Shenzhen HongJie Water Technology Co., Ltd.
One-stop Water Treatment Solution Expert
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I. Overview
Deionized water (DI water) equipment plays a central role in the raw water pretreatment stage of preparing water for injection (WFI), and its quality directly determines whether the final WFI meets the stringent standards of national pharmacopoeias.
The irreplaceable role of DI water in WFI preparation: The irreplaceable role of DI water in WFI preparation, economic barriers, the cornerstone of sterility assurance, and the core of green transformation.
System selection principles:
Choose CEDI-type DI water equipment (no chemical regeneration) + 316L stainless steel high-temperature circulation system + online TOC/conductivity monitoring, and reserve an inlet interface for the distillation unit to meet FDA/EMA dynamic production review requirements
II.Main Process
Raw Water→Pretreatment→RO Reverse Osmosis→CEDI →PW Storage Tank→Distillation/Pure Steam→WFI
III.DI Water Equipment Core Section (PW Preparation)
| Step | Measures | Parameters | |||||
| Enhanced Pretreatment | Ultrafiltration (UF, 0.03 μm): Remove colloids/microorganisms | SDI < 3; TOC < 50 ppb; Hardness < 1 ppm | |||||
| Activated carbon: Adsorb organics | |||||||
| Softener: Prevent scaling | |||||||
| Dual Desalination | Primary/Secondary RO: Desalination rate > 99% | Produced water conductivity < 5 μS/cm; Resistivity 5–18 MΩ·cm | |||||
| CEDI: Deionization | |||||||
| Microorganism Control | 254 nm UV disinfection | Microorganisms < 10 CFU/mL | |||||
| Storage tank: Heat preservation circulation (>80°C) | |||||||
IV.DI Water System Critical Process Points (CPP)
| Risk Point | Control Measures | Pharmacopoeia Compliance Basis | |||||
| Microbial Growth | Storage tank/pipeline > 80℃ circulation + Ozone disinfection | USP <1231>: High - temperature or sterile filtration recommended | |||||
| TOC Exceedance | RO membrane + CEDI + Activated carbon three - stage interception | EP 9.0: TOC detection is mandatory | |||||
| Endotoxin Source | UF ultrafiltration (Retention of substances > 10 kDa) | ChP 2020: Endotoxin only tested for final products | |||||
| Resistivity Fluctuation | Online conductivity meter + Automatic drain valve | GMP: Real - time monitoring of key parameters | |||||
V.Here is a guideline for you to get a proper quotation
Tell us the raw water/source of water(tap water, well water, or sea water, etc)
Provide water analysis report(TDS , conductivity, or resistivity, etc)
Required production capacity( 5m³/H, 50m³/H,or 500m³/H, etc)
What's the pure water used for( industrial,Food and Beverage,or agriculture, etc )