Drug and Device Kitting

Drug and Device Kitting

Safecor Medical’s drug and device kitting services provide a low cost, high-quality drug and device kitting for manufacturers and health care providers. The Safecor Medical facility features class ISO 8-rated clean room packaging space with state-of-the-art equipment, automation and vision systems. We also offer a host of package design and supply chain services.

With each project, we ensure every drug and device kit contains only high-quality packaging materials and medical supplies. Full validation services for final packaging design ensures compliance and includes process and medical packaging design validations, equipment selection, aging and shipping studies and final packaging design verification.

Clean Room Packaging and Assembly

  • Real-time particulate monitoring system
  • Sencorp tray and bar sealers
  • Peel and burst testing

Non-Sterile Packaging and Repackaging

  • Medical kitting and assembly
  • Drug and Device Combination product kitting
  • Poly-bagging
  • Boxing and labeling
  • Re-boxing and relabeling
  • Over-labeling
  • Shrink wrapping

Validation Engineering

  • Comprehensive packaging integrity testing including Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ)
    • Sealing validations
    • Distribution testing
    • Accelerated aging
    • Cleaning validation
    • Sterilization validation (Ethylene oxide and Gamma)
    • Bio compatibility testing
  • Label design and production
  • Risk analysis
  • Process Failure Mode Effects Analysis (PFMEA) Development

Safecor Medical is FDA registered, QMS compliant with CFR 210, 211, 820 and Part 4, state registered as a drug and medical device manufacturer and distributor, and compliant with ISO 12484 and 11835.

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