SWEDEN • Sometimes people who work with food packaging feel tied down by all the regulations and standards that exist to guarantee safety. However, the regulations for packaging medical technology (“medtech”) products are equally complex. These products must be manufactured in a sterile environment and then transported all the way into an operating room without risking contamination. Otherwise, people’s very lives could be in danger.
One of the most important requirements is that the packaging solution can deliver the product – which might be an implant or surgical equipment – into the operating room. To ensure this, numerous standards place demands on the packaging material’s permeability, that it can withstand the sterilisation process, that its closures are durable, that the materials do not allow microorganisms to pass through them, and much, much more.
All these requirements must not only be met, they must also be documented with the support of statistically significant data. Quality control systems that emphasise risk management must of course be in place. The natural explanation for why medtech packaging regulations are so stringent is partly that people’s lives can be at risk. Another reason is that the product itself is of high value, especially if its underlying R&D costs are included in the calculations. Last but not least, huge costs could result if something goes wrong – if a product’s packaging is inadequate the manufacturer may have to do a major recall and could also be held responsible for non-delivery.
Supplying material for use in medtech packaging can also involve demands that rarely occur in other industries. Because all input materials must go through extensive and thereby costly qualification and validation processes, subsequently altering or replacing them is strongly discouraged.
Both of Iggesund Paperboard’s paperboard brands, Invercote and Incada, are used in a number of medtech applications.