Non-Destructive Testing Methods

by | Jul 14, 2021 | 3D Printing, Design Controls, Engineering, FDA, MedTech, Product Development, Testing

Non-destructive testing methods are critical in characterizing the properties and features of any material or product that is under investigation. Non-destructive testing methods offer the advantage of allowing for a combination of testing methods while preserving the overall structure and properties of a specimen. This might be ideal for situations when a product or device being investigated is of unique design or production and is not practically or economically obtainable. To cut costs when performing lab techniques, non-destructive methods ensure minimal product or material is damaged.

RepliSet is an effective non-destructive testing method for precisely and accurately replicating the surfaces of a material or fracture. RepliSet results in a 3-dimensional topographical copy of a surface that can be easily transferred, examined, and measured. Stereomicroscopy is a method of examining rough or irregular topologies in order to render a 3-dimensional model of the surface being investigated. Compared to scanning electron microscopy or X-Ray diffraction, RepliSet is non-destructive and does not require any preparation that may damage the substrate.

Stereomicroscopy is a useful method for low magnification observation of intricate 3-dimensional topologies. Stereomicroscopes generally offer two separate viewing paths as well as two light sources, halogen light and yellow light, that could be alternated as well as dimmed to enable a wide variety of viewing conditions1. The dual-path nature of the lens enables certain surface features to appear closer or farther based on their topology.  A 3-dimensional model of a surface can also be easily rendered utilizing a stereomicroscope, with precision and accuracy of the rendition changing as a function with time.

Are you struggling to get your device or drug FDA approved? Give EMMA International a call today at 248-997-4497 to learn which regulatory pathway is right for your product. We specialize in full-circle consulting to help get your product approved and out to market in the most efficient way possible.

  1. Molecular Expressions Microscopy Primer: Anatomy of the Microscope – Stereomicroscopy. (2021). The Florida State University. https://micro.magnet.fsu.edu/primer/anatomy/stereohome.html

Kareem Arafat

Kareem Arafat

Quality Engineer- Mr. Arafat has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Arafat holds a Bachelor of Science in Materials Science & Engineering from Michigan State University.

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