Achieving Ultrapure Water Standards for Pharmaceutical Manufacturing with FEDI® Rx Fractional Electrodeionization
| Challenge: | A pharmaceutical company required a treatment system capable of producing ultrapure water, meeting strict conductivity, TOC, and silica requirements, while treating high-fluoride, hard source water to comply with Mexican and U.S. regulations. |
| Solution: | The system integrates pretreatment, ultrafiltration, and a two-pass RO system with QUA's FEDI® Rx, chosen for its consistent delivery of ultra high purity water under demanding conditions. |
| Result: | The ultrapure water treatment system has been validated by authorities, with the FEDI® Rx exceeding quality requirements for over two years, consistently delivering water with conductivity <0.1 µS/cm. |
This case study details why QUA's FEDI® Rx technology is ideal for pharmaceutical companies seeking to produce ultrapure water production, as it consistently delivers high purity, meets stringent quality standards, and withstands rigorous operational conditions, including high-temperature sanitization.
QUA's FEDI® Rx Fractional Electrodionization
QUA's FEDI® Rx Fractional Electrodionization
Challenge
A rapidly expanding pharmaceutical company in Guadalajara, Mexico, required a new manufacturing facility to produce various medication. The facility needed to be able to produce water with a conductivity (CE) of <1 µS/cm, total organic carbon (TOC) under 0.1 ppb, and silica concentrations below 1 ppm.
The source water contained high levels of fluoride and hardness, requiring treatment to comply with Mexican and U.S. quality regulations. The facility’s water treatment equipment had to meet stringent standards and pass internal validation processes while also being able to withstand weekly sanitization with hot water at 85°C (185°F).
Solution
To address these challenges, the process includes pretreatment, followed by ultrafiltration (UF) and a two-pass reverse osmosis (RO) system, which is then paired with QUA’s FEDI® Rx pharmaceutical-grade fractional electrodeionization system to produce a continuous flow of 0.5 m3/hr of high-quality water.
QUA's FEDI® Rx was chosen for its ability to consistently deliver ultrapure water up to 18 M?cm using a patented process with double sets of electrodes per stack while maintaining the system's efficiency and integrity under rigorous operating conditions. The equipment was designed to remain operational continuously, preventing water stagnation and ensuring consistent water quality.
Result
The facility, including the water treatment system, has successfully passed all necessary validations and has been approved by the Mexican regulations to produce pharmaceuticals.
For over two years in operation, the FEDI® Rx system has consistently delivered water that exceeds the facility's quality requirements, with no reported issues. The produced water quality is higher than initially expected, meeting and surpassing the required CE, TOC, and silica levels with a conductivity of <0.1 µS/cm.