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Pretreatment /Source Water. William V. Collentro ULTRAPURE WATER Pharma 2010 New Brunswick, New Jersey May 20-21, 2010. Raw Water Analysis. Compendial Water System – Feed Water Analysis. Official Monograph United States EPA National Primary Drinking Water Regulations (NPDWR)

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pretreatment source water

Pretreatment /Source Water

William V. Collentro

ULTRAPURE WATER Pharma 2010

New Brunswick, New Jersey

May 20-21, 2010

compendial water system feed water analysis
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
compendial water system raw water analysis
Compendial Water System – Raw Water Analysis

United States EPA – NPDWR

  • Regulated Items
  • Total Viable Bacteria
  • “Private” Water Supplies
slide5

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)
slide9

Compendial Water System – Raw Water – Regulated Items

Disinfection Byproducts

  • Bromate
  • Chlorite
  • Haloacetic Acids (HAA5)
  • Total Trihalomethanes (TTHMs)
slide10

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
slide11

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
slide12

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
slide13

Compendial Water System – Raw Water

Regulated Item – Disinfectants (Distribution)

  • Chlorine
  • Chloramines
  • Chlorine Dioxide
compendial water system raw water
Compendial Water System – Raw Water

Regulated Items – Inorganic Chemicals

  • Antimony
  • Arsenic
  • Asbestos
  • Barium
  • Beryllium
  • Cadmium
  • Total Chromium
  • Copper
compendial water system raw water1
Compendial Water System – Raw Water

Regulated Items – Inorganic Chemicals

  • Cyanide
  • Fluoride
  • Lead
  • Mercury
  • Nitrate
  • Nitrite
  • Selenium
  • Thallium
compendial water system raw water2
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
compendial water system raw water3
Compendial Water System – Raw Water

Regulated Item – Radionuclides

  • Alpha Particles
  • Beta Particles and Photon Emitters
  • Radium 226
  • Uranium
compendial water system feed water analysis1
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
compendial water system feed water analysis2
Compendial Water System – Feed Water Analysis

Regulated Items - Testing

  • Municipality?
  • Pharmaceutical Facility?
  • Compliance?
  • Obligation?
  • Consequences?
usp purified water system classical periodic monitoring
USP Purified Water System – “Classical” Periodic Monitoring

General Monitoring –

Storage and Distribution System

  • Point-of-Use TVB
  • Online Conductivity
  • Online TOC
usp purified water system classical periodic monitoring1
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
usp purified water system classical periodic monitoring2
USP Purified Water System – “Classical” Periodic Monitoring

Frequent Monitoring –

Water Purification System

  • Silt Density Index (Test Kit)
  • Total Hardness (Test Kit)
  • Chlorine (Test Kit)
usp purified water system classical periodic monitoring3
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
compendial water system periodic monitoring
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
raw water impurities current issues
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
raw water impurities current issues1
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
raw water impurities current issues2
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.

raw water impurities current issues3
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
raw water impurities current issues4
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
conclusions
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.

thank you

Thank you!

Questions?

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