The package is thermoformed by Plastofilm Industries, a division of IVEX Packaging, Wheaton, IL. The Barex is provided by BP Chemical, Cleveland, OH. The Clearfoil film is supplied by Rollprint Corp., Addison, IL. All three companies worked closely with Osteonics to develop the package. Because oxygen barrier was crucial, the team decided to flush both trays with nitrogen to eliminate as much entrained oxygen as possible. During packaging, the implant is placed into the primary or inner tray. The tray is purged with nitrogen and after flushing, a vacuum step is performed as the packaged is being sealed. Next, the inner tray is placed into the outer Barex tray and the process is repeated.
The final step is sealing the two trays into a Clearfoil pouch. The material is oriented polyester film (OPET) coated with a thin layer (100 to 2000 angstroms) of silicon oxide. The coating imparts excellent moisture, oxygen and chemical barriers that are unaffected by gamma sterilization. The coating is deposited on the OPET base film by either evaporation or gas plasma. The pouch is filled with nitrogen which serves as a final barrier.
The Barex trays are thermoformed with interchangeable molds, according to Plastofilm. The molds can run either Barex or PETG depending on Osteonics’ production schedule. The Barex trays are run with full plug assists. Osteon ics’ existing packaging line was retrofitted to accommodate the nitrogen flush vacuum seal system.
The geometry of the inner tray allows the implant to rest securely and be suspended in the outer tray for added protection. The two trays feature easy-to-peel lids for fast, dust-free opening by user. .PMP News
Reprinted from Pharmaceutical & Medical Packaging News • Copyright © 2004 Canon Communications LLC