling area surrounded by supporting air. This area uses sterile, filtered compressed air, which is piped into the preform. Annex 1 of the 2022 EU GMP, "Production of Sterile Pharmaceuticals," states that "for rotary equipment used for aseptic filling, the packaging material is typically sealed off from the environment once formed, and the design and maintenance of the filling environment within the packaging material should meet Class A requirements for both static and dynamic microbial and suspended particle counts." During aseptic production, the preform remains closed. Existing filling systems typically use particle detection devices inside laminar flow hoods or sterile filters to sample dust particles from within these hoods or filters, but they cannot perform online detection of the dust particle content in the air inside the preform (i.e., the supporting air). Summary of the Invention

[0003] To address the problems existing in the use of the prior art, this invention provides a sterilization detection system for BFS aseptic filling equipment that is simple in structure, reliable, and provides accurate and precise sampling results.

[0004] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0005] A sterilization detection system for a BFS aseptic filling equipment includes a filling mechanism, a forming mold, a sterilization cup, and a gas supply mechanism. The sterilization cup is connected below the forming mold. Liquid in the filling mechanism passes through the forming mold to reach the sterilization cup. The gas supply mechanism is connected to the forming mold through an air inlet pipe and is used to provide supporting gas to the sterilization cup. The sterilization cup discharges gas through an air outlet pipe. The sterilization detection system also includes a particle detection mechanism, which is disposed on the air inlet pipe and / or the air outlet pipe and is used to detect the content of gas dust particles in the sterilization cup.

[0006] As a further improvement to the above technical solution:

[0007] The particle detection mechanism includes a particle counter, a first filter, and a three-way valve. One end of the three-way valve is connected to the air outlet pipe and / or the air inlet pipe, and the other two ends are connected to the particle counter and the first filter, respectively.

[0008] The sterilization detection system further includes a first control mechanism, which includes a heat exchanger disposed on the air outlet pipe between the particle detection mechanism and the sterilization cup.

[0009] The first control mechanism further includes a first temperature detection element, which is disposed on the outlet pipe between the heat exchanger and the particle detection mechanism.

[0010] The sterilization detection system also includes a fifth pipeline and a sixth pipeline. The fifth pipeline is connected between the air inlet pipeline and the particle detection mechanism, and the sixth pipeline is connected between the air outlet pipeline and the particle detection mechanism. The fifth pipeline and the sixth pipeline are respectively equipped with a second valve and a first valve that can be opened and closed.

[0011] The gas supply mechanism includes a gas source and a second filter. The supporting gas from the gas source enters the air inlet pipe through the second filter and reaches the sterilization cup. A third valve that can be opened and closed is provided on the pipe between the gas source and the second filter. A fourth valve that can be opened and closed is provided on the pipe between the second filter and the molding mold.

[0012] The sterilization detection system also includes a first drainage pipe, a second drainage pipe, and a main pipe. The first drainage pipe is connected to the pipe located between the fourth valve and the molding die, and the second drainage pipe is connected to the pipe located between the third valve and the second filter.

[0013] The sterilization detection system further includes a pipeline control mechanism installed on the first condensate drain pipe and / or the second condensate drain pipe and / or the vent pipe. The pipeline control mechanism includes a fifth valve, a second temperature sensor, and a condensate drain valve arranged sequentially along the fluid flow direction.

[0014] The pipeline control mechanism located in the gas outlet pipeline is positioned downstream of the particle detection mechanism.

[0015] The filling mechanism includes a buffer tank, a filling head, and a filling needle connected in sequence. The filling needle passes through a molding die and is connected to the sterilization cup. The liquid in the buffer tank enters the filling head and is then filled into the sterilization cup by the filling needle.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0017] The sterilization detection system of the BFS aseptic filling equipment of the present invention, by setting a particle detection mechanism on the air outlet or air inlet pipe, can perform online detection of the dust particle content of the supporting air inside the sterilization detection system before production, during production intervals, and after production. The structure is simple and reliable. By setting a sterilization cup below the forming mold, and the sterilization cup being connected to the particle detection mechanism, the system is in a closed state during detection, resulting in accurate sampling results. The supporting air for sampling and detection follows the same path as the supporting air during actual production, making the sampling results closer to the true value and accurate. Attached Figure Description

[0018] Figure 1This is a schematic diagram of the initial state structure of the sterilization detection system of the BFS aseptic filling equipment of the present invention.

