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Why does the pharmaceutical production environment require an online temperature and humidity monitoring system
Date: 2025-04-23Read: 4
In the pharmaceutical production process, temperature and humidity monitoring is a key link to ensure product quality and safety, and is an important parameter for evaluating whether the drug production process meets specifications. With the advancement of industrial technology, the improvement of regulatory requirements, and the industry's demand for refined product quality control, digitization and intelligence are becoming increasingly importantTemperature and humidity monitoring systemMore and more pharmaceutical manufacturers are favoring it.


This article will take Rozhnik's RMS temperature and humidity online real-time continuous monitoring system as an example to understand how digital and intelligent monitoring methods help pharmaceutical companies meet strict industry standards, efficient quality control requirements, and electronic data management.



Real time online monitoring system for temperature and humidity




The temperature and humidity monitoring system is actually a part of the environmental monitoring system (EMS), which is a computer-based monitoring system composed of hardware and software, installed in the monitoring area to collect the environmental conditions (temperature, relative humidity) of the area.


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The RMS temperature and humidity online real-time monitoring system was developed by Rozhnik and Novartis in Switzerland. With its convenience, flexibility, precision, reliability, time-saving, labor-saving, and compliance traceability, it has been increasingly accepted by pharmaceutical companies and has become an integral part of automated environmental control systems.

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The RMS system can be expanded at any time, supporting input and output from other third-party devices (such as particle counters, air flow meters, and other parameters), providing real-time chart analysis, historical data queries, alarm logs, audit tracking, and other functions. It can be alerted through voice calls, SMS, or email. User permissions can also be set, such as administrator, operator, auditor, etc., to prevent unauthorized modifications.




Advantages of online real-time monitoring system for temperature and humidity




The online continuous monitoring system for temperature and humidity has gradually replaced the traditional methods of mechanical, manual recording, and localized equipment, because its own advantages better match the modern environmental management needs of pharmaceutical companies. Taking the RMS monitoring system as an example, let's take a look at its main advantages.


1
Integrity and continuity of data


The temperature and humidity online monitoring system does not require manual fixed-point inspections or paper records. After the deployment is completed, the recorder will continuously and automatically collect data in real time and transmit it to the data management platform, ensuring the integrity and continuity of the data. The RMS monitoring system can record data even in the event of a power outage (with backup batteries) and automatically transmit the data to the monitoring platform after returning to normal, ensuring compliance with GMP's strict requirements for data integrity.
2
Compliance and Traceability


The electronic records provided by the RMS monitoring system comply with the requirements of GMP (Good Manufacturing Practice)/GLP (Good Laboratory Practice)/GDP (Good Distribution Practice) and FDA 21 CFR Part 11, with timestamps to prevent tampering. 24-hour real-time centralized monitoring of all operation logs, allowing for viewing of events and times such as user login, data export, parameter modification, etc., providing a complete audit trail.
3
Call the police promptly


The RMS monitoring system can preset alarms and action limits, and provide real-time alerts through voice calls, text messages, or emails to remind responsible persons of exceeding limits. This helps to adjust on-site environmental conditions in a timely manner to avoid interference with production, storage, and other processes. The network camera can take snapshots and add them to automatically created reports. It supports remote monitoring of applications and can be viewed in real-time by hovering the mouse.


In short, the advantages of temperature and humidity monitoring systems make the risks of pharmaceutical factories more controllable, management more compliant, and efficiency more efficient.