What problem does this solve?

Pharmaceutical and medical device manufacturers face strict regulatory requirements for product identification. They must print sterilization dates, batch numbers, expiration dates, UDI (Unique Device Identification) codes, and GS1 DataMatrix codes on medical devices, pharmaceutical vials, blister packs, and sterile packaging. The ink must withstand sterilization processes (autoclave, ethylene oxide, gamma radiation) without degrading.

Solution Description

The S1000 CIJ Printer delivers compliance-grade coding for pharmaceutical lines at up to 400 m/min with medical-grade, biocompatible ink formulations. The embedded Linux system supports GS1 DataMatrix, QR codes, serial numbers, and dynamic database printing for UDI compliance. IP55-rated 304 stainless steel construction enables sterile-environment deployment and clean-in-place (CIP) wash-down.

The K20 Online Inkjet Printer provides 600 DPI HD printing for high-resolution pharmaceutical carton coding, blister pack printing, and medical device labeling. The industrial-grade TI AM3358 CPU and FPGA ensure 24/7 production reliability critical in pharmaceutical manufacturing.

Key Benefits

  • Medical-grade, biocompatible ink withstands autoclave, EtO, and gamma sterilization
  • GS1 DataMatrix and UDI-compliant code printing with dynamic database support
  • IP55-rated stainless steel construction for sterile and cleanroom environments
  • 400 m/min CIJ speed for high-volume pharmaceutical production
  • 10.1-inch industrial touchscreen with audit-trail capable print job logging
  • Supports serial numbers, batch numbers, expiration dates, and encrypted traceability codes

Target Customers

  • Pharmaceutical tablet and capsule manufacturers
  • Medical device manufacturers (syringes, catheters, surgical instruments)
  • Vaccine and injectable drug producers
  • Medical consumable manufacturers (gloves, masks, bandages)
  • IV fluid and blood bag manufacturers

Application Scenario

A medical device manufacturer produces 50,000 sterile syringes per shift. The S1000 CIJ Printer prints the UDI code, sterilization date, batch number, and GS1 DataMatrix on each syringe package at 380 m/min. After gamma radiation sterilization, the printed codes remain legible and scannable, meeting FDA UDI Rule (21 CFR 830) and EU MDR Article 27 requirements. The dynamic database feature links each printed serial number to the manufacturer’s electronic Product Information File (ePIF) for full lifecycle traceability.

FAQ

  • Q: Does the ink survive sterilization? A: Yes. SHICAI medical-grade ink formulations are tested to withstand autoclave (121°C), ethylene oxide, and gamma radiation sterilization without fading or migration.
  • Q: Can it print GS1 DataMatrix codes? A: Yes. Both S1000 and K20 support GS1 DataMatrix, QR codes, and dynamic serial numbers for UDI compliance.
  • Q: Is the printer suitable for cleanroom environments? A: Yes. The IP55-rated stainless steel construction is compatible with cleanroom protocols and supports CIP wash-down.
  • Q: Does it support 21 CFR Part 11 audit trails? A: The embedded Linux system supports print job logging and can be integrated with factory MES/ERP systems via Ethernet for audit trail compliance.