5 Reasons You Should Use X-ray in Pharmaceuticals

Why X-ray Inspection is Vital for Safe, High-quality Pharma Products

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18 Dec, 2024

Mike Pipe, Head of Global Sales, Royston, UK METTLER TOLEDO Safeline X-ray

As any responsible manufacturer knows, there can be no compromises in quality standards when it comes to the production of pharmaceutical products. Whether the medicine is in liquid or tablet form, it’s essential that foreign body contaminants are detected quickly and removed. The dosage instructions and fill levels must also be correct, plus the integrity of both the packaging and the product must remain intact.

Quality and Safety Inspection of Pharmaceuticals

Product inspection equipment is commonly used throughout production processes to enhance the quality and safety of pharmaceuticals. Metal detection systems are great for detecting extremely small metallic contaminants (less than 0.3mm in diameter) in tablets, capsules, and powders before packaging.

Checkweighers and vision inspection systems also play a vital role in verifying that products are complete, labeled correctly and are the correct weight. However, many tablets are now packed in aluminum foil-based blister packs, which makes it difficult for metal detection systems to identify metal contaminants at the final packaging stage.

This is where x-ray technology can help. It can detect a wide range of foreign body contaminants, with fewer limitations relating to packaging material compared with metal detection technology, so is ideally suited to end of line inspection. It can also deliver further quality assurance benefits like product and package integrity inspection. Here are five key areas where x-ray inspection can make a vital contribution to pharma production.

1. Detect Foreign Body Contaminants

Detection of foreign body contamination, also known as "physical contamination," is crucial for any pharmaceutical manufacturer's product inspection process. Metal detection technology is effective for identifying metal contaminants - including stainless steel - during the preparation or tableting stages. X-ray systems, however, can detect metal as well as glass, certain plastics and rubber contaminants, regardless of their shape, size, or location within the product. This makes it ideal as the final line of defense on a production line.

2. Product and Packaging Integrity

While x-ray inspection systems are vital for foreign body contamination detection, did you know they can also conduct a wide range of additional quality checks at the same time?

Quality checks include:

Product completeness checks
Identifying damaged or missing packaging
Finding product trapped in the seal
Measuring the mass of a product
Checking fill levels

These additional checks make x-ray inspection a powerful tool in the fight against unsafe and poor-quality products reaching consumers and patients.

3. Avoid Product Recalls

For pharmaceutical manufacturers, product recalls can be devastating to the reputation of their brand, and can be costly. While costs may be recouped relatively quickly, reputational harm is harder to recover from. That's why quality assurance using product inspection equipment makes good business sense, in addition to being vital for consumer safety.

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 batch. These codes can be compared with checkweigher batch data to help identify smaller contaminated batches that may need to be recalled, instead of recalling the entire production run.

4. Protect Consumers and Your Brand

The absence of a strong product inspection program can jeopardize patient safety and lead to costly legal actions. Even without a worst-case scenario lawsuit playing out, there is a significant risk to the brand's reputation. Negative press coverage of a product recall can persist long after the recall is completed. Rebuilding consumer trust can take years. Additionally, damage to the brand's reputation within the industry can cause delays and increased costs in bringing other products to market.

5. Comply with Regulations

In the highly regulated pharmaceutical sector, compliance is critical. Therefore, quality assurance programs must be thorough and comprehensive, with potential risks identified and mitigated.

X-ray technology can play a key role in supporting compliance. In addition, modern x-ray inspection systems keep digitalized records of activity, helping manufacturers prepare for product safety audits.

X-ray inspection technology clearly plays a key role in the safety and quality of pharma products. Its multi-faceted capabilities for foreign body detection and integrity checks make it the perfect choice for pharmaceutical manufacturers wanting to maintain high standards.

Find out more about x-ray inspection for pharmaceuticals and how METTLER TOLEDO Product Inspection can support your quality assurance processes by clicking the link below.

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About the Author

Mike Pipe, Head of Global Sales & Product Management, METTLER TOLEDO Safeline X-ray

Mike has worked in both commercial and technical roles helping food and pharmaceutical manufacturers and brand owners achieve compliance, maximize productivity and drive consumer safety.

In this international strategic role, Mike works closely with local and global customers to understand their business challenges and applications to identify the most appropriate x-ray solution. His experience includes helping manufacturers to reduce the risk of product recalls, increase productivity and lower total cost of ownership.