Pharma Visual Inspection AI
Tablets, Vials, Ampoules & Packaging
GxP-aligned AI visual inspection for tablets, capsules, vials, ampoules, blisters and cartons. 21 CFR Part 11 audit trails, validation support and MES integration.
Quick Answer
NeoBram delivers GxP-aligned visual inspection AI for pharma manufacturing - tablet, capsule, vial, ampoule, blister and carton inspection with full 21 CFR Part 11 audit trails, validation documentation (IQ/OQ/PQ), and integration with MES, LIMS and QMS.
Why This Matters
Visual Inspection Is A GxP-Critical Bottleneck.
Pharma visual inspection - particulates in vials, tablet defects, blister fill, carton coding - is one of the most regulated and labour-intensive steps in manufacturing. Manual inspection caps at ~85% reliability and cannot scale with batch sizes.
Modern AI visual inspection achieves 99%+ catch rates for particulates in injectables, tablet defects and packaging errors, with full traceability and audit trails that satisfy FDA, EMA and CDSCO inspections.
We deploy production-grade systems with full GxP validation support - URS, FAT/SAT, IQ/OQ/PQ documentation, computer system validation per GAMP 5, and 21 CFR Part 11 compliant audit trails. Models, datasets and inference are all version-controlled and validated.
Our Tech Stack
Production-Grade Tools We Deploy
Inspection hardware
Models
Validation & governance
Integration
Architecture Deep-Dive
How We Build It
Injectable particulate inspection
Detect glass, fibre, metal and proteinaceous particulates in vials, ampoules and pre-filled syringes at line speed - replacing or augmenting manual 100% inspection.
- Sub-50 micron particulate detection in clear and amber containers
- Air-bubble vs particulate discrimination
- Container defects (cracks, scratches, fill level)
- Stopper / cap presence and seating
Tablet & capsule defect detection
Detect chips, cracks, capping, lamination, foreign matter, embossing defects and colour variation on tablets and capsules at high throughput.
- Chips, cracks, capping, lamination, sticking
- Embossing and break-line verification
- Colour and coating uniformity
- Foreign-matter contamination
Packaging & serialisation verification
Blister fill check, carton coding (batch, expiry, serial), leaflet presence and label/artwork verification - aligned with EU FMD and DSCSA serialisation.
- Blister cavity fill and tablet integrity
- Carton batch / expiry / serial OCR & verification
- Label artwork match against approved master
- Leaflet presence and orientation
GxP-validated MLOps
Versioned, signed models with dataset lineage, IQ/OQ/PQ documentation, change-control workflow and 21 CFR Part 11 compliant audit trails for every inspection decision.
- URS / FAT / SAT / IQ / OQ / PQ documentation
- GAMP 5 software categorisation and validation
- 21 CFR Part 11 audit trail of every decision
- Change control for model retraining
Data Security, Governance & Safety
Enterprise AI demands enterprise-grade security. Every solution we deploy follows strict data sovereignty, safety, and compliance standards.
Data Sovereignty
- Your data stays in your infrastructure - always
- Deploy on your cloud (AWS, Azure, GCP) or on-premise
- No data leaves your environment
- Full compliance with regional data residency requirements
Model Safety & Guardrails
- NVIDIA NeMo Guardrails for content safety
- PII detection and redaction with Presidio
- Prompt injection defense and input sanitization
- Hallucination detection and factual grounding
Access Control & Audit
- Role-based access control for all AI systems
- Immutable audit logs for every interaction
- SOC 2 Type II, ISO 27001 compliance frameworks
- GDPR, HIPAA, and industry-specific regulations
Responsible AI
- Bias testing with Fairlearn and AI Fairness 360
- Model explainability via SHAP and LIME
- Transparency reports for stakeholders
- Continuous fairness monitoring in production
FAQ
Frequently Asked Questions
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