Configuration authority: The serial-number-specific nameplate, order confirmation, packing list, factory test report, calibration certificate, approved model datasheet, and written Blue Dragon clarification govern the delivered hardware and approved performance. The general product page should not be used to change a validated range, connection, software setting, or method.
Sample suitability: The U1600-O is designed for low-conductivity, high-purity-water matrices. Sampling location, transport time, temperature, pressure, contamination control, flushing, and representativeness must be addressed in the approved method.
Data integrity and compliance: User access, audit-trail, electronic-signature, storage, and communication functions support regulated workflows, but compliance depends on the complete validated system and site controls.
Method Scope and Intended Use
The U1600-O is intended for online measurement of TOC in pharmaceutical PW and WFI, electronic ultrapure water, deionized water, and other approved low-conductivity water systems. It is not a general wastewater or high-salt-matrix analyzer.
Data Integrity and Validation Support
The standard configuration includes multi-level access, audit-trail and electronic-signature functions. USP , current Ph. Eur. 2.2.44, applicable ChP workflows, and FDA 21 CFR Part 11-supporting functions require validation and procedural controls at the user site.
Configuration Control
The delivered nameplate, order confirmation, factory test report, calibration certificate, and approved serial-specific documentation take precedence over general website information.