Air conditioning system suitable for clean area of medicine production

CN224787300UActive Publication Date: 2026-09-22JIANGSU TIANSHENG PHARMA
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Patent Information

Application Number
CN202522310819.4
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-10-31
Publication Date
2026-09-22
Estimated Expiration
2035-10-31

AI Technical Summary

Technical Problem

生产设备所需的是“纯降温”,而洁净区空调则需要“降温除湿”,两者共用一套冷冻水供应系统,生产设备的巨大冷负荷挤占了洁净区空调所需的制冷容量,为优先满足生产设备的降温需求,洁净区空调不得不提高所需冷冻水温度,这直接导致洁净区空调表冷器表面温度无法降低至空气的露点温度以下,导致除湿功能实质性失效,洁净区内长期处于高湿状态,为微生物滋生提供了温床,严重增加了产品被微生物污染的风险

Benefits of technology

通过将现有耦合度高的共用水冷冷源替换为新的独立风冷冷源,解决了冷负荷冲突这一根本矛盾;再通过引入PLC自动控制,解决了控制精度与稳定性的问题,两项改造相辅相成,共同构成了一个高效、可靠、合规的洁净区环境控制解决方案,为产品质量与合规生产提供坚实保障。

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses a kind of air conditioning systems suitable for pharmaceutical production clean area, including air circulation system, direct expansion refrigerating unit and control system;Air circulation system includes box, and the new air inlet and return air inlet are set to box one end, and the other end is set to air supply opening, and primary filter, heater, humidifier, circulating fan and medium filter are sequentially arranged in the inside of box along air flow direction;The evaporator of direct expansion refrigerating unit is arranged between primary filter and heater in the inside of box;Control system includes temperature and humidity sensor and PLC controller, and PLC controller controls air circulation system and direct expansion refrigerating unit work according to the environmental data collected by temperature and humidity sensor;The utility model solves the fundamental contradiction of cold load conflict, simultaneously solves the problem of control precision and stability, constitutes a high-efficiency, reliable, compliant clean area environment control solution, provides solid guarantee for product quality and compliant production.
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Description

Technical Field

[0001] This utility model relates to the field of air dehumidification, purification and temperature control in clean areas of pharmaceutical production, and in particular to an air conditioning system suitable for clean areas of pharmaceutical production. Background Technology

[0002] The current air conditioning system in the clean area of ​​the pharmaceutical production workshop is a water-cooled comfort air conditioner. Its core principle is to rely on chilled water circulating in the surface cooler. When hot and humid air flows through the low-temperature surface cooler, the moisture in the air condenses and is released, thereby achieving cooling and dehumidification. The initial design of the current air conditioning system did not strictly follow the stringent requirements of GMP (Good Manufacturing Practice) for the clean area environment.

[0003] With the optimization of production processes, large heat-generating equipment such as single-effect evaporators and reaction vessels in the workshop have been successively connected to the chilled water supply system, causing the total cooling load of the chilled water supply system to far exceed the initial design value. This leads to the core issues of fundamental conflict and system overload: Production equipment requires "pure cooling," while cleanroom air conditioning requires "cooling and dehumidification." Both share a chilled water supply system. The huge cooling load of the production equipment encroaches on the cooling capacity required by the cleanroom air conditioning. In order to prioritize the cooling needs of the production equipment, the cleanroom air conditioning has to increase the required chilled water temperature. This directly results in the surface temperature of the cleanroom air conditioning's surface cooler not being able to drop below the dew point temperature of the air, causing the dehumidification function to fail substantially. The cleanroom remains in a high-humidity state for a long time, providing a breeding ground for microorganisms and seriously increasing the risk of products being contaminated by microorganisms.

[0004] Meanwhile, the existing manual adjustment and control methods for cleanroom air conditioning are outdated, with slow response and poor accuracy, failing to meet the GMP requirements for continuous and stable monitoring of environmental parameters, further amplifying the product quality risks caused by environmental fluctuations. Utility Model Content

[0005] In order to solve the problems existing in the prior art, this utility model provides an air conditioning system suitable for clean areas in pharmaceutical production.

