Clean water solutions for the pharmaceutical and electronics industries

Detailed introduction to the high-purity water/ultrapure water system industry

Pharmaceutical Purified Water, Water for Injection, and Electronic Ultrapure Water (UPW) Industry Overview - Data as of 2025

In both the pharmaceutical and electronics industries, "clean water solutions" essentially involve purifying raw water step-by-step to the extremely high standards required by their respective processes—the pharmaceutical industry focuses on controlling pharmacopoeia-related microorganisms and endotoxins, while the electronics industry focuses on controlling resistivity and particulate/metal ion levels. Both share a profound respect for the "vulnerability" of water quality: water is highly susceptible to microbial growth and the dissolution of impurities, and contamination directly threatens drug safety or chip yield. This article systematically reviews the water quality classification, process chain, market size, competitive landscape, standards and regulations, and development trends of these two types of clean water systems.

I. Industry Boundaries: The Underlying Differences in the Logic of the Two Types of "Clean Water"

The pharmaceutical industry prioritizes "sterility, pyrogen-free, and verifiability"; the electronics industry prioritizes "ultra-high resistivity, ultra-low particle and metal ion content." The former is constrained by GMP and pharmacopoeia regulations, while the latter is driven by SEMI standards and advanced process yield requirements. Both share commonalities: multi-stage series connection, online monitoring, closed-loop circulation, and stringent material requirements.

II. Clean Water Solutions for the Pharmaceutical Industry

2.1 Pharmacopoeia Water Quality Classification

The Chinese Pharmacopoeia classifies pharmaceutical water into drinking water, purified water, water for injection, and sterile water for injection; the United States Pharmacopeia (USP) also includes pure steam and water for hemodialysis; the European Pharmacopoeia includes ultrapure water. Raw water is usually drinking water, which is then processed through a series of steps.

WFI has a microbial limit that is "thousands of times stricter" than PW (10 CFU/100mL vs 100 CFU/mL); bacterial endotoxins are lipopolysaccharides from the cell walls of Gram-negative bacteria, which are heat-resistant and nanoscale, and are difficult to remove with conventional sterilization and sterilization filters. The only way to reduce the risk is to control the growth of microorganisms by "cutting off the fuel supply at the source".

2.2 Core Process Chain

• Pretreatment: multi-media filtration, activated carbon filtration, softener/scale inhibitor dosing, security filter—protecting downstream membrane elements and controlling the microbial breeding ground.

• Desalination and salt removal: Reverse osmosis (RO) is the main method, and secondary RO can be added; some systems retain ion exchange mixed beds.

• Deep polishing: Electrodeionization (EDI) produces high-purity water without chemical regeneration, continuously and stably, and is the core of modern PW systems.

• WFI Dedicated: Multi-Effect Distillation (MED) or pure steam distillation utilizes the latent heat of vapor to evaporate and condense multiple times, achieving thorough vapor-liquid separation to remove endotoxins.

• Storage and distribution: 316L stainless steel tanks and piping, complete drainage (no residual water), high Reynolds number turbulent circulation (Re>10,000), and blind pipes without dead zones (dead zone ≤ 3 times the pipe diameter).

2.3 Key Points of GMP Compliance and System Design

• Quality by Design (QbD): Water quality is not "tested" but "designed + process controlled"; it requires installation/operation/performance validation (IQ/OQ/PQ), and WFI includes the third phase validation throughout the year.

• Microbial and biofilm control: 30–55℃ is the reproduction temperature zone. The WFI system usually uses hot water circulation above 70℃ + periodic superheated water/pure steam sterilization (121℃×30min).

• Red rust prevention: Excessive water temperature causes oxidation and peeling of the inner surface of stainless steel, producing insoluble pollutants. A balance needs to be struck between water temperature, material passivation, and operation and maintenance.

• Storage period: Purified water should not be kept for more than 24 hours, and water for injection should not be kept for more than 12 hours. Otherwise, it is necessary to keep it at a temperature above 80°C or circulate it at a temperature above 65°C.

2.4 Market Size and Major Players

• In the Chinese market, the demand for pure water/pharmaceutical water equipment for biopharmaceuticals continues to grow with the expansion of biopharmaceutical, innovative drug and CDMO production; the systems mostly adopt the new RO+EDI process and 316L all stainless steel circulation pipelines.

• International leaders such as Veolia, Suez, Evoqua (Xylem), Pall, Sartorius, BWT, and Aquatech provide complete GMP solutions from water treatment to WFI distribution.

• Domestic players include leading pharmaceutical machinery manufacturers such as Chutian Technology and Dongfulong, which provide supporting water systems; professional purified water equipment suppliers such as Laitelide and Chuangyang Water Treatment; and membrane material suppliers such as Beijing OriginWater Technology, Walton Technology, and Tianjin Membrane Technology, which provide RO/EDI support.

