紧跟国家行业政策监管要求。 ※ Follow closely the national industry policy supervision requirements.
现场标定功能,可二次校准,避免长时间使用后温漂带来的精度影响。 ※ The on-site calibration function can be re-calibrated to avoid the accuracy impact caused by temperature drift after long-term use.
记录仪断电记录功能,断电后就地数据正常记录。 ※ The recorder's power-off recording function can record the local data normally after power-off.
数据恢复功能,监控主机断电或故障后,恢复后可将本地数据自动读回。 ※ Data recovery function. After the monitoring host is powered off or faulty, the local data can be read back automatically after recovery.
积木式扩展功能,方便增加检测点位,增加方便;系统应能实现接受药品监督管理部门实时监管的条件。 ※ The building block type expansion function is convenient for adding detection points and convenience; the system should be able to realize the conditions for real-time supervision by the drug supervision and administration department.
优异的软件功能,使用统一的监控平台,实现全程有效管理。 ※ Excellent software functions, using a unified monitoring platform to achieve effective management throughout.
低功耗 低功耗设计。 ※ Low power consumption Low power design.
As a special commodity, medicine is directly related to people's life and health issues. How to ensure the quality and safety of drugs in the production, transportation and storage of drugs is an important issue of common concern to government drug regulatory departments and pharmaceutical enterprises at all levels. As an important part of drug circulation, drug storage occupies a pivotal position in the process of drug circulation, and it is also an area that pharmaceutical supervision departments focus on at present.
For pharmaceutical distribution companies, there are 132 inspection items involving GSP certification, including 37 key items. Each GSP inspection becomes a major examination for pharmaceutical distribution companies. The GSP standard puts forward specific and clear requirements on the warehouse area and equipment management system. For enterprises that fail the GSP inspection, the state adopts a one-vote veto system and is not allowed to enter the pharmaceutical industry. For example, enterprises have warehouses suitable for classified drug storage and drug storage requirements. Among them, the temperature of the normal temperature storehouse is not higher than 30 degrees Celsius; the temperature of the cool storehouse is not higher than 20 degrees Celsius; the temperature of the cold storehouse is 2-8 degrees Celsius; the relative humidity of each storehouse should be maintained between 35% and 75%. The pharmaceutical distribution industry must have certain strength as the basis.
Proper temperature and humidity environment is the first condition to ensure the safety of drug storage. How to effectively monitor the temperature and humidity of the drug storage environment is a common concern for drug dealers and drug regulatory authorities. The newly revised drug GSP clearly stipulates that enterprises should adopt an automatic temperature and humidity monitoring system for drug warehouses to implement continuous and effective real-time monitoring of the storage environment; through automatic monitoring and data collection of the temperature and humidity of the warehouse environment, the temperature and humidity of the warehouse should be implemented by Hours of continuous, automatic monitoring and real-time recording. Each warehouse (or warehouse) should be equipped with multiple temperature and humidity monitoring equipment for automatic monitoring of the temperature and humidity of the warehouse and data collection; specific facilities and equipment are required for storage, transportation of refrigerated and frozen drugs.
The company has been focusing on the development and improvement of effective warehouse environment monitoring throughout the process and has accumulated rich experience. It will make a reasonable and effective management plan for the temperature and humidity management of drugs in pharmaceutical companies.
Part of the requirements for automatic monitoring and alarm system of temperature and humidity in pharmaceutical warehouses
According to the "Administrative Measures for the Management of Drug Business Licenses", the new version of "Good Manufacturing Practices for Drugs Management Standards" and the requirements of drug regulatory agencies, while reducing the monitoring costs of pharmaceutical companies and obtaining good monitoring results, automatic temperature and humidity monitoring mainly adopts the following methods:
First, automatic monitoring and recording of temperature and humidity
1. The enterprise shall be equipped with an automatic temperature and humidity monitoring system (hereinafter referred to as the system) in the warehouse where the medicine is stored and the equipment for transporting refrigerated and frozen medicine.
