Auxiliary device for monitoring temperature change in product sterilization process

Abstract

The utility model belongs to the technical field of medicine manufacturing, and particularly relates to an auxiliary device for monitoring temperature change in a product sterilization process. The auxiliary device comprises a main cylinder, an observation cover and an end cover, the main cylinder is made of a corrosion-resistant metal material, a sealing body used for inserting a temperature detection probe in a sealing mode is arranged on the end cover, and the end cover and the observation cover with the perspective performance are arranged at the two ends of the main cylinder in a sealing mode respectively. According to the technical scheme, the main cylinder can be heated and cooled together with a product, and a stable temperature field is provided for a temperature sensor for monitoring the temperature of the product in the whole sterilization process. The main cylinder can provide a stable temperature field and can be used repeatedly. Therefore, the problems of non-uniform temperature distribution and poor stability of the reference bottle / reference bag in application are solved, the situation of leakage caused by damage is avoided, and the auxiliary device can be used for sterilizing products with different volumes and has relatively good flexibility and applicability.

Description

An auxiliary device for monitoring temperature changes during product sterilization. Technical Field

[0001] This utility model belongs to the field of pharmaceutical manufacturing technology, specifically relating to an auxiliary device for monitoring temperature changes during the product sterilization process. Background Technology

[0002] A large-volume infusion water bath sterilizer is a device specifically designed for the medical industry, particularly pharmaceutical companies, to sterilize large-volume injections (commonly referred to as "large-volume infusions"). This sterilizer uses hot water as a medium to heat the containers (such as glass bottles or plastic bags) containing the medication, thereby killing microorganisms and spores and ensuring the safety and sterility of the drugs.

[0003] A sterilizer typically consists of a sterilizer body, a heat exchange system, a control system, and a sterilization cart. The sterilizer body is the container for the product to be sterilized; during operation, the product to be sterilized must be sealed within the sterilizer chamber. During the sterilization stage, high-temperature superheated water spray is used to sterilize the infusion product. The heat exchange system heats or cools the circulating water within the sterilizer. The circulating water exchanges heat with the product through a spray distribution device within the sterilizer, achieving both heating and cooling. The control system automatically controls the pressure and temperature within the sterilizer chamber according to a set sterilization parameter program (sterilization temperature, sterilization time, F0 value). It can automatically calculate the F0 value and monitor the sterilization process in real time.

[0004] In the sterilization of infusion products, existing technologies typically incorporate one or more temperature reference probes within the sterilizer body (e.g., a reference bag / bottle), which are inserted inside the reference bag / bottle. It should be noted that the reference bag / bottle is usually of the same type as the product being sterilized. Throughout the sterilization process, the reference bag / bottle is heated or cooled together with the product. Temperature changes within the reference bag / bottle are recorded by the control system, indirectly reflecting the internal temperature changes of the product being sterilized. The recorded temperature serves as a parameter in the sterilization control process, enabling temperature and pressure control and F0 value calculation during sterilization.

[0005] The reference bottles are primarily plastic and glass bottles, while the reference bags are flexible bags. Plastic bottles are typically made of polypropylene, with the bottle neck sealed to a combination cap by welding; the combination cap contains a rubber stopper. Glass bottles are usually made of soda-lime glass, with an aluminum cap sealed through a crimping process; the aluminum cap also contains a rubber stopper. A temperature sensor passes through the cap (e.g., combination cap, aluminum cap) and is inserted into the bottle to measure the liquid temperature, feeding back the measurement to the control system for temperature control. The rubber stopper inside the cap seals the sensor probe, preventing leakage.

[0006] However, in actual application testing, the following problems were found in the use of the sterilizer body (i.e., reference bottle / reference bag) in the existing technology:

[0007] 1. Limited reusability. The rubber stopper is relatively thin, and its elasticity decreases after multiple sterilizations, reducing its sealing performance to the sensor probe.

[0008] 2. Sterilized products are typically used as reference bottles / bags. These are usually changed once or more daily, with several products used each time, resulting in significant waste for high-value-added products.

