When a paper lid on a sterile medical package is opened, it can release a significant number of particulates, but that’s not an issue with DuPont™ Tyvek®. The unique structure of Tyvek®—tough, continuous filaments of high-density polyethylene (HDPE)—results in clean peel and low lint features that enhance presentation and enable virtually particulate-free delivery of devices and supplies into the sterile field.
So in addition to providing ease of opening, Tyvek® for medical packaging minimizes the risk of contaminating the device or the sterile field when a medical package is opened or handled.
Tyvek® Generates Far Fewer Particulates than Medical-Grade Papers
Particulate generation tests comparing Tyvek® to medical-grade papers showed conclusively that Tyvek® generates far fewer airborne particulates that could contaminate the medical device or the sterile field. The particulate generation testing measured the quantity and the size of particles generated by Tyvek® and by medical-grade paper both before and after being torn in half.
Untorn Tyvek® generated fewer particles than medical-grade papers across the entire size range from 0.3 microns to 10.0 microns. For example, the untorn medical-grade papers generated from 9,000 to 20,000 particles measuring 0.3 microns while untorn Tyvek® generated less than 600. When torn, the medical-grade papers generated 19,000 to 35,000 particles measuring 0.3 microns, whereas Tyvek® generated less than 1,000.
The tests proved that Tyvek®—with its clean peel and low-linting properties—generates significantly fewer airborne particulates than medical-grade papers. The bottom line is that Tyvek® for medical packaging helps reduce the risk of contamination.
How the Comparison Test Was Conducted
For the testing, samples of three different medical-grade papers and two medical packaging styles of Tyvek® were each tumbled in a tumbling drum to release particles from the tested materials. The drum was housed in a HEPA filter lab bench. The lab bench air was filtered with two pre-filters and one HEPA filter. Air was supplied by a blower with a pressure drop across the filters of 0.5 in. (1.3 cm) of water. Sampling of the number and size of the generated particles was done with a cleanroom monitor coupled to a paper tape printer. All of the equipment was in a temperature-controlled, HEPA-filtered-air cleanroom that had full air exchange approximately every minute.