Using One Polymer for a Sterile Barrier System

TEQ Thermoform Engineered Quality has developed a sterile barrier system (SBS) employing a new, proprietary blend of high-density polyethylene (HDPE) in combination with adhesive-coated Tyvek from DuPont. The company is currently working with partners Belco Packaging Systems Inc. and Spartan Design Group to arm medical device manufacturers with the data they need to switch to the new sterile barrier system.

TEQethylene features an HDPE blend that will have “less environmental impact than other materials, while also offering many additional benefits over conventional HDPE such as better clarity for improved visibility and seal inspection, better durability to hold up to the sterilization process, and better processing and dimensional control,” TEQ reported in a statement. “When used with Tyvek lidding, the result is a monopolymer package that is more easily recycled.”

“Our TEQethylene solution helps to overcome one of the biggest obstacles to recycling SBS materials, which is the fact that sterile barrier systems most often consist of more than one material—and hospital staff simply don’t have the time or interest in separating lids and trays for recycling,” said Randy Loga, president of TEQ.

The new HDPE blend also offers a 35% part cost reduction compared with that of PETG, and a 15% reduction when compared with HIPS, the company reports.

Traditionally, some HDPE supply has exhibited some limitations when it comes to dimensional stability, clarity, or formability, TEQ reports. To overcome them, TEQ worked with its suppliers to develop an HDPE blend/ tray with better clarity over conventional HDPE, better processing, and dimensional control.

Aware that changing tray materials typically requires the need for a new package stability study, TEQ enlisted the support of Belco Packaging Systems Inc. and Spartan Design Group so that TEQ can provide customers with the stability data they need to meet the requirements of Clause 6.4.1 of ISO 11607-1:2006.

Through Spartan Design Group, PMP News editorial advisory board members Curt Larsen and John Spitzley provide packaging engineering, development, and testing support and continue to develop international standards for sterile medical device packaging.

Belco Packaging Systems manufactures shrink packaging and blister sealing systems and delivers, installs, services, and sells parts for all of its equipment. “Having Belco’s sealing equipment on site as a reseller of its systems, and having direct access to the expertise of Spartan Design, we are able to offer our medical customers a complete SBS solution—and play an instrumental role in the effort to help improve the recyclability of plastic products within healthcare,” says Loga.

When the three partners complete stability testing and post aging sample evaluations, they’ll produce a report that provides:
• Rationale for the HDPE stability testing project based on the requirements of ISO 11607-1:2006.

• Description of the SBS materials and configurations tested.
• Listing of the tests conducted on the samples.
• Test data for each configuration at each test interval.
• Analysis of the test data and a conclusion regarding the stability attributes for each SBS configuration and the SBS materials.
• Biocompatibility data on the materials used in the study.

Darrel Blocksom, director of operations for TEQ, discussed the TEQetheylene solution in detail at a presentation during HealthPack in early March.

A white paper is available by contacting TEQ at www.TEQnow.com.