A fully automated silicone oil emulsification device for pre-filled syringes

Abstract

This invention discloses a fully automatic silicone oil emulsification device for pre-filled syringes, solving the problem in existing technologies where the emulsification process temperature cannot be guaranteed, easily leading to uneven siliconization on the product surface. This invention includes a control cabinet, a double-layer emulsification tank, a silicone oil tank, and a high-shear emulsification pump. The silicone oil tank is equipped with a first heating mechanism, and the double-layer emulsification tank is equipped with a second heating mechanism. The silicone oil tank is connected to the double-layer emulsification tank via a filler pipe, which is equipped with a metering pump. The outlet of the double-layer emulsification tank is connected to the inlet of the high-shear emulsification pump via a first pipe, and the inlet of the double-layer emulsification tank is connected to the outlet of the high-shear emulsification pump via a second pipe, which is equipped with a third heating mechanism. This invention ensures precise temperature control throughout the emulsification process through silicone oil heating, injection water heating, and heating during the subsequent emulsification cycle, improving emulsification efficiency and quality, and ensuring uniform surface siliconization during the later stage of product siliconization.

Description

Technical Field

[0001] This utility model relates to the field of emulsification technology, and in particular to a silicone oil emulsification device. Background Technology

[0002] Pre-filled syringes and related products require a siliconization process during production. A common method for this process is as follows: During product cleaning, the injection water is heated to a fixed temperature, and a certain volume of silicone oil is injected into the cleaning equipment through a syringe. The equipment rotates continuously at low speed, ensuring uniform contact between the product and the silicone oil, thus achieving uniform siliconization of the product surface. The disadvantage of this emulsification method is that the silicone oil floats on the surface of the injection water, and the contact area and time between the product and the surface silicone oil during the equipment rotation cannot be guaranteed to be uniform, easily leading to uneven siliconization of the product surface.

[0003] Silicone oil emulsification devices on the market, such as the one authorized by CN 222131608 U, have the following drawbacks: 1. They cannot achieve fully automatic operation. The need for manual operation implies the possibility of errors, and the cumbersome procedures can easily lead to batch-to-batch inconsistencies, making it impossible to guarantee consistency. 2. They cannot achieve full enclosure. Most existing emulsification devices require manual assistance during operation. The design and manufacturing process must consider the convenience of personnel operation, making full enclosure impossible and thus failing to meet GMP (Good Manufacturing Practice) requirements. 3. Temperature cannot be guaranteed. Silicone oil emulsification has high temperature requirements. General equipment can only use hot water from other equipment to emulsify the silicone oil, making it impossible to guarantee the temperature during the emulsification process, thus compromising emulsification consistency. Utility Model Content

[0004] To address the shortcomings in the aforementioned background technology, this utility model proposes a fully automatic silicone oil emulsification device for pre-filled syringes, which solves the problem that the temperature during the emulsification process cannot be guaranteed in the prior art, easily causing uneven siliconization on the product surface.

[0005] The technical solution of this utility model is implemented as follows: A fully automatic silicone oil emulsification device for pre-filled syringes includes a control cabinet, a double-layer emulsification tank, a silicone oil tank, and a high-shear emulsification pump. The silicone oil tank is equipped with a first heating mechanism, and the double-layer emulsification tank is equipped with a second heating mechanism. The silicone oil tank is connected to the double-layer emulsification tank via a filler pipe, which is equipped with a metering pump. The outlet of the double-layer emulsification tank is connected to the inlet of the high-shear emulsification pump via a first pipe, and the inlet of the double-layer emulsification tank is connected to the outlet of the high-shear emulsification pump via a second pipe, which is equipped with a third heating mechanism. The first heating mechanism heats the silicone oil, the second heating mechanism heats the injection water in the double-layer emulsification tank, and the third heating mechanism heats the circulating emulsion in the pipes. The temperature is well maintained, and the entire process is controlled by a controller in the control cabinet, enabling fully automatic operation and improving emulsification efficiency.

[0006] Further preferably, the double-layer emulsification tank includes a lid and a tank body, the tank body comprising an inner tank and an outer tank, with a sealed cavity formed between the inner and outer tanks for holding the heat-conducting medium. A second heating mechanism heats the heat-conducting medium. The heated heat-conducting medium then heats the injected water in the inner tank, resulting in more uniform heating.

[0007] Preferably, the second heating mechanism is an electric heater, with the heating end extending into the sealed cavity and contacting the heat-conducting medium for heating, and the other end fixed to the outer tank. The electric heater provides contact heating, resulting in faster heating.

