Sterilization detection system of BFS sterile filling equipment

Abstract

The utility model discloses a sterilization detection system of BFS sterile filling equipment, which comprises a filling mechanism, a forming die, a sterilization cup and an air supply mechanism, the sterilization cup is connected below the forming die, and liquid in the filling mechanism penetrates through the forming die to reach the inside of the sterilization cup. The gas supply mechanism is communicated with the forming mold through a gas inlet pipeline and is used for providing supporting gas for the sterilization cup, the sterilization cup is used for discharging gas through a gas outlet pipeline, and the particle detection mechanism is arranged on the gas inlet pipeline and / or the gas outlet pipeline and is used for detecting the content of gas dust particles in the sterilization cup. According to the sterilization detection system of the BFS sterile filling equipment disclosed by the utility model, the particle detection mechanism is arranged on the air outlet pipeline, so that the content of dust particles in supporting air in the sterilization detection system can be detected on line before production, during production and after production; the sampling detection support air has the same path as the support air in actual production, and the sampling result is closer to the real value.

Description

Technical Field

[0001] The utility model relates to the technical field of food and medicine packaging machinery and equipment, in particular to a sterilization detection system for BFS aseptic filling equipment. Background Art

[0002] The continuous BFS (Blow-Fill-Seal) aseptic filling system performs filling inside a closed preform. The filling area is surrounded by supporting air. This area uses sterile filtered compressed air, which is delivered to the inside of the preform through a pipe. The 2022 EU GMP Annex 1 "Production of Sterile Drugs" states that "For rotary equipment used for aseptic filling, the packaging material is usually closed from the environment once blow molded. The design and maintenance of the filling environment inside the packaging material should meet the static and dynamic microorganisms and suspended particle counts to meet Class A requirements." During the aseptic production process, the preform is always in a closed state. Existing filling systems usually install a dust particle detection device inside the laminar flow hood or sterilizing filter to sample dust particles inside the laminar flow hood or sterilizing filter, and cannot perform online detection of the dust particle content in the air (i.e., supporting air) in the preform. Utility Model Content

[0003] The utility model solves the problems existing in the prior art in use and provides a sterilization detection system for BFS aseptic filling equipment which has a simple and reliable structure and a precise and accurate sampling result.

[0004] In order to solve the above technical problems, the utility model adopts the following technical solutions:

[0005] A sterilization detection system for BFS aseptic filling equipment comprises a filling mechanism, a forming mold, a sterilization cup and an air supply mechanism, wherein the sterilization cup is connected to the bottom of the forming mold, and the 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 through an air inlet pipeline and is used to provide supporting gas to the sterilization cup, and the sterilization cup discharges gas through an air outlet pipeline. The sterilization detection system also comprises a particle detection mechanism, which is arranged on the air inlet pipeline and / or the air outlet pipeline and is used to detect the dust particle content of the gas in the sterilization cup.

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

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

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

[0009] The first control mechanism further includes a first temperature detection component, which is arranged on the air outlet pipeline 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 provided with a second valve and a first valve that can be opened and closed.

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

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

[0013] The sterilization detection system also includes a pipeline control mechanism installed on the first drain pipe and / or the second drain pipe and / or the air outlet pipe, and the pipeline control mechanism includes a fifth valve, a second temperature detection element and a drain valve arranged in sequence along the fluid flow direction.

[0014] The pipeline control mechanism located in the air outlet pipeline is arranged in the downstream direction of the particle detection mechanism.

[0015] The filling mechanism comprises a buffer tank, a filling head and a filling needle which are connected in sequence. The filling needle passes through the forming mold and is connected to the sterilization cup. The liquid in the buffer tank enters the filling head and is filled into the sterilization cup by the filling needle.

