Design and Construction of USP Purified Water Systems William V. Collentro.

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

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


• Regulated Items - Microorganisms– Cryptosporidium– Giardia lamblia– Legionella– Total Coliform– Turbidity– Viruses


• Regulated Items – Disinfection Byproducts

–Bromate–Chlorite–Haloacetic Acids (HAA5) –Total Trihalomethanes (TTHMs)


• Regulated Items – Disinfectants

–Chlorine–Chloramines–Chlorine Dioxide



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


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


• Regulated Items – Organic Chemicals (53 Total)– Sewage/Wastewater Treatment– Herbicides– Landfill Leachates– Chemical/Industrial Facility Waste– Fumigants– Petroleum /Refinery Waste– Insecticides


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


• 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


• 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


• General Monitoring – Water Purification System• Final TVB• Inline RO Feed Water and Product Water

Conductivity plus % Rejection of Ions• Inline Post RO Polishing Conductivity


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


• 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 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

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 - - -


• 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


• 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


• 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


• 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


• 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


• 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


• Objective- Proactive not reactive- Shutdown Considerations – frequency- Cost of lost production time- Cost of quarantine of product- Cost of lost product- “Micro delay”


• 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


• 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




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)


• Storage & Distribution Loop Example – USP Purified Water Storage Tank (No Ozone)


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




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

Thank you!

Questions?

Design and Construction of USP Purified Water Systems William V. Collentro.

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