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BACTERICIDAL EFFICACY TESTS (EN 1276) (PHASE 2, STEP 1) Activ8 & MRSA

 

BACKGROUND

1. As Greenbridge Environmental Control Ltd considers Activ8 to be such a powerful, safe, cleaner disinfectant that can address a wide variety of infection problems worldwide, the company felt it imperative to secure clear robust science to prove and demonstrate the product’s properties and potential. Its documented efficacy against bacteria, fungi and viruses in general and Hepatitis B&C, TB, VRE, MRSA, SARS, Avian Bird Flu in particular are detailed at www.greenbridge.cc. This investment has been rewarded with a level 2 recommendation from the UK Government’s Department of Health Rapid Review Panel (RRP), reflecting the capabilities of this new and innovative product.

THE NEED TO TRIAL ACTIV8 AS A VAPOUR

2. As part of this on-going work, it was felt prudent to carry out a specific series of trials on the efficacy of Activ8 when delivered as a vapour to clean and disinfect in a range of settings from hospitals, bird farms and sports stadia, through to cruise liners and commercial aircraft. It was therefore decided to carry out the initial investigative study in a hospital setting with known high levels of contamination.

AIM OF THE SUMMARY

3. The aim of this paper is to provide an executive summary of the trial to enable potential purchasers to assess the cost effectiveness of Activ8 in the fight against bacterial, fungal and viral infections in a wide variety of industries well beyond the healthcare sector.

AIM OF THE STUDY

4. The aim of the study was to evaluate the efficacy of Activ8 when applied in a vapouriser/fogger device in clearing a single hospital room containing MRSA in fixed innocula on standard agar plates. In addition the safety of staff using the device with Activ8™ was assessed subjectively.

STUDY DESIGN AND PROCEDURES

5. The study in Aberdeen Royal Infirmary (ARI) was designed to provide a single patient room on five occasions and allow tests to be conducted on 25 agar plates placed in identical key positions in each room (using a room template) according to the requirements for eliminating Hospital Acquired Infections (HAI) in general and MRSA in particular. Each of the 25 agar plates were seeded with a standard innoculum of MRSA using an approved spiral plated device.

6. The Contica 2400 Ultra-Lite Fogger was used as the vapouriser in the trial and after being loaded with ACTIV 8 (100ml/litre) was switched on. During the vaporisation (or fogging) process the designated microbiologist removed 5 agar plates starting at the baseline of zero minutes, and then 30, 60 and 90 minutes with the final 5 plates at 120 minutes. Each of the agar plates were subsequently transferred to routine culture in the laboratory with the zero minute samples acting as positive control at a clearly defined baseline.

7. Objective measurements of the Total Viable Count (TVC) on the plates both before and after vaporisation were made to identify the efficacy of ACTIV8 delivered by the vapouriser. Subjectively, the Medical and Nursing Staff assessed not only the ease and convenience of Activ8 being delivered by the vapouriser, but also the appearance and smell in the test rooms.

CONDUCT OF THE STUDY

8. After the data had been collated for the first three rooms it became apparent that although many plates had reduced to zero TVC after 30 minutes, the rate of application was insufficient to reduce totally the TVC levels effectively over the first 90 minutes. Therefore in the fourth room the rate of application was increased and this resulted in much improved decontamination over shorter time periods, but it did also cause extreme room soaking after 75 minutes.

9. To overcome the soaking problem, the rate of application in the fourth room, was retained and the time of exposure reduced with the Latin square structure modified to test the efficacy of vapourised Activ8 over shorter time scales – and the plates being removed at zero and then at 10, 20, 30 and 60 minutes.

SUMMARY OF RESULTS

10. The analysis of plates in the first three rooms demonstrated that although Activ8 was able to eliminate the contamination on some plates within 30 minutes, the rate of application was insufficient to ensure total TVC elimination after 120 minutes in some cases.

11. In the fourth room, analysis showed that two out of five plates had trivial levels after 30 minutes, and all five plates were at trivial levels at 60 minutes.

