The inside view on quality issues

Published: 23-Jul-2015

Non-destructive methods of product inspection can be valuable tools for investigating quality issues. Rene P Friedrichs and David M Wright, Reading Scientific Services, offer an inside view on pharmaceuticals and drug delivery devices using X-ray microtomography

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Microstructure is important to the performance and characteristics of pharmaceuticals, medical devices and pharmaceutical packaging in many different ways. For example, particle size, shape and packing all play a part in the dissolution of tablets. The coverage and thickness of a coating helps to determine the stability of a capsule, and can also affect its dissolution properties. Microstructure generally determines the flexibility of plastics and of composites assembled from them, and hence the performance of packaging, the integrity of seals, or the performance of components in medical devices. The internal structure of a delivery device will clearly affect how well the dose is targeted, particularly if internal kinks or defects in tubes or needles create blockages or other obstructions to flow, or indeed result in leakage.

Clearly, given that microstructure contributes to optimum performance, microstructural defects are often the root cause of a product’s poor performance or outright failure.

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