Transcript CleanFlow CIP Presentationx

NovaFlux Inc
CleanFlow CIP™
“The Profound Solution to Ultrapure Dialysate”
Two-Phase Flow (TPF) -- “The New Standard”
TPF uses a high-velocity mixture of gas and liquid to clean narrow tubes and lumens.
TPF creates shear forces 1,000 times higher than conventional liquid flow.
TPF
treatment
Bacterial biofilm on lumen of a narrow tube
Impact of TPF cleaning
Optimal Two-Phase Cleaning
• Liquid to Gas Ratio
• Velocity/Turbulence
• Condition of Boundary Layer and Interface
• Droplet Formation/Reformation
• Liquid Surface Tension
• Optimal Surface Chemistry
• Shear Stresses
• Mass Transfer Rate
Dialysate Quality Standards in Europe and USA
Bacteria Count
(CFU/ml)
Endotoxin Level
(EU/ml)
AAMI Old Standard
2000
None
AAMI New Standard*
200
2
ERA Current Standard**
100
0.25
< 0.1
< 0.03
ERA Ultrapure
AAMI is the American Association for the Advancement of Medical Instrumentation
ERA is the European Renal Association
* Will be very difficult to meet in the US
** Will be extremely difficult to meet in the US
Current Construction Materials of DCWS in the United States
Material of Construction
(1)
PVC – Schedule 80 *, **
(2) PVDF and Steel ***
Percentage of Dialysis Clinics
~ 95 %
<5%
* PVC is not suitable for hot-water disinfection.
** PVC is attacked by O3 at recommended treatment dose concentrations.
*** PVDF and steel are suitable for hot-water pasteurization/disinfection.
Limitations of Existing Technologies
(1) Current Manual Maintenance Protocols
(2) Ozone Disinfection
(3) Hot-water Pasteurization/Disinfection
Microbiological Results
Two-phase
Baseline
Success
Total
Percent
Success
Total
Percent
Log odds
P value
ROTO
47
52
90.4%
38
39
97.4%
1.181
0.4740
ROTR
49
52
94.2%
34
39
87.2%
-1.171
0.3521
BiTO
44
50
88.0%
39
39
100.0%
13.574
0.9719
BiTR
13
50
26.0%
39
39
100.0%
16.612
0.9656
ROM
51
88
58.0%
74
75
98.7%
3.887
0.0172
BiM
41
84
48.8%
74
75
98.7%
4.747
0.0021
Dial
41
80
51.3%
70
75
93.3%
3.485
0.0147
Endotoxin Concentrations
Baseline
Two-phase
Success
Total
Percent
Success
Total
Percent
Log odds
P value
ROTR
40
41
97.6%
32
35
91.4%
-1.064
0.4319
BiTO
5
38
13.2%
31
35
88.6%
4.830
0.0007
BiTR
6
42
14.3%
31
34
91.2%
5.503
0.0003
Dial
30
38
78.9%
30
36
83.3%
0.2
0.8325
Scanning Electron Microscopy (SEM) Results
Biofilm Density During Conventional Protocol
(CFU/cm2)
Percentage Removal
by TPF
6.16 x 107 ± 3.02 x 107
99.37%
CleanFlowTM CIP
•
CleanFlowTM Clean-in-Place (CIP) System Components:
– CleanFlowTM CIP Device
– Oil-less Compressor
– Chemicals : Peracetic Acid, Acetic Acid, and CleanFlowTM Cleaning Solution.
•
Application: CleanFlowTM cleans and disinfects the central dialysis water system,
including: RO Loop, Bicarbonate Loop, Central Dialysate Loop and Connection
Tubing to Dialysis Machines.
•
Fully Automated: Cleaning/Disinfection in about 1-2 hours
•
Eliminates: Biofilm, Endotoxin, and Planktonic Bacteria
•
Proven to deliver Ultra-Pure Fluid for Dialysis Patients
CleanFlowTM CIP Features
• Reduces Labor and Maintenance Costs
• Eradicates biofilm and bacteria
• Eliminates endotoxin
• Cleans all water system internal surfaces
• Fully-automated Process
• Usable with all piping materials: PVC, PVDF, and Stainless Steel
• Can deliver Ultrapure Dialysate
CleanFlowTM CIP Live
NovaFlux Inc
CleanFlow CIP™
“The Profound Solution to Ultrapure Dialysate”