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?
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 WaterPost Multimedia Post Activated Carbon Post UVPost Lead Water Softener Post Polish Water Softener Post Cartridge Filter NPDWR Tests X------ TVB XXXXXXX BET X-X---X Chlorine XXX---- TOC XXX---- TSS XXX-XX- Total Hardness X-X-XX- Total Iron XXX-XX- Turbidity XX----- SDI ------X
USP Purified Water System – RO/Polishing Periodic Monitoring Post RO Break Tank Post ROPost CEDIPost UVPost Final Filter TVB XXXXX BET XX--- pH XX--- TOC XXXXX Carbon Dioxide XX---
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
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
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 manufacturers 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 manufacturers 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)
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
Preventative Maintenance Program Pretreatment Component Example – Activated Carbon Unit ItemSuggested FrequencyConsequences Media ReplacementSix MonthsTOC and/or Chloramine Breakthrough Sanitize Column Internals Six MonthsMicrobial Excursion Replace GasketsTwo YearsLeak/Shutdown Access GasketsSix MonthsLeak/Shutdown Clean/Replace Distributors One YearFailure – Media in Product Water Instrument Calibration One YearImproper System Operation Replace Valve Diaphragms Two YearsBypass/Cross Contamination
Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis Unit ItemSuggested Frequency Consequences Rotate RO Membranes Six MonthsLoss in Product Water Flow Rate and Quality (Chemical and TVB) Contract Clean Rotated Membranes Six MonthsLoss in Product Water Flow Rate and Quality (Chemical and TVB) Chemical Sanitization Six MonthsTVB Excursions Interconnector O-Rings Six MonthsWaste-to-Product Leak End Fitting O-Rings Six MonthsWaste-to-Product Leak Instrument Calibration One YearLoss of System Control Replace Interconnectors One YearWaste-to-Product Leak
Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis Unit ItemSuggested Frequency Consequences Replace Feed Water Pump Seals Two YearsPump Leak – Introduction of Air/Water – TVB Increase Vale Seals/Diaphragms Two YearsBypass Sanitize Pressure Vessels Six Months TVB Excursions Change Prefilters One Week Foulant Increase Resulting in TVB Increase Hot Water Sanitize (if equipped) Two WeeksTVB Excursions Replace Rotated Membranes Three YearsLoss in Product Water Flow Rate and Quality (Chemical and TVB)
Preventative Maintenance Program Storage & Distribution Loop Example – USP Purified Water Storage Tank (No Ozone) ItemSuggested Frequency Consequences Instrument CalibrationOne YearLoss of Level Control Inspect Rupture DiscSix MonthsTVB Excursion Replace Rupture DiscOne Year TVB Excursions Replace Hydrophobic Vent Filter Cartridge Six Months TVB Excursion Inspect Tank InteriorSix MonthsRouging/Biofilm Replace Manway Gasket One YearTVB Excursion/Leak
Preventative Maintenance Program Ion Removal Component Example – Reverse Osmosis Unit ItemSuggested Frequency Consequences RepassivateOne -Two YearsRouging – Biofilm – TVB Increase Derouge & RepassivateTwo -Three YearsRouging – Biofilm – TVB Increase Hot Water Sanitization One Week – One Month TVB Excursions Chemical SanitizationSix Months Biofilm – TVB Excursion