The Crucial Role that Automated Print Inspection Systems Can and Should Play in Pharmaceutical Packaging.
Producing safe and compliant medicines – and harmless cosmetics, or good food for that matter – sometimes resemble a puzzle with countless number of components. It is only possible if all the individual parts are used and manufactured with the necessary care and precision. Quality and precision, reproducibility and exact documentation are therefore essential.
Every aspect of the manufacturing process must be closely monitored. Among the many critical procedures in this system, the inspection of the various packaging materials is an often overlooked but essential part. After all, compliant content reasonably requires compliant packaging.
This is the first point of contact between the product and the end user, where the latter receives information about the product, contents, dosage, or area of application, alongside the medicinal products. Incorrect or even false information can have fatal consequences, especially in the pharmaceutical sector.
In what follows, will be describing the importance of print inspection in the pharmaceutical industry – and it also applies, with only minor differences, to other regulated sectors such as the cosmetics and food industries – highlighting the advantages of automated inspection and discussing the safety aspects.
Why Printed Packaging Should Be Inspected
Compliance is the main keyword here. The pharmaceutical industry is subject to strict legal regulations issued by the relevant regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in the European Union and similar authorities worldwide. The relevant regulations, such as 21 CFR Part 210 or in Germany the German Medicines Act, require clear and accurate labelling of pharmaceutical products, including essential information such as dosage, expiry date and active ingredients. Any deviation or error in such labelling can lead to non-compliance. The consequences of such non-conformity can be manifold, including product recalls, fines, damage to the company reputation, or worst-case scenario, a health risk to the user. So how can you ensure that pharmaceutical packaging complies with regulations? A print inspection system plays a crucial role here by meticulously checking packaging materials for inaccuracies or defects. In such a system, the approved artwork is compared pixel by pixel with a sample of the packaging, and a scan-to-scan comparison is also possible. The system records all deviations between the two variants, which are displayed and documented for the user, much more accurately and precisely than the human eye could ever do.
This recording of deviations also serves to maintain the consistent quality of packaging. Maintaining the highest quality standards is non-negotiable in this area. Print inspection helps maintain these standards by detecting defects on packaging materials that compromise product integrity. These would include printing errors, illegible text, stains or material inclusions, missing information (such as an artwork element obscuring the text). Any of these technical errors can influence the perceived quality of the product and affect consumer confidence.
The consumer confidence in the reliability and quality of a medicine is also a significant economic factor, as brand reputation is a priceless commodity in the highly competitive pharmaceutical market. Any association with inferior or defective products can irreparably damage a brand’s reputation. The use of a print inspection system serves as a proactive measure to protect brand reputation by ensuring that the packaging meets the highest standards of accuracy and quality. And the growing use of highly refined or complex packaging in particular increases the demand for the quality-related appearance of the product. By preventing defective packaging from reaching the market, pharmaceutical companies can protect their brand value and maintain consumer confidence.