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ISPE NordicSeptember 2016
RO PretreatmentMedia and Chemical Free
Shlomo SacksteinBiopuremax - CEO
Biopuremax profile
2
Biopuremax has over 20 years of experience in thedesign, supply, installation, validation and operationof high quality Biopharmaceutical water systems.
Biopuremax specialty is water systems - PurifiedWater (PW) and Water-for-Injection (WFI) systems,with cutting edge water production technologies.
Developed the revolutionary Biopuremax process ofmedia and chemical free RO pretreatment.
Main Critical Problems for Pharma Water
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Stop scaleprecipitation in RO
Free chlorine removalbefore RO and CEDI
Prevent microbialgrowth
Ø Scale Precipitation & Chlorination
Traditional Systems - Common Problems
ProblemProcess
Salt and water wasteSofteners
Contamination build up
High maintenanceAntiscalent
Removal issues
Rapid bacteria build upGAC/ACF
Water waste
Reliability issuesSodium Bi Sulfite
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Our Solution - Chemical and Media Free System
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Electrolytic Scale Reduction (ESRTM)
Green Technology
Hot Water Sanitization
Continues Bioburden Reduction
Hydro Optical Dechlorination (HODTM)of free chlorine by UV irradiation
Chemical and Media Free Pretreatment System PFD
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Ø ESRTM Process
Electrolytic Scale Reduction (ESRTM)
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Ø Electrical current splits water in to OH- and H+
Ø Anode will have low pH
Ø Cathode will have very high pH
Ø One of the key factors for precipitation is high pH
Ø Cathode high pH will cause scale to form
Ø Fluffy scale will form on the cathode and drop to the bottom of reactor
Ø ESRTM - Scale Formation
Electrolytic Scale Reduction (ESRTM)
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Ø ESRTM Advantages
Electrolytic Scale Reduction (ESRTM)
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Ø ESRTM will precipitate magnesium, calcium, silicates, ferrites, and other cations not
removed by softeners
Ø Softener replaces magnesium & calcium with sodium
BUT total load on RO will be unchanged
Ø ESRTM will reduce RO Load
Ø Reductions in RO: concentrate, maintenance, fouling, scaling, cleaning
Ø ESRTM - Site installations
Electrolytic Scale Reduction (ESRTM)
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Ø Scale formation and removal
Electrolytic Scale Reduction (ESRTM)
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Ø Process
Hydro Optic De-Chlorination (HODTM)
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Ø Decompose the free chlorine into O2 and Chloride
Ø Chloride and Sodium ion are stopped by the RO membrane
Ø Bacteria destruction
Quartz Tube
Air BlockStainless
HODTM - Total Internal Reflection
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Ø Total Internal Reflection
Hydro Optic De-Chlorination (HODTM)
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Ø Purple line showing zero chlorine output from HODTM
Hydro Optic De-Chlorination (HODTM)
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Ø CBRTM - Meaning
Biopuremax Continuous Bioburden Reduction (CBRTM)
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Ø Inherent destruction of bacteria - via continuous operation
Ø No need of maintenance, cleaning or sanitization
Ø CBRTM - Process
Biopuremax Continuous Bioburden Reduction (CBRTM)
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Ø City water tank - bioburden reduction by dilution
Ø ESRTM - bioburden reduction by inherent chlorine generation
Ø HODTM - bioburden reduction by UV irradiation
Micro contamination level through typical system
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Cont
amin
atio
nle
vel
Position in system
Softener ACF
City water tank
Micro contamination level through BPM
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Cont
amin
atio
nle
vel
Position in system
ESRTM
HODTM
City water tank
Microbial Reduction in BPM
