Track and Trace Serialization Machine
Integrated pharmaceutical serialization and aggregation station engineered for high-speed carton coding, real-time GS1 DataMatrix verification, tamper-evident labeling, and multi-tier supply chain traceability.
Description & Operating Principle
HMEC’s Track & Trace Serialization Machine provides end-to-end pharmaceutical traceability to protect supply chains against counterfeiting, illicit diversion, and medication errors. Meeting strict global mandates including US FDA DSCSA, EU FMD, Russia Crypto-Code, and DGFT India, our serialization systems assign, print, verify, and manage unique digital identities for every saleable pharmaceutical unit.
Cartons exiting the cartoning machine pass through precision side-grip timing belts that ensure rock-solid stability during printing. A high-resolution Thermal Inkjet (TIJ) or Fiber Laser coder prints the GS1 2D DataMatrix code (GTIN, Unique Serial Number, Batch ID, and Expiry Date) alongside human-readable text. Immediately downstream, a high-speed Cognex/Keyence area-scan camera reads and grades the code against ISO 15415 standards. Illegible or duplicate codes trigger instant fail-safe pneumatic rejection into a lockable bin, while verified serial numbers are transmitted to Level 2/3 line controllers for parent-child aggregation into bundles, shipper cases, and pallets.
Target Products & Applications
Serialization is a mandatory regulatory requirement across global healthcare distribution:
📦 Unit Carton Serialization
High-speed printing and verification of 2D DataMatrix on folding cartons up to 350 CPM.
🏷️ Tamper-Evident Corner Labeling
Applying transparent security seals on both carton side flaps to prevent unauthorized opening.
📊 Bundle & Case Aggregation
Layer-by-layer optical scanning linking individual carton serials to master shipper case barcodes.
🧴 Bottle & Vial Serialization
Printing and grading helper codes on bottle bottoms and wrap-around labels for parenteral tracking.
Pros & Cons Comparison
✅ Advantages (Pros)
- Global Regulatory Compliance: Out-of-the-box support for US DSCSA, EU FMD, Russia Crypto-Code, DGFT India, and ANVISA Brazil.
- High-Speed Print & Verify: Operates at line speeds up to 350 cartons/minute with zero print jitter or blur.
- Multi-Level Aggregation: Links Unit → Bundle → Case → Pallet for seamless warehouse tracking and instant recall isolation.
- Fail-Safe Rejection: Heavy-duty pneumatic cylinder with lockable bin and sensor verification ensures non-serialized cartons never pass.
- Open Line Controller Interface: Connects to major Level 3/4 enterprise systems (TraceLink, SAP ATTP, Optel, Antares).
⚠️ Considerations & Limitations (Cons)
- IT Network Infrastructure: Requires reliable factory local area network (LAN) for real-time serial number allocation and database sync.
- Validation Complexity: Commissioning involves rigorous Computer System Validation (CSV) and IQ/OQ/PQ documentation protocols.
Type & Range of Track & Trace Stations
On basis of packaging level
- ✅ Level 1: Primary Bottle/Vial Bottom Coding
- ✅ Level 2: Secondary Carton Print & Verify
- ✅ Level 3: Multi-Carton Bundle Aggregation
- ✅ Level 4: Master Shipper Case Packing & Labeling
On basis of printing technology
- ✅ Thermal Inkjet (TIJ) HP / Wolke Technology
- ✅ Continuous Inkjet (CIJ) High-Speed Coding
- ✅ UV / Fiber Laser Marking (Permanent indelibility)
Integrated modules
- ✅ With Dual Tamper-Evident Seal Labeler
- ✅ With Integrated Dynamic Checkweigher
- ✅ With Manual Packing Workstation Scanner
- cGMP compliant compact modular stainless steel AISI 304 construction
- Synchronized side-grip positive timing belts ensure vibration-free carton conveying
- High-definition Thermal Inkjet (TIJ) printing up to 600 DPI resolution
- Industrial area-scan camera with integrated LED illumination grading codes per ISO 15415
- Pneumatic fail-safe rejection system with lockable transparent reject bin
- Optical reject confirmation sensor guaranteeing 100% defective carton segregation
- Pre-configured serialization software supporting GS1 standards (GTIN, Batch, Expiry, Serial)
- Seamless parent-child hierarchy aggregation for bundles, cases, and pallets
- Complete 21 CFR Part 11 audit trails, encrypted user management, and e-signatures
- Backed by 40+ years of pharmaceutical packaging engineering and global validation support
| Output / Speed | Up to 150 to 350+ Cartons Per Minute (CPM) |
|---|---|
| Carton Dimensions | Length: 50 - 220 mm | Width: 20 - 150 mm | Height: 15 - 90 mm |
| Printing Technology | Thermal Inkjet (TIJ) 600 DPI / Continuous Inkjet (CIJ) / Fiber Laser (30W) |
| Camera Vision System | High-speed industrial CMOS area scan camera (Cognex / Keyence / Datalogic) |
| Barcode Formats | GS1 2D DataMatrix, QR Code, GS1-128, EAN-13, Pharmacode |
| Code Grading Standard | ISO/IEC 15415 & ISO/IEC 15416 Print Quality Grading (A to F) |
| Rejection System | Pneumatic high-speed pusher / air jet into lockable stainless steel bin |
| Software Architecture | Level 2 Line Management Software with 21 CFR Part 11 Compliance & SQL Database |
| Power Supply | 220 V AC / 1 Phase / 50-60 Hz (Approx. 1.2 kW) |
| Compressed Air | 5 to 6 Bar Clean, Dry Compressed Air (80 - 120 L/min) |
Carton Format Changeover
The HMEC Track and Trace station features tool-less digital indicator handwheels for format adjustments in under 5 minutes:
- Side-Grip Belt Width: Adjusted via synchronized lead-screws with digital position readout.
- Printhead Position: Three-axis (X-Y-Z) vernier bracket for precise coding placement on carton flaps.
- Camera Focal Distance: Adjustable height bracket with laser aiming point for instant camera calibration.
- Software Batch Setup: Select new product recipe on the industrial PC to auto-load print layout and code format.
Frequently Asked Questions
Q: What happens when an unreadable or low-grade barcode is detected?
A: The camera sends a microsecond reject signal to the high-speed pneumatic cylinder. The non-compliant carton is ejected into a lockable bin, and a secondary sensor confirms that the carton physically entered the bin before allowing subsequent cartons to proceed.
Q: Can this machine connect with our enterprise TraceLink or SAP ATTP server?
A: Yes. The HMEC Level 2 Line Controller utilizes standard EPCIS and XML protocols to exchange serialized numbers with Level 3 plant servers and Level 4 enterprise cloud repositories.
Q: Can it be combined with Tamper-Evident labeling?
A: Yes. We offer an integrated Monoblock unit that performs 2D Serialization + Dual Tamper-Evident Seal Labeling + Checkweighing on a single compact chassis.