Treatment Technologies
High Purity Water Treatment Companies
High-purity water system integrators for pharma (WFI/PW), microelectronics, and laboratory applications.
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High-Purity Water Production: CEDI, Mixed-Bed Polishing, and Resistivity Targets by Application
High-purity water (HPW) and ultrapure water (UPW) are produced for semiconductor, pharmaceutical, and power generation applications by staged treatment: multimedia filtration, softening, reverse osmosis (two-pass for UPW), continuous electrodeionisation (CEDI), and mixed-bed polishing. ASTM D5127 defines UPW grades: Electronic Grade 1 (18.2 MOhm-cm resistivity, TOC below 1 micrograms per L, particles below 0.05 micron at less than 100 per mL), Electronic Grade 2 (17.5 MOhm-cm, TOC below 5 micrograms per L). Pharmaceutical purified water per USP 1231 specifies conductivity below 1.3 microS per cm at 25 degrees C; WFI (Water for Injection) conductivity below 1.1 microS per cm with TOC below 500 micrograms per L.
CEDI (Continuous Electrodeionisation) uses ion exchange membranes and electrical potential to remove ions to below 0.1 microS per cm conductivity, replacing chemical regeneration of traditional mixed beds. CEDI feedwater must have TDS below 40 mg per L (conductivity below 60 microS per cm), hardness below 0.1 mg per L CaCO3, free chlorine below 0.05 mg per L, SDI below 5, and CO2 below 10 mg per L. Mixed-bed polishers (H-OH form, strong acid cation plus strong base anion resin, volume ratio 2:3) produce 18.2 MOhm-cm water. Mixed bed regeneration: acid at 10 to 15 percent H2SO4 for cation resin, caustic at 4 to 6 percent NaOH for anion resin; generates 500 to 1,000 L of regenerant waste per m3 of resin.
Loop distribution of UPW maintains quality: all-polyvinylidene fluoride (PVDF) or electropolished 316L stainless steel piping, dead-leg elimination (maximum 6 diameters), continuous recirculation at minimum 1.5 m per s (turbulent, prevents biofilm), and UV TOC reduction at 185 nm wavelength. Online monitoring parameters: resistivity (continuous at multiple loop points), TOC (ppb analyser), dissolved oxygen, particulate counters, and endotoxin (for pharmaceutical WFI). Capital cost for a 10 m3 per hr UPW system: $1.5M to $4M. Operating cost dominated by RO membrane replacement (every 3 to 5 years) and mixed-bed resin regeneration chemicals.
Frequently Asked Questions
What is the difference between purified water and ultrapure water?
Purified water (PW) per USP 1231 requires conductivity below 1.3 microS per cm at 25 degrees C, TOC below 500 micrograms per L, and absence of objectionable organisms (below 100 CFU per mL action limit). It is produced by RO, ion exchange, or distillation and used for pharmaceutical manufacturing of non-parenteral products. Ultrapure water (UPW) for semiconductor manufacturing per ASTM D5127 Grade 1 requires 18.2 MOhm-cm resistivity (0.055 microS per cm), TOC below 1 micrograms per L, particles at 0.05 micron below 100 per mL, and bacteria below 1 CFU per litre. Water for Injection (WFI) per Ph. Eur. 2.6.14 and USP requires distillation or reverse osmosis production with bacteria below 10 CFU per 100 mL and endotoxins below 0.25 EU per mL.
What is CEDI and how does it differ from traditional mixed-bed ion exchange?
Continuous Electrodeionisation (CEDI) uses electrically driven ion transport across ion-selective membranes to remove dissolved ions, continuously regenerating the built-in resin without chemical acid or caustic addition. CEDI produces 15 to 18 MOhm-cm water continuously. Traditional mixed-bed ion exchange achieves 18.2 MOhm-cm but requires periodic offline regeneration using concentrated H2SO4 and NaOH (every 8 to 12 weeks at typical pharmaceutical flow rates), generating hazardous waste and causing production interruptions during regeneration. CEDI eliminates chemical waste streams and provides continuous operation, reducing operating cost by 30 to 50 percent versus mixed beds in large systems. CEDI capital cost is $50,000 to $500,000 for 1 to 50 m3 per hr; the trade-off is that CEDI requires cleaner RO permeate feed than mixed beds.
How do I control biofilm in a high-purity water system?
