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William V. Collentro
ULTRAPURE WATER Pharma 2010
New Brunswick, New Jersey
May 20-21, 2010
Compendial Water System – Feed Water Analysis
Official MonographUnited States EPA National Primary Drinking Water
Regulations (NPDWR)Equivalent European RegulationsEquivalent Japanese RegulationsWorld Health Organization Reference
Compendial Water System – Raw Water Analysis
United States EPA – NPDWRRegulated ItemsTotal Viable Bacteria“Private” Water Supplies
MicroorganismsCryptosporidiumGiardia lambliaHeterotrophic Plate CountLegionellaTotal Coliform (including fecal coliform and E. coli)TurbidityViruses (enteric)
Compendial Water System – Raw Water – Regulated Items
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 Legionnaire’s Disease
Total Coliform Indicator of the presence of pathogens
Turbidity Associated with disease causing organisms
Viruses Gastrointestinal Illness
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
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
Disinfection Byproducts
BromateChloriteHaloacetic Acids (HAA5) Total Trihalomethanes (TTHMs)
Compendial Water System – Raw Water – Regulated Items
Disinfection Byproduct – Bromate
MCL = 0.010 mg/lOzone Primary Disinfecting AgentIncreased Risk of Cancer
Disinfection Byproduct – ChloriteMCL = 1.0 mg/lChlorine Dioxide Primary Disinfecting AgentAnemia, Nervous System
Compendial Water System – Raw Water – Regulated Items
Haloacetic Acids (HAA5) – (0.060 mg/l)
Dichloroacetic AcidTrichloroacidic Acid Monochloroacidic Acid Bromoacetic AcidDibromoacetic AcidIncreased Risk of Cancer
Compendial Water System – Raw Water – Regulated Items
Total Trihalomethanes (0.80 mg/l)
ChloroformDibromochloromethaneBromodichloromethaneBromoformIncreased Risk of Cancer, Liver, Kidney, or
Central Nervous System
Compendial Water System – Raw Water – Regulated Items
Regulated Item – Disinfectants (Distribution)
ChlorineChloraminesChlorine Dioxide
Compendial Water System – Raw Water
Compendial Water System – Raw Water
Regulated Items – Inorganic ChemicalsAntimonyArsenicAsbestosBariumBerylliumCadmiumTotal ChromiumCopper
Compendial Water System – Raw Water
Regulated Items – Inorganic ChemicalsCyanideFluorideLeadMercuryNitrateNitriteSeleniumThallium
Compendial Water System – Raw Water
Regulated Items – Organic Chemicals (53 Total)
Sewage/Wastewater TreatmentHerbicidesLandfill LeachatesChemical/Industrial Facility WasteFumigantsPetroleum /Refinery WasteInsecticides
Compendial Water System – Raw Water
Regulated Item – RadionuclidesAlpha ParticlesBeta Particles and Photon EmittersRadium 226Uranium
Compendial Water System – Feed Water Analysis
Total Viable BacteriaNo “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 USPTVB only indicates a fraction of viable organisms
present
Compendial Water System – Feed Water Analysis
Regulated Items - TestingMunicipality? Pharmaceutical Facility?Compliance?Obligation?Consequences?
USP Purified Water System – “Classical” Periodic
Monitoring
General Monitoring –
Storage and Distribution SystemPoint-of-Use TVBOnline ConductivityOnline TOC
USP Purified Water System – “Classical” Periodic
Monitoring
General Monitoring –
Water Purification SystemFinal TVBInline RO Feed Water and Product Water Conductivity – RO Unit % Rejection of IonsInline Post RO Polishing Conductivity
USP Purified Water System – “Classical” Periodic
Monitoring
Frequent Monitoring –
Water Purification SystemSilt Density Index (Test Kit)Total Hardness (Test Kit)Chlorine (Test Kit)
USP Purified Water System – “Classical” Periodic
Monitoring
Less Frequent Monitoring –
Water Purification SystemInline ORP for Reducing Agent Injection Inline Total Hardness MonitorInline Chlorine Monitor
USP Purified Water System – Suggested Periodic
Monitoring Raw Water Post
MultimediaPost 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
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 - - -
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
Trihalomethanes (Chloroform)Removal Process?VolatilePresence in USP/EP Water for Injection?Ozonated USP Purified Water SystemsChloride Pitting Corrosion of Austenitic Stainless
Raw Water Impurities – Current Issues
MononchloramineDisinfection Properties in Raw Feed WaterpH of Feed WaterType of Activated Carbon“EBCT” Critical!!!DetectionTOC Interference During RemovalEffect on Microbial ResultsCareful Selection of Polishing Components
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 Issues
Use of 185 Nanometer UV Downstream of ROTOC Reduction to Meet 0.50 mg/l?TOC Reduction to Control Bacteria?Generation of Hydroxyl RadicalVery Strong OxidantViolation of USP General Notices SectionFragmentation of Organic MaterialChloride and Nitrate Ions - GenerationDegradation in Conductivity
Raw Water Impurities – Current Issues
Use of 185 Nanometer UV Downstream of RONon Representative TVB Data“Delivered” Water – With Hydroxyl Radical“Delivered” Water – Without Hydroxyl RadicalEffect on Other Product IngredientsEffect on Research“Duplication” of Data Based on Use
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.
Questions?