Electronic Batch Recording

Our client- a USFDA approved manufacturer of pharmaceutical drugs, needed a SCADA system to log the process data from all the manufacturing machines like Coater, Blender, Granulator, Compressor, Roll compactor and Water System. 

Keeping adherence to strict conditions of the US FDA’s 21CFR Part11 with respect to data integrity and system qualification is imperative in the production of pharmaceuticals drugs. 

Radix offered a complete SCADA solution wherein which the client can log data of the mentioned machines to the control room. Different people in departments like Production, QA, Engineering were given rights to monitor, print different machines and process data from their respective locations.


The highlights of the system were 

  • Real time monitoring of machine condition including mimics
  • Facility to monitor machines from remote locations
  • Automatic generation of Process reports as per desired formats of batch manufacturing records
  • Ability to superimpose environmental data ( Rh, temperature, DP) with process data.
  • Historical data analysis for quality related and investigation and efficiency improvements
  • Standardised data bus for connecting to different makes of PLCs and machines 


Products Used
  • Comprehensive Integration of production line and utility equipments.
  • Using PLC and RS485 Modbus protocol.
  •  21 CFR compliant SCADA


Data from various machines like  Blender, Granulator, Compressor, Roll compactor and Water System were transmitted using PLC, via RS485 Modbus protocol to a SCADA computer located in a control room.

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.

Radix also provided validation documents for Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification for every Radix-make instrument installed in the facility.

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