How TekniPlex Healthcare helped a leading supplier of urinary catheters correct a recall-inducing sterility seal failure.

Redefining Urinary Catheter Packaging

A leading manufacturer of urinary catheters faced a critical challenge with its legacy packaging process, which resulted in sterility breaches and costly product recalls. In an industry where product protection and sterility are paramount, the company discovered that its current packaging—comprising a combination of ethylene-vinyl acetate and DuPont™ Tyvek®—was prone to weak seals. This flaw not only jeopardized patient safety but also risked the company’s reputation and market share. TekniPlex's team swiftly identified that the problem stemmed from the sterilization process, particularly during ethylene oxide (ETO) cycles. They proposed a high-performance coating on a Tyvek® 2FS substrate designed to enhance seal strength and durability under demanding conditions.