2. The system shall automatically monitor and record the temperature and humidity conditions of the drug storage process and the temperature conditions of the refrigerated and frozen drug transportation process in real time.
3. The system consists of measurement terminal, management host, uninterruptible power supply and related software. Each measuring point terminal can collect, transmit and alarm the temperature and humidity of the surrounding environment in real time. The management host can collect, process and record the data monitored by each measuring point terminal, and has the function of alarm management when abnormal conditions occur.
4. The measured values of the temperature and humidity data of the system shall be set in accordance with the relevant provisions of Article 85 of the Code.
5. The system should automatically generate temperature and humidity monitoring records, including the temperature value, humidity value, date, time, measurement point location, reservoir area or transportation vehicle category.
6.The allowable error of the system temperature and humidity measurement equipment should meet the following requirements:
6.1 The measurement range is between 0 ℃ ～ 40 ℃, the allowable error of temperature is ± 0.5 ℃;
6.2 The measurement range is between -25 ℃ ～ 0 ℃, and the allowable error of temperature is ± 1.0 ℃;
6.3 The allowable error of relative humidity is ± 5% RH.
7. The system should automatically monitor and record the temperature and humidity environment during the storage and transportation of drugs.
7.1 The system should update the temperature and humidity data of the measurement points at least once every 1 minute.
7.2 Automatically record real-time temperature and humidity data at least every 30 minutes during drug storage.
7.3 Automatically record real-time temperature data at least every 5 minutes during transportation.
7.4 When the monitored temperature and humidity value exceeds the specified range, the system should record real-time temperature and humidity data at least every 2 minutes.
8. When the monitored temperature and humidity value reaches the set critical value or exceeds the specified range, the system should be able to implement audible and visual alarms on-site and at designated locations, and at the same time use SMS communication to send alarm messages to at least 3 designated personnel . When a power outage occurs, the system should send a warning message to at least 3 designated personnel by means of SMS communication.
9. The monitoring data collected by each measuring point terminal of the system shall be true, complete, accurate and effective.
9.1 The data collected by the measurement terminal is automatically transmitted to the management host through the network for processing and recording, and the data is saved in a reliable manner to ensure that it is not lost and unchanged.
9.2 The system has the function that the recorded data cannot be changed or deleted, and it must not have the function of importing data in the reverse direction.
9.3 The system shall not open the function of temperature and humidity sensor monitoring value correction and adjustment to the user to prevent the user from adjusting at will and causing distortion of the monitoring data.
10. The enterprise shall adopt a safe and reliable method to back up the monitoring data on a daily basis. The backup data shall be stored in a safe place. The time limit for data storage shall meet the requirements of Article 42 of the Code.
11. The system should be docked with the computer terminal of the enterprise and automatically store the data in the computer terminal. Real-time data query and historical data query can be performed through the computer terminal.
12. The system should operate independently and uninterruptedly to prevent the normal operation of the system or data loss due to factors such as power interruption, computer shutdown or failure.
13. The system maintains independent and safe operation, and must not be linked with temperature and humidity control facilities and equipment to prevent the risk of system failure caused by abnormal temperature and humidity control facilities and equipment.
14. The enterprise shall test and confirm the layout of the measurement terminal terminals of the storage and transportation facilities and equipment to ensure that the number and location of the measurement terminal terminals installed in the pharmaceutical warehouse and transportation equipment can accurately reflect the actual temperature and humidity of the environment.
15. The measuring point terminal shall be firmly installed in a confirmed and reasonable position to avoid the storage and transportation operations and personnel activities from affecting or damaging the monitoring equipment, and its installation position shall not be changed at will.
16. The enterprise shall calibrate the measuring terminal at least once a year, and shall regularly inspect, repair and maintain the system equipment and establish a file.
17. The system should meet the conditions for online remote supervision by relevant departments.
Collection and layout rules of temperature and humidity automatic monitoring system
1.Each independent drug warehouse or warehouse should be installed with at least 2 measuring point terminals and evenly distributed.
