AMRI has a dedicated unit focused on providing support and testing for compliance with drug delivery device-related regulatory standards. The FDA Guidance document entitled “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products” recommends that the final injector for submission undergoes a variety of performance tests, including, but not limited to:

  • Functional Testing
    • Injection Time
    • Freedom from Leakage Testing
    • Verification of Non-coring
    • Breakloose and Glideability
    • Needle Shield Removal Force / Torque
    • Safety Mechanism Activation Force
    • Needle Bond Strength
    • Needle Penetration Force
  • Biocompatability
  • Shelf-Life Stability and Expiration Dating
    • Freedom from defects
    • Proper assembly of replacement needles and cartridges
    • Accuracy of delivered dose
  • Environmental Conditions
    • Extreme operating environments
    • Extreme storage environments
    • Extreme conditions of use
    • Packaging
    • Shipping conditions
  • Extractables or Leachables
  • Container Closure Integrity (CCI)
  • Comprehensive Drug Delivery Device Services

AMRI specializes in drug delivery and combination product testing for all types of applications, and can provide comprehensive testing services to support your regulatory submission, as well as design verification, method feasibility and validation, and routine analysis services.

We will gladly develop a customized comprehensive drug delivery device testing program to meet your company’s regulatory requirements. An example of an all-encompassing combination product project is as follows:

  • Method Feasibility and Validation for Functional (Needle Shield Removal Force, Breakloose and Glideability, & Dose Accuracy) and CCI Testing
  • Plunger Movement Study
  • Simulated Distribution for Syringes in Shippers, with freedom from defect testing posttest
  • Functional and CCI Testing post Distribution Testing (T=0)
  • Real Time and Accelerated Aging
  • Additional Functional and CCI Testing at T=3, 6, 12, and 24 for Real Time and Accelerated Aging, as well as freedom from defect testing at each time point

Relevant Regulatory Standards

Shown below are various standards that are applicable to drug delivery device testing:

  • ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11608-1: Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems
  • ISO 11608-3: Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers
  • ISO 11040-4: Prefilled Syringes – Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
  • ISO 11040-6: Prefilled syringes – Part 6: Plastic barrels for injectables
  • ISO 7886-1: Sterile hypodermic syringes for sterile use – Part 1: Syringes for manual use
  • ISO 8537: Sterile single-use syringes, with or without needle, for insulin
  • ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications