GMP-Compliant Tablet Line Automation
Full batch automation and machine vision quality system for a pharmaceutical manufacturer
A pharmaceutical tablet manufacturer was running coating and packaging lines with minimal automation. Batch records were paper-based, quality inspection was 100% manual, and regulatory submissions were consuming significant quality team time. OEE was at 61% against a target of 80%.
Peunier designed and deployed a fully automated tablet coating and packaging line with 21 CFR Part 11 compliant electronic batch records, inline machine vision inspection, and SCADA integration with the client's existing ERP system.
GMP Compliance Assessment
Mapped existing documentation practices against 21 CFR Part 11 and EU GMP Annex 11 requirements. Identified 23 compliance gaps to be addressed.
Automation System Design
Designed Allen-Bradley PLC-based control architecture for coating, blister packaging, and cartoning lines with full interlock and safety logic.
Machine Vision Integration
Deployed 4 camera inspection stations for tablet appearance, blister fill verification, and print check with <50ms cycle time.
eBMR System Development
Built custom electronic batch manufacturing record system with audit trail, electronic signatures, and SCADA data auto-population.
Validation & Commissioning
Full IQ/OQ/PQ validation protocol execution with documentation package for regulatory submission.
The validation package Peunier delivered was comprehensive enough to sail through our regulatory inspection without a single observation. The quality of their documentation matched our internal standards.