April 1, 2016

Pharmaceuticals

Projects handled by CSIL in Pharmaceuticals:

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Case Study:

Monitoring EOU Plant

LUPIN.136142402_std

LUPIN PHARMA LTD., Tarapur (Boisar) :

LUPIN PHARMA LTD. located in Tarapur, Boisar is a company dealing with manufacture and supply of pharmaceutical products. The company had a requirement for automatic monitoring system for their EOU plant and MICRO LAB. CSIL has satisfactorily fulfilled the client requirement by installing INDUSOFT SCADA for automated monitoring of the plant along with compliance to US FDA 21 CFR part 11 regulations.

The Challenge:

LUPIN Limited required automatic monitoring for their EOU plant and MICRO LAB in order to avoid man made errors and to improve the system performance. The main challenge was to meet the clauses specified by the US Food and Drug Administration and provide round the clock reliability along with cost effectiveness and regulatory compliance.

The Solution:

CSIL installed INDUSOFT SCADA v5.1 in order to provide 21 CFR compliance. The features provided in order to provide compliance are as stated below:

  • Electronic signature,
  • Password aging,
  • E-signature timeout,
  • Block and unblocking of user,
  • User creation in engineering and runtime environment,
  • User account lockup after specified no. of attempts,
  • Automatic logoff to guest mode,
  • Event logging,
  • Tamper proof Electronic records.

The system included PC based SCADA system which was connected to 3 Scanner devices and 24 PID controllers. The data was pulled from the plants into SCADA through scanners and PID controllers using Modbus RTU inbuilt driver. Tamper proof Electronic reports are generated through INDUSOFT SCADA to provide cross check and auditing for improving system performance.