PURIFIED WATER DESIGN IHEA - PD Seminar 1 / 2017 Epworth Hospital, Waurn Ponds Rick Zolcinski Mob: 0418 326 332 Email: rick.zolcinski@merckgroup.com 17 th February 2017,
2 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
3 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
Why purify water and where do we start? Why care about purified water? Why does it matter? Surely purified water is all the same isn t it? 1 2 The 3 Some Water is the most commonly used chemical reagent / solvent. quality of the purified water will affect the quality of experimental outcomes, products and processes. equipment and standards require a certain quality or purification method. 4
Why purify water and where do we start? Two sources of water in nature Ground Water Surface Water Higher in dissolved ions Lower in organic materials Lower in particulates Lower in biological Material Lower in dissolved ions Higher in organic materials Higher in particulates Higher in biological material 5
Why purify water and where do we start? Contaminants in Potable Water Salts Inorganic ions (Na+, Cl- etc.) Organics Pesticides, herbicides, animal and plant breakdown Particles/Colloids Sand, iron precipitate etc. Microorganisms Bacteria, viruses, DNA/RNA and endotoxins Dissolved Gases Carbon Dioxide, Oxygen, Nitrogen, Noble gases 6
7 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
Monitoring pure water In-line measurement Two main contaminants can be measured in the system: TOC (in ppb) Resistivity in Megohm.cm @25ºC (Conductivity µs/cm @25ºC = 1/Resistivity) Other measurements need to be performed externally due to the nature of the tests involved. 8
Monitoring pure water Measurement of Contaminants Contaminants Inorganic Ions Organics Particles (Colloids) Bacteria Endotoxin Measurement Conductivity (Resistivity) Total Oxidizable Carbon (T.O.C.) Silt Density Index / Fouling Index Colony count on 0.45 μm Membrane. Rabbit Inoculation test LAL Test Unit μs/cm MΩ.cm ppb (μg/l) Rate of pluggage of 0.45 μm membrane. cfu/ml Endotoxin units/ml
10 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
Standards and Common Terms Pure Water Standards Types of Water Ultrapure Ultrapure/Reagent Grade Critical Applications Water for HPLC,GC, HPLC,AA, ICP-MS, for buffers and culture media for mammalian cell culture & IVF, reagents for molecular biology... Pure Type I Type II Type III Pure/Analytical Grade Standard Applications Buffers, ph solutions,culture media preparation,clinical analysers and weatherometers feed. Pure/Laboratory Grade General Applications Glassware rinsing, heating baths, humidifiers and autoclaves filling 11
Pure Water Standards ASTM Standards* *ASTM (American Society for Testing and Materials)
Pure Water Standards US and European Pharmacopoeia
Pure Water Standards CLSI* water quality specifications Water qualities defined by the CLSI: **Clinical laboratory Reagent Water (CLRW) CLRW Quantitative Specifications: Resistivity: 10 MΩ.cm referenced to 25 C; Total Heterotrophic Plate Count: < 10 cfu/ml; TOC: < 500 ng/g (ppb); Particulates: puridication stage that blocks the passage of particles 0.22 μm at or near the output stage. Special Reagent Water (SRW) Instrument Feed Water (IFW) Water Supplied by a method manufacturer for use as a Diluent or Reagent Commercial bottled, Purified Water Autoclave and Wash Water Applications *CLSI: Clinical and Laboratory Standards Institute (previously NCCLS) ** Concerning CLSI Water Qualities, complete CLSI corresponding sections should be read in order to understand the philosophy, method, limitations, recommendations for each requirement. 14
Pure Water Standards CSSD - AS/NZS 4187:2014 Amendment No. 1 15
16 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
System Design Design Stages Step 1: Define the requirements and specifications for Pure and Ultrapure water Step 2: Design the Solution Distribution Loop or Point of use Production System and Storage Volume and Quality Step 3: Review and Finalise Specifications and Design 17
System Design Water Requirements and Specifications First questions to be asked: What is the required purity level? What is the quantity of water needed? When is it needed? Where is it needed? What is it needed for? 18
System Design Water Requirements and Specifications More specific questions to be asked: How much water is needed each day? In each lab, at each location..? By individual users, to feed instruments, for ultrapure polishing systems? How is the demand distributed during the day? Steady demand over the course of a day? Peak demands at certain times of the day? 19
System Design Water Requirements and Specifications How many floors need water? What labs and locations need purified water? Where is each location? Are there remote locations that need water? What are the distances between each location? What kind of work will be carried out in each lab and each location? General rinsing/washing Sensitive trace analysis 20
System Design Water Requirements and Specifications Are there instruments that will need pure water? Glassware washers, steam sterilizers, autoclaves..? Are there any maximum purity level requirements? What water quality is needed for each location? Ionic, Organic, and Microbiological Quality? Are there any standard specifications to follow? Are there alert and action levels? 21
System Design Designing the Distribution Loop Define the distribution piping (for central solutions) Design Layout Materials, welding method, valve type, pipe diameter Design Considerations Define Loop Purification and Monitoring Equipment Determine distribution pump performance Flow rate and pressure 22
System Design Distribution Piping: Avoiding Dead Legs 6D rule CFR212 regulations of 1976 Good Engineering practice requires minimizing the length of dead legs and there are many good instrument and valve designs available to do so. 6D rule Maximum dead leg = 6 times the pipe diameter 0.59 X 6 = 3.5 - Maximum dead length of 3.5 inches 23
