design and construction of usp purified water systems william v. collentro
TRANSCRIPT
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Design and Construction of USP Purified Water Systems
William V. Collentro
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Feed Water Analysis
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USP Purified Water System – Feed Water Analysis
• Official Monograph– United States EPA NPDWR– Equivalent European Regulations– Equivalent Japanese Regulations– World Health Organization Reference
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• United States EPA – National Primary Drinking Water Regulations (NPDWR)–Regulated Items–Total Viable Bacteria–“Private” Water Supplies
USP Purified Water System – Feed Water Analysis
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• Regulated Items - Microorganisms– Cryptosporidium– Giardia lamblia– Legionella– Total Coliform– Turbidity– Viruses
USP Purified Water System – Feed Water Analysis
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• Regulated Items – Disinfection Byproducts
–Bromate–Chlorite–Haloacetic Acids (HAA5) –Total Trihalomethanes (TTHMs)
USP Purified Water System – Feed Water Analysis
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• Regulated Items – Disinfectants
–Chlorine–Chloramines–Chlorine Dioxide
USP Purified Water System – Feed Water Analysis
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USP Purified Water System – Feed Water Analysis
• Regulated Items – Inorganic Chemicals– Antimony– Arsenic– Asbestos– Barium– Beryllium– Cadmium– Total Chromium– Copper
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USP Purified Water System – Feed Water Analysis
• Regulated Items – Inorganic Chemicals– Cyanide– Fluoride– Lead– Mercury– Nitrate– Nitrite– Selenium– Thallium
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USP Purified Water System – Feed Water Analysis
• 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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USP Purified Water System – Feed Water Analysis
• Regulated Item – Radionuclides– Alpha Particles– Beta Particles and Photon Emitters– Radium 226– Uranium
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USP Purified Water System – Feed Water Analysis
• Total Viable Bacteria– No 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 may only indicate a fraction of viable
organisms present
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USP Purified 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 – Periodic Monitoring
• General Monitoring – Storage and Distribution System• Point-of-Use TVB• Online Conductivity• Online TOC
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USP Purified Water System – Periodic Monitoring
• General Monitoring – Water Purification System• Final TVB• Inline RO Feed Water and Product Water
Conductivity plus % Rejection of Ions• Inline Post RO Polishing Conductivity
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USP Purified Water System – 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 – Periodic Monitoring
• Less Frequent Monitoring – Water Purification System• Inline ORP for Reducing Agent Injection
Monitoring• Inline Total Hardness Monitor• Inline Chlorine Monitor
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USP Purified Water System – Pretreatment 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 – RO/Polishing 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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USP Purified Water System – Periodic Monitoring
• Summary• 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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Sanitization Provisions
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USP Purified Water System –Sanitization Provisions
• Frequency– Determined by microbial monitoring– Must include storage, distribution, ion removal, and
pretreatment– Employs chemical and thermal methods– Ineffectiveness of Steam– Biofilm requires chemical sanitizing agent
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USP Purified Water System –Sanitization Provisions
• Fundamentals– TVB destruction a function of concentration and
time for chemical sanitization– TVB destruction a function of temperature and
time for hot water with 65°C lowest temperature– Dead Leg for thermal sanitization– Dead leg for chemical sanitization
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USP Purified Water System –Sanitization Provisions
• Fundamentals– Removal of Biofilm– Activated Carbon Issues– RO Waste Recirculation Issues– Pretreatment and Ion removal Recirculation Issues– Hot water sanitizable ion removal systems– Pretreatment must be included
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USP Purified Water System –Sanitization Provisions
• Execution - Pretreatment– Hot Water Sanitizable Activated Carbon– Chemical Sanitization with 1% solution of Hydrogen
Peroxide and Peracidic Acid (except activated carbon unit)
– Replace activated carbon media every 6-12 months– Dynamic-Stagnant-Dynamic Procedure
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USP Purified Water System –Sanitization Provisions
• Execution – Ion Removal– Continuous operation (make-up and recirculation)– Hot Water Sanitization Provisions (entire system)– RO membrane rotation every 6 months– Chemical Sanitization with 1% solution of
Hydrogen Peroxide and Peracidic Acid annually – Dynamic-Stagnant-Dynamic Procedure
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USP Purified Water System –Sanitization Provisions
• Execution – Storage & Distribution– Ozonation – Periodic Hot Water– Membrane Filtration discouraged– Chemical Sanitization with 1% solution of
Hydrogen Peroxide and Peracidic Acid annually – Dynamic-Stagnant-Dynamic Procedure
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Validation Criteria
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Validation Criteria
• Commissioning Documentation– Reference in IQ and OQ– “Credit” for inspection and testing– Factory Acceptance Test (FAT) Documentation– Turnover Packages (TOP)– Coordination– Interface
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Validation Criteria
• IQ Format– Unit operation based with all support
documentation for components and accessories verified. Support documents in document or as an appendix/attachment. Provides understanding of component by individuals preparing, reviewing, and executing IQ
– Component based program for items such as valves, gauges, pumps, etc. Poor tool for individuals to understand the system.
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Validation Criteria
• IQ Information– Limits on material? The more information
available, the better. If a accessory breaks, it must be replaced. The model number, serial number, and/or manufacturer may change or no longer exists. “Cut sheets” of accessories provide an excellent vehicle for identifying a “like-for-like” replacement which significantly reduces the “Change Control” effort.