[0009] 3. Plastic bottles or soft bags may be punctured by the sensor probe. If damage occurs, it will cause production deviations, and in severe cases, it will cause a large number of products to be scrapped.

[0010] 4. The internal sensor probe has no fixed support, and the position of the probe is not fixed. It may shift. If the probe touches the bottle wall, bag wall or is not immersed in the liquid, the measured temperature will be inaccurate, which will have a significant impact on temperature control. This will affect the sterilization temperature of the entire product and affect product quality.

[0011] 5. The liquid volume in the reference bottle / bag is not easy to observe, and leakage is not easily detected. If the liquid decreases, it will affect temperature control, and consequently affect the overall sterilization effect of the products in the sterilizer.

[0012] Therefore, in order to address the problems of uneven temperature distribution, inaccurate detection results, and easy breakage and leakage of reference bottles / bags in the application of existing technologies, it is necessary to optimize and improve the structure of the sterilizer to solve the current technical problems. Summary of the Invention

[0013] The purpose of this invention is to provide an auxiliary device for monitoring temperature changes during product sterilization, which can solve the problems of uneven temperature distribution, inaccurate detection results, and easy breakage and leakage of reference bottles / bags in the application of existing technologies.

[0014] This utility model is achieved through the following technical solution:

[0015] An auxiliary device for monitoring temperature changes during product sterilization includes a main cylinder, an observation cap, and end caps. The main cylinder is made of corrosion-resistant metal material, and the end caps are provided with a sealing body for sealing a temperature detection probe. The end caps and the transparent observation caps are respectively and sealed at both ends of the main cylinder.

[0016] Alternatively, the auxiliary device may further include a sleeve eccentrically disposed within the main cylinder, the end of the sleeve being connected to the end cap; wherein the bottom wall of the sleeve has a gap relative to the bottom wall of the main cylinder.

[0017] Alternatively, a sleeve made of corrosion-resistant metal material is welded to the end cap.

[0018] Alternatively, the sleeve may be provided with a groove located in a region close to the axis of the main cylinder.

[0019] Alternatively, the main tube may also be provided with a support, which has a limiting groove or limiting hole for constraining the sleeve.

[0020] Alternatively, the sleeve may be shorter than the length of the temperature sensing probe, such that the temperature sensing probe protrudes from the sleeve.

[0021] Alternatively, the end of the main cylinder is provided with a first flange, the first flange having a sealing groove and a sealing ring therein, the observation cover covering the end of the main cylinder and fitting against the sealing ring, and the gland being detachably connected to the first flange by a first fastener, so that the observation cover is sealed to the main cylinder.

[0022] Alternatively, the cap may be provided with scale markings to indicate the liquid level.

[0023] Alternatively, the end of the main cylinder is provided with a second flange, the second flange having an annular groove, the end cover having an annular boss adapted to the annular groove, the annular groove having a second sealing ring embedded therein, and the end cover being detachably connected to the second flange by fasteners, such that the annular boss is inserted into the annular groove and presses against the second sealing ring.

[0024] Alternatively, liquid inlets are provided on both sides of the main cylinder, and the liquid inlets are provided with caps.

[0025] Compared with the prior art, this utility model has the following advantages and beneficial effects:

[0026] The main cylinder, made of corrosion-resistant metal, possesses excellent thermal conductivity, providing a stable temperature field. Furthermore, its high strength, high temperature resistance, and corrosion resistance allow for repeated use. The transparent observation cap allows for direct observation of the liquid level inside the main cylinder (the probe's immersion in the liquid) and the liquid state (e.g., whether the liquid volume has changed). Simultaneously, the position of the temperature detection probe can be observed through the observation cap, enabling timely correction in case of displacement and preventing physical damage or external interference. This provides effective protection and, to a certain extent, ensures the validity of the temperature detection results.

