Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated.

A programming issue with humidity controls could affect drug efficacy and stability, requiring critical drug products and finished goods to be destroyed. The wrong temperature could encourage growth of microbial contaminants, resulting in expensive disruptions and fines. An undetected blip in room pressurization and volumetric flow rate could mean contamination of a vaccine, affecting not only your bottom line and reputation but the health of millions.

Facilities regulated by the FDA’s Current Good Manufacturing Practice (CGMP) need a robust Building Management System (BMS) to manage physical systems and an Environmental Monitoring System (EMS) to monitor critical environmental data. When completely validated, these systems provide essential functionality for your facility as well as significant benefits:

  • BMS controls allow you to stabilize your environment and adjust conditions based on environmental monitoring data
  • EMS data can be used for trend analysis, allowing you to better predict and prevent issues
  • Customizable alerts can decrease reaction times so you can respond to and resolve problems sooner and prevent system breakdowns

Robust, integrated monitoring and control systems allow constant oversight of your CGMP facility.

As the command center for your facility, the BMS serves as the foundation for your EMS. The BMS monitors utilities, gathering information from throughout the building to maintain the desired temperatures, relative humidity, and differential pressures. It can actuate dampers, adjust fans, react to sensors, and manage other HVAC system functions. The BMS can also control power, lighting and water, adjusting controls for peak and restricted usage; monitor door interlocks and alarms; and run analytics and reports on readings.

For CGMP facilities, the trick is commissioning and thoroughly testing the BMS while creating an autonomous EMS to collect, analyze, and archive critical information and data. As a hybrid sensor-and-software system, the customizable EMS is vital to establishing safe production and, ultimately, your brand’s reputation for safe products.

Confidence in your BMS and EMS originates in a thorough and complete validation that allows you to focus on day-to-day operations.

All systems—hardware and software, networks and connections, mechanical and human—need to be qualified and validated. Five areas deserve particular attention:

Asking the right questions early in the process will determine what to monitor. What essential parameters should the BMS be able to control? What is the most effective way to calculate differential pressure for your facility? Do you plan to expand the facility? If so, how will that impact the capacity of the EMS? Understanding the desired functionality of both systems can help set the right course and avoid costly errors and re-validation later.

Data Collection and Storage
For aseptic processing, the FDA requires “a system for monitoring environmental conditions.” Long-term data are critical to proving that products were manufactured according to regulations. Real-time data are critical to ensuring effective responses to incidents. If a damper was manually opened at 3:00 AM or an alarm was overridden, do the data detail by whom and why?

Deciding what data will be collected for daily and historic needs, as well as specific data points and frequency of collection, will establish your data storage requirements. Testing of data storage, access to collected data, and data reporting are all essential to proper monitoring. Audit trails should be challenged to historically review any system changes.

Dashboards and Graphic Representation
During BMS and EMS development, focus is on programming. But during the final stages of design, focus moves to the graphical user interface. Dashboards and graphics will be accessed continuously for visual monitoring and control of both systems. System status, alarms, damper positions, fan speeds, and sensor readings must be visually straightforward and accessible.

Access and User Rights
System access should be well defined according to established procedures. Who will be logging in to the system? Who will be maintaining it? Who has daily access for viewing? Standard operating procedures (SOPs) should spell out user rights and passwords, maintenance responsibilities, and change management. Limiting and allowing access will ensure that system changes are controlled.

Training and System Documentation
Typical EMS interfaces are complex. Users must be able to understand and respond to data efficiently. Once qualification is complete, it’s important to take the time to train personnel on the intricacies of the system. Having a concise SOP is critical to ensuring efficient practices.

CGMP-compliant manufacturing facilities require sophisticated digital control and monitoring systems to maintain the appropriate environment for manufacturing. Qualifying and validating your BMS/EMS helps ensure safe, effective products—and sets your facility on a successful path to market with greater speed, efficiency, and profitability.

Kymanox supports an integrated validation of BMS/EMS systems during roll out and systems qualification. Our Computer System Validation Team provides documentation and expertise at all phases of commissioning, including—but not limited to—the following:

  • – Drafting requirements and specifications
  • – Conducting risk and gap assessments
  • – Design review and traceability analysis
  • – Writing SOPs to fit your systems and processes
  • – Drafting and executing qualification and validation protocols


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Contact Kymanox today at 919.246.4896 to leverage robust BMS controls and EMS data collection for your facility.