Biofilm control in HPW systems requires: (1) Continuous recirculation in all distribution loops at above 1.5 m per s (turbulent flow, no stagnation); (2) UV 254 nm disinfection at minimum 40 mJ per cm2 and 185 nm for TOC reduction in UPW loops; (3) Sanitisation by heat (80 degrees C minimum, 30-minute hold, weekly to monthly depending on system) or ozone (50 micrograms per L in loop, quarterly or continuous in advanced UPW); (4) Elimination of all dead legs (pipes ending in closed valves) exceeding 6 diameters in length; (5) PVDF or electropolished 316L construction with roughness Ra below 0.8 micron to prevent biofilm attachment sites. Alert limits: pharmaceutical PW 50 CFU per mL, action limit 100 CFU per mL per USP 1231. Trending upwards from baseline triggers a sanitisation cycle.
What are the typical stages in a high-purity water treatment train?
A complete UPW system for semiconductor manufacture consists of: (1) Pretreatment: multimedia filtration, activated carbon (chlorine removal to below 0.05 mg per L), 5-micron cartridge filter; (2) Primary deionisation: first-pass RO (95 to 99 percent TDS removal, 75 to 80 percent recovery); (3) Degassing: membrane degasser (CO2 below 1 mg per L for stable CEDI operation); (4) Secondary deionisation: second-pass RO (conductivity below 10 microS per cm); (5) Polishing: CEDI (conductivity 0.1 to 0.5 microS per cm) and mixed-bed polishers (18.2 MOhm-cm); (6) Distribution: UV 185+254 nm, ultrafiltration (0.01 micron, removes particles and bacteria). Each stage serves a specific function; bypassing any stage compromises final water quality and downstream process yield.
A UK pharmaceutical site manufacturing parenteral products required a new 5 m3/h Water for Injection (WFI) system to replace an aging multi-effect distillation unit that was failing MHRA GMP inspections due to unacceptably high endotoxin variability (0.05 to 0.35 EU/mL against a limit of 0.25 EU/mL). EU GMP Annex 1 (2022) now permits membrane-based WFI production as an alternative to distillation.
Designed and installed a validated WFI system: pretreatment (5 um cartridge, activated carbon), double-pass RO (180 bar, total rejection 99.8 percent), degassing, CEDI, and final UV 185+254 nm followed by 0.22 um absolute membrane filtration. All wetted surfaces in electropolished 316L (Ra below 0.5 um). Distribution loop in orbital-welded 316L at 80 degrees C hot-water sanitisation (maintained continuously). System qualified under GAMP 5: IQ, OQ, PQ completed and MHRA accepted.
WFI quality: conductivity consistently below 0.3 microS/cm, TOC below 50 ug/L, endotoxin below 0.03 EU/mL (10x below limit). MHRA GMP inspection passed first time post-installation. Eliminated 300,000 GBP per year in steam costs for distillation. RO+CEDI system energy consumption 60 percent lower than distillation. Validation documentation package accepted by both MHRA and FDA during FDA pre-approval inspection.
Questions to Ask Shortlisted Providers
- 1
What validation documentation do you provide (IQ, OQ, PQ protocols and reports), and have your systems been accepted by MHRA or FDA during a GMP inspection within the last 3 years?
MHRA and FDA require pharmaceutical-grade water systems to be qualified under a validation lifecycle approach per GAMP 5 and ICH Q7. A supplier who has not had a WFI or purified water system accepted during a regulatory inspection within 3 years has an unvalidated track record in the regulatory environment that matters most. Ask for the inspection observation letter from the regulatory body confirming the system was acceptable.
- 2
What resistivity, TOC, conductivity, and endotoxin do you guarantee at the point-of-use in the distribution loop, and at what flow rate and temperature?
WFI quality at the point-of-use is the regulatory standard, not quality at the production unit outlet. Hot water sanitisation loops lose some quality through loop transit if distribution is poorly designed. Guarantees must be at the furthest point-of-use in the loop, at maximum flow rate, after the specified sanitisation cycle.
- 3
What is the loop design to eliminate dead legs, and how do you define and verify compliance with the 6-diameter dead-leg rule?
Dead legs in UPW and WFI distribution loops accumulate biofilm and endotoxin. The 6-diameter rule (no dead-leg exceeds 6 times the pipe diameter) is an industry standard to minimise stagnation. However, application of the rule requires careful analysis of every valve, sample port, and instrument connection. Confirm that the P&ID review includes a dead-leg register with compliance verification.
- 4
What sanitisation frequency and method do you recommend for the production unit and the distribution loop, and what is the routine bioburden monitoring protocol?
