Effects of X-Ray Inspection on Pharmaceutical Products

X-ray inspection of pharmaceutical products and over-the-counter (OTC) medications are steadily increasing in use as pharmaceutical manufacturers worldwide strive to safeguard their brand reputations, protect consumers’ welfare and comply with national and international regulations and legislation. Some manufacturers, however, still have reservations about adopting x-ray inspection as a safe method of product inspection. Their primary concern is that products being inspected could be affected by radiation during the inspection process, and that their therapeutic effectiveness might be compromised. This white paper examines the potential effects of x-ray inspection on pharmaceutical products. The paper begins by exploring the nature of radiation, outlining the difference between man-made x-rays and naturally occurring radiation (‘background radiation’). The document then discusses why and how manufacturers use x-rays to inspect a wide variety of products to detect potentially harmful contaminants and defects that can damage brand reputation, potentially leading to costly recalls and lawsuits. There then follows a summary of the published research conducted on the effects of x-ray inspection on the efficacy and other physical properties of pharmaceuticals. The available research shows that the pharmaceutical and OTC products tested are not affected in terms of their chemical makeup and efficacy following exposure to x-ray in inspection systems.

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