[0006] The technical solution of this utility model is as follows: Air conditioning systems suitable for clean areas in pharmaceutical production include air circulation systems, direct expansion refrigeration units, and control systems. The air circulation system includes a housing, with a fresh air inlet and a return air inlet at one end and an air supply outlet at the other end. Inside the housing, along the airflow direction, a pre-filter, a heater, a humidifier, a circulating fan, and a medium-efficiency filter are arranged in sequence. The evaporator of the direct expansion refrigeration unit is located inside the housing, between the primary filter and the heater. The condenser of the direct expansion refrigeration unit is located outdoors and is cooled by an outdoor fan. The control system includes a temperature and humidity sensor and a PLC controller. The temperature and humidity sensor is installed at the main air supply outlet and the main air return outlet in the clean area and is connected to the PLC controller. The PLC controller controls the operation of the air circulation system and the direct expansion refrigeration unit based on the environmental data collected by the temperature and humidity sensor.

[0007] As a preferred embodiment of this invention, the heater is a steam heater, which is connected to an external heating steam supply system via a steam pipe.

[0008] Furthermore, a steam regulating valve is installed on the steam pipeline. The steam regulating valve is communicatively connected to a PLC controller, and the opening degree of the steam regulating valve is controlled by the PLC controller.

[0009] As a preferred embodiment of this invention, the humidifier is connected to an external humidifying steam supply system via a humidifying pipe.

[0010] Furthermore, a humidification regulating valve is installed on the humidification pipeline. The humidification regulating valve is communicatively connected to the PLC controller, and the opening degree of the humidification regulating valve is controlled by the PLC controller.

[0011] As a preferred embodiment of this utility model, a water receiving tray is provided inside the casing at the bottom of the evaporator. The water receiving tray has a sloping structure, and a drain pipe is provided at the bottom of the sloping surface of the water receiving tray.

[0012] The advantages of this utility model are: By replacing the existing highly coupled shared water-cooled cold source with a new independent air-cooled cold source, the fundamental contradiction of cooling load conflict was resolved. Furthermore, by introducing PLC automatic control, the issues of control accuracy and stability were resolved. These two modifications complement each other and together constitute an efficient, reliable, and compliant cleanroom environmental control solution, providing a solid guarantee for product quality and compliant production. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the structure of this utility model; Meaning of the reference numerals in the diagram: 1-Box housing, 2-Fresh air inlet, 3-Return air inlet, 4-Supply air outlet, 5-Primary filter; 6-Heater, 7-Humidifier, 8-Circulating fan, 9-Medium-efficiency filter, 10-Drain tray; 11-Evaporator, 12-Outdoor unit, 13-Control cabinet; 14-Steam pipe, 15-Steam regulating valve; 16-Humidification pipe, 17-Humidification regulating valve. Detailed Implementation

[0014] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0015] like Figure 1 As shown, this embodiment is an air conditioning system suitable for clean areas in pharmaceutical production, including an air circulation system, a direct expansion refrigeration unit, and a control system. The air circulation system includes a housing 1, with a fresh air inlet 2 and a return air inlet 3 at one end of the housing 1, and a supply air outlet 4 at the other end. The fresh air inlet 2 is connected to the outdoor atmospheric environment. The return air inlet 3 is connected to the clean area space via a return air duct; specifically, the return air inlet 3 is connected to the end of the return air outlet of each functional room in the clean area via the return air duct. The supply air outlet 4 is connected to the clean area space via a supply air duct; specifically, the supply air outlet 4 is connected to the end of the supply air outlet of each functional room in the clean area via the supply air duct. In practical applications, high-efficiency filters can also be installed at the end of the supply air outlet of each functional room in the clean area. In this embodiment, a pre-filter 5, a heater 6, a humidifier 7, a circulating fan 8, and a medium-efficiency filter 9 are sequentially arranged inside the housing 1 along the airflow direction.

[0016] The direct expansion refrigeration unit includes components such as an evaporator 11, a compressor, a condenser, and an expansion valve. The evaporator 11, compressor, condenser, and expansion valve are connected by refrigeration pipes to form a refrigeration cycle loop, which is filled with refrigerant. The evaporator 11 of the direct expansion refrigeration unit is located inside the housing 1, between the primary filter 5 and the heater 6. In order to drain the condensate generated during dehumidification, a water collection tray 10 is provided inside the housing 1 at the bottom of the evaporator 11. The water collection tray 10 has a sloping structure, and a drain pipe is provided at the bottom of the sloping surface of the water collection tray 10. The condenser of the direct expansion refrigeration unit is located outdoors and is cooled by an outdoor fan. The compressor, condenser, expansion valve, and outdoor fan are modularly arranged in the form of an outdoor unit 12.

