QbD1200 TOC Analyzer
|Performance||0.4 ppb detection limit (<2% or 3 ppb, whichever is greater)|
|Industry Standards||21 CFR Part 11, USP <643> (including Sterile Water SST), JP-16 <2.59>, EP <2.2.44>, IP, CP, KP, US EPA 5310c, ICH guidelines for instrument validation included in IQ/OQ|
|Light Source||Broadband silicate photodiode sensor UV lamp confirmation|
|Calibration Intervals and Options||18-point calibration using KHP (6 concentrations/3 replicates) automated test routine, 4 ppm KHP (125 mL bottle), USP SST bulk water (blank/500 ppb (sucrose/benzoquinone), USP SST sterile water (blank/8 ppm surcrose/benzoquinone), JP-16 <2.59> validation (blank, 500 ppb as carbon SDBS) automated test routines|
|Throughput||Data acquisition time: 1 to 3600 sec|
|Detection||Digital NDIR Detector (limit: 0.4ppb)|
|Reporting||Reporting Units: μg/L (ppb)|
|Temperature Range||Operating temperature range: 10°C to 35°C|
|Humidity Restrictions||Up to 90% relative humidity (non-condensing)|
|Power Requirements||47-63 Hz, 100-240 VAC|
|Operating System||Paperless reporting via secure FTP over Ethernet|
|Display||10.4" high-resolution color touch screen|
|Weight||10 kg / 22 lb|
|Width||32 cm / 12.6 in|
|Depth||50.7 cm / 20 in|
|Height||41 cm / 16.1 in|
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.