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Products Description
Lasensor is a leading manufacture of 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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2.1 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.
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.
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