Summary of Lumen Sterilization Testing: Comparison of the Noxilizer and STERRAD Cycles Summary The ability of the Noxilizer sterilization process to sterilize rigid and flexible lumens was compared to the ASP STERRAD 100NX hydrogen peroxide process. For this test, three different lumen geometries were used. These were: stainless steel, 300 mm long and 2 mm diameter; stainless steel, 500 mm long and 2 mm diameter; and, Teflon, 4000 mm long and 1 mm diameter. Lumens were inoculated with more than 10 6 spores of Geobacillus stearothermophilus prior to exposure to the sterilization processes. The NO2 processed lumens were treated in a prototype hospital sterilizer, called the ARTS unit. The lumens processed by hydrogen peroxide were taken to a hospital for processing in a STERRAD 100 NX system. The results show that, for rigid and flexible lumens, the Noxilizer cycle (with the cycle parameters chosen) was at least equivalent to the H2O2 cycle in the STERRAD 100 NX. Testing Outline For this head-to-head comparison, rigid lumens were prepared for exposure by inoculation with a liquid spore suspension. Each cycle had 8 stainless steel lumens, as shown in Table 1, which were packaged in a Tyvek/mylar pouches (2 lumens per package). The NO2 exposure cycle for the rigid lumens was 10 mg/L NO2 concentration, 5 minutes per exposure pulse, four pulses, and > 75% relative humidity. This cycle is represented by the graph shown in Figure 1. The Noxilizer cycle conditions were chosen so that some number of spores would survive and could be enumerated. A total of 3 cycles were completed in the Noxilizer sterilizer (ARTS 4 unit) and 3 cycles were completed in the STERRAD unit, 8 lumens per cycle, for a total of 24 lumens tested in each unit. The lumens were inoculated with either a clean spore suspension or with spores mixed with artificial soils. The artificial soils are comprised of synthetic hard water (≥ 500 ppm salts) and fetal bovine serum (FBS, 10%). The purpose of the artificial soil (hard water and FBS) was to determine the impact on lethality that might be posed by the salt and protein soil mixture. The flexible lumens were Teflon, with a 1 mm diameter and were 4 meters in length. The inoculum was a clean spore suspension (no artificial soils were used). These lumens were coiled and packaged in Tyvek/mylar pouches. Six lumens were included in each NO2 load and 4 lumens tested in the STERRAD load. The Noxilizer exposure cycle consisted of 10 mg/L NO2 concentration, 2 exposure pulses, >75% relative humidity. This NO2 exposure cycle corresponded to a half-cycle, as shown in Figure 1.
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Summary Geobacillus stearothermophilus - Noxilizer, Inc.noxilizer.com/pdf/news/WhitePaper-NO2-vs-H2O2-Lum… · · 2017-10-25The STERRAD exposure of the flexible lumens was a full
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Summary of Lumen Sterilization Testing:
Comparison of the Noxilizer and STERRAD Cycles
Summary
The ability of the Noxilizer sterilization process to sterilize rigid and flexible lumens was
compared to the ASP STERRAD 100NX hydrogen peroxide process. For this test, three
different lumen geometries were used. These were: stainless steel, 300 mm long and 2 mm
diameter; stainless steel, 500 mm long and 2 mm diameter; and, Teflon, 4000 mm long and
1 mm diameter. Lumens were inoculated with more than 106 spores of Geobacillus
stearothermophilus prior to exposure to the sterilization processes. The NO2 processed
lumens were treated in a prototype hospital sterilizer, called the ARTS unit. The lumens
processed by hydrogen peroxide were taken to a hospital for processing in a STERRAD 100
NX system. The results show that, for rigid and flexible lumens, the Noxilizer cycle (with the
cycle parameters chosen) was at least equivalent to the H2O2 cycle in the STERRAD 100 NX.
Testing Outline
For this head-to-head comparison, rigid lumens were prepared for exposure by inoculation
with a liquid spore suspension. Each cycle had 8 stainless steel lumens, as shown in Table
1, which were packaged in a Tyvek/mylar pouches (2 lumens per package). The NO2
exposure cycle for the rigid lumens was 10 mg/L NO2 concentration, 5 minutes per
exposure pulse, four pulses, and > 75% relative humidity. This cycle is represented by the
graph shown in Figure 1. The Noxilizer cycle conditions were chosen so that some number
of spores would survive and could be enumerated. A total of 3 cycles were completed in the
Noxilizer sterilizer (ARTS 4 unit) and 3 cycles were completed in the STERRAD unit, 8
lumens per cycle, for a total of 24 lumens tested in each unit.
The lumens were inoculated with either a clean spore suspension or with spores mixed
with artificial soils. The artificial soils are comprised of synthetic hard water (≥ 500 ppm
salts) and fetal bovine serum (FBS, 10%). The purpose of the artificial soil (hard water and
FBS) was to determine the impact on lethality that might be posed by the salt and protein
soil mixture.
The flexible lumens were Teflon, with a 1 mm diameter and were 4 meters in length. The
inoculum was a clean spore suspension (no artificial soils were used). These lumens were
coiled and packaged in Tyvek/mylar pouches. Six lumens were included in each NO2 load
and 4 lumens tested in the STERRAD load. The Noxilizer exposure cycle consisted of 10