1.1 If the area of the flat warehouse is less than 300 square meters, install at least 2 measuring point terminals; for those over 300 square meters, add at least 1 measuring point terminal for every additional 300 square meters. If the area is less than 300 square meters, the calculation will be based on 300 square meters.
1.2 The installation position of the measuring point of the flat warehouse shall not be lower than 2/3 of the height of the medicine shelf or medicine stacking height.
1.3 For high-bay warehouses or fully automatic three-dimensional warehouses with shelf heights between 4.5 meters and 8 meters, at least 4 measuring terminal terminals are installed for every 300 square meters, and at least 2 measuring terminal terminals are added for each additional 300 square meters. It is distributed on the shelves and lower levels; if the shelf height is more than 8 meters, at least 6 measuring terminal terminals are installed for every 300 square meters, and at least 3 measuring terminal terminals are added for each additional 300 square meters, and they are evenly distributed on the shelves. Lower, middle and lower ranks; less than 300 square meters are calculated as 300 square meters. The installation location of the upper-level measuring point terminal of the elevated warehouse or full-automatic three-dimensional warehouse shall not be lower than the location of the upper shelf for storing medicines.
1.4 The installation quantity of the measuring terminal of the storage refrigerated and frozen medicine warehouse shall meet the requirements of the above items in this article, and the installation quantity shall be calculated per 100 square meters of area.
1.5 Each independent refrigerated or frozen medicine transport vehicle or compartment must have at least two temperature measurement terminal terminals installed.
1.6 If the volume of the carriage exceeds 20 cubic meters, at least 1 additional measuring point terminal will be added for each additional 20 cubic meters. If the volume is less than 20 cubic meters, it will be calculated as 20 cubic meters.
1.7 Each refrigerated box or incubator should be equipped with at least one measuring terminal.
3. The system should have emergency safeguard measures, which can operate independently and uninterruptedly, and should not affect the normal operation of the system or cause data loss due to factors such as power interruption, computer shutdown or failure.
Configuration scheme: Adopt temperature and humidity recorder with power supply, automatically switch equipment backup power in the case of power failure, and automatically collect recorded data, automatically switch to system power supply after a call, and can charge in real time, and the data can be downloaded to the local area after power on. System to achieve 7 * 24 hours uninterrupted operation;
Four, temperature and humidity automatic alarm
The temperature and humidity automatic monitoring system shall have the command output function of the control node. When the average temperature and humidity in the warehouse is close to the specified upper and lower limit thresholds or exceeds the specified range, the system should be able to implement local and specified sound and light alarm functions or SMS alarm functions. This product comes with a buzzer alarm.
Fifth, the system can realize the conditions for real-time supervision of the drug regulatory department.
Part two, overview of temperature and humidity automatic monitoring and alarm system
环境监控系统,能适用于各类型的冰箱,培养箱,冷库,医药库房、烟草库房、图书馆档案室等各行业温湿度的监测。 Xinxin IoT environmental monitoring system can be used to monitor the temperature and humidity of various types of refrigerators, incubators, cold storage, medical warehouses, tobacco warehouses, library archives and other industries.
Xinxin IOT environmental monitoring system can monitor the temperature and humidity of a large area and multiple points, and transfer the data to a PC for data storage and analysis, and output print curves. The data can be output in various forms. The temperature and humidity monitoring interface can be easily viewed in list form and trend chart form. In the event of equipment abnormality, various types of alarms are also used to notify the corresponding personnel; at the same time, the system has a powerful hierarchical management function, which provides a multi-level management and monitoring platform for user management at different levels. The system also has good extensibility, which provides huge expansion space for users' future function expansion.
Temperature and humidity controller can be equipped on site to set the temperature and humidity controller's upper and lower limits. Switch on and off the air conditioner and dehumidifier through the controller output signal to achieve the temperature and humidity range requirements set by the user.
