Soclean Lab Results

SoClean kills 99.9% of CPAP germs and bacteria

SoClean has been independently lab tested and proven to reduce various pathogen species in CPAP equipment by an average minimum of 99.9%.

Does CPAP equipment really contain bacteria if not properly cleaned?

Yes! In a clinical report from the Journal of Clinical Sleep Medicine, bacteria were recovered in 9 of 11 tests from the breathing tubes of CPAP devices fitted with heated humidifiers.

Which Microorganisms Were Tested?

 

STAPHYLOCOCCUS HAEMOLYTICUS 29970


This is a Gram-positive, spherical-shaped bacteria commonly found on both the skin of humans and animals. This bacteria is known for being the second most common bacterial isolate from human blood and has been known to cause infections in people with compromised immune systems. Typically not a public health pathogen, recent strains of this microorganism has demonstrated antibiotic resistance.

STAPHYLOCOCCUS HOMINIS 27844


This is a Gram-positive, spherical-shaped bacteria commonly found on both the skin of humans and animals. This bacteria is known for producing compounds that contribute to body odor and has been known to cause infections in people with compromised immune systems. Typically not a public health pathogen, recent strains of this microorganism has demonstrated antibiotic resistance.

STAPHYLOCOCCUS EPIDERMIDIS 12228


This bacteria is a Gram-positive, cocci-shaped, facultative anaerobe. S. epidermidis is part of the human bacterial flora, mostly located on skin. It is not usually pathogenic, however, antibiotic resistant strains have evolved. Most Staphylococcus species are a hardy microorganisms capable of surviving on surfaces and under dry conditions. This bacteria, specifically, is regularly used in quality control, media testing, and pharmacuetical/personal care products testing.

CANDIDA ALBICANS 10231


This fungi is facultatively aerobic and can grow both as a yeast and as a filamentous fungus. Candida albicans is a commensal microorganism meaning it normally inhabits the human mouth and gastrointestinal tract but is opportunistic and can cause candidiasis or thrush. Candida albicans can survive for long periods of time without nutrients and is known to form biofilms on medical devices, therefore, disinfection to kill these fungi is very important.

Lab Report Summary

Protocols, test method setups, and results are included in the enclosed reports. In addition to the Biofocus 2017 test findings, included for reference is the 2012 Biofocus document.

According to Healthy Facilities Institute (www.healthyfacilitiesinstitute.com) “Log” stands for logarithm, which is the exponent of 10. For example, Log-2 represents 102 or 10 x 10 or 100. Log Reduction stands for a 10-fold (one decimal) or 90% reduction in numbers of live bacteria.

Another way to look at it is: 1-Log Reduction would reduce the number of bacteria 90%. This means, for example, that 100 bacteria would be reduced to 10, or 10 reduced to 1.

90% .................. 1 Log reduction: Number of germs is 10 times smaller
99% .................. 2 Log reduction: Number of germs is 100 times smaller
99.9% ............... 3 Log reduction: Number of germs is 1000 times smaller
99.99% ............. 4 Log reduction: Number of germs is 10,000 times smaller
99.999% ........... 5 Log reduction: Number of germs is 100,000 times smaller
99.9999% ......... 6 Log reduction: Number of germs is 1,000,000 times smaller

Results Summary


Various pathogen species were used for disinfection testing and the SoClean 2 in all testing facilities/species resulted in a minimum average Log 3 reduction (99.9% Disinfection) with many tests performing over a Log 4 reduction (99.99% Disinfection).

The following is taken from the 2012 Biofocus test:

Figure 1: Result of the swab-test before (left) and after (right) one sanitising cycle with SoClean.

1. DISINFECTION OF USES CPAP EQUIPMENT


Setup: A used “Mojo Vented Full Face Mask” (Sleepnet Corp.) was examined by swab sampling before and after sanitising the mask with one standard cycle of the SoClean system (15min Ozone generation, wait time 2 hours).

Results: The swab-test showed slight contamination of the mask with aerobic sporulating bacteria. Fungi could not be detected.

After one sanitising cycle no bacteria and fungi could be detected (Fig. 1).

2. INACTIVATION OF ENTEROCOCCUS FAECALIS IMMOBILISED ON FILTER PAPER


Setup: A reference cell culture of Enterococcus faecalis (ATCC 29212) was diluted 1/10 with sterile water. A membrane filter paper (0.45µm, Whatman, ME25) was contaminated with the bacteria by normal filtering. Each filter was separated into two parts. One part was positioned within the CPAP-mask (Fig.2), the other part was used as reference and was stored outside the incubation camber during the sanitising process. After one standard cycle the filter was directly placed on a culture medium
(Slanetz and Burtley, Oxoid, P05018A) and incubated for 60h at 37°C.

Results: Enterococcus faecalis was completely inactivated on all filter papers subjected to the sanitising process. The part of the filter not placed in the ozone chamber showed almost the same bacterial activity as a freshly prepared filter.

Figure 2 (top): Positioning of the contaminated filter papers in the mask.
Figure 3: Result of the filter incubation form the left and right side of the mask. The red colour of the reference filters (left side of each plate) indicates the presence of bacteria. The white colour indicates complete elimination of the bacteria.

3. SANITISING A MASK, DIRECTLY INCUBATED WITH ENTEROCOCCUS FAECALIS


Setup: The mask and hose were contaminated by an Enterococcus faecalis (ATCC 29212) cell culture solution (Fig. 4). The contaminated surfaces of mask were examined by swab testing after one sanitising cycle within the SoClean. A directly contaminated swab was used as reference.

Results: On the contaminated surfaces all bacteria were inactivated (Fig. 5).

Figure 4: Contaminated surfaces (marked blue) in the hose (left) and the mask (right).
Figure 5: Result of the swab-test. Reference (left), mask (middle) hose (right). The red colour indicates the presence of bacteria. The white colour indicates complete elimination of the bacteria.