[0019] Figure 2 This is a schematic diagram of the sterilization status structure of Embodiment 1 in the sterilization detection system of the BFS aseptic filling equipment of the present invention.

[0020] Figure 3 This is a schematic diagram of the sampling and detection state structure in the sterilization detection system of the BFS aseptic filling equipment of the present invention, according to Embodiment 1.

[0021] Figure 4 This is a schematic diagram of the initial state structure of the sterilization detection system of the BFS aseptic filling equipment of the present invention, in embodiment two.

[0022] Figure 5 This is a schematic diagram of the sterilization state structure in Embodiment 2 of the sterilization detection system of the BFS aseptic filling equipment of the present invention.

[0023] Figure 6 This is a schematic diagram of the sampling and detection status structure in Embodiment 2 of the sterilization detection system of the BFS aseptic filling equipment of the present invention.

[0024] Figure 7 This is a schematic diagram of the initial state structure of the sterilization detection system of the BFS aseptic filling equipment of the present invention, in embodiment three.

[0025] Figure 8 This is a schematic diagram of the sterilization status structure in Embodiment 3 of the sterilization detection system of the BFS aseptic filling equipment of the present invention.

[0026] Figure 9 This is a schematic diagram of the sampling and detection state structure in the sterilization detection system of the BFS aseptic filling equipment of the present invention, according to Example 3.

[0027] Figure 10 This is another structural schematic diagram of the sampling and detection state in the sterilization detection system of the BFS aseptic filling equipment of the present invention, according to Embodiment 3.

[0028] Legend: 1. Filling mechanism; 11. Buffer tank; 12. Filling head; 13. Filling needle; 2. Molding mold; 3. Sterilization cup; 4. First control mechanism; 41. First temperature detection element; 42. Heat exchanger; 5. Gas supply mechanism; 51. Second filter; 52. Gas source; 6. Particle detection mechanism; 61. Particle counter; 62. First filter; 63. Three-way valve; 71. First valve; 72. Second valve; 73. Third valve; 74. Fourth valve; 81. Gas outlet pipeline; 82. Gas inlet pipeline; 83. First drain pipeline; 84. Second drain pipeline; 85. Fifth pipeline; 86. Sixth pipeline; 87. Main pipeline; 9. Pipeline control mechanism; 91. Fifth valve; 92. Second temperature detection element; 93. Drain valve. Detailed Implementation

[0029] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0030] In the description of this invention, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and 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. Therefore, they should not be construed as limitations on this invention.

[0031] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0032] In this invention, unless otherwise explicitly specified and limited, the terms "assembly," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0033] Example 1:

[0034] like Figures 1 to 3As shown, the sterilization detection system of the BFS aseptic filling equipment in this embodiment includes a filling mechanism 1, a forming mold 2, a sterilization cup 3, and an air supply mechanism 5. The sterilization cup 3 is connected to the bottom of the forming mold 2. The liquid in the filling mechanism 1 passes through the forming mold 2 and reaches the sterilization cup 3. The air supply mechanism 5 is connected to the forming mold 2 through an air inlet pipe 82 and is used to provide supporting gas to the sterilization cup 3. The sterilization cup 3 discharges gas through an air outlet pipe 81. The sterilization detection system also includes a particle detection mechanism 6, which is disposed on the air outlet pipe 81 and is used to detect the content of gas dust particles in the sterilization cup 3.

