BMS (Building Management System) also known as a building automation system (BAS), is a computer-based control system installed in buildings to control and monitor mechanical and electrical equipment such as heating, cooling, ventilation, lighting, power, fire, and security systems.

Control (BMS) and Monitoring (EMS) solutions are required in industries such as aseptic pharmaceutical medicinal product manufacturing.

Difference between EMS and BMS:

BMS: Building Management System (BMS) regulates the temperature, humidity, and pressure of a facility and its processes. Other controls may include process automation equipment. BMS’s primary function is to control environmental conditions while also providing other levels of facility control and access. BMS operates at a macro-level, which means it provides high-level, real-time control based on the configurations of the facility manager or building owner.

Features of BMS:

  • Monitoring of all required facility parameters to determine the health of the running plant.
  • Automatic controls for critical parameters can be configured so that the system controls those parameters only within the specified range.
  • To avoid untoward incidents, suitable Alarms, Interlocks, and System shutdowns can be programmed for safety-critical parameters.
  • Completely adaptable to the process and user requirements.
  • Data is automatically recorded at regular intervals so that history can be examined.
  • The creation of intelligent graphs.
  • Integration with third-party services such as compressors, chillers, vacuum pumps, fire alarm systems, CCTV systems, particle counters in clean rooms, and so on.

EMS: An EMS monitors GMP-critical environmental conditions such as particle counts, humidity, temperature, and pressure, as well as critical data logging of support equipment such as fridges, freezers, incubators, or product warehouse storage. An EMS’s sensors collect and analyse every piece of device-level telemetry data at the micro-level.

All are GMP-critical for product release based on set parameters for environmental and support equipment not exceeding certain alarm set-points throughout the product life-cycle from manufacturing to shipping. Some EMS systems use data logging sensors to monitor transportation environments for products that must maintain constant environmental conditions during transport.

Why maintain separate EMS and BMS systems?

EMS systems necessitate strict security access control, including an audit trail, electronic records, and electronic signatures on computerized systems.

 If BMS control system is also used to provide GMP data, data integrity risks arise that must be addressed, especially since the FDA and other regulatory bodies are scrutinizing data integrity and validation. 

Below listed are few advantages of maintaining separate EMS and BMS:

  • All GMP data from critical environmental locations is logged and stored on a secure, backed-up database using the EMS. Having separate systems only necessitates EMS system validation. The BMS will require some level of commissioning to ensure that the control limits and functions are working properly.
  • If the BMS system fails due to a software or sensor failure, the EMS will keep data records from critical locations.
  • Some BMS systems employ lower-rated HVAC quality sensors that are difficult to calibrate in the field. EMS system providers typically use field-calibrated, high-resolution sensors that are also cleanroom-ready.
  • Segregation of control and monitoring is desirable from a regulatory standpoint because critical data is verifiable and integrity is maintained – unless the end-user can justify using BMS to the regulator.  BMS cannot be programmed to function as an EMS.

Wrapping up:

Control (BMS) and Monitoring (EMS) solutions are required aseptic manufacturing of pharmaceutical medicinal products.

Because critical steps for Good Manufacturing Practices (GMP) based on validation and regulatory compliance are mandated, an EMS is authenticated by validating that the system design meets the system’s functionality, as outlined in a User Requirement Specification (URS) document.

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