iopharmaceutical Ultrapure Water System | GMP EDI Purified Water Equipment

Biopharmaceutical

Purified Water Equipment Technical Parameters
Parameter			Specification
Product Name			Purified Water Equipment
Water Production Capacity			0.25T/H – 100T/H
Equipment Material			SUS304 / SUS316 Stainless Steel
Produced Water Quality			Conductivity ≤ 2 μS/cm
Operating Temperature			0 – 45°C
Operating Pressure			0.1 – 0.6 MPa
pH Range			1 – 11
Microorganism & Bacteria Removal Rate			99.90%
Suspended Solids Removal Rate			99.50%

Zhongnuo Water Treatment provides cGMP and FDA compliant pharmaceutical-grade ultrapure water and WFI (Water for Injection) systems for the biopharmaceutical industry. Widely used in biopharmaceuticals, vaccine production, antibody drugs, genetic engineering, cell culture, diagnostic reagents and other high-end fields, meeting the extreme water quality requirements of biopharmaceutical manufacturing.

Adopting full-process treatment technology of double-pass RO + EDI continuous electrodeionization + terminal ultrafiltration, with full system SUS316L hygienic stainless steel material, fully automatic PLC control and online monitoring, ensuring produced water resistivity up to 18.2MΩ·cm, pyrogen, endotoxin and microorganisms fully compliant, with complete GMP validation document package.

Advantages of Medical Industry Applications

✅ Regulatory Compliance: Fully compliant with cGMP, FDA, USP, EP, ChP pharmaceutical standards

✅ Hygienic Design: SUS304/316L electropolished, automatic welding, no dead legs

✅ Online Monitoring: Real-time monitoring of resistivity, TOC, endotoxin, microorganisms

✅ Sterilization System: Pure steam sterilization + pasteurization ensures system sterility

✅ Complete Validation: Full DQ/IQ/OQ/PQ GMP validation documents and services

✅ Data Traceability: 21 CFR Part 11 compliant for electronic records and signatures

✅ Redundant Design: Dual water supply system ensures 7×24 continuous production

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