Validated Label Materials

In the medical device market, using the correct label materials is crucial. Using the wrong adhesive, label, or ribbon can result in noncompliance and labeling errors. Validation is not just about the materials. The combination of those materials is also important.

Warren Ward-Stacey

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

Medical device companies spend time and resources on the label format validation processes. The goal is to ensure that, when a company sends a label to print, all the drivers and other components are correct. However, businesses increasingly are failing to match the materials and ribbons they use for quality.

Over the last four years, the price of label stock has increased, leading to an increase of as much as 20 percent in overall costs. However, simply buying the cheapest materials is more likely than not a false economy. If a business cannot guarantee that the label it prints will last as long as the product's shelf life, that business is at risk of noncompliance.

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

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


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Warren Ward-Stacey, Sales Director, Prisym ID

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