[0027] Through the above technical solution, during the sterilization process, the main cylinder can be heated and cooled together with the product, providing a stable temperature field for the temperature sensor monitoring the product temperature throughout the sterilization process, thereby ensuring the accuracy and reliability of the test results. This main cylinder can not only hold different types of liquids, such as purified water or contents identical to the product being sterilized; but also, based on its stable and non-deformable structure, it can hold liquids of different volumes and effectively sterilize them, exhibiting good flexibility and applicability. This solves the problem of inaccurate test results caused by uneven temperature distribution and poor stability in existing reference bottles / bags, while also addressing the issue of reference bottles / bags being easily deformed or damaged and unable to be reused, demonstrating good economic efficiency and applicability. Attached Figure Description

[0028] The accompanying drawings, which are included to provide a further understanding of the embodiments of the present invention and form part of this application, do not constitute a limitation thereof. In the drawings:

[0029] Figure 1 is a schematic diagram of the reference bottle described in the background art;

[0030] Figure 2 is a schematic diagram of the structure of the reference bag described in the background art;

[0031] Figure 3 is a schematic diagram of the structure of an auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure in one embodiment;

[0032] Figure 4 is a schematic diagram of the main structure of the auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure in one embodiment. The main cylinder has been removed to show the internal structure.

[0033] Figure 5 is a schematic diagram of the connection structure of the end cap and the second flange in the auxiliary device for monitoring temperature changes during the product sterilization process provided in this disclosure.

[0034] Figure 6 is a side view of one embodiment of the auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure.

[0035] Figure 7 is a schematic diagram of the connection structure between the sealing body and the temperature detection probe in the auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure in the second embodiment;

[0036] Figure 8 is a schematic diagram of the connection structure between the sealing body and the temperature detection probe in the third embodiment of the auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure.

[0037] Figure 9 is a schematic diagram of the connection structure of the sealing body and the temperature detection probe in the fourth embodiment of the auxiliary device for monitoring temperature changes during product sterilization provided in this disclosure.

[0038] The attached diagram shows the markings and corresponding component names:

[0039] 1-Main cylinder, 11-First flange, 12-Second flange, 13-Liquid guide port, 2-Observation cover, 3-End cover, 4-Sleeve, 41-Strip groove, 5-Bracket, 51-Limiting hole, 6-Temperature detection probe, 71-First sealing ring, 72-Second sealing ring, 81-Pressure cap, 82-Scale marking, 91-First fastener, 92-Second fastener, 111-First connector, 112-Second connector, 113-O-ring, 114-Clamp, 115-Conical rubber stopper. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the embodiments and accompanying drawings. The illustrative embodiments and descriptions of this utility model are only used to explain this utility model and are not intended to limit this utility model.

[0041] According to specific embodiments of this disclosure, an auxiliary device for monitoring temperature changes during product sterilization is provided, as shown in Figures 3 to 9, which illustrate specific embodiments of the auxiliary device.

[0042] Referring to Figures 3 to 9, the auxiliary device for monitoring temperature changes during product sterilization includes a main cylinder 1, an observation cover 2, and an end cover 3. The main cylinder 1 is made of corrosion-resistant metal material, and the end cover 3 is provided with a sealing body for sealing the temperature detection probe 6. The end cover 3 and the transparent observation cover 2 are respectively sealed at both ends of the main cylinder 1.

[0043] The main cylinder, made of corrosion-resistant metal, possesses excellent thermal conductivity, providing a stable temperature field. Furthermore, its high strength, high temperature resistance, and corrosion resistance allow for repeated use. The transparent observation cap allows for direct observation of the liquid level inside the main cylinder (the probe's immersion in the liquid) and the liquid state (e.g., whether the liquid volume has changed). Simultaneously, the position of the temperature detection probe can be observed through the observation cap, enabling timely correction in case of displacement and preventing physical damage or external interference. This provides effective protection and, to a certain extent, ensures the validity of the temperature detection results.

