We are all aware that the pharmaceutical industry operates within a highly regulated environment, where upholding product safety and quality is paramount. Manufacturers invest significant resources in validation processes to meet regulatory requirements. One technology solution to complete quality assurance checks in the pharmaceutical sector is product inspection. While many manufacturers rely on systems like vision inspection and metal detection, the use of x-ray inspection is gaining recognition as an additional tool for quality assurance. To understand the benefits of x-ray inspection, we must first look at its functionalities, then address the misconceptions. In this article, we will explore why x-ray inspection should be an invaluable asset in the pharmaceutical industry, providing manufacturers with comprehensive and accurate quality checks while dispelling concerns about its impact on products.
More than Contaminant Detection
The primary function of x-ray inspection is contaminant detection of a wide range of foreign bodies including metal, glass, mineral stone and high-density plastics. Simultaneously, x-ray systems perform valuable in-line quality checks including counting components, identify missing or broken products, monitoring fill levels, checking for damaged packaging and detecting agglomerates such as flavour and powder lumps.
Addressing the Misconceptions
To understand the benefits of x-ray inspection, we must first address the misconceptions. Pharmaceutical manufacturers often express concerns about the potential impact of x-ray inspection on their products. However, studies have consistently shown that the quantity and energy of x-rays used during product inspection are minimal, and the duration of exposure is extremely brief. For example, tablets undergoing x-ray inspection are typically exposed to low-energy x-rays for less than 0.2 seconds. In comparison, the dose of background radiation that pharmaceutical products receive while on the shelf, in transit or during consumer ownership is significantly higher than the levels delivered by an end- of-production line x-ray inspection system.
The US Food and Drug Administration (FDA) acknowledges that the dose levels received by objects passing through an x-ray inspection system are lower than the dose of background radiation received in a single day. Furthermore, and perhaps most crucially, the FDA asserts that there is no known danger in consuming medicines that have undergone x-ray inspection.