12. In the fifth room, two out of five plates reached trivial levels after 20 minutes, four out of five after 30 minutes and all TVC levels reduced to almost zero after 60 minutes. This suggests that there is a minimum time between 30 and 60 minutes for successful elimination. The results at Appendix 1 are included for scientific readers who wish to see examples of the analysed evidence.

13. Although the increase in the rate of application of the vapourised Activ8 for the last two rooms enabled the study to evaluate the efficacy of ACTIV8 to more refined TVC and time criteria in a relatively short time, there is certainly a need to investigate either modifying the Contica 2400 Ultra-Lite Fogger or using another type that has more control over the rate of delivery of the vapour.

REPORT CONCLUSIONS

14. The ARI report concluded that:

a. ACTIV8 has effective antibacterial properties when applied via a fogging device (CONTICA 2400 Ultra-Lite Fogger) according to the Bristol protocol and using fixed innocula of MRSA on agar gel plates.
b. There were no adverse effects on any of the operators involved in this study though all used standard nasal/mouth vented masks for the application of Activ8 from this vapourising device.
c. Effective decontamination is achieved over varying periods of time depending on both the rate and flow of vapourisation of the liquid delivered.
d. Further studies would enable the optimal rates and volumes of ACTIV8 using a fogging device to be defined specifically.

COMPARISON OF COST EFFECTIVENESS BETWEEN PRODUCTS

15. Because the use of Activ8 as a safe cleaner disinfectant delivered by a vapouriser potentially offers a unique and significant step forward in infection control, the report includes factual data on a toxic product delivered by vapouriser for comparison. While the ARI report restricts itself to scientific fact and does not draw any commercially comparative conclusions, market research by Greenbridge into the toxic product indicates that the toxic product:

a. Vapouriser costs at least £70,000 compared with £250 for the Contica.
b. Requires personal protection equipment (PPE) for specially trained staff who cost around £3000 for each fogging evolution as opposed to simple face masks for locally trained domestic staff who are already on the pay roll/contract.
c. Requires the area/space being fogged to be out of commission for 12-24 hours while Activ8 allows patients to be returned to the area within one our.

OVERALL CONCLUSION

16. Taking into account the ARI report conclusions and further market research, Greenbridge confirms that decontaminating a hospital room with Activ8 as a vapour can be achieved within sixty minutes or less using locally trained and employed staff with no specialised personal protection equipment.

WAY AHEAD

17. The Board of Greenbridge has been greatly encouraged by the potentially significant findings of the ARI vapourisation study and has therefore taken immediate action to forge ahead with its marketing strategy to penetrate a wide variety of markets that can benefit from this new and innovative product that has so much potential to offer public health worldwide.

Appendix 1 - Analysis of Room 5

8.3.1 TVC Levels for Room 5 by Time and Row

Rows 1 and 5 have reduced to zero after 20 minutes and row 3 is very low after this time. Row 4 remains high until after 20 minutes and row 2 until after 30 minutes.

8.3.2 TVC Levels for Room 5 by Time and Column

Columns 2 and 3 have reduced to zero after 20 minutes and column 4 is very low after this time. Column 5 remains high until after 20 minutes and column 1 until after 30 minutes.

8.3.3 TVC + 1 Levels on Log Scale for Room 5 by Time and Row

TVC + 1 used because of problems with log at zero levels.

Log scale enables comparative studies of low levels of TVC at 20, 30 and 60 minutes. It can be seen that these levels are trivial with the exceptions of rows 2 and 4 at 20 minutes and row 2 at 30 minutes.

8.3.4 Oneway Analysis of Variance

ANOVA
TVC Tests mean TVC levels are the same at all time intervals
  Sum of Squares df Mean Square F Sin
Between Groups 1.06E+08 4 26428915.04 12.318 .000 (TVC levels differ across time groups)
Within Groups 42910702 20 2145535.100    
Total 1.49E+08 24      

8.3.7 TVC Means Plot

 
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