[0017] After the circulating fan 8 starts, fresh air from the outside first enters the housing 1 through the fresh air inlet 2 and mixes with the return air from the clean room. After being filtered by the pre-filter 5, it then passes through the evaporator 11 and the heater 6 for dehumidification and temperature control. The circulating fan 8 blows the air to the medium-efficiency filter 9 for filtration, and then it enters the clean area through the air outlet 4 and the air supply duct. The clean area air flows back into the housing 1 through the return air duct and return air outlet 3, mixes with the fresh air, and is filtered again by the pre-filter 5. This cycle repeats continuously.

[0018] The control system in this embodiment includes a temperature and humidity sensor and a PLC controller. The PLC controller is located in the control cabinet 13. The temperature and humidity sensor is located at the main air supply outlet and main air return outlet at key process points in the clean area and is connected to the PLC controller. The PLC controller controls the operation of the air circulation system and the direct expansion chiller unit based on the environmental data collected by the temperature and humidity sensor. Specifically, the circulating fan 8 of the air circulation system is connected to the PLC controller, and the PLC controller controls the speed of the circulating fan 8. The compressor and expansion valve of the direct expansion chiller unit are connected to the PLC controller, and the PLC controller controls the start and stop of the compressor and the opening degree of the expansion valve.

[0019] In this embodiment, the heater 6 is a steam heater, which is connected to an external heating steam supply system through a steam pipe 14. A steam regulating valve 15 is installed on the steam pipe 14. The steam regulating valve 15 is connected to a PLC controller and the PLC controller controls the opening of the steam regulating valve 15 to control the heating heat of the steam heater.

[0020] In this embodiment, the humidifier 7 is connected to an external humidifying steam supply system through a humidifying pipe 16. A humidifying regulating valve 17 is installed on the humidifying pipe 16. The humidifying regulating valve 17 is connected to a PLC controller and the PLC controller controls the opening of the humidifying regulating valve 17 to control the humidification humidity. When the clean area does not need dehumidification but needs humidification, the humidifier 7 is used for humidification.

[0021] This embodiment involves upgrading the existing air conditioning system in the clean area of ​​a pharmaceutical production workshop, adhering to the core principle of "load separation and precise control," and thoroughly upgrading and transforming it from two levels: the air conditioning system architecture and the control strategy.

[0022] The first step is to transform the air conditioning system architecture: from a shared water-cooled source to an independent air-cooled source; When existing air conditioning systems share a chilled water supply system, they rely on a central chiller unit to produce low-temperature chilled water, which is then pumped and piped to the surface cooler inside the existing air conditioning system enclosure. The surface cooler then exchanges heat with the air to achieve dehumidification. The main drawback of this dehumidification method is that the existing air conditioning system is large and highly coupled. The cooling load of the workshop production equipment and the cooling load required by the air conditioning system are superimposed and all are borne by the same central chiller unit. This inevitably leads to the air conditioning system operating under non-design conditions, and the dehumidification function, which has higher requirements for the temperature of the cold source, is the first to be affected.

[0023] The air conditioning system in this embodiment uses an independent air-cooled cold source and relies on a direct expansion refrigeration unit for cooling. Its working principle is that the refrigerant expands and evaporates directly in the evaporator 11 (replacing the original surface cooler) inside the casing 1, absorbing heat. This makes the surface temperature of the evaporator 11 lower than the dew point temperature of the air. When air flows through the evaporator 11, which is at a temperature lower than the dew point temperature, the moisture in the air condenses and precipitates out, thereby achieving dehumidification. The air conditioning system in this embodiment is dedicated to environmental control in clean areas and is completely separated from the chilled water supply system of the workshop production equipment, forming a cooling load separation. From then on, no matter how large the cooling load generated by the production equipment is, it will no longer impact or affect the cooling capacity and dehumidification capacity of the air conditioning system.

[0024] Meanwhile, the air conditioning system in this embodiment uses direct expansion refrigeration to lower the surface temperature of the evaporator 11, ensuring strong dehumidification capacity and effect, and can solve the high humidity problem in the clean area from the root. The air conditioning system in this embodiment uses an independent air-cooled cold source, has a compact structure, fast response speed, and stable operation, and is more suitable for clean areas that require continuous and stable environmental control.

