Our client- a major manufacturer of pharmaceutical drugs, needed a Building Management System (BMS) to monitor the conditions of all areas and equipment of the facility. Adherence to strict conditions of the US FDA’s 21CFR Part11 within all units of the manufacturing facility is imperative in the production of pharmaceuticals drugs. Radix as manufacturers of sensors and as providers of SCADA solutions understood this need of our client and provided a turnkey solution.
The BMS monitored all major units of the plants : manufacturing line, warehouse, packing, quality control. We provided Radix-make sensors (Hawkeye) to monitor and display humidity, pressure and temperature across all these units. The BMS also integrated utility equipment like air handling units and water systems.
All the departments directly related to production and storage of the pharmaceutical drugs – manufacturing line, packing, quality control, and warehouse had 110 Hawkeye Room Display Units (Radix make) placed to measure temperature, relative humidity and pressure. Radix differential transmitters were installed on the mezzanine floor and connected to the Hawkeyes in each room. Hawkeyes measured temperature and humidity via an integral sensor.
A 21CFR compliant Elipse E3 SCADA 5000 tags and 3 additional remote viewers connected all areas and machines of the plant in a centralized system.
Radix provided a user friendly interface for a large and complex system. Operators had status screens, mimic screens, trend and historical data, audit trails, alarm logs and more at their disposal.
A standard status screen showed operators the status of all instruments and present room conditions at a glance. A quick report compiling a time-stamped status of every instrument in the facility could be generated at the click of a button.
Mimic screens displayed individual mimics for each floor to make it easy for the operator monitor and control every instrument independently. The mimic screens also displayed alarms from each instrument for quick response by operators.
Trend and historical data screens allowed operators to view instrument data over any time frame starting from the installation of the BMS. The SCADA easily generated PDF and Excel reports.
Initially, Radix linked utility equipment like the water system as well as production machines to the BMS for monitoring. In a later phase, real-time-clock based scheduling of Air Handling Units was given via a PLC panel.
Radix also provided validation documents for Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification for every Radix-make instrument installed in the facility.
