Wearable Injector/ Bolus Injector Validation Laboratory

Mar 17, 2017

By M.Turner

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.

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