How long does a medical device package design and validation take from start to finish?

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Package Design (Phase 1): 13 Weeks

  • Package System Requirements
  • Sterile Barrier Design
  • Protective Package Design
  • Prototyping
  • Verification Testing
  • Sterile Presentation Test

Sealing and Manufacturing Process Development (Phase 2 – 3): 16 Weeks

  • Thermoforming & Sealing Tooling
  • Thermoforming IQ/OQ
  • Sealing IQ/OQ
  • Device Assembly IQ/OQ
  • Label Development
  • Build OQ-Low for Transit Test

Transit Testing and Seal Testing (Phase 4 – 6): 13 Weeks

  • Expose to Worst-Case Sterilization
  • Transit Simulation
  • Accelerated Aging Testing
  • Real-Time Aging Testing
    • Seal Integrity Test
    • Seal Strength Test
    • Product Stability Test
  • Seal Testing
    • Accelerated Aging
    • Real-Time Aging
    • Seal Integrity Test
    • Seal Strength Test

Sterilization Validation: 8 Weeks

  • Manufacturing PQ
  • Single Lot Verification 1
  • Single Lot Verification 2/3 (Additional 16 Weeks)

These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.