Industry Standards
Europe & Americas Standards:United States: United States Pharmacopeia (USP-NF 2025)
Southeast Asia Standards:United States Pharmacopeia(USP-NF 2025),European Pharmacopoeia (EP 12.0),Japanese Pharmacopoeia (JP 18),Indonesia: Indonesian Pharmacopoeia 2020
European Union: European Pharmacopoeia (EP 12.0)
Middle East Standards:United States Pharmacopeia (USP-NF 2025),
European Pharmacopoeia (EP 12.0)
Africa Standards:International Pharmacopoeia 2025
Basic Parameters
Design Features
Separation Device: Utilizes special cyclone separation technology (patented)
Performance Features: Utilizes automatic working pressure stabilization control and automatic condenser heat load control for feed water
Steam Regulation: The steam valve automatically adjusts the industrial steam pressure to regulate the pressure of the required pure steam for production.
Material Selection: The main components of the entire unit are constructed from 316L stainless steel, the frame is fabricated by welding 304 stainless steel square tubes, and the sealing materials include polytetrafluoroethylene (PTFE) and other compatible materials.
Tube Sheet Design: The preheater, condenser, and evaporator are all equipped with a double tube sheet design, effectively preventing cross-contamination.
Welding Process: The welding is performed using automatic TIG welding machines, followed by endoscope inspection to ensure weld quality.
No dead ends or blind pipes, branch pipes comply with the 3D principle, and dead-end-free valves are adopted.
Control Unit: Utilizes PLC for data acquisition and touch screen for operation, with remote monitoring functionality available.
Pharmacopoeial Specifications and Vaughan Standards for Water for Injection (WFI)
Parameter | Unit | Chinese Pharmacopoeia | USP-NF (U.S. Pharmacopoeia) | EP (European Pharmacopoeia) | Vaughan Specification |
Conductivity | us/cm | <1.1@20℃ | <1.3@20℃ | <1.1@20℃ | <0.5@20℃ |
TOC | ppb | <500 | <500 | <500 | <500 |
Microorganisms | cfu/100mi | <10 | <10 | <10 | <10 |
Endotoxin | EU/ml | <0.25 | <0.25 | <0.25 | <0.01 |
Product Parameters
Model Number | Water Output (L/H) | Steam Consumption (Kg/H) | Raw Water Consumption (L/H) | Steam Pressure (Mpa) | Power (KW) | Equipment Dimensions (L×W×H) |
WD200-3S | >200 | <75 | <260 | 0.25-0.4 | 0.55 | 1100x900x1800 |
WD500-5S | >500 | <135 | <575 | 0.25-0.4 | 0.75 | 1850x1100x2200 |
WD500-6S | >500 | <135 | <575 | 0.25-0.4 | 0.75 | 2000x1000x3100 |
WD1000-6S | ≥1000 | <230 | <1150 | 0.25-0.4 | 17 | 2830x1000x3380 |
WD2000-6S | ≥2000 | <540 | <2300 | 0.25-0.4 | 1.5 | 3610x1200x3630 |
WD2000-6S | >2000 | <460 | <2300 | 0.25-0.4 | 1.5 | 3610x1200x3630 |
WD3000-6S | ≥3000 | <690 | <3450 | 0.25-0.4 | 2.2 | 4058x1025x3700 |
WD4000-6S | ≥4000 | <920 | <4600 | 0.25-0.4 | 3.0 | 4300x1400x3800 |
WD5000-6S | ≥5000 | <1150 | <5750 | 0.25-0.4 | 3.5 | 4500x1500x3800 |
WD6000-6S | >6000 | <1380 | <6900 | 0.25-0.4 | 5.0 | 4910x1550x3800 |
Price：As it is a non-standard product, the price needs to be quoted based on specific requirements.