System Design Distribution Piping: Avoiding Dead Legs 2D rule ASME Bioprocessing Equipment Guide of 1997 Good Engineering practice requires minimizing the length of dead legs and there are many good instrument and valve designs available to do so. 2D rule Ø 25 mm Example: Ø 25 mm X 2 = 50mm Maximum dead length of 50 mm Maximum dead leg = 2 times the pipe diameter This rule is primarily for stainless steel loop design, and loops that can be heat sanitized. In general, cold water loops should have no dead legs whatsoever. 24
System Design Distribution Piping: Valves Ball and Diaphragm valves Hole in ball allows flow in open position Hole is perpendicular to flow path in closed position 90 o turn from close to open position Poor control of flow Water is trapped inside ball in closed position Elastomer diaphragm open-closes against valve seat to allow flow, stop flow and control flow Multiple turns from closed to open Good control of flow No-Minimal water trapped 25
System Design Distribution Piping: Outlets Recirculating point of use Aquataps 26
System Design Purification Loop & Monitoring Equipment
System Design Purification Loop & Monitoring Equipment - Bacteria Testing Sanitary Sampling Valve Designed for sanitary sampling (bacteria and endotoxins) Midstream sampling Zero dead leg when closed Sanitize easily in place Direct attachment to samplers 28
System Design Purification Loop & Monitoring Equipment - Bacteria Testing 29
System Design Distribution Pump Pump selection is based on flow rate and pressure requirements Flow rate required defined in step 1 Pressure requirement Total Pressure requirement can be estimated by adding: Piping pressure loss Loop equipment pressure loss Pressure due to elevation changes + Pressure required at furthest point of use (1.5 bar typical) Total Pressure Requirement Select a pump that delivers the required flow rate and pressure Reduce pressure loss by increasing pipe diameter, (keeping balance with flow required and target velocity) For added reliability a duplex pumping system can be used 30
System Design Flow Velocity Design system for ~1 to 1.5 m/s to: Maintain turbulent flow Minimize biofilm on internal walls Balance between velocity and pressure drop Higher velocity results in too high a pressure drop requiring a larger pump and risk of increased water temperature 31
System Design Velocity in PP Loop PP 25 PN 10 Length Pressure Velocity Volume m bar m/s l/min 50 3,0 2,5 1,20 20 200 lit tank, JP 5 Köping 2.6 MΩcm 28.4 ºC, TOC11ppb PP 25 PN 10 Loops 350 lit tank, CHI 2-40 Uppsala 1.25 MΩcm, 20 ºC, TOC 1ppb PP 32 PN 10 0,28 5,0 PP 25 PN 10 450 5,2 2,5 0,69 12 1600 lit tank, CHI 2-60 Stockholm 2.91 MΩcm,21.5 ºC, TOC 1ppb 1)PP 32 PN 10 0,52 16 1)PP 25 PN 10 800 7,5 3,0 0,85 15 2)PP 32 PN 10 0,45 14 2)PP 25 PN 10 700 7,5 3,0 0,90 15 Huddinge 3)PP 32 PN 10 0,45 15 Hospital 3)PP 25 PN 10 700 7,5 3,0 0,85 15 2x1600 lit tank, 3xCRN 2-90 2.51 MΩcm, 22 ºC, TOC 1ppb 430 3,5 2,5 0,60 10 Total bact < 1-10 CFU/100 ml, all loops socket welded.
System Design Design the Production System How to select the appropriate system for the building: 1. Select the water purification system to match the water quality required 2. Size the water purification system to match the quantity required per day 3. Size the storage tank to meet peak demands during the day 4. Determine the pretreatment needed 33
System Design Production System Sizing and Quantity Match the quality requirement RO/EDI or RO/DI system for Type 2 pure water applications RO system for Type 3 more general applications Size the production system to match the quantity required per day Plans for future expansion? Are Duplex systems needed? Back-up for maintenance-down time. Option to add for future expansion 34
35 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
Storage of Pure Water Biofilm Formation Organics Particles Bacteria Surface Time
Storage of Pure Water Biofilm Formation Condensation droplets Filter Chemical sanitisation (NaOCl, NaOH...etc) : Effective on surface in direct contact with water (tank and distribution loop) Ineffective on surfaces above the water level (condensation droplets on the roof of the tank) Drain Drawoff Rinsing / decontamination is time consuming 37
Pure Water Storage Degradation of Water Pure water stored in the most ideal conditions should still be turned over at least once every day or two. Pure water degrades in quality over time Biofilm/Bacterial contamination Ionic degradation (CO2 contamination) Organic contamination Filter CO 2 trap Rate of degradation varies depending on water quality Type III water can be stored with minimal degradation Type II water will degrade over time Type I water cannot be stored it must be point of use Drain Drawoff
Pure Water Storage Degradation of Water Without UV Lamp With UV Lamp Bacteria in condensation water droplets above water level Biofilm development below water level 39
Pure Water Storage Putting it together 40
41 WHY PURIFY WATER AND WHERE DO WE START? MONITORING PURE WATER PURE WATER STANDARDS SYSTEM DESIGN STORAGE OF PURE WATER SYSTEM DESIGN OPTIONS
System Design Options Central Water System Design 42
System Design Options Central System with Facility-Wide Distribution
System Design Options Duplicate Central System with Facility-Wide Distribution
System Design Options Floor by Floor or Department by Department
System Design Options By Floor or by Department, Combined with Point-of-Use Modules
System Design Options Individual Water System Design 47
System Design Options CSSD Design Considerations Pipe Size Limitations 1 Loop or 2? 1 tank or 2? Future upgrades impact on supply, weekend work, time involved, allow for full sanitisation
System Design Options The Future of Pure Water 24/7 Real-Time Monitoring ERA Technology Reduced water consumption Constant permeate flow rate Maximise pretreatment lifetime Connectivity
QUESTIONS?