The Institute of Packaging Professionals has announced the winners of its 2013 AmeriStar Package Awards Competition, and among the winners is a thermoformed tray system featuring one novel component. The TKA Femoral Packaging System for Arthrex uses Perfecseal’s new PerfecForm OrthoSecure, a new material combining both polyurethane (PU) and PETG in one two-layer formable film, instead of using a separate PU insert, minimizing the number of package components.
Arthrex’s new orthopedic packaging system is designed to accommodate a total of 80 different products. The system consists of an outer tray and an inner tray both made of PETG, a bottom insert and a retainer made of PerfecForm OrthoSecure, and two Tyvek lids, for a total of six components. The PU/PETG snap-in retainer and bottom insert can be modified or entirely redesigned for new products without having to modify the inner or outer trays.
|Perfecseal’s PerfecForm OrthoSecure used for Arthrex’s TKA Femoral Packaging System|
Alternative packaging systems based on past approaches could have consisted of seven components (either an outer tray, an inner tray, an inner tray PU liner, a retainer, a retainer liner, and two Tyvek lids, or an outer tray, an inner tray, an upper foam insert, a middle foam insert, a lower foam insert, and two Tyvek lids), explained Perfecseal in its Ameristar submission.
Typically, medical device manufacturers use “closed-cell foam or PU inserts, liners, or sleeves to protect trays against abrasive medical device components,” explains Tad Kinyon, Perfecseal’s product manager. “But there is a visibility issue.” In addition, the insert is an additional component both for MDMs to inventory and assemble and for healthcare professionals in the operating room to count, adds Bill Wetzel, Perfeceseal’s marketing director, medical devices, Perfecseal.
So Perfecseal set out to form straight PU material to serve as a tray component. “But it was difficult to control the trim registration around the formed material,” says Kinyon. “We felt it would be beneficial to have the material rigid enough so we could control it.”
Perfecseal then pursued different ways “to bond PU onto PETG and over time identified a method to conjoin the two polymers into one formable material,” explains Kinyon. “The result is a two-polymer material that can be used as a forming film.” The material also improves component visibility. “There is a nominal increase in haze, but it is not like looking through a milk jug,” he says.
Wetzel believes that PerfecForm OrthoSecure can provide additional value by “allowing for creative designs for aseptic presentation.” There’s even the potential for the new material to be used for the inner tray, once it has been qualified for use as a sterile barrier. “It needs testing by a medical device manufacturer,” says Kinyon.
Arthrex’s TKA Femoral Packaging System has been tested according to ASTM F88 and ASTM F1886 as well as ISTA-6-FedEx-A, and it has also been evaluated for particulates. All test results met requirements under ANSI/AAMI/ISO 11607.
Perfecseal’s own laboratory has conducted aging studies on unformed and unsealed PerfecForm OrthoSecure as well as heat-sealed to Tyvek 1073B coated with Perfecseal’s CR27 and SBP2000 coatings. “We’ve tested sealed strips after EtO sterilization and gamma,” says Kinyon.
Kinyon says that by reducing the number of packaging components MDMs may improve their products’ overall carbon footprints.