III. Clean Water Solutions for the Electronics Industry (Ultrapure Water, UPW)

3.1 Definition and Indicators of Ultrapure Water

Ultrapure water (UPW) refers to highly purified water with a resistivity of up to 18.2 MΩ·cm (25℃) after the removal of ions, organic matter, microorganisms, dissolved gases, and particulate matter, and impurities measured in ppt (parts per trillion). It is an irreplaceable process consumable in semiconductors, photovoltaics, and panels. Advanced processes now require testing down to the ppq (parts per quadrillion) level.

3.2 Process Chain (Multi-stage Series)

A typical UPW station follows a complete supply chain: "pretreatment—RO membrane—EDI/ion exchange—terminal polishing".

• Pretreatment: Multi-media, activated carbon, softening, ultrafiltration (UF) to remove suspended solids and macromolecular organic matter.

• First-stage/second-stage reverse osmosis (RO): Two-stage desalination in series, with no chemical regeneration pollution.

• Electrodeionization (EDI)/polishing mixed bed: deep desalination to the upper limit of resistivity.

• Terminal polishing: UV oxidation (UVOx) to reduce TOC, membrane degassing (removal of dissolved oxygen/CO₂), terminal ultrafiltration (UF) to control particles, and partial fractional EDI to remove boron/silicon.

• Circular distribution: High flow rate (advanced node single plant >500 m³/h, newly built fab 2,000–5,000 m³/day) closed-loop circulation + online real-time monitoring.

3.3 Application Scenarios

• Wafer cleaning (dominant usage), CMP chemical mechanical polishing, etching/stripping, back grinding, immersion lithography—water directly contacts the silicon wafer, and water quality directly affects yield.

• Advanced Packaging: 3D ICs, chiplets, and through-silicon via (TSV) cleaning introduce new specifications for UPW.

• Panels and photovoltaics: LCD/OLED displays and the texturing and cleaning of photovoltaic cells also rely on high-purity water.

3.4 Market Size and Data

3.5 Competitive Landscape and Localization

• International oligopolies: Kurita, Organo, and Nomura Micro Science of Japan together account for more than 80% of global semiconductor UPW installations; Veolia and Evoqua (Xylem) are cross-industry leaders.

• Current situation in China: The overall localization rate of ultrapure water systems is less than 15%, making it an "overlooked hard track in the semiconductor industry"; the domestic market share of RO membranes is about 10% (Walton Technology is the leader), and electronic-grade resins have long been monopolized by Dow and Lanxess.

• Domestic breakthroughs: Zhichun Technology (a leading system integrator), High Frequency Technology (PPT-level systems), Lanxiao Technology (electronic-grade uniform particle resin), Wharton Technology (ultrapure water RO membrane), Chuangyuan Technology/Jiangsu Sujing (12-inch wafer complete water station) and others have entered the supply chain.

IV. Overview of the Standards System

• Pharmaceutical manufacturing: Compliant with national pharmacopoeias (ChP/USP/EP/JP) + GMP; WFI requires distillation and has stringent endotoxin limits; systems must be validated and regularly sterilized.

• Electronics: SEMI series standards (such as F57 TOC control <1ppb, F60 material compatibility, F61 microbiology); in-plant specifications become stricter with each node (<7nm, <5nm, <3nm).

• General: Raw water is mostly sourced from municipal drinking water sources, requiring pretreatment as a backup; ISO 9001/14001 is a basic qualification for equipment manufacturers, and EU CE certification is commonly found for exported equipment.

V. Trends and Challenges

Common Trends

• Modular/containerized: Reduces initial capital by 30-40%, suitable for small and medium-sized factories and flexible for capacity expansion.

• Digital operation and maintenance: AI + online monitoring optimizes water quality, predicts membrane life, and reduces waste and emissions.

• Closed-loop recycling and zero emissions: Semiconductor system recycling rates have reached 85-90%, alleviating pressure in water-scarce regions.

Pharmaceutical focus

• Continuous manufacturing (CMC) drives continuous water production and distribution for PW/WFI; pure steam systems are incorporated into the water system.

• Anti-rust, low-dissolution materials and passivation processes have become the direction for upgrading pharmaceutical machinery.

Electronic Focus and Challenges

• Advanced nodes (<3nm) require ppq-level testing, and real-time monitoring can cost $1-2 million per plant.

• Capital-intensive: UPW accounts for 5-15% of the construction cost of a fab, with a single advanced system costing over US$50 million and annual maintenance costing US$3-5 million.

• High energy consumption: UPW generates 3–5 kWh/m³, which is about 10 times that of conventional treatment, accounting for 15–20% of the plant's total energy consumption. This, coupled with carbon reduction commitments, forces the adoption of efficient recycling and green electricity.

• Supply chain localization: Specialty resins and membrane materials are subject to trade restrictions, opening up the window for domestic substitution, but the ramp-up period is long.