[0035] In this embodiment, the sterilization and detection system of the BFS aseptic filling equipment operates as follows: During production, the liquid medicine enters the molding mold 2 from the filling mechanism 1, and the supporting air enters from the air supply mechanism 5, passes through the air inlet pipe 82, and reaches the molding mold 2 to blow-mold and fill the preform (not shown in the figure) below the molding mold 2; During sterilization, steam enters from the filling mechanism 1, passes through the sterilization cup 3, the molding mold 2, and the air inlet pipe 82 in sequence, and reaches the air supply mechanism 5 to sterilize the various components and pipes of the system; During sampling and testing, the supporting air enters from the air supply mechanism 5, passes through the air supply mechanism 5, the air inlet pipe 82, the molding mold 2, the sterilization cup 3, and the air outlet pipe 81 in sequence, and finally reaches the particle detection mechanism 6 to detect dust particles. The sterilization detection system of the BFS aseptic filling equipment in this embodiment, by setting a particle detection mechanism 6 on the air outlet pipe 81, can perform online detection of the dust particle content of the supporting air inside the sterilization detection system after production. The structure is simple and reliable. By setting a sterilization cup 3 below the molding mold 2, and the sterilization cup 3 is connected to the particle detection mechanism 6, the system is in a closed state during detection, and the sampling results are accurate. The supporting air for sampling and detection has the same path as the supporting air during actual production, and the sampling results are closer to the true value, so the sampling results are accurate.

[0036] In this embodiment, the sterilization cup 3 is installed on the lower surface of the molding mold 2 and sealed by a sealing ring.

[0037] Furthermore, in this embodiment, the particle detection mechanism 6 includes a particle counter 61, a first filter 62, and a three-way valve 63. One end of the three-way valve 63 is connected to the exhaust pipe 81, and the other two ends are connected to the particle counter 61 and the first filter 62, respectively. During sterilization, the valve connected to the exhaust pipe 81 of the three-way valve 63 is closed, and the particle counter 61 is not sterilized. During sampling and testing, the valves connected to the exhaust pipe 81 and the particle counter 61 of the three-way valve 63 are opened, and the valve connected to the first filter 62 of the three-way valve 63 is closed for dust particle detection. After sampling and testing, the valve connected to the first filter 62 of the three-way valve 63 is opened, and the first filter 62 is connected to the atmosphere, which can eliminate the residual vacuum in the particle counter 61 after sampling.

[0038] Furthermore, in this embodiment, the sterilization detection system also includes a first control mechanism 4, which includes a heat exchanger 42. The heat exchanger 42 is disposed on the air outlet pipe 81 between the particle detection mechanism 6 and the sterilization cup 3. Since the supporting air is heated after passing through the high-temperature molding die 2, the temperature after being blown out reaches 40-50°C. During sampling and testing, circulating cooling water is passed through the heat exchanger 42 to lower the temperature of the supporting air to below 40°C for sampling and testing, thereby avoiding damage to the particle counter 61. The heat exchanger 42 is a pipe heat exchanger.

[0039] Furthermore, in this embodiment, the first control mechanism 4 also includes a first temperature detection element 41, which is disposed on the air outlet pipe 81 between the heat exchanger 42 and the particle detection mechanism 6. By setting the first temperature detection element 41, the heat exchanger 42 can more accurately control the temperature of the supporting air.

[0040] Furthermore, in this embodiment, the gas supply mechanism 5 includes a gas source 52 and a second filter 51. The supporting gas from the gas source 52 passes through the second filter 51 and enters the air inlet pipe 82 to reach the sterilization cup 3. A third valve 73 that can be opened and closed is provided on the pipe between the gas source 52 and the second filter 51, and a fourth valve 74 that can be opened and closed is provided on the pipe between the second filter 51 and the molding mold 2. During production and sampling testing, the third valve 73 and the fourth valve 74 are opened, and the supporting gas enters the air inlet pipe 82 from the gas source 52 through the second filter 51. During sterilization, the fourth valve 74 is opened and the third valve 73 is closed, which can sterilize the second filter 51, resulting in a high sterilization coverage.

[0041] Furthermore, in this embodiment, the sterilization detection system also includes a first drain pipe 83, a second drain pipe 84, and a main pipe 87. One end of the first drain pipe 83 and the second drain pipe 84 are connected in parallel to the main pipe 87. The other end of the first drain pipe 83 is connected to the pipe located between the fourth valve 74 and the molding die 2. The other end of the second drain pipe 84 is connected to the pipe located between the third valve 73 and the second filter 51. By setting the first drain pipe 83 and the second drain pipe 84, during sterilization, the steam passing through the air inlet pipe 82 and the second filter 51 can be discharged from the main pipe 87 through the first drain pipe 83 and the second drain pipe 84.

