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Pretreatment /Source Water
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  1. Pretreatment /Source Water William V. Collentro ULTRAPURE WATER Pharma 2010 New Brunswick, New Jersey May 20-21, 2010

  2. Raw Water Analysis

  3. Compendial Water System – Feed Water Analysis Official Monograph • United States EPA National Primary Drinking Water Regulations (NPDWR) • Equivalent European Regulations • Equivalent Japanese Regulations • World Health Organization Reference

  4. Compendial Water System – Raw Water Analysis United States EPA – NPDWR • Regulated Items • Total Viable Bacteria • “Private” Water Supplies

  5. Compendial Water System – Raw Water – Regulated Items Microorganisms • Cryptosporidium • Giardia lamblia • Heterotrophic Plate Count • Legionella • Total Coliform (including fecal coliform and E. coli) • Turbidity • Viruses (enteric)

  6. Raw Water Microorganisms – Health Effects

  7. Raw Water Microorganisms – Health Effects

  8. Raw Water Microorganisms – Health Effects

  9. Compendial Water System – Raw Water – Regulated Items Disinfection Byproducts • Bromate • Chlorite • Haloacetic Acids (HAA5) • Total Trihalomethanes (TTHMs)

  10. Compendial Water System – Raw Water – Regulated Items Disinfection Byproduct – Bromate • MCL = 0.010 mg/l • Ozone Primary Disinfecting Agent • Increased Risk of Cancer Disinfection Byproduct – Chlorite • MCL = 1.0 mg/l • Chlorine Dioxide Primary Disinfecting Agent • Anemia, Nervous System

  11. Compendial Water System – Raw Water – Regulated Items Haloacetic Acids (HAA5) – (0.060 mg/l) • Dichloroacetic Acid • Trichloroacidic Acid • Monochloroacidic Acid • Bromoacetic Acid • Dibromoacetic Acid • Increased Risk of Cancer

  12. Compendial Water System – Raw Water – Regulated Items Total Trihalomethanes (0.80 mg/l) • Chloroform • Dibromochloromethane • Bromodichloromethane • Bromoform • Increased Risk of Cancer, Liver, Kidney, or Central Nervous System

  13. Compendial Water System – Raw Water Regulated Item – Disinfectants (Distribution) • Chlorine • Chloramines • Chlorine Dioxide

  14. Compendial Water System – Raw Water Regulated Items – Inorganic Chemicals • Antimony • Arsenic • Asbestos • Barium • Beryllium • Cadmium • Total Chromium • Copper

  15. Compendial Water System – Raw Water Regulated Items – Inorganic Chemicals • Cyanide • Fluoride • Lead • Mercury • Nitrate • Nitrite • Selenium • Thallium

  16. Compendial Water System – Raw Water Regulated Items – Organic Chemicals (53 Total) • Sewage/Wastewater Treatment • Herbicides • Landfill Leachates • Chemical/Industrial Facility Waste • Fumigants • Petroleum /Refinery Waste • Insecticides

  17. Compendial Water System – Raw Water Regulated Item – Radionuclides • Alpha Particles • Beta Particles and Photon Emitters • Radium 226 • Uranium

  18. Compendial Water System – Feed Water Analysis Total Viable Bacteria • No “enforceable” limit in NPDWR • Total Coliform (Confirmed as Fecal Coliform or E. coli, used as indicator) • “Action Limit” of 500 cfu/ml in non enforceable General Information Section of USP • TVB only indicates a fraction of viable organisms present

  19. Compendial Water System – Feed Water Analysis Regulated Items - Testing • Municipality? • Pharmaceutical Facility? • Compliance? • Obligation? • Consequences?

  20. Periodic Monitoring

  21. USP Purified Water System – “Classical” Periodic Monitoring General Monitoring – Storage and Distribution System • Point-of-Use TVB • Online Conductivity • Online TOC

  22. USP Purified Water System – “Classical” Periodic Monitoring General Monitoring – Water Purification System • Final TVB • Inline RO Feed Water and Product Water • Conductivity – RO Unit % Rejection of Ions • Inline Post RO Polishing Conductivity

  23. USP Purified Water System – “Classical” Periodic Monitoring Frequent Monitoring – Water Purification System • Silt Density Index (Test Kit) • Total Hardness (Test Kit) • Chlorine (Test Kit)

  24. USP Purified Water System – “Classical” Periodic Monitoring Less Frequent Monitoring – Water Purification System • Inline ORP for Reducing Agent Injection • Inline Total Hardness Monitor • Inline Chlorine Monitor

  25. USP Purified Water System – Suggested Periodic Monitoring

  26. USP Purified Water System – Suggested Periodic Monitoring

  27. Compendial Water System – Periodic Monitoring • Monitoring of Pretreatment and Ion Removal steps identifies a problem before it effects point-of-use values. • Frequency of the monitoring program established for each application • Regulatory concerns

  28. Raw Water Impurities – Current Issues Trihalomethanes (Chloroform) • Removal Process? • Volatile • Presence in USP/EP Water for Injection? • Ozonated USP Purified Water Systems • Chloride Pitting Corrosion of Austenitic Stainless

  29. Raw Water Impurities – Current Issues Mononchloramine • Disinfection Properties in Raw Feed Water • pH of Feed Water • Type of Activated Carbon • “EBCT” Critical!!! • Detection • TOC Interference During Removal • Effect on Microbial Results • Careful Selection of Polishing Components

  30. Raw Water Impurities – Current Issues Catalytic Activated Carbon Volume Required = (EBCT) x Flow Rate/7.48 Where, EBCT is the “Empty Bed Contact Time” expressed in minutes, Flow Rate is expressed in gallons per minute and the Catalytic Activated Carbon volume is expressed in cubic feet. AT pH = 8.0, Monochloramine = 3.0 mg/l, and TOC < 3.0 mg/l, EBCT = 8.0.

  31. Raw Water Impurities – Current Issues Use of 185 Nanometer UV Downstream of RO • TOC Reduction to Meet 0.50 mg/l? • TOC Reduction to Control Bacteria? • Generation of Hydroxyl Radical • Very Strong Oxidant • Violation of USP General Notices Section • Fragmentation of Organic Material • Chloride and Nitrate Ions - Generation • Degradation in Conductivity

  32. Raw Water Impurities – Current Issues Use of 185 Nanometer UV Downstream of RO • Non Representative TVB Data • “Delivered” Water – With Hydroxyl Radical • “Delivered” Water – Without Hydroxyl Radical • Effect on Other Product Ingredients • Effect on Research • “Duplication” of Data Based on Use

  33. Conclusions There is an increasing regulatory focus on the quality of water (chemical and microbial) throughout a compendial water system. Knowledge of impurities in raw water and their removal by water purification unit operations is critical. There is no “magic” bullet. A technical sound pretreatment system remains a critical part of any compendial water system.

  34. Thank you! Questions?