Pharmaceutical Packaging Line Achieves FDA Serialization Compliance
FDA-compliant serialization and packaging automation for pharmaceutical manufacturing
Project Overview
The Drug Supply Chain Security Act (DSCSA) mandates that pharmaceutical manufacturers serialize products at the unit level and track them through the supply chain. For a mid-sized pharmaceutical company producing over 100 million bottles annually, this requirement meant a complete packaging line upgrade.
The challenge: implement full serialization without sacrificing the 200+ bottles per minute throughput their customers depend on.
Serialization Architecture
The system implements a complete serialization solution:
Unit Level
- Unique serial number printed on each bottle label
- 2D DataMatrix barcode for machine readability
- Human-readable serial number for manual verification
- Real-time verification of every printed code
Case Level
- Serial numbers aggregated as bottles are packed
- Case label with parent serial number and child list
- Verification that all units are present and readable
Pallet Level
- Cases aggregated during palletizing
- Pallet label with complete hierarchy
- Data transmitted to enterprise serialization repository
High-Speed Labeling
Achieving 200+ bottles per minute with serialization requires precision engineering:
- Servo-Driven Labeling: Precise label placement at high speed
- Thermal Transfer Printing: Durable codes that withstand distribution
- Inline Verification: Every code read and verified in real-time
- Automatic Rejection: Non-conforming units removed without stopping the line
Validation and Compliance
The complete system was validated per GAMP 5 guidelines:
- IQ/OQ/PQ Documentation: Complete qualification protocols
- 21 CFR Part 11 Compliance: Electronic signatures, audit trails, access controls
- Data Integrity: Secure, tamper-evident record keeping
- Periodic Review: Ongoing compliance monitoring
Customer Testimonial
"AMD Automation delivered a serialization solution that exceeded our speed requirements while ensuring FDA compliance. The system has processed over 50 million units flawlessly."
— VP of Operations, Pharmaceutical Manufacturer
01The Challenge
The client needed to upgrade their packaging line to meet FDA Drug Supply Chain Security Act (DSCSA) serialization requirements while maintaining high-speed production and minimizing changeover time between products.
- DSCSA serialization mandate compliance deadline
- 21 CFR Part 11 electronic record requirements
- 200+ bottles per minute throughput requirement
- 15 different bottle sizes and label configurations
- Aggregation from unit to case to pallet level
02Our Solution
AMD Automation integrated a complete serialization and packaging solution including high-speed labeling, vision verification, aggregation, and a validated serialization software platform.
High-Speed Serialization
Print-and-apply labeling system generates unique serial numbers at 200+ bottles per minute with real-time verification.
Multi-Level Aggregation
Automated case packing and palletizing with parent-child relationship tracking from unit to pallet.
Vision Verification
100% inspection of serial numbers, barcodes, and label placement with automatic rejection of non-conforming units.
Validated Software Platform
21 CFR Part 11 compliant serialization software with electronic signatures, audit trails, and secure data exchange.
03The Results
The system achieved FDA compliance ahead of the deadline and has maintained 99.8% OEE while processing over 50 million serialized units in its first year.
Technical Specifications
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