[0016] Compared with the prior art, the beneficial effects of the utility model are:

[0017] The sterilization detection system of the BFS aseptic filling equipment of the utility model 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 by arranging a particle detection mechanism on an air outlet pipeline or an air inlet pipeline, and has a simple and reliable structure; a sterilization cup is arranged below the forming mold, and the sterilization cup is connected with the particle detection mechanism, so that during the detection, the system is in a closed state and the sampling result is accurate; the supporting air for sampling detection has the same path as the supporting air during actual production, and the sampling result is closer to the true value and the sampling result is accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic diagram of the initial state structure of the first embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0019] Figure 2 It is a schematic diagram of the sterilization state structure of the first embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0020] Figure 3 It is a schematic diagram of the sampling detection state structure of the first embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0021] Figure 4 It is a schematic diagram of the initial state structure of the second embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0022] Figure 5 It is a schematic diagram of the sterilization state structure of the second embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0023] Figure 6 It is a schematic diagram of the sampling detection state structure of the second embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0024] Figure 7 It is a schematic diagram of the initial state structure of the third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0025] Figure 8 It is a schematic diagram of the sterilization state structure of the third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0026] Fig. 9 It is a schematic diagram of the sampling detection state structure of the third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0027] Fig.10 It is another structural schematic diagram of the sampling and testing state of the third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model.

[0028] Legend: 1. Filling mechanism; 11. Buffer tank; 12. Filling head; 13. Filling needle; 2. Forming mold; 3. Sterilization cup; 4. First control mechanism; 41. First temperature detection element; 42. Heat exchanger; 5. Air supply mechanism; 51. Second filter; 52. Air 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. Air outlet pipeline; 82. Air 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 DESCRIPTION

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

[0030] In the description of the present invention, it should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0031] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present utility model, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0032] In the present invention, unless otherwise clearly specified and limited, the terms "assemble", "connect", "connect", "fix" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0033] Embodiment 1:

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

[0035] In the sterilization detection system of the BFS aseptic filling equipment of this embodiment, during production, the drug liquid enters the forming mold 2 from the filling mechanism 1, and the supporting air enters from the air supply mechanism 5 through the air inlet pipeline 82 to reach the forming mold 2, and the parison (not shown in the figure) below the forming mold 2 is blown and filled; during sterilization, steam enters from the filling mechanism 1, and the steam passes through the sterilization cup 3, the forming mold 2 and the air inlet pipeline 82 in turn, and reaches the air supply mechanism 5 to sterilize the various components and pipelines of the system; during sampling and detection, the supporting air enters from the air supply mechanism 5, and the supporting air passes through the air supply mechanism 5, the air inlet pipeline 82, the forming mold 2, the sterilization cup 3, the air outlet pipeline 81 in turn, and finally reaches the particle detection mechanism 6 for dust particle detection. The sterilization detection system of the BFS aseptic filling equipment of this embodiment can perform online detection of the dust particle content of the supporting air inside the sterilization detection system after production by arranging a particle detection mechanism 6 on the air outlet pipeline 81, and has a simple and reliable structure; by arranging a sterilization cup 3 under the forming mold 2, the sterilization cup 3 is connected to the particle detection mechanism 6, so that during the detection, the system is in a closed state and the sampling result is accurate; the supporting air for sampling detection has the same path as the supporting air during actual production, and the sampling result is closer to the true value and the sampling result is accurate.

[0036] In this embodiment, 3, the sterilization cup 3 is installed on the lower surface of the forming mold 2 and is 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 air outlet pipeline 81, and the other two ends are respectively connected to the particle counter 61 and the first filter 62. During sterilization, the valve connecting the three-way valve 63 to the air outlet pipeline 81 is closed, and the particle counter 61 is not sterilized; during sampling and detection, the valve connecting the three-way valve 63 to the air outlet pipeline 81 and the valve connecting the three-way valve 63 to the particle counter 61 are opened, and the valve connecting the three-way valve 63 to the first filter 62 is closed, and dust particle detection is performed; after sampling and detection, the valve connecting the three-way valve 63 to the first filter 62 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 is completed.

[0038] Furthermore, in this embodiment, the sterilization detection system also includes a first control mechanism 4, which includes a heat exchanger 42, and the heat exchanger 42 is arranged on the air outlet pipeline 81 between the particle detection mechanism 6 and the sterilization cup 3. Since the supporting air will be heated after passing through the high-temperature molding mold 2, the temperature after blowing out will reach 40-50°C. During sampling and detection, circulating cooling water is passed through the heat exchanger 42, and the supporting air temperature is reduced to below 40°C through the heat exchanger 42 for sampling and detection to avoid damaging the particle counter 61. The heat exchanger 42 is a pipeline heat exchanger.

