Water quality in healthcare and pharmaceuticals
In this sector, water is not an auxiliary substance but a direct element of product and patient safety. ISO 23500 / AAMI for dialysis water, EN 285 for sterilisation steam, and the European Pharmacopoeia (Ph. Eur.) "Purified Water" and "Water for Injections" monographs for pharmaceutical production define conductivity, TOC and microbiological limits. Systems must not only be installed correctly but also be verifiable (IQ/OQ/PQ) and traceable.
Typical requirements
| Use | Quality target | Typical stages |
|---|---|---|
| Haemodialysis | Conductivity < 10 µS/cm, endotoxin < 0.25 EU/mL | Softening + carbon + double-pass RO + UV, loop line |
| Sterilisation (autoclave feed water) | Conductivity < 15 µS/cm (EN 285) | Softening + RO |
| Purified water (PW) – pharmaceuticals, cosmetics | Conductivity ≤ 4.3 µS/cm @20 °C, TOC ≤ 500 ppb, < 100 CFU/mL | Pretreatment + RO + EDI + UV, recirculating storage |
| Laboratory, instrument feed | Type II / Type III water | RO + deionisation cartridge |
| General use (kitchen, laundry, boiler) | Scale-free, disinfected | Multimedia + softening + UV |
Design principles
- No dead legs: recirculating loop line, sanitary connections, the 6D rule.
- Redundancy: interruptions are unacceptable in dialysis and production; duplex softener, standby pump, bypass.
- Monitoring: continuous conductivity/TOC measurement, alarms and data logging.
- Sanitisation: membranes and piping suitable for chemical or hot water sanitisation.
- Documentation: P&ID, material certificates, validation protocols.
How do we proceed?
- Preparing the user requirement specification (URS) together.
- Raw water analysis and capacity calculation; designing the pretreatment around the raw water.
- Installation, commissioning, IQ/OQ support and periodic validation measurements.
