Clean area environment monitoring system

Abstract

The utility model relates to the technical field of biopharmaceutical clean workshops, and discloses a clean area environment monitoring system, which comprises an environment monitoring module, a personnel monitoring module and a process equipment monitoring module, and is characterized in that the environment monitoring module comprises a temperature and humidity data monitor, a pressure difference data monitor and a wind speed data monitor which can be used for acquiring the environment of a clean area; the temperature and humidity data monitoring module, the pressure difference data monitoring module and the wind speed data monitoring module are connected with the monitoring server through an RS485 bus, the personnel monitoring module comprises a personnel identification access control system and regional people number limitation, and the personnel identification access control system and the regional people number limitation are connected with the personnel monitoring server. Compared with the prior art, the utility model has the advantages that the monitoring of temperature, humidity and pressure difference is more intelligent, the personnel control is enhanced, the influence of personnel on environmental parameters is reduced, and the product quality is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of clean workshops for biopharmaceuticals, specifically referring to an environmental monitoring system for clean areas. Background Technique

[0002] In the field of biopharmaceuticals, the "Good Manufacturing Practice" (GMP) for drugs, as the basic criterion for drug production, plays a crucial role in the domestic biopharmaceutical industry. It covers all factors affecting drug quality. Article 48 of the "Good Manufacturing Practice for Drugs (Revised in 2010)" stipulates that an air-conditioning purification system should be configured according to drug varieties, production operation requirements, external environmental conditions, etc., to ensure effective ventilation in the production area, with temperature, humidity control, and purification filtration, so as to ensure that the production environment of drugs meets the requirements. The pressure difference between the clean area and the non-clean area, as well as between different levels of clean areas, should not be less than 10 Pascals. When necessary, an appropriate pressure difference gradient should also be maintained between different functional areas (operation rooms) with the same cleanliness level. Article 58 states that the storage area should be able to meet the storage conditions (such as temperature, humidity, light protection) and safety storage requirements of materials or products. The provisions of many articles illustrate the importance of environmental requirements.

[0003] In the previous environmental control process, it was difficult to ensure the timeliness of the monitoring of temperature, humidity, and pressure difference, and the recording of the environmental state remained at single-point recording, with a long recording cycle, low credibility, and no control over personnel in the clean area. The frequent entry and exit of personnel caused the environmental parameters in this area to always be in an alarm state. These factors directly affect the quality of biopharmaceutical products. Content of the Utility Model

[0004] (1). Technical Problems to be Solved

[0005] The technical problem to be solved by the utility model is that the monitoring of temperature, humidity, and pressure difference is not intelligent, lacking personnel control, which affects environmental parameters and further affects the quality of pharmaceutical products.

[0006] (2). Technical Solutions

[0007] To solve the above technical problems, the technical solution provided by the present utility model is: a clean area environment monitoring system, including an environment monitoring module, a personnel monitoring module, and a process equipment monitoring module. The environment monitoring module includes temperature and humidity data monitoring, differential pressure data monitoring, and wind speed data monitoring that can collect the environment of the clean area. The temperature and humidity data monitoring, differential pressure data monitoring, and wind speed data monitoring are connected to the monitoring server through the RS485 bus. The personnel monitoring module includes a personnel identification access control system and a regional personnel number limit. The personnel identification system and the regional personnel number limit are connected to the personnel monitoring server. The process equipment monitoring module includes the production progress monitoring and process flow monitoring of process equipment. The production progress monitoring and process flow monitoring of the process equipment are connected to the process equipment server. The monitoring server, the personnel monitoring server, and the process equipment server as a whole adopt a CS network architecture, and data is sorted out through the server and centrally monitored through the HMI human-machine interaction screen.

[0008] Further, the process equipment monitoring module further includes a monitoring camera that can observe the current production situation and process operations within the observable area. The monitoring camera is connected to the monitoring server.

[0009] Further, the personnel identification access control system adopts face recognition or fingerprint recognition methods.

[0010] (III) Beneficial effects

[0011] The advantages of the present utility model compared with the prior art are as follows:

[0012] Through temperature and humidity data monitoring, differential pressure data monitoring, and wind speed data monitoring, it is convenient to monitor the temperature and humidity, differential pressure, and wind speed of the room, and transmit the data to the monitoring server. At the same time, transmit the data of the personnel identification system and the regional personnel number limit to the personnel identification system and the regional personnel number limit, and transmit the production progress monitoring and process flow monitoring of the process equipment to the process equipment server, which is convenient to centrally monitor the environment monitoring module, the personnel monitoring module, and the process equipment monitoring module through the HMI human-machine interaction screen, reduce labor costs, avoid the inaccuracy of manual inspections and the interference to the clean room environment, improve the stability of the clean workshop parameters, and also facilitate the real-time monitoring of the entire production process. Description of the drawings

[0013] Figure 1 It is a schematic structural diagram of the clean area environment monitoring system of the present utility model. Specific implementation manners

[0014] The following will clearly and completely describe the technical solutions in the embodiments of the present utility model in conjunction with the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all the embodiments; based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the protection scope of the present utility model.