[0044] Through the above technical solution, during the sterilization process, the main cylinder can be heated and cooled together with the product, providing a stable temperature field for the temperature sensor monitoring the product temperature throughout the sterilization process, thereby ensuring the accuracy and reliability of the test results. This main cylinder can not only hold different types of liquids, such as purified water or contents identical to the product being sterilized; but also, based on its stable and non-deformable structure, it can hold liquids of different volumes and effectively sterilize them, exhibiting good flexibility and applicability. This solves the problem of inaccurate test results caused by uneven temperature distribution and poor stability in existing reference bottles / bags, while also addressing the issue of reference bottles / bags being easily deformed or damaged and unable to be reused, demonstrating good economic efficiency and applicability.

[0045] In this disclosure, the eccentric arrangement of the sealing body allows the temperature detection probe 6 to fully contact the liquid, thereby ensuring the accuracy of the detection results.

[0046] In one specific embodiment, the main cylinder 1 is made of SUS316 stainless steel. Because SUS316 stainless steel contains molybdenum, the main cylinder 1 exhibits good corrosion resistance in purified water or other solutions. Simultaneously, based on the high-temperature resistance and oxidation resistance of SUS316 stainless steel, it is effectively suitable for operation in high-temperature environments. Furthermore, the main cylinder 1 also possesses excellent thermal conductivity, allowing for uniform heat distribution, thereby providing a stable detection environment for the temperature detection probe 6 and ensuring the accuracy of the detection results.

[0047] Of course, in other embodiments, the main cylinder 1 can also be made of SUS306. Those skilled in the art can choose any other suitable metal material within the framework of this disclosure.

[0048] In one embodiment, the auxiliary device further includes a sleeve 4 eccentrically disposed within the main cylinder 1, the sleeve 4 being positioned opposite the sealing body, and the end of the sleeve 4 being connected to the end cap 3; wherein the bottom wall of the sleeve 4 has a gap relative to the bottom wall of the main cylinder 1. The sleeve 4 serves to position and guide the insertion of the probe, thereby reducing probe displacement and preventing the probe from contacting the bottle wall, bag wall, or lifting up without being submerged in the liquid. This, in turn, protects the probe from physical damage or external interference to a certain extent, which helps improve the accuracy of temperature measurement, provides an effective reference for temperature control, and ensures the sterilization effect of the product.

[0049] Furthermore, the sleeve 4, made of corrosion-resistant metal material, is welded to the end cap 3. This welding connection ensures a secure bond between the sleeve 4 and the end cap 3. The sleeve 4, made of corrosion-resistant metal material, not only possesses good rigidity, strength, high-temperature resistance, and corrosion resistance, but also maintains excellent performance even after repeated use, preventing any interaction with the liquid in the main cylinder 1.

[0050] The sleeve 4 and / or end cap 3 are made of stainless steel of grade SUS316, which gives the sleeve 4 and / or end cap 3 good corrosion resistance in purified water or other solutions and makes them suitable for operation in high-temperature environments.

[0051] Of course, in other embodiments, the sleeve 4 and / or end cap 3 may also be made of alloy materials such as SUS306, SUS304, or SUS314. Those skilled in the art can choose any other suitable metallic material within the framework of this disclosure.

[0052] It should be noted that the "and / or" in the text refers to three possibilities: A can exist alone, B can exist alone, or A and B can exist simultaneously.

[0053] In the first embodiment, the sealing body is made of a flexible material and has a compression channel in the middle. When the temperature sensing probe 6 is inserted, the sealing body is compressed and deformed, thereby creating a channel that allows the temperature sensing probe 6 to be inserted in a sealed manner. During this process, the sealing body fills the gap through its own deformation, preventing liquid leakage. When the temperature sensing probe 6 is removed, the sealing body is subjected to an outward pulling force due to friction and thus deforms, thereby filling the gap created by the probe removal and achieving a seal.

[0054] In the second embodiment, referring to Figure 9, the temperature detection probe is fixed to the first connector (e.g., by screwing or welding). The end cap is provided with a second connector that matches the first connector. The second connector presses against the first connector, and an O-ring is provided between the first connector and the second connector. The clamp is then tightened to the first connector and the second connector, thereby sealingly and securely connecting the first connector to the second connector, thus fixing the temperature detection probe.

