With the increase in regulatory requirements on sterile products, the quality of the packaging is an integral part of the product. How will medical technology companies respond to these completely new demands?
In the past, while packaging was necessary, it was often considered an afterthought. This mindset is now significantly changing. The EU’s Notified Bodies have recognized that a larger focus should be placed on packaging during the annual audits.
This change has clear implications for the entire medical technology industry! The storage conditions of sterile products, as well as pre-stored packaging materials have recently become the focus of inspections. Packaging materials have historically been identified as the weakest part. Hospitals/end users demand a longer sterility of products.
During Covid, the number of products running out of shelf-life was staggering. This increased demand for sterile products is causing drastic supply shortages and price increases. More companies are recognizing that the greatest potential savings depends on selecting the correct sterile packaging.