Product Description
The Reverse Osmosis + Electrodeionization (RO + EDI) system is designed to produce pharmaceutical-grade water. It includes a complete pretreatment section followed by primary purification stages, with a Reverse Osmosis (RO) unit upstream of the final Electrodeionization (EDI) module.
The ELETTRACQUA RO + EDI system is designed to produce both non-compendial and compendial Purified Water (PW) that complies with the requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).
ELETTRACQUA Reverse Osmosis and Electrodeionization systems have been successfully validated and implemented in pharmaceutical facilities worldwide.
Highly Purified Water (HPW), as defined by the European Pharmacopoeia, must meet the same microbiological specifications as Water for Injection (WFI), including a microbial limit of 10 CFU/100 mL and an endotoxin limit of 0.25 EU/mL.
ELETTRACQUA's double-pass RO + EDI configuration can be engineered to meet the European Pharmacopoeia requirements for Highly Purified Water (HPW). ELETTRACQUA Purified Water (PW) Systems are designed and manufactured in full compliance with current cGMP requirements.
Main Features and Benefits
- Frame: AISI 304 stainless steel
- Piping & Fittings: AISI 316L stainless steel, ASME BPE SF1 finish
- Internal Surface Finish: Ra < 0.51 μm
- Gaskets: FDA-compliant PTFE
- Welding: Orbital welding is performed whenever possible. Where orbital welding is not feasible, manual welds are completed by ELETTRACQUA-certified welders in accordance with ASME Section IX and EN ISO 15614-1
- Connections: Tri-Clamp® sanitary connections
- Membrane Housings: AISI 316L stainless steel
- Valves: AISI 316L stainless steel
- PLC/HMI-based automation
- Compliance with GAMP 5 guidelines
- Optional 21 CFR Part 11 compliance
- Compatibility with all major PLC manufacturers
- Alternative PC-based SCADA architecture available upon request
