Pretreatment /Source Water

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Pretreatment /Source Water

• William V. Collentro
• ULTRAPURE WATER Pharma 2010
• New Brunswick, New Jersey
• May 20-21, 2010

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Raw Water Analysis

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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

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Compendial Water System Raw Water Analysis

• United States EPA NPDWR
• Regulated Items
• Total Viable Bacteria
• Private Water Supplies

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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)

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Raw Water Microorganisms Health Effects
Parameter Health Effects
Cryptosporidium Gastrointestinal Illness
Giardia lamblia Gastrointestinal Illness
Heterotrophic Plate Count No direct health effects but employed to indicate the general bacteria contamination level of water
Legionella Legionnaires Disease
Total Coliform Indicator of the presence of pathogens
Turbidity Associated with disease causing organisms
Viruses Gastrointestinal Illness
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Raw Water Microorganisms Health Effects
Parameter Source
Cryptosporidium Human and Animal Fecal Waste
Giardia lamblia Human and Animal Fecal Waste
Heterotrophic Plate Count Environmental Bacteria
Legionella Environment Cooling/Heating Systems
Total Coliform Natural, Human Fecal Waste, Animal Fecal Waste
Turbidity Soil Runoff, Construction
Viruses Human and Animal Fecal Waste
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Raw Water Microorganisms Health Effects
Parameter Maximum Contaminant Level/Treatment Technique
Cryptosporidium SWTR Monitored and Controlled
Giardia lamblia 99.9 Removal/Inactivation
Heterotrophic Plate Count 500 cfu/ml
Legionella No Limit but Requires Control of Giardia and Viruses
Total Coliform NMT 5 positive/month (40 samples/month), NMT 2 consecutive confirmation for E.coli or Fecal Coliform
Turbidity 1 NTU (0.3 NTU at least 95 of tests)
Viruses 99.99 Removal/Deactivation
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Compendial Water System Raw Water Regulated
Items

• Disinfection Byproducts
• Bromate
• Chlorite
• Haloacetic Acids (HAA5)
• Total Trihalomethanes (TTHMs)

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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

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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

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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

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Compendial Water System Raw Water

• Regulated Item Disinfectants (Distribution)
• Chlorine
• Chloramines
• Chlorine Dioxide

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Compendial Water System Raw Water

• Regulated Items Inorganic Chemicals
• Antimony
• Arsenic
• Asbestos
• Barium
• Beryllium
• Cadmium
• Total Chromium
• Copper

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Compendial Water System Raw Water

• Regulated Items Inorganic Chemicals
• Cyanide
• Fluoride
• Lead
• Mercury
• Nitrate
• Nitrite
• Selenium
• Thallium

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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

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Compendial Water System Raw Water

• Regulated Item Radionuclides
• Alpha Particles
• Beta Particles and Photon Emitters
• Radium 226
• Uranium

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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

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Compendial Water System Feed Water Analysis

• Regulated Items - Testing
• Municipality?
• Pharmaceutical Facility?
• Compliance?
• Obligation?
• Consequences?

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Periodic Monitoring

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USP Purified Water System Classical
Periodic Monitoring

• General Monitoring
• Storage and Distribution System
• Point-of-Use TVB
• Online Conductivity
• Online TOC

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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

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USP Purified Water System Classical
Periodic Monitoring

• Frequent Monitoring
• Water Purification System
• Silt Density Index (Test Kit)
• Total Hardness (Test Kit)
• Chlorine (Test Kit)

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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

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USP Purified Water System Suggested Periodic
Monitoring
Raw Water Post Multimedia Post Activated Carbon Post UV Post Lead Water Softener Post Polish Water Softener Post Cartridge Filter
NPDWR Tests X - - - - - -
TVB X X X X X X X
BET X - X - - - X
Chlorine X X X - - - -
TOC X X X - - - -
TSS X X X - X X -
Total Hardness X - X - X X -
Total Iron X X X - X X -
Turbidity X X - - - - -
SDI - - - - - - X
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USP Purified Water System Suggested Periodic
Monitoring
Post RO Break Tank Post RO Post CEDI Post UV Post Final Filter
TVB X X X X X
BET X X - - -
pH X X - - -
TOC X X X X X
Carbon Dioxide X X - - -
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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

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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

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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

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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 lt 3.0
  mg/l, EBCT 8.0.

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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

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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

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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.

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Thank you!

• Questions?