[0042] Furthermore, in this embodiment, the sterilization detection system also includes a pipeline control mechanism 9 installed on the first condensate drain pipe 83, the second condensate drain pipe 84, and the exhaust pipe 81. The pipeline control mechanism 9 includes a fifth valve 91, a second temperature sensor 92, and a condensate trap 93 arranged sequentially along the fluid flow direction. By setting up the pipeline control mechanism 9, during steam sterilization, condensate in the steam in the exhaust pipe 81, the first condensate drain pipe 83, and the second condensate drain pipe 84 can be discharged in a timely manner according to temperature changes, preventing condensate accumulation and avoiding pipe corrosion or reduced heating efficiency.

[0043] In this embodiment, the first temperature detection element 41 and the second temperature detection element 92 are temperature sensors, and the first valve 71, the second valve 72, the third valve 73 and the fourth valve 74 are all pneumatic diaphragm valves.

[0044] Furthermore, in this embodiment, the pipeline control mechanism 9 located on the exhaust pipe 81 is positioned downstream of the particle detection mechanism 6. Positioning the pipeline control mechanism 9 downstream of the particle detection mechanism 6 on the exhaust pipe 81 facilitates the passage of steam through a longer pipeline, thereby improving the sterilization effect.

[0045] Furthermore, in this embodiment, the filling mechanism 1 includes a buffer tank 11, a filling head 12, and a filling needle 13 connected in sequence. The filling needle 13 passes through the molding die 2 and is connected to the sterilization cup 3. The liquid in the buffer tank 11 enters the filling head 12 and is then filled into the sterilization cup 3 by the filling needle 13. During production, the medicine is transported from the buffer tank 11 to the filling head 12, and after being diverted by the filling head 12, it enters the filling needle 13, and then is filled into the sterilization cup 3 from the filling needle 13, thus realizing the filling of the medicine.

[0046] Example 2:

[0047] like Figures 4 to 6 As shown, the second embodiment of the sterilization detection system of the BFS aseptic filling equipment of the present invention is basically the same as that in the first embodiment, except that: the particle detection mechanism 6 is set on the air inlet pipe 82, and one end of the three-way valve 63 is connected to the air inlet pipe 82.

[0048] In this embodiment, the particle detection mechanism 6 is installed on the air inlet pipe 82, located at the front end of the molding die 2. Since the air here is not heated by the molding die 2, it can be directly connected to the particle detection mechanism 6 for detection, without the need to install an additional heat exchanger 42 to reduce the temperature.

[0049] The sterilization detection system of the BFS aseptic filling equipment in this embodiment, by setting a particle detection mechanism 6 on the air inlet pipe 82, can detect the content of dust particles in the supporting air inside the sterilization detection system online before production and during production intervals. The structure is simple and reliable.

[0050] Example 3:

[0051] like Figures 7 to 10 As shown, the third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the present invention is basically the same as that of the first embodiment, except that: the particle detection mechanism 6 is disposed on the air inlet pipe 82 and the air outlet pipe 81, one end of the three-way valve 63 is connected to the air outlet pipe 81 and the air inlet pipe 82, and the sterilization detection system also includes a fifth pipe 85 and a sixth pipe 86. The fifth pipe 85 is connected between the air inlet pipe 82 and the particle detection mechanism 6, and the sixth pipe 86 is connected between the air outlet pipe 81 and the particle detection mechanism 6. The fifth pipe 85 and the sixth pipe 86 are respectively provided with a second valve 72 and a first valve 71 that can be opened and closed.

[0052] The sterilization detection system of the BFS aseptic filling equipment in this embodiment, by setting a fifth pipeline 85 and a sixth pipeline 86, allows the particle detection mechanism 6 to be simultaneously connected to the air inlet pipeline 82 and the air outlet pipeline 81. By controlling the second valve 72 and the first valve 71 to switch the particle detection mechanism 6 to be connected to the air inlet pipeline 82 or the air outlet pipeline 81, it is possible to realize online detection of the dust particle content of the supporting air inside the sterilization detection system before production, during production intervals, and after production. The system has a simple structure, is reliable, and has strong adaptability.

[0053] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention using the methods and techniques disclosed above, or modify them into equivalent embodiments with equivalent changes, without departing from the spirit and technical essence of the present invention. Therefore, any simple modifications, equivalent substitutions, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solutions of the present invention shall still fall within the protection scope of the technical solutions of the present invention.

