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 controlled U1600-L specification uses a 1-1600 µg/L range, 1 µg/L detection limit and resolution, approximately three-minute analysis, 0-10 µS/cm conductivity range, non-pressurized sample presentation, 16 GB storage, RS232/RS485/USB interfaces, and 370 × 350 × 220 mm dimensions.
Sample suitability: Low-level TOC work is highly sensitive to containers, tubing, handling, particles, bubbles, carryover, and environmental contamination. Sampling and wash procedures must be validated for the reporting objective.
Data integrity and compliance: User access, audit-trail, electronic-signature, storage, printing, and communication functions support regulated workflows, but compliance depends on the complete validated laboratory system and site controls.
Method Scope and Intended Use
The U1600-L is intended for offline laboratory measurement of TOC in pharmaceutical PW and WFI, electronic ultrapure water, deionized water, cleaning-validation rinse water, and other approved low-conductivity samples. It is not a general wastewater or high-salt-matrix analyzer.
Laboratory Sampling
Routine testing uses a clean, non-pressurized sample container with at least 300 mL unless the approved method specifies otherwise. Low-TOC container control, filtration where required, flushing, and bubble removal are essential to representative results.
Data Integrity and Validation Support
The standard configuration includes three-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.