Pharma blister inspection — 21 CFR Part 11, zero escapes since
Cavity-fill and color verification on blister packs with full electronic-record audit trail.
- Client
- Confidential — Generic Pharma
- Location
- New Jersey, USA
- Capabilities
- Machine Vision · Retrofit & Upgrades
The challenge
Generic pharma plant had an FDA observation for inadequate inspection on a tablet blister line. Their existing fixed-light camera missed off-color and partial-tablet cavities at 300+ bpm.
What we built
Four-camera Cognex VisionPro DL system with diffuse dome lighting per blister. Audit trail writes to a 21 CFR Part 11 compliant server, with all reject images retained for the lot.
Key equipment
- Cognex VisionPro DL ×4
- Smart Vision Lights diffuse dome
- Audit-trail server (Part 11)
- Belt reject station
From the floor
Illustrative image — representative of project scope; customer-identifying details have been removed.
Results
FDA observation closed, zero customer-found defects in 14 months, and inspection rate sustained at 320 bpm.
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