<span style="text-shadow: 2px 2px #000000">Tyvek® outperforms competitive material in low-temperature sterilization</span>
Critical temperature-sensitive medical devices that require the use of low-temperature sterilization processes must have a trusted packaging solution that does not compromise microbial barrier performance nor mechanical properties.
Currently, hospitals and healthcare providers can choose from several different porous packaging materials for the sterilization pouches and reels they use to sterilize medical devices that are heat- and moisture-sensitive. However, it is important to note that performance of these materials varies significantly.
To illustrate this point, tests of the most important properties defining best-in-class performance before and after sterilization were conducted on DuPont™ Tyvek® 1073B and a competitive spunbonded polypropylene (PP) based material currently promoted for in-hospital use. Both materials were exposed to standard cycles of vaporized hydrogen peroxide (H2O2).
Microbial barrier performance
Both Tyvek® 1073B and the competitive spunbonded PP material were tested according to ASTM F1608, an industry-recognized standard used to measure the microbial barrier performance of porous healthcare packaging materials. The higher the log reduction value (LRV), the better the microbial barrier performance.
As shown in Figure 1, the difference in microbial barrier performance of Tyvek® 1073B and the competitive spunbonded PP material is over 3 units on a logarithmic scale both before and after H2O2 sterilization. This means that, on average, Tyvek® retains over 1,000 times more microorganisms compared to the competitive spunbonded PP material.
Figure 1. Comparison of the microbial barrier performance of Tyvek® 1073B vs. a competitive spunbonded PP material before and after H2O2 sterilization.
While this clearly shows the superior microbial barrier performance of Tyvek® 1073B, it also raises important concerns about the performance of the competitive spunbonded PP material, which has an LRV of about 1 (corresponding to only 90% retention of microorganisms). This is also significantly below the microbial performance of current sterilization wraps. To support the continuous fight to minimize the risks of nosocomial infections of patients, it is essential that porous material provides state-of-the-art microbial performance.
Liquid transfer resistance
To measure the risk of liquid transfer to the medical device before and after H2O2 sterilization, the hydrostatic head of both Tyvek® 1073B and the competitive spunbonded PP material were tested according to AATCC TM 127.
As shown in Figure 2, Tyvek® performs about 2.5 times better than the competitive spunbonded PP material before sterilization and about 2 times better after sterilization.
Liquid transfer resistance (AATCC TM 127)
Figure 2. Comparison of the liquid transfer resistance of Tyvek® 1073B vs. a competitive spunbonded PP material both before and after H2O2 sterilization.
The decrease in hydrostatic head after sterilization for both of these packaging materials is due to the fact that sterilization modalities using hydrogen peroxide (H2O2) gas technology may increase the surface energy of the packaging materials, resulting in a lower resistance to liquid transfer.
Sterile integrity
It is essential for a sterile barrier system (SBS) to meet the barrier requirements before, during and after the sterilization process, including handling and storage. Sterile barrier properties must not be compromised during the lifecycle of packaging—whether it has a short or long shelf life.
That’s why it is important to select a robust packaging material that will maintain integrity of the SBS, especially during handling and storage. Two tests commonly used to determine the robustness of sterile packaging materials are Mullen burst and puncture resistance.
Mullen burst performance
Mullen burst measures the ability of a material to resist forces applied uniformly throughout the material (e.g., where pressure changes take place or where a force is applied over a relatively large area).
The Mullen burst performance of both Tyvek® 1073B and the competitive spunbonded PP material were tested according to ISO 2758.
As shown in Figure 3, Tyvek® 1073B has superior burst strength, measuring nearly 2 times better than the competitive spunbonded PP material.
Bursting strength (ISO 2758)
Figure 3. Comparison of the burst strength of Tyvek® 1073B vs. a competitive spunbonded PP material.
Puncture resistance
To maintain the sterile integrity of a packaged medical device, the sterile packaging material must help protect against product breakthrough inside—even from the irregular or sharp edges of many surgical devices—and from rough handling outside.
The puncture resistance of both Tyvek® 1073B and the competitive spunbonded PP material were tested according to ASTM F1306. As shown in Figure 4, Tyvek® 1073B offers superior puncture resistance.
Puncture resistance (ASTM F1306)
Figure 4. Comparison of the puncture resistance of Tyvek® 1073B vs. a competitive spunbonded PP material.
Tyvek® —best-in-class for low-temperature sterilization
Hospitals and healthcare providers can feel confident when choosing Tyvek® 1073B for sterilizing heat- and moisturesensitive medical devices with H2O2 sterilization. That’s because in tests of the most important properties defining best-in-class performance—microbial barrier, liquid transfer resistance, burst strength and puncture resistance—Tyvek® 1073B consistently outperforms other porous packaging materials, including a competitive spunbonded PP material currently promoted for in-hospital use. Simply stated, Tyvek® 1073B provides superior performance before and after H2O2 sterilization.
