EMS collects environmental data (temperature, humidity, pressure, dust particle count, etc.) in real-time through a network of sensors and dynamically adjusts environmental conditions in conjunction with an automated control system to ensure compliance with GMP standards.

The core functions include:
• Real-time Monitoring: Continuous tracking of environmental parameters 24 hours a day.
• Automated Control: Proactive adjustment of equipment (such as air conditioning and purification systems) when parameters are abnormal.
• Data Management: Comprehensive recording, storage, retrieval, and analysis of historical data.
• Alert Mechanism: Immediate alarms and notifications to personnel when limits are exceeded.
• Compliance Support: Generation of audit trail reports and visual charts.

Lasensor FMS Cleanroom Monitoring System

In the modern pharmaceutical industry, Environmental Monitoring Systems (EMS) are crucial for ensuring the quality of pharmaceutical products. The stringent global pharmaceutical regulatory systems and the demand for patient safety require pharmaceutical companies to control parameters such as temperature, humidity, pressure, and dust particle counts within specified limits in their production environments, in order to comply with Good Manufacturing Practices (GMP). EMS ensures the stability and controllability of the production environment by real-time monitoring and automatic adjustment of environmental parameters, reduces the risk of contamination, and safeguards the safety and efficacy of pharmaceutical products.

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  Definitions and Functions
EMS collects environmental data (temperature, humidity, pressure, dust particle count, etc.) in real-time through a network of sensors and dynamically adjusts environmental conditions in conjunction with an automated control system to ensure compliance with GMP standards.

Advantages of Online Real-time Monitoring System for Temperature and Humidity
The online continuous monitoring system for temperature and humidity is gradually replacing the traditional methods dominated by mechanical devices, manual recording, and localized equipment, because its inherent advantages are more in line with the modern environmental management needs of pharmaceutical companies.

Let's take the RMS monitoring system as an example to look at its main advantages.
1. Data Integrity and Continuity
The online monitoring system for temperature and humidity eliminates the need for manual spot inspections and paper records. Once the monitoring points are set up, the data loggers will automatically collect and transmit data to the data management platform in real-time and continuously, ensuring the integrity and continuity of the data. Even in the event of a network or power outage (with a backup battery), the RMS monitoring system can still record data and automatically transmit it to the monitoring platform once normal conditions are restored, ensuring strict compliance with GMP requirements for data integrity.
2. Compliance and Traceability
The electronic records provided by the RMS monitoring system comply with GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GDP (Good Distribution Practice), and FDA 21 CFR Part 11 requirements. They are timestamped to prevent tampering. The system provides 24-hour real-time centralized monitoring of all operational logs, allowing users to view events and their timings, such as user logins, data exports, and parameter modifications, thus providing a complete audit trail.

3. Timely Alarms
The RMS monitoring system allows for the presetting of alarm and action limits and can send real-time alerts via voice calls, text messages, or emails to notify responsible personnel of limit exceedances. This helps to promptly adjust on-site environmental conditions to avoid interference with production, storage, and other activities. Network cameras can take snapshots and add them to automatically generated reports, supporting remote monitoring of the application. Real-time viewing is available simply by hovering the mouse over the relevant section.

Feature of Lasensor  FMS Cleanroom Monitoring System

1. On-site Display and Continuous Monitoring
The system provides on-site display and 24×7 continuous monitoring of critical parameters in cleanrooms, including cleanliness levels, differential pressure, temperature/humidity, air velocity, and ozone concentration.

2. Historical Data Review and Export
Users can review historical data from any period and any position within the system.Data can be easily exported in the form of an Excel file for further analysis and record-keeping.

3. Customizable Sensor Scheduling
The start-up and stop times of each sensor can be individually set, allowing for flexible and efficient monitoring schedules tailored to specific operational needs.

4. Automatic Cleanliness Level Assessment
The system automatically assesses cleanliness levels in accordance with GMP requirements, ensuring compliance and quality assurance in real-time.
5. Alarm Functions
On-site alarm and SMS alarm functions are available, allowing users to freely set overrun alarm levels and early warning levels for proactive monitoring and immediate response.

6. Ethernet Communication and Scalability
The system utilizes Ethernet communication, making it easy to extend and integrate additional devices or modules as needed.

7. User Management and Event Logging
The system features a three-level user management function, ensuring secure access and operation. Additionally, an event logging function records all critical activities for audit and traceability purposes.


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Product details of HR-FMS Cleanroom Monitoring System :                    

1. Remote Particle Counter Sensors

2. Microbial Air Sampler

3. Air Velocity Sensors
4. Differential Pressure Sensors
5. Temperature and Humidity Sensors

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Applications of HR-FMS Cleanroom Monitoring System :

• Pharmaceutical Cleanroom Monitoring

• Semiconductor Cleanroom Monitoring

• Medical Device 

• Hospital Pharmacies 

• Aerospace

• Operating Theaters