[0039] Furthermore, in this embodiment, the first control mechanism 4 further includes a first temperature detection member 41, which is disposed on the air outlet pipeline 81 between the heat exchanger 42 and the particle detection mechanism 6. By providing the first temperature detection member 41, the heat exchanger 42 can more accurately control the support air temperature.

[0040] Furthermore, in this embodiment, the gas supply mechanism 5 includes an air source 52 and a second filter 51, the supporting gas of the air source 52 enters the air inlet pipeline 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 pipeline between the air source 52 and the second filter 51, and a fourth valve 74 that can be opened and closed is provided on the pipeline between the second filter 51 and the molding mold 2. During production and sampling inspection, the third valve 73 and the fourth valve 74 are opened, and the supporting gas enters the air inlet pipeline 82 from the air source 52 through the second filter 51; during sterilization, the fourth valve 74 is opened and the third valve 73 is closed, so that the second filter 51 can be sterilized, and the sterilization coverage rate is high.

[0041] Furthermore, in this embodiment, the sterilization detection system also includes a first drain pipe 83, a second drain pipe 84 and a main pipeline 87, one end of the first drain pipe 83 and the second drain pipe 84 are connected in parallel to the main pipeline 87, the other end of the first drain pipe 83 is connected to the pipeline between the fourth valve 74 and the molding mold 2, and the other end of the second drain pipe 84 is connected to the pipeline between the third valve 73 and the second filter 51. By providing the first drain pipe 83 and the second drain pipe 84, during sterilization, the steam passing through the air intake pipe 82 and the second filter 51 can be discharged from the main pipeline 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 drain pipe 83, the second drain pipe 84 and the air outlet pipe 81, and the pipeline control mechanism 9 includes a fifth valve 91, a second temperature detection member 92 and a drain valve 93 arranged in sequence along the fluid flow direction. By setting the pipeline control mechanism 9, during steam sterilization, the condensed water in the steam in the air outlet pipe 81, the first drain pipe 83 and the second drain pipe 84 can be discharged in time according to the temperature change, so as to prevent the accumulation of condensed water, avoid causing pipeline corrosion or reducing the heating efficiency.

[0043] In this embodiment, the first temperature detection component 41 and the second temperature detection component 92 are temperature sensors respectively, 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 gas outlet pipeline 81 is arranged downstream of the particle detection mechanism 6. The pipeline control mechanism 9 located on the gas outlet pipeline 81 is arranged downstream of the particle detection mechanism 6, which is conducive to the steam passing through a longer pipeline and 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 which are 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 filled into the sterilization cup 3 by the filling needle 13. During production, the liquid medicine is transported from the buffer tank 11 to the filling head 12, enters the filling needle 13 through the shunting control of the filling head 12, and is then filled into the sterilization cup 3 from the filling needle 13 to achieve the filling of the liquid medicine.

[0046] Embodiment 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 utility model is basically the same as the first embodiment, except that: the particle detection mechanism 6 is arranged on the air intake pipeline 82, and one end of the three-way valve 63 is connected to the air intake pipeline 82.

[0048] In this embodiment, the particle detection mechanism 6 is arranged on the air intake pipe 82, located at the front end of the molding die 2. Since the air here is not heated by the molding die 2, the particle detection mechanism 6 can be directly connected for detection without the need to additionally set up a heat exchanger 42 to lower the temperature.

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

[0050] Embodiment three:

[0051] like Figures 7 to 10 As shown, a third embodiment of the sterilization detection system of the BFS aseptic filling equipment of the utility model is basically the same as the first embodiment, except that: the particle detection mechanism 6 is arranged on the air inlet pipeline 82 and the air outlet pipeline 81, one end of the three-way valve 63 is connected to the air outlet pipeline 81 and the air inlet pipeline 82, and 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, and 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.

[0052] The sterilization detection system of the BFS aseptic filling equipment of this embodiment, by setting the fifth pipeline 85 and the sixth pipeline 86, allows the particle detection mechanism 6 to be connected to the air inlet pipeline 82 and the air outlet pipeline 81 at the same time, and switches the particle detection mechanism 6 to be connected to the air inlet pipeline 82 or the air outlet pipeline 81 by controlling the second valve 72 and the first valve 71, so that the dust particle content of the supporting air inside the sterilization detection system can be detected online before production, during production intervals and after production, and the structure is simple, reliable and highly adaptable.

