Designed to measure the thickness and properties of thin film coatings on orthopaedic products, stents and related devices, the n-Gauge metrology instrument puts beam profile reflectometry technology within reach of a range of sectors for the first time, according to UK-based Nightingale-EOS Ltd. “Previously available only to high-volume semiconductor manufacturers, the technology’s ability to make accurate on-device measurements of coating thickness, strain and refractive index—even if the sample has a complex shape, high surface curvature or is otherwise difficult to align—will benefit medical device manufacturers,” explains company founder and managing director Stephen Morris, PhD. “This should significantly reduce the use of test coupons and off-line device analysis and make it easier for device manufacturers to comply with US FDA’s Process Analytical Technology initiative,” he adds.
The n-Gauge is described as a compact self-contained unit with no moving parts that sits on top of a standard optical microscope. The device replaces the microscope’s illumination module and eyepiece assembly. An Ethernet cable connects the n-Gauge to an external computer, which provides the graphical user interface and data analysis capability.
When the n-Gauge’s highly focused laser beam is located on the coated area of a substrate, the reflected light can be automatically analysed to determine the thickness, refractive index, orientation and strain of the coating at that point.
The instrument will be exhibited at MD&M Minneapolis in the United States on 13 and 14 October and, in the UK, at the Commercial Micro Manufacturing (MM Live) trade show in Coventry on 19 and 20 October.Norbert Sparrow