Claims

1. A sterilization detection system of a BFS aseptic filling device, comprising a filling mechanism (1), a forming die (2), a sterilization cup (3) and a gas supply mechanism (5), the sterilization cup (3) is connected below the forming die (2), the liquid in the filling mechanism (1) reaches the sterilization cup (3) through the forming die (2), the gas supply mechanism (5) is communicated with the forming die (2) through a gas inlet pipeline (82) and is used for providing support gas to the sterilization cup (3), and the sterilization cup (3) discharges gas through a gas outlet pipeline (81), characterized in that: The sterilization detection system also includes a particle detection mechanism (6), which is installed on the air inlet pipe (82) and the air outlet pipe (81) and is used to detect the content of dust particles in the supporting gas inside the sterilization cup (3). ​ 2. The sterilization detection system for the BFS aseptic filling equipment according to claim 1, characterized in that: The particle detection mechanism (6) includes a particle counter (61), a first filter (62) and a three-way valve (63). One end of the three-way valve (63) is connected to the outlet pipe (81) and / or the inlet pipe (82), and the other two ends are connected to the particle counter (61) and the first filter (62) respectively.

3. The sterilization detection system for the BFS aseptic filling equipment according to claim 1, characterized in that: The sterilization detection system further includes a first control mechanism (4), which includes a heat exchanger (42) and is located on the air outlet pipe (81) between the particle detection mechanism (6) and the sterilization cup (3).

4. The sterilization detection system for the BFS aseptic filling equipment according to claim 3, characterized in that: The first control mechanism (4) further includes a first temperature detection element (41), which is disposed on the outlet pipe (81) between the heat exchanger (42) and the particle detection mechanism (6).

5. The sterilization detection system for the BFS aseptic filling equipment according to claim 3, characterized in that: The sterilization detection system also includes a fifth pipeline (85) and a sixth pipeline (86). The fifth pipeline (85) is connected between the air inlet pipeline (82) and the particle detection mechanism (6). The sixth pipeline (86) is connected between the air outlet pipeline (81) and the particle detection mechanism (6). The fifth pipeline (85) and the sixth pipeline (86) are respectively provided with a second valve (72) and a first valve (71) that can be opened and closed.

6. The sterilization detection system for the BFS aseptic filling equipment according to any one of claims 1 to 5, characterized in that: The gas supply mechanism (5) includes a gas source (52) and a second filter (51). The supporting gas of the gas source (52) enters the air inlet pipe (82) through the second filter (51) and reaches the sterilization cup (3). A third valve (73) that can be opened and closed is provided on the pipe between the gas source (52) and the second filter (51). A fourth valve (74) that can be opened and closed is provided on the pipe between the second filter (51) and the molding die (2).

7. The sterilization detection system for the BFS aseptic filling equipment according to claim 6, characterized in that: The sterilization detection system also includes a first drainage pipe (83), a second drainage pipe (84) and a main pipe (87). The first drainage pipe (83) is connected to the pipe located between the fourth valve (74) and the molding die (2), and the second drainage pipe (84) is connected to the pipe located between the third valve (73) and the second filter (51).

8. The sterilization detection system for the BFS aseptic filling equipment according to claim 7, characterized in that: The sterilization detection system further includes a pipeline control mechanism (9) installed on the first condensate drain (83) and / or the second condensate drain (84) and / or the vent pipe (81), the pipeline control mechanism (9) including a fifth valve (91), a second temperature sensor (92) and a condensate drain (93) arranged sequentially along the fluid flow direction.

9. The sterilization detection system for the BFS aseptic filling equipment according to claim 8, characterized in that: The pipeline control mechanism (9) located in the gas outlet pipeline (81) is positioned downstream of the particle detection mechanism (6).

10. The sterilization detection system for the BFS aseptic filling equipment according to any one of claims 1 to 5, characterized in that: The filling mechanism (1) includes a buffer tank (11), a filling head (12) and a filling needle (13) connected in sequence. The filling needle (13) passes through the molding die (2) and is connected to the sterilization cup (3). The liquid in the buffer tank (11) enters the filling head (12) and is then filled into the sterilization cup (3) by the filling needle (13).

Images