[0008] In a further preferred embodiment, both the first and second pipes are connected to the inner tank, and temperature sensors are installed in both the inner and outer tanks; the controller controls the heating temperature based on the temperature sensors, resulting in more precise temperature control.

[0009] Further preferably, the first heating mechanism includes a heating sleeve that matches the silicone oil can. The heating sleeve is fitted onto the silicone oil can and has an electric heating wire inside. The electric heating wire heats the silicone oil can, thereby heating the silicone oil inside the can. A bracket is provided at the bottom of the silicone oil can for easy fixation.

[0010] In a further preferred embodiment, the third heating mechanism includes a stainless steel inner tube and a stainless steel outer tube that are nested together, with a PTC heating core provided between the stainless steel inner tube and the stainless steel outer tube; both ends of the stainless steel inner tube are connected to the second pipeline through chuck joints.

[0011] Further preferably, the stainless steel inner tube is provided with an insulation cotton layer and a thermoplastic tube from the inside out; a temperature controller is connected to the stainless steel inner tube. The insulation cotton layer is a 5mm thick aluminum silicate insulation cotton layer.

[0012] The fully automatic silicone oil emulsification device for pre-filled syringes also includes a sealing shell, a double-layer emulsification tank, a silicone oil tank, a high-shear emulsification pump, a metering pump, and a control cabinet, all of which are housed inside the sealing shell. The sealing shell is equipped with an openable door and wheels at the bottom.

[0013] The beneficial effects of this invention are as follows: This invention ensures precise temperature control throughout the emulsification process by heating the silicone oil, the injection water, and during the subsequent emulsification cycle, thereby improving emulsification efficiency and quality. Furthermore, the entire process is controlled by a controller within the control cabinet, enabling fully automated operation and ensuring uniform surface siliconization during the later stages of product siliconization. This invention employs a fully enclosed design to avoid cross-contamination. This fully automatic silicone oil emulsification device, through its three core advantages—high-precision emulsification, fully automated control, and GMP-compliant design—solves the pain points of traditional siliconization processes, such as uneven coating, silicone oil migration, and low production efficiency. It has become a key piece of equipment for the production of pre-filled syringes, helping pharmaceutical companies achieve high-quality, high-efficiency, and low-cost silicone oil coating processes. Attached Figure Description

[0014] To more clearly illustrate the embodiments of this utility model, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is a schematic diagram of the overall front view of this utility model;

[0016] Figure 2 This is a schematic diagram of the internal structure of this utility model;

[0017] Figure 3 This is a schematic diagram of the interior of the double-layer emulsifying tank of this utility model;

[0018] Figure 4 This is a schematic diagram of the third heating mechanism. Detailed Implementation

[0019] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0020] Example 1, as Figure 2As shown, a fully automatic silicone oil emulsification device for pre-filled syringes includes a control cabinet 9. The controller inside the control cabinet is the control center of the emulsification device and is a necessary condition for the device to achieve full automation. However, it should be noted that this utility model improves the equipment components and does not involve improvements to the circuit or control program. The device only controls the operation and stop of each electronic component through a PLC control system. Since the PLC control system is a mature automatic control system in industry, the circuit and control program will not be described in detail here. The key feature of this utility model is that it also includes a double-layer emulsification tank 1, a silicone oil tank 2, and a high-shear emulsification pump 3. The silicone oil tank 2 is equipped with a first heating mechanism 4, which heats the silicone oil in the silicone oil tank. The double-layer emulsification tank 1 is equipped with a second heating mechanism 5, which heats the injection water in the double-layer emulsification tank. The silicone oil tank 2 is connected to the double-layer emulsification tank 1 through a filling pipe 6, and a metering pump 7 is installed on the filling pipe 6. The metering pump 7 is a gear metering pump, which realizes high-precision filling of silicone oil into the double-layer emulsification tank 1. The outlet of the double-layer emulsification tank 1 is connected to the inlet of the high-shear emulsification pump 3 via a first pipe 11. The inlet of the double-layer emulsification tank 1 is connected to the outlet of the high-shear emulsification pump 3 via a second pipe 12. A third heating mechanism 8 is installed on the second pipe 12. After the injected water and silicone oil in the emulsification tank are mixed, they enter the high-shear emulsification pump through the first pipe for primary emulsification. Then, they re-enter the double-layer emulsification tank through the second pipe for heating, and then enter the high-shear emulsification pump again for secondary emulsification. This cycle is repeated to ensure emulsification efficiency and quality. The third heating mechanism heats the circulating emulsion in the pipes, ensuring a good temperature. The entire process is controlled by a controller in the control cabinet, enabling fully automatic operation and improving emulsification efficiency. It also ensures uniform surface siliconization during the subsequent product siliconization process.

