
BlueBox designs and manufactures advanced RO systems engineered to meet the stringent water quality and regulatory requirements of the pharmaceutical, biotechnology, and food & beverage industries. Our systems are built to support compliance with USP (United States Pharmacopeia), WHO, and GMP guidelines, ensuring water purity suitable for critical process, formulation, cleaning, and utility applications.
Each system incorporates validated automation, continuous conductivity and TOC monitoring, controlled sanitization cycles, and documented performance logging to maintain consistent water quality and regulatory traceability. Intelligent control logic ensures stable operating conditions, while automated flushing and membrane protection prevent fouling and microbial growth.
Designed for integration with PW, HPW, and pre-treatment loops, BlueBox RO systems support hygienic design principles, material compatibility, and data integrity requirements. With 24×7 monitoring, alarm management, and audit-ready reports, our solutions reduce compliance risk, simplify validation, and deliver reliable, regulation-ready water—day after day.
Compliance Area |
Requirement |
BlueBox RO System Compliance |
|---|---|---|
Regulatory Standards |
USP, WHO, FDA, EU-GMP alignment |
System design and operation aligned with USP, WHO, FDA, and EU-GMP guidelines |
Water Quality Monitoring |
Continuous conductivity monitoring |
Online conductivity sensors with real-time display, alarms, and logging |
Data Integrity |
21 CFR Part 11 readiness |
Time-stamped data logs, audit trails, secure access, and report generation |
Automation & Control |
Controlled and validated operation |
PLC-based automation with predefined operating limits and interlocks |
Alarm Management |
Deviation and fault alerts |
Configurable alarms with event logging and notification |
Sanitization & Microbial Control |
Controlled sanitization cycles |
Automated flushing and sanitization sequences to prevent microbial growth |
Material Compatibility |
Hygienic and pharmaceutical-grade materials |
Compatible wetted parts suitable for PW/HPW applications |
System Integration |
PW / HPW loop compatibility |
Seamless integration with purified water distribution systems |
Documentation |
Audit-ready records |
Complete system documentation, manuals, and compliance reports |
Validation Support |
DQ / IQ / OQ / PQ |
Validation-ready design with support documentation for qualification |
Remote Monitoring |
Continuous system supervision |
24×7 remote monitoring with performance and compliance tracking |
Change Control |
Controlled system modifications |
Parameter change logging and traceability for compliance |
Operational Reliability |
Continuous, stable operation |
Designed for 24×7 automated operation with minimal human intervention |