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Environmental Monitoring System

Equipment: Environmental Monitoring System (EMS) & Laminar Air Flow (LAF) Unit

Use Hardware: PLC Base Control Panel with PC Base Control and Monitoring System

An Environmental Monitoring System (EMS) is a critical component in pharmaceutical manufacturing, designed to ensure
continuous compliance with stringent regulatory standards such as cGMP, FDA 21 CFR Part 11, and EU GMP Annex 1.
The EMS provides real-time monitoring and recording of key environmental parameters including:

  • Temperature
  • Relative Humidity
  • Differential Pressure
  • Airborne Particulate Levels
  • Viable Microbial Contamination

By maintaining tight control over these parameters, the EMS ensures product integrity, regulatory compliance, and
supports data integrity through secure logging, audit trails, and alarm management systems.

Laminar Air Flow (LAF) Systems

Laminar Air Flow (LAF) systems are essential in pharmaceutical cleanroom environments, particularly in aseptic
processing areas. These systems create a unidirectional airflow that moves at a uniform velocity, typically through
HEPA filters, to sweep away particulates and contaminants from the critical processing zone.

Key benefits include:

  • Maintenance of ISO Class 5 / Grade A cleanroom conditions
  • Prevention of cross-contamination
  • Support for sterile manufacturing processes in filling lines, weighing booths, and sampling areas

LAF systems are a cornerstone of cleanroom design, ensuring a controlled, sterile environment for high-risk operations
in pharmaceutical production.

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