RO Pretreatment Media and Chemical Free

Transcription

1 Shlomo Sackstein Biopuremax - CEO RO Pretreatment Media and Chemical Free ISPE Nordic September 2016

2 Biopuremax profile Biopuremax has over 20 years of experience in the design, supply, installation, validation and operation of high quality Biopharmaceutical water systems. Biopuremax specialty is water systems - Purified Water (PW) and Water-for-Injection (WFI) systems, with cutting edge water production technologies. Developed the revolutionary Biopuremax process of media and chemical free RO pretreatment. 2

3 Main Critical Problems for Pharma Water Stop scale precipitation in RO Free chlorine removal before RO and CEDI Prevent microbial growth 3

4 Traditional Systems - Common Problems Scale Precipitation & Chlorination Process Softeners Problem Salt and water waste Contamination build up Antiscalent GAC/ACF Sodium Bi Sulfite High maintenance Removal issues Rapid bacteria build up Water waste Reliability issues 4

5 Our Solution - Chemical and Media Free System Electrolytic Scale Reduction (ESR TM ) Hydro Optical Dechlorination (HOD TM ) of free chlorine by UV irradiation Hot Water Sanitization Continues Bioburden Reduction Green Technology 5

6 Chemical and Media Free Pretreatment System PFD 6

7 Electrolytic Scale Reduction (ESR TM ) ESR TM Process Electrical current splits water in to OH - and H + Anode will have low ph Cathode will have very high ph One of the key factors for precipitation is high ph Cathode high ph will cause scale to form Fluffy scale will form on the cathode and drop to the bottom of reactor 7

8 Electrolytic Scale Reduction (ESR TM ) ESR TM - Scale Formation 8

9 Electrolytic Scale Reduction (ESR TM ) ESR TM Advantages ESR TM will precipitate magnesium, calcium, silicates, ferrites, and other cations not removed by softeners Softener replaces magnesium & calcium with sodium BUT total load on RO will be unchanged ESR TM will reduce RO Load Reductions in RO: concentrate, maintenance, fouling, scaling, cleaning 9

10 Electrolytic Scale Reduction (ESR TM ) ESR TM - Site installations 10

11 Electrolytic Scale Reduction (ESR TM ) Scale formation and removal 11

12 Hydro Optic De-Chlorination (HOD TM ) Process Decompose the free chlorine into O 2 and Chloride Chloride and Sodium ion are stopped by the RO membrane Bacteria destruction 12

13 HOD TM - Total Internal Reflection Stainless Air Block Quartz Tube 13

14 Hydro Optic De-Chlorination (HOD TM ) Total Internal Reflection 14

15 Hydro Optic De-Chlorination (HOD TM ) Purple line showing zero chlorine output from HOD TM 15

16 Biopuremax Continuous Bioburden Reduction (CBR TM ) CBR TM - Meaning Inherent destruction of bacteria - via continuous operation No need of maintenance, cleaning or sanitization 16

17 Biopuremax Continuous Bioburden Reduction (CBR TM ) CBR TM - Process City water tank - bioburden reduction by dilution ESR TM - bioburden reduction by inherent chlorine generation HOD TM - bioburden reduction by UV irradiation 17

18 Micro contamination level through typical system Contamination level City water tank Softener ACF Position in system 18

19 Micro contamination level through BPM Contamination level City water tank ESR TM HOD TM Position in system 19

20 Microbial Reduction in BPM Micro Total Count CFU/100ml E. COLI CFU/100ml Pseudomonas CFU/100ml Position in system Average Range Average Range Average Range City water inlet 15, , Exit City storage tank , After ESR TM After HOD TM After RO Storage and distribution

21 Microbial Reduction in BPM Coliforms CFU/100ml Fungus CFU/100ml Position in system Average Range Average Range City water inlet Exit City water storage tank After ESR TM After HOD TM After RO Storage and distribution

22 PQ product, sampled over a 12 month period Total Micro CFU/100ml Average E.COLI CFU/100ml Average Pseudomonas CFU/100ml Average Coliforms CFU/100ml Average Fungus CFU/100ml Average Product Water WFI Criteria <10cfu/100ml <1cfu/100ml <1cfu/100ml <1cfu/100ml <1cfu/100m l 22

23 PQ product, sampled over a 12 month period Endotoxin (EU/mL) TOC (ppb) Heavy Metals (ppm) Nitrate <0.1 mg/l Average Average Average Average Product Water <0.005 <50 <0.1 <0.1 WFI Criteria <0.25 <500 <0.1 <0.2 23

24 Biopuremax Continues Membrane Performance Permeate Flow (m 3 /hr) No deterioration of the membrane after over a year of operation Normalized Permeate Flow Operating Time (weeks) 24

25 Biopuremax Continues Membrane Performance No deterioration of the membrane after over one year of operation. Pressure Differential Pressure (bar) 1,50 1,40 1,30 1,20 1,10 1,00 0,90 0,80 0,70 0,60 0,50 0,40 0,30 0,20 0,10 0, Operating Time (weeks) 25

26 Biopuremax Continues Membrane Performance No deterioration of the membrane after one year of operation. Permeate Conductivity (µs/cm) Conductivity Permeate Conductivity Feed Conductivity Feed Conductivity (µs/cm) Operating Time (weeks) 26

27 Biopuremax Hi Recovery % Single stage RO recovery over 80% with no chemicals! 88% 86% 84% 82% 80% 78% 76% 74% 72% 70% RO Recovery % Operating Time (weeks) 27

28 Very low maintenance ESR TM No maintenance, automatic cleaning HOD TM Replace UV lamps & gaskets, wash every 6 months Filters Replace post E ESR TM filters 1-2 months RO-CEDI No additional maintenance needed Sanitization Automatic hot water sanitization after maintenance 28

29 Green Technology - Cost Reductions Reliability and clean operationsavings in maintenance No Salt, No Chemicals - No purchase and solution makeup Water savings compared to softeners and GAC/ACF No high chloride effluent Low energy consumption 29

30 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 30

31 European Standards EU cgmp European Pharmacopoeia, EP8.1 version Annex 11 EU-GMP-Guideline Part 1, Annexes 1, 15 & 17 CE Mark 31

32 US Standards FDA cgmp PW United States Pharmacopeia ASME BPE-2014 CFR 21 part 11 ISPE Pharmaceutical Engineering Guide, Volume 4: Water and Steam Systems ISPE Pharmaceutical Engineering Guide, Volume 5: Commissioning & Qualification 32

33 Added Values of ESR-HOD Combination High reliability Simplicity of operation ESR-HOD Low maintenance Low life cycle costs Low bacteria 33

34 Shlomo Sackstein THANK YOU