[0015] The clean area environment monitoring system includes an environment monitoring module, a personnel monitoring module, and a process equipment monitoring module. The monitoring server, the personnel monitoring server, and the process equipment server as a whole adopt a CS network architecture. Data is sorted through the server, and centralized monitoring is carried out through the HMI human-machine interaction screen.

[0016] Among them, the environment monitoring module includes temperature and humidity data monitoring, differential pressure data monitoring, and wind speed data monitoring that can collect the environment of the clean area. The temperature and humidity data monitoring, differential pressure data monitoring, and wind speed data monitoring are connected to the monitoring server through the RS485 bus;

[0017] By monitoring the supply air duct, return air duct, exhaust air duct, etc., and adjusting the temperature and humidity of the supply air, return air, and exhaust air to adapt to the indoor temperature and humidity requirements. At the same time, the control system drives the fan to control the air volume ratio between the fresh air, return air, and exhaust air to maintain an appropriate differential pressure, so as to effectively achieve precise control of environmental conditions such as room temperature, humidity, and differential pressure to avoid sample contamination and ensure the accuracy of experimental results; in case of a fire, immediately close the fresh air and return air systems and turn on the exhaust air system to discharge the smoke and ensure the safety of personnel.

[0018] The personnel monitoring module includes a personnel identification access control system and a regional personnel number limit. The personnel identification system and the regional personnel number limit are connected to the personnel monitoring server. The personnel identification access control system adopts face recognition or fingerprint recognition methods;

[0019] Through the above structure, it is convenient to manage and control the personnel in the clean area, and prevent the environmental parameters of this area from fluctuating due to frequent entry and exit of personnel, which affects the stability of microbial culture.

[0020] The process equipment monitoring module includes the production progress monitoring and process flow monitoring of process equipment. The production progress monitoring and process flow monitoring of process equipment are connected to the process equipment server. The process equipment monitoring module also includes a monitoring camera, which can observe the current production situation and process operations within the observable area. The monitoring camera is connected to the monitoring server.

[0021] Through the cooperative setting of the above structure, it is convenient to observe the current production situation and the correctness of process operations within the monitoring camera's field of view, accurately control the process flow, and achieve accurate and efficient environmental control in the clean area to ensure product quality.

[0022] Through the cooperative setting of the above structure, it is convenient to monitor the production progress and process flow of process equipment in real time, avoiding

[0023] It should be noted that in this text, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variation thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article or device.

[0024] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

[0025] The above describes the present invention and its implementation manners, and this description is not restrictive. What is shown in the drawings is only one of the implementation manners of the present invention, and the actual structure is not limited thereto. Generally speaking, if those of ordinary skill in the art are inspired by it and design similar structural manners and embodiments without creative efforts without departing from the creative purpose of the present invention, they shall fall within the protection scope of the present invention.

Claims

1. Clean area environment monitoring system, characterized by: It includes an environment monitoring module, a personnel monitoring module, and a process equipment monitoring module. The environment monitoring module includes temperature and humidity data monitoring, pressure difference data monitoring, and wind speed data monitoring that can collect clean area environment. The temperature and humidity data monitoring, pressure difference data monitoring, and wind speed data monitoring are connected to the monitoring server through an RS485 bus. The personnel monitoring module includes a personnel identification access control system and an area number limit. The personnel identification system and the area number limit are connected to the personnel monitoring server. The process equipment monitoring module includes production progress monitoring and process flow monitoring of process equipment. The production progress monitoring and process flow monitoring of the process equipment are connected to the process equipment server. The monitoring server, personnel monitoring server, and process equipment server adopt a CS network architecture as a whole, organize data through the server, and centrally monitor through the HMI human-computer interaction screen.

2. The clean area environment monitoring system according to claim 1, characterized in that: The process equipment monitoring module also includes a monitoring camera, which can observe the current production situation and process operation in the area, and the monitoring camera is connected to the monitoring server.

3. The clean area environment monitoring system according to claim 1, characterized in that: The personnel identification access control system adopts face recognition or fingerprint recognition.

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