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Homogenizing Vessel Control Panel

Equipment: 100L Homogenizing Vessel

Use Hardware: PLC Base Control Panel with PC Base Control and Monitoring System

We have successfully commissioned a PLC-based control system for a 100L Homogenizing Vessel at Serum Institute of India,
fully compliant with FDA 21 CFR Part 11 requirements.

21 CFR Part 11 is a regulation enforced by the U.S. Food and Drug Administration (FDA) that governs electronic records and
electronic signatures, ensuring they are as trustworthy, reliable, and legally equivalent to traditional paper records.
This regulation is applicable to FDA-regulated industries including pharmaceuticals, biotechnology, and medical devices.

Our supplied control system features:

  • Validated electronic records and signatures compliant with 21 CFR Part 11
  • Audit trail functionality for complete traceability of user actions and system events
  • Role-based access control and secure authentication mechanisms
  • System validation protocols to ensure data integrity, reliability, and repeatability
  • Comprehensive documentation supporting qualification (IQ/OQ/PQ) and compliance audits

This deployment ensures that all operational and batch-related data from the homogenizing vessel is securely captured,
stored, and managed in full alignment with regulatory expectations—supporting both regulatory compliance and GMP best practices.

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