A small thermoformed clamshell for Wright Medical’s complete line of implant screws has earned Barger, a division of Placon, a 2013 AmeriStar award. The result of a collaboration between the two companies, the clamshell can be used to package about 350 SKUs and can be used for both sterile and nonsterile presentations. 

Developed to be a universal solution for a family of existing components, Wright Medical’s Extremities Clamshell replaces a variety of previously used packaging materials, including poly-bags, urethane/silicon-type end caps, and even foam.

The redesign had to accommodate several different sized and shaped extremity implant screws, many of which are sharp. Wright therefore needed a design that would protect against part abrading as well as pinholes or fractures in pouches. The new package also needed to hold up under EtO and gamma sterilization.

As a potential solution, Wright had considered placing the screws directly into bags, but testing showed that specific parts were being damaged during shipping or storage, Barger reports.

Barger and Wright devised a 2.5 in. long x 1.5 in. wide PETG clamshell with no sharp edges that can touch primary packaging material. For double-barrier sterile applications, the clamshells can be packaged into chevron poly/Tyvek pouches, then in secondary chevron poly/Tyvek pouches, and ultimately placed in cartons with instructions for use (IFU).

Barger reports that the package is suitable for EtO, gamma, gas plasma, E-Beam, and other sterilization methods.

For non-sterile presentations, a double compartment poly bag can be used with an IFU sealed in one compartment and the clamshell in the other.

Using ASTM 4169 as a base for transportation testing, Wright conducted a series of additional in-house ship testing (shake, rattle and roll) to ensure the packages’ and products’ structural integrity remained intact, Kelly South, Barger’s design engineer, tells PMP News.

Subjected to six cycles of tests, the packaging went through 12 hours of vibration testing and 60 drops. The packaging passed all testing requirements with no scratches or abrasions found on the clamshell or any evidence of particulate.

Both packaging production staff and hospital operating room personnel have found the new packaging easy to handle, South adds.

Scott Duehmig, director of sales for Placon/Barger’s Custom and Medical Divisions, said in a statement that the design “is a great example of how collaborating with our customers can lead to exceeding expectations with a design that is simplistic, not only filling today’s requirements but with added flexibility for future products.”

For more details, visit www.bargerpkg.com.