GMP Purified Water Systems for Pharma & Biotech — USP <1231>, EP and ChP 2020 Compliant
Softening → RO → EDI → 254 nm UV → 316L sanitary storage and distribution loop, built to GAMP 5 and delivered with a full validation package. Capacities from 0.5 t/h for R&D to 100 t/h for multi-line API and formulation plants.
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Why a Purified Water System Is a Validation Project, Not a Purchase Order
In a GMP plant, water is an excipient. When a PW loop fails an audit, the cost is the batch record, the deviation report, and the release date. We engineer and document to USP 39 <1231>, Ph. Eur. (EP) and Chinese Pharmacopoeia (ChP) 2020, every design decision traceable to those monographs or to ISPE GAMP 5.
| What you test | Pharmacopoeia limit (PW) | What we design to |
|---|---|---|
| Conductivity | ≤ 1.3 µS/cm @ 25 °C (USP Stage 1) | ≤ 1.0 µS/cm @ 25 °C at point-of-use |
| TOC | ≤ 500 ppb | ≤ 300 ppb (online monitored) |
| Microbial | ≤ 100 CFU/mL | ≤ 50 CFU/mL with sanitisation cycle |
| Endotoxin | Not required for PW | Monitored on request for WFI-ready designs |
Our Standard Purified Water Process Train
| Stage | Equipment | Function | Key spec |
|---|---|---|---|
| ① Pretreatment | MMF + AC + Softener | Remove chlorine, organics, hardness | SDI < 4, Cl₂ < 0.1 ppm |
| ③ RO | DOW™ BW30-400 | Remove 95–99% dissolved ions | Recovery 70–80% |
| ④ EDI | Veolia / Suez / QKH-EDI | Continuous deionisation, no acid/caustic | ≥ 5 MΩ·cm, ≤ 0.2 µS/cm |
| ⑤ UV (254 nm) | Medium-pressure UV | Microbial control | Dose ≥ 30 mJ/cm² |
| ⑦ PW tank | 316L SS, electropolished | Hold PW without re-contamination | Ra ≤ 0.8 µm |
| ⑧ Loop | 316L orbital-welded | Deliver PW to every point-of-use | 1.0–2.0 m/s, dead-leg L/D ≤ 3 |
Sanitisation is your call: hot (≥ 80 °C), ozone, or ambient + periodic chemical.
Materials We Use
| Wetted part | Material | Surface finish |
|---|---|---|
| Distribution piping | 316L SS, orbital welds | Ra ≤ 0.8 µm (EP on request) |
| Valves | Sanitary diaphragm, EPDM/PTFE | 3.1 cert + FDA elastomer |
| Tanks | 316L SS | Ra ≤ 0.8 µm, 100% drainable |
| Gaskets | EPDM / PTFE / Viton | FDA 21 CFR 177 |
Standard PW Size Classes
| Size | Output | Power | Typical application |
|---|---|---|---|
| PW-0.5T | 0.5 t/h | 5 kW | R&D, QC lab |
| PW-2T | 2 t/h | 14 kW | Small biotech |
| PW-5T | 5 t/h | 28 kW | Oral solid dose |
| PW-10T | 10 t/h | 55 kW | API synthesis |
| PW-20T | 20 t/h | 100 kW | Large API |
| PW-50T | 50 t/h | 230 kW | Pharma park |
| PW-100T | Custom | Custom | Campus-scale |
Engineering Reference — 10 t/h Purified Water for an Oral Solid Dose Plant
| Parameter | Design value |
|---|---|
| Feed | Municipal potable, TDS ≈ 180 ppm |
| PW demand | 10 t/h avg, 1.5× peak |
| Loop | 1.2–1.8 m/s, ≥ 3× turnover/h, 12 points-of-use |
| PW quality | ≤ 1.0 µS/cm, TOC ≤ 300 ppb, microbial ≤ 50 CFU/mL |
| RO / EDI | Single-pass RO 75% recovery; EDI 10 t/h ≥ 5 MΩ·cm |
| Storage / Loop | 10 m³ 316L tank; orbital-welded 316L, Ra ≤ 0.8 µm |
| Validation | DQ+FAT+SAT+IQ/OQ+3-phase PQ; USP <1231>, ChP 2020, GAMP 5 |
| Delivery | 16–20 weeks from PO |
5 Pitfalls We Design Around
- Microbial excursions in an ambient loop — we size ≥ 1.0 m/s and build an automated sanitisation cycle in from day one.
- Dead leg L/D > 3 — zero dead-leg valve bodies on critical drops; every take-off drawn on the P&ID with L/D calculated.
- Rouging in hot 316L loops — 316L, electropolish, passivate to ASTM A967, documented temperature band.
- TOC drift after carbon exhaustion — duplex AC, monitor ΔTOC, scheduled replacement in the O&M manual.
- Validation docs delivered after the machine — DQ and IQ/OQ issued during fabrication for your QA to approve before FAT.
Standards We Design and Document To
- USP 39 <1231> — Purified Water
- Ph. Eur. (EP) — Purified Water monograph
- ChP 2020 — 纯化水 monograph
- FDA 21 CFR 211 / Part 11 — cGMP / electronic records
- ISPE GAMP 5 & Baseline Vol. 4
- ASTM A967, EN 10204 3.1, ISO 9001 / 14001 / 45001
Frequently Asked Questions
Q1. Can your system hold USP <1231> conductivity and TOC limits?
Yes. We design to ≤ 1.0 µS/cm @ 25 °C and ≤ 300 ppb TOC at point-of-use — inside the USP limits, verified during OQ and across the three PQ phases.
Q2. Do you supply IQ/OQ/PQ protocols?
Yes, in English: DQ, FAT, SAT, IQ, OQ with alarm/interlock tests, 3-phase PQ, weld logs, passivation report, 3.1 material certificates.
Q3. Hot loop or ambient loop — which do you recommend?
Hot loops (≥ 80 °C) give the lowest microbial risk for injectables and biologics. Ambient + ozone suits sites where steam is expensive.
Q4. Can you make Water for Injection (WFI)?
PW is our standard scope. WFI is a separate monograph: EP permits membrane-based (RO+EDI+UF), USP requires distillation. We confirm in writing before quotation.
Q5. How do you handle data integrity and 21 CFR Part 11?
Role-based access with unique IDs, non-editable audit trail, secure electronic records with tested backup/restore, calibration certificates.
Q6. What is the warranty?
12 months on the complete system plus 36 months on critical parts (RO membranes, EDI stacks, UV lamps). On-site labour and travel included in the first 12 months.
Q7. Do you stock consumables and spares for international customers?
Yes — a 2-year consumables forecast for every system; standard spares stocked in our Shenzhen warehouse for 7-day international dispatch.
Q8. Can our QA team attend the FAT?
Yes — customer FATs at our Shenzhen facility, or remote video FAT if travel is constrained.
Related Equipment & Industries
PW-1500 — GMP Purified Water · RO-4000 — Reverse Osmosis · UF-2000 — Ultrafiltration · DI-1000 — Deionized Water · WFI-1000 — Water for Injection
Semiconductor & Electronics (UPW) · Food & Beverage · Laboratory & Analytical
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Request a PW Sizing Sheet Talk to a pharma engineerTechnical content reviewed by Ella Liu, Industrial Water Treatment Specialist at Rong Water — 10+ years sizing RO, EDI and GMP purified water systems for pharmaceutical clients.