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Pharmaceutical & Life Sciences

Validated control systems and audit-trail-ready HMIs for GMP-regulated production.

Overview

Pharmaceutical manufacturing operates under FDA 21 CFR Part 11, EU GMP Annex 11, and local CDSCO regulations. Every process parameter must be logged, every batch traceable. Machies supplies Siemens S7-1500 PLCs, Schneider Modicon controllers, and audit-trail-capable HMIs that pass validation without compromise.

Key Automation Challenges

  • 121 CFR Part 11 / GMP Annex 11 audit trail and e-signature requirements
  • 2Clean-room compatible enclosures and minimal particulate-generating equipment
  • 3Precise filling, mixing, and granulation control
  • 4Environmental monitoring: temperature, humidity, pressure differential
  • 5Batch record generation and SCADA integration

How We Help

  • Siemens S7-1500 series PLCs with integrated safety and audit functions
  • Schneider Modicon M580 for redundant process control
  • HMIs with user-login, electronic signature, and alarm history
  • Servo systems for high-accuracy dosing and filling
  • Validated communication protocols: Profinet, OPC-UA

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