Quality and Safety Increase with EMS Use in Pharmaceutical Production

[Cengiz Özemli]

## Quality and Safety Increase with the Use of EMS in Pharmaceutical Production

An environmental monitoring system (EMS) plays a critical role in pharmaceutical manufacturing facilities to improve product quality and reduce the risk of deviations. This article details what an EMS is, its components, installation process, and requirements under GMP.

An EMS is a system designed to manage the production environment. Air quality in pharmaceutical production areas is subject to very strict standards. In addition to basic parameters such as pressure, temperature, and humidity, special measurements such as the number of aerosol particles in the room or laminar airflow velocity are also required. The EMS ensures the measurement, processing, visualization, control, recording, and reporting of this data.

### EMS Operator Perspective

In an EMS project implemented in a pharmaceutical factory in Kazakhstan, a SCADA-based monitoring and control system is used. This system includes a line-based zoning concept and monitoring pressure differences between rooms. Each control element numerically displays the parameter value and indicates the alarm level with a color code. Additionally, each monitor has its own properties window where values, statuses, and limits are displayed.

The system shows active and historical alarm events, monitors parameter trends, and keeps detailed records of user activities such as logins, operations, and changes.

### Physical Layer and System Resilience

The EMS network has a three-stage redundancy with the PLC (programmable logic controller) at its center. The PLC collects information from sensors, manages alarm conditions, and ensures the system can operate independently even under critical conditions. SCADA and HMI panels take on the roles of display and setpoint modification, which are outside the main functions.

This structure increases the system's multi-level control and fault tolerance, offering various backup and monitoring possibilities through SCADA, HMI panels, and signal towers.

### EMS Requirements

EMS requirements are divided into non-critical and critical. Non-critical ones generally cover user experience, design, and user interface elements, while critical requirements include standards such as GMP, ISO, ALCOA+, and necessities like system security, hardware architecture, and data integrity.

Critical requirements are:

• PLC polling interval
• Data archiving frequency
• Local visualization and control elements (HMI, signal towers)
• Data backup
• Electronic and paper-based reporting
• User and access rights management
• Automatic logout
• Interpretation and approval of user actions
• User authentication, change, and action logs

### Place of EMS in the Automation Pyramid

Architecturally, EMS is located between levels 0-2 of the automation pyramid and is typically integrated with MES and enterprise reporting systems. Therefore, an EMS engineer must have deep knowledge of PLCs, SCADA, and communication protocols, and also possess fundamental knowledge of electrical engineering, industrial Ethernet, server infrastructure, and cybersecurity.

### Conclusion

EMS is a practical and comprehensive automation system in the pharmaceutical sector. It is important from an engineering, regulatory, and operator convenience perspective. Correct design and components (local logic in the PLC, redundancy, comprehensive records, and reports) directly improve product quality and reduce the risk of deviations.