[0025] Secondly, the control strategy needs to be transformed: from manual adjustment and control to PLC automatic control; This embodiment eliminates the manual adjustment and control of the current air conditioning system and introduces a fully automatic control system with a PLC controller (programmable logic controller) as the core. High-precision temperature and humidity sensors are deployed at key process points in the clean area to collect environmental data in real time. The PLC controller compares the collected real-time environmental data with the preset temperature and humidity values ​​required by GMP specifications (e.g., temperature 18-24℃, relative humidity 45%-65%). When the air humidity exceeds the standard, the PLC controller commands the expansion chiller to start or enhance cooling, prioritizing dehumidification. When the air temperature is low but the humidity is moderate, the PLC controller controls the opening of the steam regulating valve 15 to control the heating heat of the steam heater and heat the air as needed.

[0026] The PLC controller achieves decoupled control of temperature and humidity in the clean area by comprehensively regulating the compressor start / stop, expansion valve opening, circulating fan speed, steam regulating valve opening, and humidification regulating valve opening, ensuring that both temperature and humidity in the clean area remain stable within the set range.

[0027] This embodiment of the air conditioning system uses an independent air-cooled cold source, avoiding cold load interference. Combined with feedback from temperature and humidity sensors and control by a PLC controller, the temperature and humidity fluctuations in the clean area are controlled within an extremely narrow range, completely eliminating condensation and dampness in the clean area, and achieving "unattended" automatic control, significantly reducing labor costs and the risk of operational errors. The modified air conditioning system can meet the constant temperature and humidity requirements of the clean area, realize real-time monitoring of environmental parameters, and fully meet the GMP requirements for hardware facilities and quality management systems. The stable and dry environment of the clean area will greatly inhibit the growth and reproduction of microorganisms, reducing the risk of microbial contamination of products from the source, especially the risk of microbial contamination of dipotassium products.

[0028] This embodiment of the air conditioning system resolves the fundamental contradiction of cooling load conflict by replacing the existing highly coupled shared water-cooled cold source with a new independent air-cooled cold source; furthermore, by introducing PLC automatic control, it solves the problems of control accuracy and stability. The two modifications complement each other and together constitute an efficient, reliable, and compliant cleanroom environmental control solution, providing a solid guarantee for product quality and compliant production.

[0029] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" 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 utility model 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 utility model.

[0030] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," "setting," and "forming" should be interpreted broadly; for example, they can refer to fixed connections or settings, detachable connections or settings, or integrated structures; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium, or internal connections between two components; those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0031] The above embodiments are only used to illustrate the technical solutions of this utility model. Those skilled in the art should understand that the above embodiments do not limit this utility model in any way. All technical solutions obtained by equivalent substitution or equivalent transformation fall within the protection scope of this utility model.

Claims

1. An air conditioning system suitable for clean areas in pharmaceutical production, characterized in that: This includes the air circulation system, the direct expansion refrigeration unit, and the control system; The air circulation system includes a housing, with a fresh air inlet and a return air inlet at one end and an air supply outlet at the other end. Inside the housing, along the airflow direction, a pre-filter, a heater, a humidifier, a circulating fan, and a medium-efficiency filter are arranged in sequence. The evaporator of the direct expansion refrigeration unit is located inside the housing, between the primary filter and the heater. The condenser of the direct expansion refrigeration unit is located outdoors and is cooled by an outdoor fan. The control system includes a temperature and humidity sensor and a PLC controller. The temperature and humidity sensor is installed at the main air supply outlet and the main air return outlet in the clean area and is connected to the PLC controller. The PLC controller controls the operation of the air circulation system and the direct expansion refrigeration unit based on the environmental data collected by the temperature and humidity sensor.

2. The air conditioning system for clean areas in pharmaceutical production according to claim 1, characterized in that, The heater is a steam heater, which is connected to an external heating steam supply system via a steam pipe.

3. The air conditioning system for clean areas in pharmaceutical production according to claim 2, characterized in that, A steam regulating valve is installed on the steam pipeline. The steam regulating valve is connected to a PLC controller and the opening degree of the steam regulating valve is controlled by the PLC controller.

4. The air conditioning system for clean areas in pharmaceutical production according to claim 1, characterized in that, The humidifier is connected to an external humidifying steam supply system via humidification pipes.

5. The air conditioning system for clean areas in pharmaceutical production according to claim 4, characterized in that, A humidification regulating valve is installed on the humidification pipeline. The humidification regulating valve is connected to a PLC controller and the opening degree of the humidification regulating valve is controlled by the PLC controller.

6. The air conditioning system for clean areas in pharmaceutical production according to claim 1, characterized in that, A water collection tray is installed inside the casing at the bottom of the evaporator. The water collection tray has a sloping structure, and a drain pipe is installed at the bottom of the sloping surface of the water collection tray.