X-ray technology can solve problems underlying the packaging area of pharma products: detection of foreign body contaminants, identifying incomplete or missing medicines, and identifying damaged packaging. Micheal Pipe, Head of Global Sales of Mettler Toledo, talks about Safeline X-ray looks at how pharma manufacturers can benefit from investing in x-ray inspection.
As any responsible manufacturer knows, there can be no trade-offs in quality standards when it comes to the manufacture of pharmaceutical products. Whether the medicine is in liquid or tablet form, it is essential that foreign body contaminants are detected and removed. The dosage or fill levels must be correct, plus the integrity of both the packaging and the product has not been compromised.
Metal detection systems can be used before tablets are pressed or packed, to detect ferrous, non-ferrous and stainless steel metal contaminants. Vision systems and check-weighers also play a vital role in ensuring that products are complete, labeled correctly and at the correct weight. However, with tablets increasingly being packaged in aluminum foil-based blister packs, it is difficult in these scenarios for metal detection systems to identify if metal contaminants are present if inspected after packaging.
This is where x-ray technology can help. It can detect a wide range of foreign body contaminants, including metal, both before and during packaging. It can also deliver several further quality assurance benefits. Here are five key areas where x-ray inspection can make an important contribution in pharma production and packaging:
Foreign body detection is a critical aspect of any pharma manufacturer’s product inspection operation. Metal detection is a robust inspection technology for detecting metal contaminants, including stainless steel, in the preparation or tabletting process. However, x-ray inspection systems can complete contamination checks early in the production process but can also inspect for contaminants including metal at the final packaging stage, after the blister packing process
X-ray works by measuring differences in absorption between low and high-density matter and can provide exceptional detection of contaminants such as metal, glass, and certain plastics and rubbers, regardless of the contaminant’s shape, size or location within the product.
Help ensure product and packaging integrity
X-ray inspection can carry out a wide range of additional quality control tasks at the same time as detecting foreign body contaminants. These tasks include: Product completeness checks, including counting components and identifying damaged components – with comparison to the known number of items that should be in a pack. Identifying damaged packaging, inspecting seal quality to detect product trapped in the seal, and identifying missing components such as screw caps
Measuring the mass of a product and comparing this to a known mass value for a reference pack. Checking fill levels – the x-ray inspection image shows clear discrepancies in fill levels between packs, where perhaps one is under-filled and one over-filled, making the overall pack weight seemingly correct.
Avoid product recalls
For pharma manufacturers, product recalls represent a twin-headed peril: the costs of wasted products and production time on the one hand; the damage to its good name on the other. While the costs of the former are often quickly absorbed, the negative effects on brand reputation can be much more long lasting.
Implementing a well-designed x-ray inspection program can cut the risks and the costs involved in product recalls. X-ray “run codes” are assigned to each product run, and these can be compared to check weigher batch data, potentially helping to isolate smaller contaminated batches that need to be recalled, instead of an entire production run.
The absence of good product inspection can endanger patient health and safety, and such incidents can lead to major legal action being taken. Even without a worst-case scenario like this playing out, there is still huge danger to a pharma brand. This can have a huge impact on public trust in the brand – not to mention, the brand’s reputation in the industry – as well as causing extra delays and costs in bringing products to market.
Comply with regulations
In a sector as highly regulated as pharmaceuticals, compliance is critical, both for patient safety and for the furtherance of responsible drug supply. Therefore, quality assurance programmes must be robust and comprehensive, with risks identified and mitigated. X-ray technology can play a key part in helping to ensure compliance. In addition, modern x-ray inspection systems keep digitized records of activity, helping producers to meet the demands of CFR 21 Part 11.