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Pharmaceutical Grade Distillation Unit for Water for Injection (WFI) With 316L Stainless Steel and Sanitary Design
Product Spotlights
Pharmaceutical-grade WFI distillation unit crafted from 316L stainless steel with sanitary design, achieving conductivity ≤1.0 µS/cm and endotoxins ≤0.12 EU/mL. Energy-efficient vapor compression technology reduces steam consumption by 40%. Intelligent PLC control with HMI; customizable capacities 50–1000 L/h. Backed by ISO9001 & cGMP compliance and a 10,000–30,000 m² manufacturing facility with over 200 experienced employees.
US$ 6450 - 954000
MOQ: 2 Combos
Key Specifications
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Application:
Other, Pharmaceutical Water for Injection (WFI)
Certification:
ISO9001, Other, ISO14000
material:
316L Stainless Steel
Payment & Shipping
Payment Methods:
Port of Shipment:
Qingdao
Delivery Detail:
60 days
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Application
Other, Pharmaceutical Water for Injection (WFI)
Certification
ISO9001, Other, ISO14000
material
316L Stainless Steel
design
Sanitary Design, cGMP Compliant
capacity
50-1000 L/h (customizable)
power supply
380V/50Hz or customized
control system
PLC with HMI touchscreen
distillation method
Vapor Compression or Multiple Effect (optional)
Welcome to Qingdao Conqinphi Environmental Technology Group Co., Ltd. — a professional manufacturer established in 2015 with a factory spanning 10,000–30,000 square meters and over 200 skilled employees. We specialize in designing and producing Pharmaceutical Grade Distillation Units for Water for Injection (WFI) that meet the highest industry standards. Our unit is constructed from premium 316L stainless steel with a sanitary design, ensuring exceptional purity and reliability for injectable water production. With annual exports exceeding US$10–50 million and shipments to markets worldwide, including North America, Europe, and Asia, we bring proven expertise and global compliance to every project.
Key Features & Technical Specifications
- 316L Stainless Steel Construction: All wetted parts are made of AISI 316L stainless steel, offering outstanding corrosion resistance and compatibility with WFI production. Electropolished surfaces (Ra ≤ 0.5 μm) prevent bacterial adhesion.
- Sanitary Design: Complete with clamp connections, no dead legs, and automatic draining for CIP/SIP. Designed according to cGMP, ASME BPE, and sanitary standards.
- High-Purity Output: Produces water with conductivity ≤ 1.3 µS/cm (at 25°C) and endotoxins ≤ 0.25 EU/mL, meeting USP & EP pharmacopoeia requirements.
- Energy-Efficient Operation: Utilizing a vapor compression distillation method (or multi-effect option), the system recovers latent heat, reducing steam consumption by up to 40% compared to traditional units.
- Intelligent Control: PLC-based automation with HMI touchscreen enables real-time monitoring of temperature, pressure, flow rate, and conductivity. Adjustable parameters for different batch sizes.
- Compact Footprint & Easy Maintenance: Modular design allows for flexible installation in cleanrooms. Quick-access ports for inspection and cleaning reduce downtime.
| Parameter | Specification |
|---|---|
| Distillation Capacity | 50 – 1000 L/h (customizable) |
| Product Water Conductivity | ≤ 1.0 µS/cm (at 25°C) typical |
| Endotoxin Level | ≤ 0.12 EU/mL |
| Total Organic Carbon (TOC) | ≤ 50 ppb |
| Operating Pressure | 0.3 – 0.6 MPa (steam side) |
| Material Surface Finish | Ra ≤ 0.5 μm (contact parts) |
Customer Benefits
- Regulatory Confidence: Our unit is designed to comply with global pharmacopoeia (USP, EP, JP) and cGMP guidelines. The 316L sanitary construction simplifies validation and audit processes.
- Cost Savings: Lower steam consumption and minimized maintenance intervals reduce total cost of ownership. Energy recovery technology cuts operational expenses by 20–30%.
- Uninterrupted Production: Redundant safety features (low/high pressure alarms, auto-shutdown) ensure continuous operation with minimal manual intervention.
- Future-Proof: Modular design allows capacity expansion or integration with existing purified water (PW) and clean steam systems. Customizable control interfaces support OEM requirements.
At Qingdao Conqinphi, we have delivered over 300 distillation units to pharmaceutical facilities worldwide. Our factory is ISO9001, ISO14000, HACCP, OHSAS18001 certified, and we hold multiple other quality management certifications (including TS16969 and SA8000). With a dedicated team of 201–300 personnel and a 10,000–30,000 m² production base, every unit undergoes rigorous testing — from hydrostatic pressure checks to in-process conductivity validation — before shipment from Qingdao port. We also provide comprehensive documentation (IQ/OQ/PQ protocols) and on-site commissioning support.
Experience the difference of true Pharmaceutical Grade Distillation. Contact us today for a tailored quotation or to schedule a factory visit. Let us help you achieve flawless WFI production with our proven 316L sanitary design.
Frequently Asked Questions (FAQ)
-
Q: Why is 316L stainless steel preferred for WFI distillation?
A: 316L has lower carbon content and molybdenum addition, providing superior resistance to chloride stress corrosion and pitting. Its low carbon content minimizes carbide precipitation during welding, maintaining sanitary surfaces. -
Q: What capacity options are available?
A: Standard capacities range from 50 L/h to 1000 L/h. Custom designs for higher outputs (up to 5000 L/h) can be engineered upon request based on your feed water quality and production demand. -
Q: Does the unit require special installation conditions?
A: The system is designed for cleanroom installation. Requirements include a stable steam supply (0.4–0.6 MPa), cooling water (optional), and a pharmaceutical-grade feed water (purified water or RO permeate). Electrical power: 380V/50Hz three-phase (other voltages available). -
Q: How often does preventive maintenance need to be performed?
A: Routine maintenance every 3–6 months includes cleaning the evaporator tubes, replacing sanitary gaskets, and checking sensors. With proper operation, major overhauls are required every 2–3 years. A maintenance manual is provided. -
Q: What quality control tests are performed before shipment?
A: Each unit undergoes hydrostatic testing, conductivity verification, endotoxin challenge tests, and a 24-hour continuous run test. A performance report and validation documents are included. -
Q: Can the distillation unit be integrated with a CIP/SIP system?
A: Yes, the sanitary design includes automated spray balls and drain ports for Clean-in-Place (CIP) and Steam-in-Place (SIP). The control system can be programmed for automatic cleaning cycles. -
Q: Are spare parts available for quick replacement?
A: We stock common spare parts (gaskets, valves, sensors, heating elements) in our Qingdao warehouse. Express shipping to major ports is available. A recommended spare parts list is provided with each unit. -
Q: Does Conqinphi provide installation and training services?
A: Yes. We offer on-site installation supervision, commissioning, and operator training. Remote technical support is available 24/7. Our after-sales service team is fluent in English and Chinese.
Send Inquiry to This Supplier
Miss scarlet
Sales
1Yr
Qingdao, Shandong, China
1Yr
Business Type
Manufacturer
Year Established
2015
Factory Size
10,000-30,000 square meters
Annual Export Value
US$10 Million - US$50 Million
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