[0055] A third embodiment is provided, an improvement upon the second embodiment. Referring to Figure 8, a conical rubber stopper is added in this embodiment. The first connector pushes the conical rubber stopper to the diameter change point of the sleeve, further enhancing the sealing effect. Specifically, the temperature detection probe (by welding) is sealed and fixed to the first connector. The end cap has a second connector that matches the first connector, which presses against the first connector. An O-ring is provided between the first and second connectors. A clamp is then tightened around the first and second connectors, thereby sealingly and securely connecting the first connector to the second connector, thus fixing the temperature detection probe.

[0056] An improvement upon the second embodiment is provided in a fourth embodiment. Referring to Figure 9, a conical rubber stopper is added in this embodiment. The first connector pushes the conical rubber stopper to the diameter change point of the sleeve, further enhancing the sealing effect. Specifically, the temperature detection probe (via threaded connection) is sealed and fixed to the first connector. The end cap has a second connector that matches the first connector, which presses against the first connector. An O-ring is provided between the first and second connectors. A clamp is then tightened around the first and second connectors, thereby sealingly and securely connecting the first connector to the second connector, thus fixing the temperature detection probe.

[0057] Furthermore, the sleeve 4 is provided with a strip groove 41, which is located in the area close to the axis of the main cylinder 1. The strip groove 41 helps the liquid to flow freely and helps to maintain a uniform flow field of the liquid inside and outside the sleeve, thereby reducing the impact on the temperature detection probe 6 and ensuring the accuracy and reliability of the temperature detection results.

[0058] In this disclosure, the main cylinder 1 is further provided with a support 5, which has a limiting groove or limiting hole 51 for constraining the sleeve 4. This allows the sleeve 4 to be placed in the limiting groove or limiting hole 51, thus providing reliable support for the sleeve 4. When the reference device contains liquids of different volumes, this facilitates the complete immersion of the temperature detection probe 6 in the liquid, thereby ensuring the accuracy of the temperature detection results.

[0059] In this disclosure, the length of the sleeve 4 is shorter than the length of the temperature sensing probe 6, causing the temperature sensing probe 6 to protrude from the sleeve 4. By making the temperature sensing probe 6 partially protrude, it can be made to contact the liquid more directly, thereby reducing the thermal resistance caused by the material of the sleeve 4. This helps to improve the response speed and accuracy of temperature measurement. When the temperature sensing probe 6 is closer to the environment being measured, it can provide a more accurate temperature reading (i.e., temperature detection result).

[0060] Although the temperature sensing probe 6 needs to protrude from the sleeve 4 to obtain more accurate measurement values, the sleeve 4 can still protect the probe from physical damage or external interference to a certain extent, especially when the probe needs to be inserted into a relatively rough medium.

[0061] In one embodiment, the end of the main cylinder 1 is provided with a first flange 11, the first flange 11 is provided with a sealing groove, the sealing groove is provided with a sealing ring, the observation cover 2 covers the end of the main cylinder 1 and fits against the sealing ring, and the pressure cover 81 is detachably connected to the first flange 11 by a first fastener 91, so that the observation cover 2 is sealed to the main cylinder 1.

[0062] The sealing groove, sealing ring and pressure cap 81 work together to press the observation cover 2 tightly and seal the main cylinder 1.

[0063] Specifically, the deformation of the sealing ring provides a buffering effect, resulting in better sealing performance. For example, after a period of use, the user can adjust the first fastener 91 to change the resistance of the observation cover 2, thereby giving the observation cover 2 a certain pre-tightening force relative to the main cylinder 1. This provides a more stable and reliable sealing environment, allowing the main cylinder 1 to effectively adapt to different temperature and pressure conditions. Furthermore, the second fastener 92 facilitates the replacement and maintenance of the auxiliary device. For instance, when the sealing ring ages, the observation cover 2 can be removed and replaced with a new one. This operation is simple and convenient, reducing wear and tear on parts within the auxiliary device.

[0064] Furthermore, to facilitate a clear understanding of the liquid level in the main cylinder 1, the pressure cap 81 is provided with a scale mark 82 for displaying the liquid level. This allows the liquid level in the main cylinder 1 to be determined by comparing the liquid level with the scale mark 82.

