Wearable Injector/ Bolus Injector Validation Laboratory
Assessment of ambulatory injection devices by MET
Innovation continues to drive the development of new wearable injector devices with the need for adapting to different dosing regimens and fluid viscosities.
These new designs require a variety of Design Verification Testing, some of which is detailed in:
ISO 11608-6 2016 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems.
Here at MET we provide complete support for NIS, pen injector, and auto-injector development testing. In addition to biological safety evaluation and human factors studies MET’s laboratories provide assessments of:
- Component compatibility
- Cleaning and disinfection
- Medicinal product compatibility
- Strength of union between needle hub and needle tube
- Peak tensile force of soft catheter for injection
- Tensile strength of fluid line connections
- Residual volume
- Medicinal product visibility
- Resistance to dust, moisture, and water
- Leakage from OBDS
- Means of attachment
- Dose accuracy, dose consistency, and device essential functions
- Cannula insertion depth
- Particulate release
- Skin adhesion
Scientists at Medical Engineering Technologies are ready and happy to help you develop your validation process. Contact us now for testing to ISO standards and FDA Guidance on pen injectors.