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Validation Criteria
• IQ Information– All support information should reference the
original manufacturer’s part number. Project specifications should clearly state that the name of the manufacturer as well as the part number be provided. The vast majority of this information is “coded” to the water purification equipment manufacturer’s model number, useless for replacement on a “like-for-like” basis.
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Validation Criteria
• OQ Information– Prepared and executed in an integrated basis.
Individual Unit Operation will impact the operation of other components.
– Execution must provide exact operating condition. As an example, if media is not installed in a pretreatment component during execution of a FAT, execution (partial) may be required after installation and start-up.
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Validation Criteria
• OQ Information – Considerations– Fixed alarm and operating set points versus
adjustable set points– Processor access levels– Alarm set points and time delays– Control set points and time delays– View screen navigation– “ALERM” banner display– “OPERATOR OVERRIDE” banner display
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Validation Criteria
• PQ Criteria– Post start-up and commissioning– 30 day sample period– Sampling plan to duplicate water use• “Working days”• Attempt to duplicate water demand• Attempt to duplicate actual conditions at individual
points-of-use
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Validation Criteria
• PQ Criteria– Every point-of-use every day if practical– TOC “grab” samples from each points-of-use– Conductivity “grab” samples from points-of-use– Suggest transition for about 30-60 days after
successful execution– Continues for one year period– Monitoring never stops
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Validation Criteria
• PQ Microbial Monitoring– Duplicate sampling schedule over length of
intense monitoring program and less frequently thereafter
– Different agar (PCA versus R2A)– Different incubation temperatures (22°C and 30-
35°C)– Extended incubation time period (3, 5, 8, and 10
days)
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Validation Criteria
• PQ Microbial Monitoring– EP Monograph Reference– Verify enumeration parameters– Bacteria identification• MIS• Riboprinter
– Gram Stain– Objectionable organisms– Summary Report
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Operating Procedures
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Standard Operating Procedures
• General Considerations– Prepared, reviewed, and accepted before OQ
execution– Verbatim compliance– Keep as concise as possible– Do not include maintenance procedures– “Control” of copies important– Formal training
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Standard Operating Procedures
• General Considerations– Video tape training sessions– Training Manuals– System P&IDs mounted in water system area– Documentation of individual attending training
sessions– Periodic retraining– Personnel incident/excursion retraining
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Preventative Maintenance Program
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Preventative Maintenance Program
• Objective- Proactive not reactive- Shutdown Considerations – frequency- Cost of lost production time- Cost of quarantine of product- Cost of lost product- “Micro delay”
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Preventative Maintenance Program
• Pretreatment Component Example – Activated Carbon Unit
Item Suggested Frequency Consequences
Media Replacement Six Months TOC and/or Chloramine Breakthrough
Sanitize Column Internals
Six Months Microbial Excursion
Replace Gaskets Two Years Leak/Shutdown
Access Gaskets Six Months Leak/Shutdown
Clean/Replace Distributors
One Year Failure – Media in Product Water
Instrument Calibration
One Year Improper System Operation
Replace Valve Diaphragms
Two Years Bypass/Cross Contamination
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Preventative Maintenance Program
• Ion Removal Component Example – Reverse Osmosis Unit
Item Suggested Frequency
Consequences
“Rotate RO Membranes”
Six Months Loss in Product Water Flow Rate and Quality (Chemical and TVB)
Contract Clean Rotated Membranes
Six Months Loss in Product Water Flow Rate and Quality (Chemical and TVB)
Chemical Sanitization Six Months TVB Excursions
Interconnector O-Rings Six Months Waste-to-Product Leak
End Fitting O-Rings Six Months Waste-to-Product Leak
Instrument Calibration One Year Loss of System Control
Replace Interconnectors
One Year Waste-to-Product Leak
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Preventative Maintenance Program
• Ion Removal Component Example – Reverse Osmosis Unit
Item Suggested Frequency
Consequences
Replace Feed Water Pump Seals
Two Years Pump Leak – Introduction of Air/Water – TVB Increase
Vale Seals/Diaphragms Two Years Bypass
Sanitize Pressure Vessels
Six Months TVB Excursions
Change Prefilters One Week Foulant Increase Resulting in TVB Increase
Hot Water Sanitize (if equipped)
Two Weeks TVB Excursions
Replace “Rotated Membranes”
Three Years Loss in Product Water Flow Rate and Quality (Chemical and TVB)
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Preventative Maintenance Program
• Storage & Distribution Loop Example – USP Purified Water Storage Tank (No Ozone)
Item Suggested Frequency
Consequences
Instrument Calibration One Year Loss of Level Control
Inspect Rupture Disc Six Months TVB Excursion
Replace Rupture Disc One Year TVB Excursions
Replace Hydrophobic Vent Filter Cartridge
Six Months TVB Excursion
Inspect Tank Interior Six Months Rouging/Biofilm
Replace Manway Gasket
One Year TVB Excursion/Leak
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Preventative Maintenance Program
• Ion Removal Component Example – Reverse Osmosis Unit
Item Suggested Frequency
Consequences
Repassivate One -Two Years Rouging – Biofilm – TVB Increase
Derouge & Repassivate Two -Three Years Rouging – Biofilm – TVB Increase
Hot Water Sanitization One Week – One Month
TVB Excursions
Chemical Sanitization Six Months Biofilm – TVB Excursion
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Thank you!
Questions?