Acta MalaysiaACTAMALAYSIA
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Live OEE and critical utilities on a validated shop floor

GMP pharmaceutical plant, Selangor · 2 solid-dose lines · clean utilities · 8 months

Measured outcomes

+7.0 pts
OEE improvement
-30%
Utility excursions
-17%
Changeover time
<3 min
Excursion alert latency

Starting point

OEE was calculated weekly from batch records and manual line logs. Cleanroom pressure and WFI temperature excursions were discovered during QA review, hours after the event. Changeover losses on blister lines were invisible until month-end.

We finally see line performance and clean utilities in the same place — before QA finds it in a review.
Head of Manufacturing, Pharma

What we deployed

  • Non-invasive machine-state sensing on compression, blister and cartoning with GMP audit trail
  • OPC UA and validated CSV gateways where MES and packaging PLCs were available
  • IoT monitoring for HVAC differentials, WFI loop temperature and compressed-air dew point
  • Shift OEE dashboard with batch ID, downtime codes and utility excursion alerts to QA

What changed

  • Production and QA review the same live OEE and utility picture at every shift handover
  • Batch release discussions reference timestamped line and utility data, not reconstructed logs
  • Changeover playbook updated from measured micro-stoppages on blister and cartoning

Client names are withheld under commercial confidentiality; figures are drawn from post-deployment reviews agreed with each client.