[0021] In this preferred embodiment, the double-layer emulsifying tank 1 includes a cover 1-1 and a tank body 1-2. The cover is sealed and fastened to the tank body to ensure the airtightness of the entire emulsifying tank. The tank body 1-2 in this embodiment includes an inner tank body 101 and an outer tank body 102. The inner tank body is located inside the outer tank body and the two are fixedly connected. A sealed cavity 103 for holding the heat-conducting medium is formed between the inner tank body 101 and the outer tank body 102. The second heating mechanism 5 heats the heat-conducting medium. The heat-conducting medium is preferably heat-conducting oil. The heat-conducting oil enters the interlayer (sealed cavity) between the inner tank body 101 and the outer tank body 102 through an inlet on the outer tank body, and is then heated by the second heating mechanism and maintained at a constant temperature, thus heating the medium inside the inner tank. The heat-conducting oil uses a method similar to "water bath heating" to uniformly heat the inner tank body, resulting in a rapid heating rate and rapid, uniform heating of the medium inside the inner tank body; it is also stable and easy to control, improving temperature control accuracy.

[0022] Example 2, as Figure 3As shown, a fully automatic silicone oil emulsification device for pre-filled syringes is further optimized based on Embodiment 1. In this embodiment, the second heating mechanism 5 is an electric heater. The heating end of the electric heater extends into the sealed cavity 103 and contacts the heat-conducting medium for heating, while the other end is fixed to the outer tank 102. The heating end of the electric heater adopts a heating tube, which extends into the sealed cavity to heat the heat-conducting medium, i.e., the heat-conducting oil. The tail end of the electric heater extends out of the outer tank and is connected to an external power source through a wire. The external power source can be integrated into the control cabinet, and the controller controls whether it is powered on or off through a switch.

[0023] In this embodiment, both the first pipe 11 and the second pipe 12 are connected to the inner tank 101, enabling the circulation of the medium within the inner tank between the emulsifying tank and the high-shear emulsifying pump, thereby improving emulsification efficiency. In this embodiment, both the inner tank 101 and the outer tank 102 are equipped with temperature sensors to monitor the temperature of the heat-conducting medium and the medium within the inner tank, respectively. Furthermore, the controller adjusts the heating temperature based on the temperature sensors to achieve more precise temperature control and automated heating.

[0024] In this preferred embodiment, the first heating mechanism 4 includes a heating sleeve 41 that matches the silicone oil tank 2. The heating sleeve 41 is fitted onto the silicone oil tank 2 and fixed by bolts. An electric heating wire is installed inside the heating sleeve 41. The silicone oil tank can be made of stainless steel. After the electric heating wire is energized, it heats the silicone oil tank, thereby heating the silicone oil inside. A bracket is provided at the bottom of the silicone oil tank 2 to facilitate the fixed installation of the silicone oil tank and ensure its stability. In addition, a temperature sensor can also be installed on the silicone oil tank to monitor the temperature of the silicone oil.

[0025] like Figure 4 As shown, the third heating mechanism 8 in this embodiment includes a stainless steel inner tube 81 and a stainless steel outer tube 82 that are fitted together. The outer tube is fitted onto the inner tube, and both ends are fixed to the inner tube by welding. A PTC heating core 83 is provided between the inner and outer tubes. The PTC heating core 83 is connected to an external power source via a wire, and its energization is controlled by a controller via a switch. Both ends of the inner tube 81 are connected to the second pipe 12 via chuck connectors 84. When the PTC heating core 83 is energized, it heats the inner tube, thereby heating the medium passing through it.

[0026] In this preferred embodiment, the stainless steel inner tube 81 is provided with a thermal insulation cotton layer 85 and a thermoplastic tube 86 from the inside to the outside; wherein, the thermal insulation cotton layer 85 is a 5mm thick aluminum silicate thermal insulation cotton layer, which plays a role in heat insulation; a thermostat 87 is connected to the stainless steel inner tube 81 to control the heating temperature of the stainless steel inner tube 81, so as to achieve precise heating of the flowing medium inside the stainless steel inner tube.

[0027] Example 3, as Figure 1 As shown, a fully automatic silicone oil emulsification device for pre-filled syringes is further optimized based on Example 1. In this example, the fully automatic silicone oil emulsification device for pre-filled syringes also includes a sealed housing 10. A double-layer emulsification tank 1, a silicone oil tank 2, a high-shear emulsification pump 3, a metering pump 7, and a control cabinet 9 are all housed within the sealed housing 10; this achieves equipment integration, complete enclosure, and compliance with good operating procedures. The sealed housing 10 is equipped with an openable door for easy inspection and maintenance. The bottom of the sealed housing 10 is equipped with casters 13 for easy movement of the entire device.