The system combines SMS and GSM short message technology, and uses the global resources of the Internet to create a low-cost, feature-rich unattended factory environment temperature and humidity solution . When the laboratory's environmental indicators are abnormal, short message alarms can be set, and short messages can be sent in batches, and different duty personnel can be notified at different times to fully realize unattended remote monitoring.
The basic functions of the system include: real-time monitoring data display, over-line alarms, real-time recording of monitoring data and alarm data, real-time graphs, historical data query printing, automatic generation of historical graphs, historical data export, automatic data backup, system operation logs, multi-country Language selection, user rights management.
The system has a reasonable design, strong expandability, safe and reliable equipment control, flexible and diverse control methods, easy maintenance, low system upgrade costs, and good scalability.
The concept of cold chain logistics generally refers to a systematic project in which temperature-sensitive products are always in a prescribed low temperature environment during production, storage, transportation, and sales, and before consumption. . Foods that need to be transported in the cold chain are generally cold drinks, dairy products, meat products, medicines, vaccines and so on. Most of these dairy products need to be in the low temperature cold chain during the whole process to ensure the quality.The storage temperature of dairy products during the entire distribution and sales is specified as 0-10 ℃; the temperature of the mall or supermarket refrigerators and cold air cabinets should be controlled at about 2-6 ℃ . Most of the medical blood, biological agents and medicines, because of the instability of the proteins they contain, make biological medicines susceptible to environmental temperature changes, leading to deterioration of medicines, blood and vaccines, so strict temperature control is even more necessary.
How to prove that the temperature is within the specified range during the logistics process, and how to promptly remind the relevant personnel when the temperature exceeds the specified range, is critical to guarantee the cold chain logistics. Xinxin IOT wireless vehicle temperature monitoring alarm system stores the temperature of the refrigerated truck in the recorder in real time, and transmits it back to the management center through the wide-covering GPRS network and CDMA network. When the temperature exceeds the range, an audible and visual alarm is issued. Remind those who follow the car, and send SMS alarm to relevant personnel in the management center.
The third part, the main software and hardware products
First, software system functions
The system can run 24 hours, monitor the temperature and humidity changes of the drug storehouse stably for a long time, and realize unattended intelligent management.
Temperature and humidity real-time monitoring system configuration
数据统计分析功能 1.Data statistical analysis function
Real-time display or historical display of each parameter curve of the room, can simultaneously display the environmental parameter curves of multiple different rooms, more convenient for comparison and analysis. It can display parameter list, real-time curve graph (corresponding to specific values and adjust coordinates arbitrarily), real-time data, conversion data, cumulative data, history, alarm screen, reports and other display, statistical functions are more close to user needs.
数据存储功能 2.Data storage function
All data are collected and recorded on the host computer, and the data can be automatically backed up, printed, archived, etc. regularly according to the requirements of the user.
打印/报表功能 3.Print / Report Function
Scheduled printing (select line or page by page) and manual printing (including screen, curve, parameter and report); and can output reports in different formats according to the specific requirements of the user, such as: PDF, WORD, EXCEL, TXT, HTML, etc.
超限报警功能 4. Over-limit alarm function
When the parameters are abnormal, SMS alarm, short message group sending can be set, and different duty personnel can be notified at different times.
用户分级管理 5. User hierarchical management
Different operators enter the system for operation with different user names and passwords. The administrator account is used to authorize user accounts and to define the permission level of each account. Super users can configure various functional modules, configure the permissions of ordinary users, and check usage logs. Ordinary users can perform daily monitoring and management. Passwords for all levels of users will be changed periodically to ensure security.
6. Log comments
According to the administrator's settings, the corresponding system events and alarm conditions will be recorded, and the corresponding important operations will be required to enter comments before proceeding.
System hardware equipment
、一体式无线物联温湿度监测采集记录仪 1.Integrated wireless IoT temperature and humidity monitoring acquisition recorder
Features: Designed to meet high accuracy requirements: no need to configure UPS, no external sound and light alarm, automatic recording, automatic alarm
Xinxin Wulian H series intelligent temperature and humidity data logger is an LCD screen display, high precision and large storage instrument developed by the company, which is suitable for agricultural research, food, medicine, chemical, meteorology, environmental protection, electronics, laboratory and other fields Monitoring records of multiple climate parameters.
