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cGMP Engineering

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PW System
WFI System
Loop Piping
Cleaning & Passivation

PW System

Ecell Purified Water System for Pharmaceutical Use delivers the highest level of water quality and full GMP compliance, providing a stable and hygienic purified water supply that meets the stringent quality standards of the pharmaceutical and biopharmaceutical industries.

Applications

Pharmaceutical manufacturing (APIs and finished pharmaceutical products)
Biopharmaceutical production facilities
Cosmetics, food, and testing laboratories

Production

GMP & cGMP-Compliant Design – Hygienic design in accordance with European, US, and Korean GMP standards; all welds are orbital-welded and passivated.
High-Efficiency Purification Process – Integrated pre-treatment, RO, and EDI system achieves low energy consumption and high recovery rates.
Fully Hygienic Design – 316L stainless steel and EP piping; 70–80°C hot water circulation to inhibit microbial growth; includes automated CIP/SIP cleaning system.
Smart Control System – PLC-based automatic control and HMI monitoring allow real-time tracking of conductivity, TOC, temperature, and flow rate.
Custom Engineering Services – Tailored design to match production capacity, quality standards, and process requirements; provides one-stop service from installation to validation.

WFI System

Ecell Pharmaceutical WFI (Water for Injection) System meets the strict standards for injectable water and pharmaceutical quality requirements. Utilizing advanced purification technologies and hygienic design, it provides a reliable and cost-effective production of WFI. The system fully complies with domestic and international GMP, EP, USP, and KP standards, delivering uncompromised water quality for pharmaceutical and biopharmaceutical production facilities.

Applications

Production of injectables, infusion solutions, vaccines, and biopharmaceuticals
Sterile cleaning water and water for culture media preparation
High-purity water for cosmetics and laboratory research

Production

Full Compliance with International Standards – Meets EP, USP, KP, JP, and other pharmacopoeia standards; designed and documented to comply with GMP, cGMP, and PIC/S requirements.
Advanced Production Technology – Options include RO + EDI + UF or 2-Pass RO + Distillation, Multi-Effect Distiller, or Vapor Compression systems, maximizing energy efficiency while maintaining stable water quality.
Ultra-Hygienic Design – 316L electropolished (EP) piping with orbital welding, minimized dead legs, 1/100 slope design, and 80–85°C circulation loops to prevent microbial growth.
Fully Automated Control System – PLC + HMI-based automatic control with real-time data logging, monitoring TOC, conductivity, temperature, pressure, and flow; supports remote control and alarm systems.
Validation and Documentation Support – Complete IQ/OQ/PQ validation documentation; full support for FAT/SAT and qualification processes.

Loop Piping

Ecell Pharmaceutical Utility Piping Systems, designed for cleanliness and safety, provide fully hygienic design and validation for WFI, PW, and Clean Steam, implementing GMP-compliant solutions. From high-purity piping design to construction and validation, these systems deliver a complete solution to enhance reliability in pharmaceutical processes.

Applications

WFI, PW, and Clean Steam piping systems
Pharmaceutical and biopharmaceutical hygienic processes
Sterile processes and CIP/SIP systems
Single-use piping connections

Production

GMP-compliant design and construction
High-purity piping design with customized fabrication
Validation support
Turnkey service including installation, testing, and commissioning

Cleaning & Passivation

Ecell Cleaning & Passivation for Specialized Pharmaceutical & Biopharmaceutical GMP Facilities delivers “Perfect Cleaning, Complete Protection.” Compliant with GMP standards, it ensures the cleanliness and corrosion resistance of piping and tank systems, removes even microscopic surface contaminants, and enhances the durability and reliability of high-purity systems.

Applications

Pharmaceutical & biopharmaceutical GMP piping and tank systems
High-purity fluid processes and hygienic facilities
Sterile processes and CIP/SIP lines
Any equipment where surface cleanliness and corrosion resistance are critical

Production

Achieves “Perfect Cleaning, Complete Protection”
GMP-compliant with validation support
Removes microscopic surface contaminants to enhance high-purity system reliability
Improves piping and tank durability and corrosion resistance