The XR Vision™ Platform
How It Works //
Scan • Verify • Log
DEPLOYMENTS //
Pilot • Prove • Expand.
PROPRIETARY RADIOPAQUE MARKERS //
Threads • Inks • Labels
Compliance & Reporting // DSCSA/ UDI-ready logs, APIs, audit trails
Sealed-Box Verification for Vials, Lyophilized, & Cold Chain Products
DESIGNED TO ADDRESS COMMON FDA OBSERVATIONS:
Completeness verification, packaging integrity, and digital audit trail for CAPA and re-inspection.
1 // The Challenge
Sterile injectables, lyophilized products, and other cold-chain therapies are high-value and sensitive. Once sealed in cartons, traditional vision systems cannot verify contents.
UNDETECTED ISSUES LIKE BROKEN VIALS, STOPPER LEAKS, OR MIXED LOTS LEAD TO:
1. Expensive product loss and batch write‐offs
1.
Expensive product loss and batch write‐offs
2. Delayed deliveries and cold chain breaches
2.
Delayed deliveries and cold chain breaches
3. Regulatory observations and recalls
3.
Regulatory observations and recalls
2 // Our Solution
XR Vision uses compact X-ray technology with AI analytics to inspect sealed shippers without breaking the pack.
THE SYSTEM:
1. Confirms vial counts, lot layout, and correct product configuration
1.
Confirms vial counts, lot layout, and correct product configuration
2. Detects cracked or empty vials, stopper defects, and abnormal density patterns
2.
Detects cracked or empty vials, stopper defects, and abnormal density patterns
3.Works for vials, lyophilized products, and prefilled syringes across cold-chain SKUs
3.
Works for vials, lyophilized products, and prefilled syringes across cold-chain SKUs
THREE DEPLOYMENT POINTS:
1. INLINE: Optional scan after packaging for immediate process control
1.
INLINE: Optional scan after packaging for immediate process control
2. OUTBOUND: Final verification pre‐shipment to ensure correct, intact product leaves site
2.
OUTBOUND: Final verification pre‐shipment to ensure correct, intact product leaves site
3. INBOUND: Quick verification at receipt to match ASN and lot before stocking
3.
INBOUND: Quick verification at receipt to match ASN and lot before stocking
3 // WHY IT MATTERS
EFFICIENT:
Inspect sealed boxes without disrupting packing or cold chain
ACCURATE:
Find defects invisible to cameras or manual inspection
COMPLIANT:
Creates digital, time‐stamped records supporting GMP and CFR 21 audits
PREVENTIVE:
Stops problems before they reach distributors, hospitals, or patients
4 // Applications
VIAL SHIPPERS:
Catch missing or damaged vials before release
LYOPHILIZED PRODUCTS:
Confirm moisture‐sensitive products are complete and intact
COLD-CHAIN CASES:
Verify high-value shipments without breaking temperature control