Foreign Material Contamination in a Pharmaceutical Tablet

RSSL was asked to investigate a dark foreign body contamination of pharmaceutical tablets, which had been detected during routine quality checks in the client’s manufacturing process.

pharmaceutical foreign body

Background

RSSL was asked to investigate a dark foreign body contamination of pharmaceutical tablets, which had been detected during routine quality checks in the client’s manufacturing process. It was deemed critical to identify the source of the contamination as quickly as possible.


Approach

An initial in situ analysis by X-ray microfluorescence (µXRF) identified the dark contaminant as chromium nickel stainless steel, and was considered to be a SAE 316 grade stainless steel. The tablet was then examined further non-destructively by X-ray Microtomography (XRT) to determine the position of the visible foreign material, and to determine whether more chromium nickel stainless steel inclusions were embedded inside the tablet.


Results

The reconstructed 3-D X-ray microtomography data revealed no other radiopaque material inside the tablet, and that the visible dark contamination was located only in the outermost layer. These results ultimately helped the client to identify the source of the contamination which was the tablet press on this occasion.

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