Basic Information
Certification
CE, GMP, ISO
Control System
Fully Automatic
Treatment Process
Reverse Osmosis, EDI, Ultrafiltration, Ozonation
Type
Pharmaceutical Water Treatment Equipment
Production Capacity
30 Per Year
Product Description
Compliance: Follow up international standard European pharmacopoeia EP, US pharmacopoeia USP etc, comply with WHO GMP, EU cGMP, US FDA regulations.
Pharmaceutical Water Production & Storage System
The Purified water plant is composed of Reverse-Osmosis system (RO) with pre-treatment filtering system. The main RO system is from USA. Pipelines from RO system to user points are stainless steel sanitary level in accordance with cGMP regulations.
Technical Process: Raw water tank → Source water pump → Mechanical Sand Filter → Active Carbon Filter → Fine filter → High-pressure Pump → 1 or 2 RO System → CIP Unit
Optional Systems
- Electro De-ION (EDI): Continuous production, stable quality, no acid/alkali chemicals needed. Conductivity < 1.3uS/cm.
- Ultra-Filtering System (UF): Advanced membrane separation to remove impurities by physical interception.
- Multi-Column Distill Water Plant: For WFI (Water for Injection) production, endotoxin content ≤0.25 EU/ml.
Pure Steam Generator (PSG)
Uses industrial steam or electrical heating to generate pure steam. Suitable for SIP (Sterilization In Place) of mixing tanks, pipelines, and user points.
Frequently Asked Questions (FAQ)
Q1: Which international standards does the water system comply with?
The system follows EP, USP standards and complies with WHO GMP, EU cGMP, and US FDA regulations.
Q2: What is the benefit of using an EDI system?
EDI provides continuous production of stable high-quality water without the need for acid or alkali chemicals, making it environmentally friendly and cost-effective.
Q3: What is the quality standard for the produced WFI?
The Water for Injection (WFI) meets USP and EU regulations, with endotoxin content ≤0.25 EU/ml and conductivity ≤1 us/cm at 20ºC.
Q4: What capacity ranges are available for the RO systems?
We offer capacities ranging from 0.5 T/h up to 30 T/h to suit various pharmaceutical production scales.
Q5: Can the control system be automated?
Yes, the system features a fully automatic control system utilizing Siemens PLC and Touch Screen interfaces with online conductivity monitoring.
Q6: What materials are used for the distribution pipelines?
All pipelines from the treatment system to user points are constructed from sanitary-level stainless steel in accordance with strict cGMP guidelines.
Fintrace Window