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Micro Total CountCFU/100ml
E. COLICFU/100ml
PseudomonasCFU/100ml
Position in system Average Range Average Range Average Range
City water inlet 15,800 78-0 ,000 47 227-1 24 82-0
Exit City storage tank 127 1,000-0 0 0 0.167 1-0
After ESRTM 50 300-0 0 0 0.167 1-0
After HODTM 5 100-0 0 0 0.167 1-0
After RO 5 100-0 0 0 0 0
Storage anddistribution
0 0 0 0 0 0
Microbial Reduction in BPM
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ColiformsCFU/100ml
FungusCFU/100ml
Position in system Average Range Average Range
City water inlet 201 910-28 13.16 48-0
Exit City water storage tank 1.375 11-0 0 0
After ESRTM 0.25 4-0 0 0
After HODTM 0 0 0.167 1-0
After RO 0 0 0 0
Storage and distribution 0 0 0 0
PQ product, sampled over a 12 month period
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Total Micro
CFU/100ml
Average
E.COLI
CFU/100ml
Average
Pseudomonas
CFU/100ml
Average
Coliforms
CFU/100ml
Average
Fungus
CFU/100ml
AverageProduct Water 0 0 0 0 0
WFI Criteria <10cfu/100ml <1cfu/100ml <1cfu/100ml <1cfu/100ml <1cfu/100m
l
PQ product, sampled over a 12 month period
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Endotoxin (EU/mL)
Average
TOC (ppb)
Average
Heavy Metals (ppm)
Average
Nitrate <0.1 mg/l
Average
Product Water <0.005 <50 <0.1 <0.1
WFI Criteria <0.25 <500 <0.1 <0.2
Biopuremax Continues Membrane Performance
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No deterioration of the membrane after over a year of operation
0100200300400500600700800900
1000
1 20 29 38 47 56 65 74Operating Time (weeks)
Normalized Permeate Flow
Per
mea
teFl
ow
(m3/
hr)
Biopuremax Continues Membrane Performance
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No deterioration of the membrane after over one year of operation.
0,000,100,200,300,400,500,600,700,800,901,001,101,201,301,401,50
1 20 29 38 47 56 65 74
Pressure(bar)
Operating Time (weeks)
Differential Pressure
Biopuremax Continues Membrane Performance
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No deterioration of the membrane after one year of operation.
0
200
400
600
800
1000
1200
0
10
20
30
40
50
60
70
80
Feed
Co
nd
uct
ivit
y(µ
S/
cm)
Per
mea
teC
on
du
ctiv
ity
(µS
/cm
)
Operating Time (weeks)
ConductivityPermeate Conductivity Feed Conductivity
Biopuremax Hi Recovery %
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Single stage RO recovery over 80% with no chemicals !
70%72%74%76%78%80%82%84%86%88%
Operating Time (weeks)
RO Recovery %
Very low maintenance
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RO-CEDINo additionalmaintenanceneeded
SanitizationAutomatic hotwater sanitizationafter maintenance
ESRTM
No maintenance,automatic cleaning
HODTM
Replace UV lamps& gaskets, washevery 6 months
FiltersReplace post EESRTM filters 1-2 months
Green Technology - Cost Reductions
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Reliability andclean operation-
savings inmaintenance
No Salt,No Chemicals -
No purchase andsolutionmakeup
Water savingscompared tosofteners and
GAC/ACF
Nohigh chloride
effluent
Lowenergy
consumption
Fulfill Corporate Directives
§ Total Cost of Ownership§ Reliability – Continuous Bioburden Reduction§ Environmental Footprint
- Carbon Footprint – low energy consumption and NO chemical dosing- Water footprint – NO loss of water
§ Operability – ease of operations§ Maintainability – less down time
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European Standards
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Ø EU cGMP
Ø European Pharmacopoeia, EP8.1 version
Ø Annex 11
Ø EU-GMP-Guideline Part 1, Annexes 1, 15 & 17
Ø CE Mark
US Standards
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Ø FDA cGMPØ PW United States PharmacopeiaØ ASME BPE-2014Ø CFR 21 part 11Ø ISPE Pharmaceutical Engineering Guide, Volume 4: Water and
Steam SystemsØ ISPE Pharmaceutical Engineering Guide, Volume 5:
Commissioning & Qualification
Added Values of ESR-HOD Combination
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Simplicityof
operation
Low lifecycle costs
Lowmaintenance
Lowbacteria
Highreliability
ESR-HOD