[0028] The operating procedure for cleaning products using this utility model is as follows:

[0029] (1) Inject a measured amount of injection water into the double-walled emulsification tank;

[0030] (2) The second heating mechanism uses electric heating to heat the injection water in the double-layer emulsification tank to the set temperature;

[0031] (3) The first heating mechanism heats the silicone oil tank to the set temperature by electric heating, and then injects a certain amount of silicone oil into the double-layer emulsification tank by metering pump;

[0032] (4) After the silicone oil is injected, the emulsification cycle is carried out: the injection water in the double-layer emulsification tank is mixed with the silicone oil and then enters the high-shear emulsification pump through the first pipeline for first-stage high-shear emulsification. Then it enters the double-layer emulsification tank again through the second pipeline for heating, and then enters the high-shear emulsification pump for second-stage high-shear emulsification. This cycle is repeated until the emulsification operation is completed.

[0033] (5) When the cleaning machine reaches the siliconization step, the cleaning machine will automatically stop and start automatically adding emulsified silicone oil;

[0034] (6) After the filling is completed, the cleaning machine will start the next step automatically;

[0035] (7) After cleaning, the system will perform a cycle cleaning, automatic discharge, and then the next cycle will begin.

[0036] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A fully automatic silicone oil emulsification device for pre-filled syringes, comprising a control cabinet (9), characterized in that: It also includes a double-layer emulsifying tank (1), a silicone oil tank (2) and a high-shear emulsifying pump (3). The silicone oil tank (2) is equipped with a first heating mechanism (4), and the double-layer emulsifying tank (1) is equipped with a second heating mechanism (5). The silicone oil tank (2) is connected to the double-layer emulsifying tank (1) through a filling pipe (6). A metering pump (7) is provided on the filling pipe (6). The outlet of the double-layer emulsifying tank (1) is connected to the inlet of the high-shear emulsifying pump (3) through a first pipe (11). The inlet of the double-layer emulsifying tank (1) is connected to the outlet of the high-shear emulsifying pump (3) through a second pipe (12). A third heating mechanism (8) is provided on the second pipe (12).

2. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 1, characterized in that: The double-layer emulsification tank (1) includes a cover (1-1) and a tank body (1-2). The tank body (1-2) includes an inner tank body (101) and an outer tank body (102). A sealed cavity (103) for holding a heat-conducting medium is formed between the inner tank body (101) and the outer tank body (102). The second heating mechanism (5) heats the heat-conducting medium.

3. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 2, characterized in that: The second heating mechanism (5) is an electric heater. The heating end of the electric heater extends into the sealed cavity (103) and comes into contact with the heat-conducting medium for heating, while the other end is fixed on the outer tank (102).

4. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 3, characterized in that: Both the first pipe (11) and the second pipe (12) are connected to the inner tank (101), and temperature sensors are provided in both the inner tank (101) and the outer tank (102).

5. The fully automatic silicone oil emulsifying device for pre-filled syringes according to any one of claims 1 to 4, characterized in that: The first heating mechanism (4) includes a heating sleeve (41) that matches the silicone oil tank (2). The heating sleeve (41) is fitted onto the silicone oil tank (2) and an electric heating wire is provided inside the heating sleeve (41).

6. The fully automatic silicone oil emulsification device for pre-filled syringes according to claim 5, characterized in that: The bottom of the silicone oil tank (2) is equipped with a support.

7. The fully automatic silicone oil emulsifying device for pre-filled syringes according to any one of claims 1 to 4 and 6, characterized in that: The third heating mechanism (8) includes a stainless steel inner tube (81) and a stainless steel outer tube (82) that are nested together. A PTC heating core (83) is provided between the stainless steel inner tube (81) and the stainless steel outer tube (82). The two ends of the stainless steel inner tube (81) are connected to the second pipe (12) through a chuck connector (84).

8. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 7, characterized in that: The stainless steel inner tube (81) is provided with an insulation cotton layer (85) and a thermoplastic tube (86) from the inside to the outside; a thermostat (87) is connected to the stainless steel inner tube (81).

9. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 8, characterized in that: The insulation cotton layer (85) is a 5mm thick aluminum silicate insulation cotton layer.

10. The fully automatic silicone oil emulsifying device for pre-filled syringes according to claim 1 or 9, characterized in that: It also includes a sealing shell (10), a double-layer emulsifying tank (1), a silicone oil tank (2), a high-shear emulsifying pump (3), a metering pump (7), and a control cabinet (9), all of which are located inside the sealing shell (10). The sealing shell (10) is equipped with an openable door, and the bottom of the sealing shell (10) is equipped with wheels (13).

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