Puncture-resistant pouches from Tolas feature a clean fiber-free peel after sterilization.
Sealing a tray within a durable pouch is an alternative packaging method to traditional tray and lid assemblies for medical device manufacturers. If they are not properly constructed, these assemblies can lead to problems such as lid tearing. But pouches are not immune to tearing either, especially when the contents of the package have sharp angles. To remedy this situation, Tolas Healthcare Packaging (Feasterville, PA, www.tolas.com ), an Oracle Packaging company, has developed what it considers to be a puncture-resistant pouch.
“The standard polyester and polyethylene films used in some Tyvek-and-film pouches are not puncture resistant enough for all applications,” says Denise DiLissio, marketing team leader at Tolas. “Implants that are first packaged in a tray-and-lid [package] and then inserted into a pouch may fail because of these films.” DiLissio describes these failures as tears in the pouches caused by the corners or edges of the inserted trays or devices.
Strength was only one of the properties that Tolas was looking for in a film. It also needed to be flexible, clear, sealable, and, because the package is for medical devices, sterilizable. “Our biggest challenge,” adds DiLissio, “was identifying a film that could successfully contain angular-shaped devices without puncturing, while providing a uniform peel for sterile presentation of the device and a visible seal transfer for assurance of seal integrity.”
Tolas tested several of its Seal Science brand adhesives. Ultimately, the company chose its TPT-0270 heat-seal coated Tyvek. This material produces a clean, fiber-free peel after sterilization to prevent airborne particulates from contaminating the enclosed device.
In addition to Tyvek, the pouch features a 4-mm nylon lamination to increase durability and abrasion resistance. The pouch seal also provides positive indication of seal integrity in the form of a solid white adhesive transfer visible upon opening without any potential contamination to the contents from seal residue.
The pouch film is designed to prevent microbial contamination under rigorous handling or transporting conditions. “It is the overall thickness and the layer of nylon in the film that provide the puncture and abrasion resistance desired by the industry and our customers,” says DiLissio. The film can be sterilized using EtO and radiation methods.
Tolas tested the material for puncture resistance in accordance with ASTM F1306 test method, the Standard Test Method for Slow Rate Penetration Resistance for Flexible Barrier Films and Laminates. The company also conducted the standard compliance testing required to provide ISO 11607 information and data.