Presentation is loading. Please wait.

Presentation is loading. Please wait.

Design and Construction of USP Purified Water Systems

Similar presentations


Presentation on theme: "Design and Construction of USP Purified Water Systems"— Presentation transcript:

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

2 Feed Water Analysis

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

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

5 USP Purified Water System – Feed Water Analysis
Regulated Items - Microorganisms Cryptosporidium Giardia lamblia Legionella Total Coliform Turbidity Viruses

6 USP Purified Water System – Feed Water Analysis
Regulated Items – Disinfection Byproducts Bromate Chlorite Haloacetic Acids (HAA5) Total Trihalomethanes (TTHMs)

7 USP Purified Water System – Feed Water Analysis
Regulated Items – Disinfectants Chlorine Chloramines Chlorine Dioxide

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

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

10 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

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

12 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

13 USP Purified Water System – Feed Water Analysis
Regulated Items - Testing Municipality? Pharmaceutical Facility? Compliance? Obligation? Consequences?

14 Periodic Monitoring

15 USP Purified Water System – Periodic Monitoring
General Monitoring – Storage and Distribution System Point-of-Use TVB Online Conductivity Online TOC

16 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

17 USP Purified Water System – Periodic Monitoring
Frequent Monitoring – Water Purification System Silt Density Index (Test Kit) Total Hardness (Test Kit) Chlorine (Test Kit)

18 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

19 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 BET Chlorine TOC TSS Total Hardness Total Iron Turbidity SDI

20 USP Purified Water System – RO/Polishing Periodic Monitoring
Post RO Break Tank Post RO Post CEDI Post UV Post Final Filter TVB X BET - pH TOC Carbon Dioxide

21 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

22 Sanitization Provisions

23 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

24 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

25 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

26 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

27 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

28 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

29 Validation Criteria

30 Validation Criteria Commissioning Documentation Reference in IQ and OQ
“Credit” for inspection and testing Factory Acceptance Test (FAT) Documentation Turnover Packages (TOP) Coordination Interface

31 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.

32 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.

33 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.

34 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.

35 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

36 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

37 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 days after successful execution Continues for one year period Monitoring never stops

38 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)

39 Validation Criteria PQ Microbial Monitoring EP Monograph Reference
Verify enumeration parameters Bacteria identification MIS Riboprinter Gram Stain Objectionable organisms Summary Report

40 Operating Procedures

41 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

42 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

43 Preventative Maintenance Program

44 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”

45 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 Microbial Excursion Replace Gaskets Two Years Leak/Shutdown Access Gaskets Clean/Replace Distributors One Year Failure – Media in Product Water Instrument Calibration Improper System Operation Replace Valve Diaphragms Bypass/Cross Contamination

46 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 Chemical Sanitization TVB Excursions Interconnector O-Rings Waste-to-Product Leak End Fitting O-Rings Instrument Calibration One Year Loss of System Control Replace Interconnectors

47 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 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 Replace “Rotated Membranes” Three Years Loss in Product Water Flow Rate and Quality (Chemical and TVB)

48 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 TVB Excursions Replace Hydrophobic Vent Filter Cartridge Inspect Tank Interior Rouging/Biofilm Replace Manway Gasket TVB Excursion/Leak

49 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 Hot Water Sanitization One Week – One Month TVB Excursions Chemical Sanitization Six Months Biofilm – TVB Excursion

50 Thank you! Questions?


Download ppt "Design and Construction of USP Purified Water Systems"

Similar presentations


Ads by Google