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Design and Construction of USP Purified Water Systems - USPEP

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Design and Construction of USP Purified Water Systems - USPEP Powered By Docstoc
					Design and Construction of USP
    Purified Water Systems


       William V. Collentro
Feed Water Analysis
     USP Purified Water System –
        Feed Water Analysis

• Official Monograph
  – United States EPA NPDWR
  – Equivalent European Regulations
  – Equivalent Japanese Regulations
  – World Health Organization Reference
     USP Purified Water System –
        Feed Water Analysis

• United States EPA – National Primary
  Drinking Water Regulations (NPDWR)
  –Regulated Items
  –Total Viable Bacteria
  –“Private” Water Supplies
      USP Purified Water System –
         Feed Water Analysis

• Regulated Items - Microorganisms
  – Cryptosporidium
  – Giardia lamblia
  – Legionella
  – Total Coliform
  – Turbidity
  – Viruses
      USP Purified Water System –
         Feed Water Analysis
• Regulated Items – Disinfection Byproducts
  –Bromate
  –Chlorite
  –Haloacetic Acids (HAA5)
  –Total Trihalomethanes (TTHMs)
      USP Purified Water System –
         Feed Water Analysis
• Regulated Items – Disinfectants
  –Chlorine
  –Chloramines
  –Chlorine Dioxide
       USP Purified Water System –
          Feed Water Analysis

• Regulated Items – Inorganic Chemicals
  –   Antimony
  –   Arsenic
  –   Asbestos
  –   Barium
  –   Beryllium
  –   Cadmium
  –   Total Chromium
  –   Copper
        USP Purified Water System –
           Feed Water Analysis

• Regulated Items – Inorganic Chemicals
  –   Cyanide
  –   Fluoride
  –   Lead
  –   Mercury
  –   Nitrate
  –   Nitrite
  –   Selenium
  –   Thallium
        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
      USP Purified Water System –
         Feed Water Analysis

• Regulated Item – Radionuclides
  – Alpha Particles
  – Beta Particles and Photon Emitters
  – Radium 226
  – Uranium
       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
      USP Purified Water System –
         Feed Water Analysis

• Regulated Items - Testing
   – Municipality?
   – Pharmaceutical Facility?
   – Compliance?
   – Obligation?
   – Consequences?
Periodic Monitoring
      USP Purified Water System –
         Periodic Monitoring
• General Monitoring – Storage and Distribution
  System
  • Point-of-Use TVB
  • Online Conductivity
  • Online TOC
      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
      USP Purified Water System –
         Periodic Monitoring
• Frequent Monitoring – Water Purification
  System
  • Silt Density Index (Test Kit)
  • Total Hardness (Test Kit)
  • Chlorine (Test Kit)
      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
          USP Purified Water System –
       Pretreatment Periodic Monitoring
                 Raw Water   Post         Post Activated   Post UV   Post Lead   Post Polish   Post Cartridge
                             Multimedia   Carbon                     Water       Water         Filter
                                                                     Softener    Softener
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 –
RO/Polishing Periodic Monitoring

             Post RO Break   Post RO   Post CEDI   Post UV   Post Final
             Tank                                            Filter
    TVB            X              X          X          X          X
    BET           X               X          -           -          -
     pH           X               X          -           -          -
    TOC           X               X          X          X          X
   Carbon         X               X          -           -          -
   Dioxide
      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
Sanitization Provisions
     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
     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
     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
     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
     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
      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
Validation Criteria
            Validation Criteria
• Commissioning Documentation
  – Reference in IQ and OQ
  – “Credit” for inspection and testing
  – Factory Acceptance Test (FAT) Documentation
  – Turnover Packages (TOP)
  – Coordination
  – Interface
            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.
             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.
            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.
            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.
            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
             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
            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
            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)
             Validation Criteria
• PQ Microbial Monitoring
  – EP Monograph Reference
  – Verify enumeration parameters
  – Bacteria identification
     • MIS
     • Riboprinter
  – Gram Stain
  – Objectionable organisms
  – Summary Report
Operating Procedures
  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
  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
Preventative Maintenance
        Program
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”
Preventative Maintenance Program
• Pretreatment Component Example – Activated
  Carbon Unit
      Item          Suggested Frequency             Consequences
Media Replacement       Six Months        TOC and/or Chloramine Breakthrough
 Sanitize Column        Six Months                Microbial Excursion
    Internals
 Replace Gaskets         Two Years                  Leak/Shutdown
  Access Gaskets        Six Months                  Leak/Shutdown
  Clean/Replace          One Year           Failure – Media in Product Water
   Distributors
   Instrument            One Year             Improper System Operation
   Calibration
  Replace Valve          Two Years            Bypass/Cross Contamination
   Diaphragms
Preventative Maintenance Program
• Ion Removal Component Example – Reverse
  Osmosis Unit
         Item            Suggested              Consequences
                         Frequency
    “Rotate RO           Six Months   Loss in Product Water Flow Rate and
    Membranes”                             Quality (Chemical and TVB)
Contract Clean Rotated   Six Months   Loss in Product Water Flow Rate and
     Membranes                             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           One Year           Waste-to-Product Leak
   Interconnectors
Preventative Maintenance Program
• Ion Removal Component Example – Reverse
  Osmosis Unit
        Item             Suggested                  Consequences
                         Frequency
 Replace Feed Water      Two Years     Pump Leak – Introduction of Air/Water –
     Pump Seals                                     TVB Increase
Vale Seals/Diaphragms    Two Years                      Bypass
  Sanitize Pressure      Six Months                 TVB Excursions
       Vessels
  Change Prefilters      One Week      Foulant Increase Resulting in TVB Increase
Hot Water Sanitize (if   Two Weeks                  TVB Excursions
     equipped)
  Replace “Rotated       Three Years     Loss in Product Water Flow Rate and
    Membranes”                                Quality (Chemical and TVB)
Preventative Maintenance Program
• Storage & Distribution Loop Example – USP
  Purified Water Storage Tank (No Ozone)
         Item            Suggested       Consequences
                         Frequency
Instrument Calibration   One Year     Loss of Level Control
 Inspect Rupture Disc    Six Months      TVB Excursion
 Replace Rupture Disc    One Year        TVB Excursions
 Replace Hydrophobic     Six Months      TVB Excursion
 Vent Filter Cartridge
 Inspect Tank Interior   Six Months     Rouging/Biofilm
   Replace Manway        One Year     TVB Excursion/Leak
        Gasket
Preventative Maintenance Program
• Ion Removal Component Example – Reverse
  Osmosis Unit
        Item               Suggested                Consequences
                           Frequency
     Repassivate         One -Two Years     Rouging – Biofilm – TVB Increase
Derouge & Repassivate    Two -Three Years   Rouging – Biofilm – TVB Increase

Hot Water Sanitization   One Week – One             TVB Excursions
                             Month
Chemical Sanitization      Six Months           Biofilm – TVB Excursion
Thank you!

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