Pharmaceutical-grade water generation and distribution systems compliant with cGMP, WHO, and USFDA standards
Complete solutions for purified water, highly purified water, and water for injection
Traditional approach combining reverse osmosis with mixed bed ion exchange technology for high-purity water production.
Modern continuous deionization technology using electrodeionization for consistent high-quality water production.
Water for Injection generation through distillation or hot water methods meeting stringent pharmaceutical requirements.
Efficient and compliant water storage and distribution solutions
Continuous circulation loop systems preventing water stagnation and maintaining consistent quality throughout the facility.
Sanitizable hot water distribution maintaining temperatures above 65°C to prevent microbial growth.
SS316L storage vessels with spray ball cleaning systems, vent filters, and level monitoring.
Hygienic sampling valves and diaphragm valves designed for pharmaceutical water applications.
Sanitary centrifugal pumps with mechanical seals and CIP/SIP capability.
Point-of-use UV units for continuous microbial control in distribution loops.
Typical treated-water performance parameters
Conductivity (RO+EDI)
Endotoxin Level (WFI)
Total Organic Carbon
Hot Water Circulation
Versatile solutions for multiple pharmaceutical processes
WFI for sterile product formulation and washing
Purified water for granulation and coating
High-purity water for creams and ointments
Process water for active ingredient synthesis
Reagent-grade water for analytical procedures
CIP/SIP applications in production areas
What Purified Water and WFI must meet under USP and Ph. Eur.
Pharmaceutical water is defined by pharmacopoeial monographs, not by the treatment technology used to make it. A system is designed backwards from these limits, with margin, so that water at every point of use stays within specification between sanitisation cycles.
RO+EDI, RO+Mixed Bed or distillation — how to decide
RO+EDI is the usual first choice for Purified Water in new facilities. Electrodeionisation polishes RO permeate continuously, with no acid or caustic regeneration, which removes chemical handling from the water room and keeps quality stable.
RO+Mixed Bed has a lower capital cost and suits smaller or intermittent demand, but needs periodic regeneration or resin replacement and shows a gradual rise in conductivity as resin exhausts.
For Water for Injection, multi-effect distillation and vapour compression remain the established route. Since April 2017 the European Pharmacopoeia also allows WFI produced by reverse osmosis combined with techniques such as EDI and ultrafiltration — an option that can cut energy use, but which needs a robust sanitisation and monitoring strategy.
The right answer depends on feed water analysis, required capacity and peak draw, the water grades needed, the target markets' pharmacopoeias, and utility costs on site.
Where most microbial problems actually start
A generation system can produce excellent water that is then spoiled in storage and distribution. Good loop design keeps water moving, hot or regularly sanitised, and free of places where biofilm can form.
DQ, IQ, OQ and the three phases of PQ
Pharmaceutical water systems are qualified in stages. Design Qualification confirms the design meets the user requirement specification; Installation Qualification verifies materials, welds, slopes and instruments as installed; Operational Qualification tests alarms, interlocks and sanitisation cycles.
Performance Qualification follows the phased approach described in WHO and FDA guidance: intensive daily sampling for about 2–4 weeks, a further 2–4 weeks confirming consistent operation under SOPs, and one year of routine monitoring to capture seasonal changes in feed water. Systems are supplied with the DQ/IQ/OQ/PQ documentation needed to support this, aligned with WHO good practices for pharmaceutical water and India's revised Schedule M.
Common questions on specifications, technology and validation
Under USP <645> stage 1, Purified Water and Water for Injection must have a conductivity of no more than 1.3 µS/cm at 25 °C. Well-designed RO+EDI systems typically produce water well below that limit.
Total Organic Carbon (TOC) for Purified Water and WFI must not exceed 500 ppb (0.5 mg/L) under USP <643> and the equivalent Ph. Eur. test.
Yes. USP has long allowed WFI to be produced by distillation or an equivalent purification process, and since April 2017 the European Pharmacopoeia also permits WFI produced by reverse osmosis combined with other suitable techniques such as EDI and ultrafiltration, subject to appropriate controls.
RO+EDI is usually preferred for new pharmaceutical systems: it runs continuously without acid and caustic regeneration and gives stable water quality. RO+Mixed Bed has a lower capital cost and suits smaller or intermittent demand, but needs periodic chemical regeneration or resin replacement.
Performance qualification is normally done in three phases: about 2–4 weeks of intensive daily sampling (phase 1), a further 2–4 weeks confirming consistent operation under SOPs (phase 2), and one year of routine monitoring to capture seasonal variation in feed water (phase 3).
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