Purified Water (PW) Systems for Pharmaceutical Production: USP / Ph. Eur.
Turnkey purified water production, storage and distribution solutions that meet the strict standards (USP, Ph. Eur.) of the pharmaceutical, biotechnology and cosmetics industries.
Purified Water Systems
Purified Water (PW) is a critical raw material in pharmaceutical production: water that passes through dedicated purification stages and is held to defined chemical and microbiological limits. In industries subject to strict regulation, above all pharmaceutical, biotechnology and medical manufacturing, a purified water system must provide stability and fully meet all validation requirements (IQ/OQ/PQ).
Our modern system designs use RO + EDI + UV + UF combinations (reverse osmosis, electrodeionization, ultraviolet and ultrafiltration) to deliver consistent water quality.
System Design Components
Top-level purification steps based on advanced membrane technologies and continuous deionization.
Purification Steps
- RO + EDI combination: Instead of resin-based systems, uninterrupted water production with reverse osmosis and Ionpure CEDI modules that need no chemical regeneration.
- Advanced disinfection: Microbiological control with Nuvonic 254 nm UV disinfection units and TOC reduction with 185 nm UV.
- Ultrafiltration (UF): Final barrier for removal of bacteria and endotoxins.
- WFI production: Water for Injection (WFI) from membrane-based systems, made possible by the Ph. Eur. 9.1 revision.
Storage and Loop Design
- Continuous recirculation: Continuous recirculation to prevent microbial growth, in line with ISPE Baseline Guide Vol. 4.
- Flow dynamics: Turbulent flow (Re > 4000) ensured, with a velocity of at least 1 m/s (velocity ≥1 m/s) throughout the line.
- Hot and cold sanitization: Periodic or continuous hot water (80-85°C) sanitization, or ozone-based sanitization procedures.
- Material standard: 316L stainless steel throughout, with orbital welding to ASME BPE (surface roughness Ra≤0.51µm).
Specifications and Standards
Quality parameters achieved according to international pharmacopoeia monographs.
| Parameter | USP Purified Water | Ph. Eur. 0008 (Purified Water in Bulk) |
|---|---|---|
| Conductivity (@20-25°C) | ≤1.3 µS/cm (25°C Stage 1) | ≤5.1 µS/cm (20°C) |
| Total Organic Carbon (TOC) | ≤500 ppb (or a suitable oxidizable substances test) | ≤500 ppb |
| Microbiological load | ≤100 CFU/mL | ≤100 CFU/mL |
| Heavy metals | - | ≤0.1 ppm |
| Nitrate | - | ≤0.2 ppm |
Industry Applications
Pharmaceutical
Purified water to GMP norms in tablet, syrup and ointment formulations and in API (Active Pharmaceutical Ingredient) production processes, including the final rinse of equipment.
Biotechnology
Critical feed water of high microbiological purity and low TOC for cell culture preparation, buffer solution preparation and laboratory analyses.
Cosmetics and Personal Care
Deionized water production systems with low microbial load for products with high water content such as shampoo, lotion and cream, to preserve shelf life and improve quality.
Frequently Asked Questions about Purified Water Systems
Common questions about the design, standards and validation of purified water (PW) systems.
What is Purified Water (PW) and how does it differ from tap water?
Purified Water (PW) is water that has been taken through dedicated purification steps to bring it down to defined chemical and microbiological limits. According to the USP and Ph. Eur. 0008 monographs, conductivity must be ≤ 1.3 µS/cm (25 °C), TOC ≤ 500 ppb and bacteria ≤ 100 CFU/mL. Tap water is far above these limits.
What is the difference between PW and WFI (Water for Injection)?
The conductivity and TOC limits are the same (≤ 1.3 µS/cm, ≤ 500 ppb). The difference lies in the endotoxin and microbiology limits: WFI must meet endotoxin < 0.25 EU/mL and a bacteria limit of 10 CFU/100 mL. Purified water has no endotoxin requirement and its bacteria limit is 100 CFU/mL.
Which treatment technologies are used in purified water systems?
Modern systems use a combination of RO + EDI + UV + UF (reverse osmosis, electrodeionization, ultraviolet, ultrafiltration). This design allows uninterrupted production with Ionpure CEDI modules, which need no chemical regeneration. Microbiological control is provided by 254 nm UV and TOC reduction by 185 nm UV.
How is a purified water distribution loop designed?
Continuous recirculation is applied in line with ISPE Baseline Guide Vol. 4. The loop is designed for turbulent flow (Re > 4000) and a velocity of at least 1 m/s. 316L stainless steel is used as material, with orbital welding to ASME BPE (surface roughness Ra ≤ 0.51 µm).
How is a purified water system validated?
Validation has three stages: IQ (Installation Qualification) confirms that the installation matches the design; OQ (Operational Qualification) verifies that the equipment operates within its limits; PQ (Performance Qualification) demonstrates system performance through sampling and analysis over several months.
Which industries use purified water systems?
They are used in pharmaceutical production (tablet, syrup and ointment formulation and equipment rinsing), in biotechnology (cell culture and buffer solution preparation) and in cosmetics and personal care products with high water content, such as shampoo, lotion and cream.
Planning a project? Send us your flow rate, feed water source and target water quality to [email protected] — our engineers will reply with a technical proposal.