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Originally Published EMDM November 2005

SPECIAL REPORT

Orthopaedic Packaging Concept Takes Stress Out of Travel

Norbert Sparrow

Prosthetic devices are very fragile and require protective packaging. Blister packs are typically used, but vibration during transport can cause the product to scrape against the packaging, producing dust that may settle on the implant. To prevent this from happening, foam is often used to secure the product. But that raises cost and other issues. Velfor Group (Saint-Pal-en-Chalançon, France) developed the Velairpack system to address these concerns. The concept was awarded the Prix Pharmapack 2005 at the Pharmapack event in Paris at the beginning of the year.

“We focused on two targets in developing this system,” says François Bonnier, medical products sales director. “We wanted to lower costs by providing a generic blister pack for implants . . . one model that would be suitable for packaging most stems, another that would fit all knee implants, and so forth. Our second objective was to immobilize the product in such a way that there would be no risk of abrasion.”

The Velairpack system achieves the latter goal through the use of thermoformed bubbles that protect the device from impacts originating outside the packaging and a sealed elastic envelope that conforms to the shape of the device and allows it to “float” inside the blister pack. The advantages include a substantial cost reduction, because a single blister design can hold a range of orthopaedic products, and immobilization of the product is achieved without the use of foam inserts.

Although foam is commonly used to immobilize implants within their packaging, companies are not entirely comfortable with the material, according to Bonnier. “Foam has a lot of bubbles, so there is the potential for contamination. And there is the cost issue as well,” he adds. “We believe that manufacturers will gladly replace foam if there is a viable alternative.”

Enter Velairpack. Major implant manufacturers are currently evaluating the system for their products, according to Bonnier. The packaging comprises an external PETG blister and a bottomless inner blister made of modified PETG. Because the implant only touches the membrane, which serves as a barrier material, tests are being conducted to determine the material’s aging properties and to ensure that sterility can be ensured for the shelf life of the implant. Velfor also offers a refined packaging system in which the membrane is welded onto an internal blister pack with a PETG bottom. In this way, the membrane serves only to immobilize the implant, while the PETG blister provides a microbial barrier.

Velfor Group manufactures a range of blister packaging and pouches for implants and medical instruments. PA and PE bags can be produced on a contract basis for Class III implants. Class 10,000 and Class 100,000 cleanrooms are on-site, and the firm employs a team of engineers who are dedicated to new product development and packaging customization.

Copyright ©2005 European Medical Device Manufacturer