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USP 788 Medical Device Testing

Particle shedding of intravenous and implantable devices is under increasing scrutiny by the FDA. Our expertise in particle analysis, gained while aiding the semiconductor industry, extends naturally into this field. We have the knowledge and equipment to verify your product is clean enough for market.

Our inline method allows for the collection of real-time particle data from individual device manipulations. Furthermore, this eliminates sample handling, variability, and contamination risks associated with beaker methods. A supply of our house-generated ultrapure water (UPW), heated to body temperature (37 ± 2 °C), is directed through your anatomical flow model, and then directly to an inline Accusizer 780 Single Particle Optical Sizer (SPOS) for high resolution particle counting and sizing.

Accusizer Data from a Medical Device Manipulation

PSS Accusizer data of a medical device manipulation

Method and anatomical model validation is also conducted in-place using particle transmission efficiency as the metric. This validation ensures that particulate transport through the model is well characterized and sufficiently high for accurate measurement of device shedding. Monodisperse particles of known sizes (typically 10, 25, and 50 µm) are injected into the supply of UPW, and measured at the outlet of the model. The model is then replaced with a simple fitting, and the measurement is repeated. The ratio of these measurements is the transmission efficiency of the model/method.

Combined 1, 10, and 25 µm Monodisperse Particle Standards

PSS Accusizer data of a mixture of monodisperse particle standards

Whether you're experienced in particulate studies and development, or just getting on your feet, we can quickly get you started, and collecting the data you need. We also pride ourselves on making this testing as accessible and transparent as possible. Our facilities are open to clients every step of the way, and pricing is based on our standard labor and equipment hourly rates.

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