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Validated label materials

Using the correct label materials in the medical device market is crucial; using the wrong adhesive, label or ribbon can result in non-compliance and labeling errors. To be validated it’s not just about the materials but the combination of those materials that’s important.

With the ongoing need to reduce the cost of packaging and labeling, how can manufacturers ensure that trying to cut cost in consumables does not actually add cost through errors and recalls?

Medical device companies spend time and resource on the processes to validate label format, ensuring that when they send a label to print all the drivers and other components are correct. However, there is an increasing trend for businesses to fail to match the materials and ribbons they use for quality.

Over the last four years, the price of label stock has increased, leading to as much as an overall increase in cost of up to 20%. However, simply buying the cheapest materials is more likely than not to be a false economy. If a business cannot guarantee that the label printed will last for the duration of that product’s shelf life, then they are at risk of non-compliance.

Furthermore, if an organization ends up throwing away more labels due to poor quality issues, this has clear cost implications. But there are additional hidden risks. Does the organization know how many labels are being thrown away? Are they destroying and reconciling these labels? If there is any doubt over this, then there is the additional risk that the labels might end up being used on counterfeit products.

The risks associated with using unvalidated label materials are undoubtedly high. To seek small cost benefits and buy cheap label stock is a false economy and risks undoing effort the organization has put into developing validated labeling processes.