This sensor is an independent design of our company that draws on the advantages of similar foreign products and combines the characteristics of our country. It can record temperature and humidity and other climatic parameters. ,将采样数据保存在记录仪存储器内。 The high-precision integrated temperature and humidity digital sensor imported from Switzerland is used to save the sampling data in the recorder memory. It can also transfer the collected data to the computer for processing and upload to the cloud. The sensor is powered by a high-energy lithium battery and can be optionally equipped with an external power supply, which is small and portable, and the power consumption of the whole machine is very small.
The short message control system is specially used in computer rooms, warehouses, laboratories and other places. In the case, the user needs to build a mobile phone card into the SMS alarm host, and set the alarm value of the upper and lower limits of temperature and humidity through the monitoring platform. When used, once the upper and lower limits are exceeded, an alarm SMS will be sent to the user's mobile phone (or choose to dial out Alarm), support multiple groups of mobile numbers to alarm at the same time.
Part IV. Service Commitment
Chengdu Xinxin Electronic Technology Co., Ltd. (hereinafter referred to as "our company"), in order to better serve users, do a good job of guiding and using timely after-sales service, make the following commitments to users: all products sold by our company can provide free sales Prior technical consultation and corresponding after-sales technical support.
Our products enjoy a 12-month warranty (subject to the contract warranty period) and system software free lifetime upgrade service. Product repairs performed beyond the warranty period are charged at a cost.
Customers can contact our company's after-sales service personnel at any time.After dialing the fault report and repair phone, our engineers will contact the customer within 2 hours to understand the failure phenomenon, determine the maintenance issues, propose solutions, and solve the user system at a fast speed. Problems. If there is a need for on-site guidance, the company will arrange relevant professionals to provide guidance to the designated location within 48 hours. In order to do better after-sales service and receive user feedback in a timely manner! The company has a special after-sales service phone: 400-662-8160 There are professionals to answer and promptly make feedback records, and provide corresponding methods to solve problems Provide round-the-clock, no-weekend response services.
On-site repair service
First, we provide free maintenance for the system equipment during the warranty period.
The following conditions are not covered by the warranty, and we will implement fee-based services:
1.The product has problems during abnormal use;
2.Store and expose the product to an environment beyond the product's appropriateness;
3.Unauthorized repair, misuse, negligence, abuse, accident, alteration, incorrect installation;
4.Damage caused by food or liquid splashing;
5. Factors caused by force majeure;
For the system maintenance caused by the above situation, the customer shall bear the cost of parts and components and maintenance labor costs. The ordinary parts are subject to the market price. All the maintenance costs charged are issued by the invoice or receipt.
3. For system maintenance beyond the warranty period, the customer shall bear the cost of parts and components and maintenance labor costs. The maintenance staff will explain to the customer and show the charging standard before the maintenance. After obtaining consent, our company will carry out the maintenance. We will provide the customer with a valid invoice or receipt for the maintenance fee charged.
操作人员培训 Part V. Operator Training
Our company is responsible for the purchaser's use, maintenance personnel for equipment installation, commissioning, use and daily maintenance free training, until the staff are proficient. 在今后使用过程中,对于采购方提出的任何关于本系统的技术问题,我方无条件予以回答,直至采购方满意为止具体的培训内容包括: The training process guarantees patience and meticulousness, and the completion of the training guarantees the transfer of detailed technical information. In the future use process, we will answer any technical questions raised by the purchaser unconditionally until the purchaser is satisfied. The training content includes:
1.System architecture and related technologies;
2.System installation and commissioning;
3. System administrator and user training.
4. Knowledge and precautions for correct operation of the equipment.
5. Identify primary failures and necessary recovery methods and common troubleshooting methods.