Pharmaceutical water systems require routine sanitisation (typically heat at 80 degrees C continuously or ozone at 0.05 to 0.1 mg/L with 30-minute contact time weekly). The monitoring protocol (sample frequency, sample volume, culture method per ISO 11731 or US Pharmacopeia 62, action and alert limits) must align with the site's water system risk assessment and be accepted by the authorised quality person (QP) before the system is qualified.
- 5
What is the product change process if a component (membrane, lamp, UV housing) fails during GQP production, and how does your system support a change control submission to MHRA?
In GMP environments, any change to a validated system requires a change control process submitted to the relevant regulatory authority. Understanding whether component replacements (RO membranes, UV lamps, CEDI modules) are like-for-like substitutions or require revalidation determines the operational disruption and regulatory compliance burden when the first component replacement is due.
What Drives Cost in This Category
A purified water system (USP, conductivity below 1.3 microS/cm) costs 150,000 to 600,000 GBP for 2 to 10 m3/h. A WFI-quality system (USP/Ph. Eur., endotoxin below 0.25 EU/mL, 0.22 um final filtration) costs 400,000 to 1,500,000 GBP. Semiconductor UPW (ASTM D5127 Grade 1) costs 1,000,000 to 4,000,000 GBP for equivalent flow. Each quality step up approximately doubles system cost through additional unit operations and qualification overhead.
Electropolished 316L orbital-welded distribution loops cost 1,500 to 3,500 GBP per metre installed, including fittings and instrumentation. A 200 m WFI loop costs 300,000 to 700,000 GBP in distribution pipework alone. PVDF distribution loops (for semiconductor UPW) are similar in cost but have lower extractable organics. The loop represents 40 to 60 percent of total system cost on large pharmaceutical installations.
GMP system validation (IQ, OQ, PQ) adds 15 to 25 percent to system cost in documentation, testing, and consultant time. A 600,000 GBP WFI system requires 90,000 to 150,000 GBP in validation activities. Validation costs escalate if the first regulatory inspection finds gaps requiring remediation and re-inspection. This overhead is unavoidable and should be budgeted from project inception, not retrofitted after MHRA inspection.
Mixed-bed polishing resins require replacement every 6 to 18 months depending on influent quality (cost 8,000 to 25,000 GBP per resin changeout). CEDI modules have 3 to 5 year service life (cost 20,000 to 60,000 GBP per module replacement). RO membranes require replacement every 3 to 5 years (cost 15,000 to 50,000 GBP depending on array size). Total annual consumables budget for a 5 m3/h WFI system is typically 40,000 to 120,000 GBP per year.
Key Regulations & Standards
EU GMP Annex 1 (2022 revision, effective August 2023) confirms that Water for Injection (WFI) can be produced by membrane-based processes (RO, CEDI, ultrafiltration) as an alternative to distillation, provided the system delivers equivalent microbiological quality (endotoxin below 0.25 EU/mL, bioburden below 10 CFU/100 mL). The system must be qualified (IQ, OQ, PQ) and the process validated. Ph. Eur. monograph 0169 (WFI) and 0169 (Purified Water) set the chemical and microbiological quality standards.
MHRA GMP Guidelines for pharmaceutical manufacturers require pharmaceutical water systems to be validated in accordance with GAMP 5 (Good Automated Manufacturing Practice). Validation lifecycle: user requirements specification (URS), functional specification (FS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Systems must be maintained in a qualified state throughout their operational life, with change control for any modifications.
High-purity water systems for haemodialysis (dialysis water treatment) must comply with AAMI/ANSI/ISO 23500-3:2019 specifying microbiological quality (bacteria below 100 CFU/mL, endotoxin below 0.25 EU/mL) and chemical purity standards. CQC Fundamental Standards require haemodialysis units to maintain water quality monitoring records. MHRA Guidance on Quality of Dialysis Water and Dialysis Fluid sets the UK regulatory expectations.
Laboratory water for analytical chemistry, clinical testing, and calibration standards is classified into three grades: Grade 1 (below 0.1 microS/cm, below 10 ug/L TOC, for the most exacting analytical work including HPLC, AAS, and ICP-MS), Grade 2 (below 1.0 microS/cm), and Grade 3 (below 5.0 microS/cm for general glassware washing and qualitative chemistry). ISO 3696 specifies the production methods, quality parameters, and testing procedures for each grade, applicable to laboratory water systems separate from process water or WFI systems.
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