[0065] Specifically, the observation cover 2 is configured with a glass substrate. Based on the characteristics of the glass substrate, the observation cover 2 also has the properties of high temperature resistance, high pressure resistance, cold and heat resistance, and impact resistance. It can provide a stable and reliable detection environment during use, so that the auxiliary device can be used repeatedly.

[0066] In one embodiment provided in this disclosure, the end of the main cylinder 1 is provided with a second flange 12, the second flange 12 is provided with an annular groove, the end cover 3 is provided with an annular boss adapted to the annular groove, the annular groove is embedded with a second sealing ring 72, and the end cover 3 is detachably connected to the second flange 12 by fasteners, so that the annular boss is inserted into the annular groove and presses against the second sealing ring 72.

[0067] In one embodiment provided in this disclosure, liquid inlets 13 are respectively provided on both sides of the main cylinder 1, and caps are provided at the liquid inlets 13. In this way, the caps can be selectively opened to realize liquid injection or drainage, which has good flexibility and practicality.

[0068] Alternatively, the cap can be configured as a blind flange. By installing a blind flange at the liquid inlet 13, the medium can be separated, thereby achieving an effective sealing effect.

[0069] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of this utility model. It should be understood that the above description is only a specific embodiment of this utility model and is not intended to limit the scope of protection of this utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the scope of protection of this utility model.

Claims

1. An auxiliary device for monitoring temperature changes during product sterilization, characterized in that, The auxiliary device includes a main cylinder, an observation cover, and end caps. The main cylinder is made of corrosion-resistant metal material, and the end caps are provided with a sealing body for sealing the insertion of a temperature detection probe. The end caps and the transparent observation cover are respectively and sealed at both ends of the main cylinder.

2. The auxiliary device for monitoring temperature changes during product sterilization as described in claim 1, characterized in that, The auxiliary device also includes a sleeve eccentrically disposed in the main cylinder, the end of the sleeve being connected to the end cap; wherein the bottom wall of the sleeve has a gap relative to the bottom wall of the main cylinder.

3. The auxiliary device for monitoring temperature variations in a product sterilization process according to claim 2, characterized in that, A sleeve made of corrosion-resistant metal material is welded to the end cap.

4. The auxiliary device for monitoring temperature changes during product sterilization according to claim 2, characterized in that, The sleeve is provided with a strip groove, which is located in the region close to the axis of the main cylinder.

5. The auxiliary device for monitoring temperature changes during product sterilization according to claim 2, characterized in that, The main cylinder is also provided with a support, which has a limiting groove or limiting hole for constraining the sleeve.

6. The supplementary device for monitoring temperature variations in product sterilization processes according to claim 2, characterized in that, The length of the sleeve is shorter than the length of the temperature detection probe, so that the temperature detection probe protrudes from the sleeve.

7. The auxiliary device for monitoring temperature changes during product sterilization according to claim 1, characterized in that, The end of the main cylinder is provided with a first flange, the first flange is provided with a sealing groove, the sealing groove is provided with a first sealing ring, the observation cover covers the end of the main cylinder and fits against the first sealing ring, and the pressure cover is detachably connected to the first flange by a first fastener so that the observation cover is sealed to the main cylinder.

8. The auxiliary device for monitoring temperature changes during product sterilization according to claim 7, characterized in that, The cap is equipped with scale markings to indicate the liquid level.

9. The auxiliary device for monitoring temperature changes during product sterilization according to claim 1, characterized in that, The end of the main cylinder is provided with a second flange, the second flange is provided with an annular groove, the end cover is provided with an annular boss adapted to the annular groove, the annular groove is embedded with a second sealing ring, and the end cover is detachably connected to the second flange by a second fastener, so that the annular boss is inserted into the annular groove and presses against the second sealing ring.

10. The auxiliary device for monitoring temperature changes during product sterilization according to any one of claims 1 to 9, characterized in that, The main cylinder is provided with liquid guide ports on both sides, and the liquid guide ports are provided with caps.

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