[0053] The above is only a preferred embodiment of the utility model, and does not limit the utility model in any form. Although the utility model has been disclosed as above in the preferred embodiment, it is not used to limit the utility model. Any technician familiar with the field can make many possible changes and modifications to the technical solution of the utility model by using the methods and technical contents disclosed above without departing from the spirit and technical solution of the utility model, or modify it into an equivalent embodiment of equivalent changes. Therefore, any simple modification, equivalent replacement, equivalent change and modification made to the above embodiments based on the technical essence of the utility model without departing from the content of the technical solution of the utility model, still fall within the scope of protection of the technical solution of the utility model.

Claims

1. A sterilization detection system for a BFS aseptic filling device, comprising a filling mechanism (1), a forming mold (2), a sterilization cup (3) and an air supply mechanism (5), wherein 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) to reach the sterilization cup (3), the air supply mechanism (5) is connected to the forming mold (2) through an air inlet pipeline (82) and is used to provide supporting gas to the sterilization cup (3), and the sterilization cup (3) discharges gas through an air outlet pipeline (81), characterized in that: The sterilization detection system further comprises a particle detection mechanism (6), which is arranged on the air inlet pipeline (82) and / or the air outlet pipeline (81) and is used to detect the dust particle content of the gas in the sterilization cup (3).

2. The sterilization detection system of the BFS aseptic filling equipment according to claim 1 is characterized in that: The particle detection mechanism (6) comprises 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 an air outlet pipeline (81) and / or an air inlet pipeline (82), and the other two ends are respectively connected to the particle counter (61) and the first filter (62).

3. The sterilization detection system of the BFS aseptic filling equipment according to claim 1 is characterized in that: The sterilization detection system further comprises a first control mechanism (4), wherein the first control mechanism (4) comprises a heat exchanger (42), and the heat exchanger (42) is arranged on an air outlet pipeline (81) between the particle detection mechanism (6) and the sterilization cup (3).

4. The sterilization detection system of the BFS aseptic filling equipment according to claim 3 is characterized in that: The first control mechanism (4) further comprises a first temperature detection component (41), wherein the first temperature detection component (41) is arranged on an air outlet pipeline (81) between the heat exchanger (42) and the particle detection mechanism (6).

5. The sterilization detection system of the BFS aseptic filling equipment according to claim 3 is characterized in that: The sterilization detection system further comprises 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); and 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 of the BFS aseptic filling equipment according to any one of claims 1 to 5, characterized in that: The gas supply mechanism (5) comprises an air source (52) and a second filter (51); the supporting gas of the air source (52) passes through the second filter (51) into the air inlet pipeline (82) and reaches the sterilization cup (3); a third valve (73) that can be opened and closed is provided on the pipeline between the air source (52) and the second filter (51); and a fourth valve (74) that can be opened and closed is provided on the pipeline between the second filter (51) and the molding mold (2).

7. The sterilization detection system of the BFS aseptic filling equipment according to claim 6 is characterized by: The sterilization detection system further comprises a first drain pipe (83), a second drain pipe (84) and a main pipe (87), wherein the first drain pipe (83) is connected to a pipe between the fourth valve (74) and the molding die (2), and the second drain pipe (84) is connected to a pipe between the third valve (73) and the second filter (51).

8. The sterilization detection system of the BFS aseptic filling equipment according to claim 7 is characterized in that: The sterilization detection system further comprises a pipeline control mechanism (9) installed on the first drain pipeline (83) and / or the second drain pipeline (84) and / or the air outlet pipeline (81), wherein the pipeline control mechanism (9) comprises a fifth valve (91), a second temperature detection element (92) and a drain valve (93) arranged in sequence along the fluid flow direction.

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

10. The sterilization detection system of the BFS aseptic filling equipment according to any one of claims 1 to 5, characterized in that: The filling mechanism (1) comprises a buffer tank (11), a filling head (12) and a filling needle (13) which are connected in sequence. The filling needle (13) passes through the forming mold (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).

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