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Instruments

TOC QbD1200

The new QbD1200 TOC analyzer is designed to make testing easier, reproducible and accurate. The new TOC analyzer promises highest performance while dramatically reducing cost of ownership by using one reagent for the test and requiring only one annual service call rather than frequent maintenance. The new TOC analyzer eliminates the dependency on lengthy overnight routines that may fail. In the first of its kind the QbD1200 TOC analyzer calibrates in only 90 minutes. The QbD1200 is designed for use in 21 CFR part 11 lab environments and is fully compliant with all global pharmacopeia regulations. It offers convenient validation as it is not operated by a separate PC eliminating the need for an additional CSV file and provides paperless reporting to distribute all auditable reports over secure protocol to a central server.

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Benefits

Reliable data
Stop throwing away your first sample! The QbD1200 has virtually eliminated sample-to-sample carryover! Highly repeatable results!

Simplify your validation and analysis
Automated calibrations, System Suitability Testing and report generation! Only one reagent is needed for ALL analysis!

Low cost of ownership
Say goodbye to frequent maintenance; Reduced service calls!

Fast calibration
Automated calibration in less than 90 minutes saves the user precious time and is the fastest in the industry!

Ensure regulatory compliance
Fully complies with all global pharmacopeia regulations: USP, JP, EP, IP, ICH.

Specifications

Spec Value
Range 0.4 ppb – 100,000 ppb
Detection Limit 0.4ppb
Precision <2% or 3ppb (whichever is greater)
Accuracy ± 2%
Calibration Time 90 minutes
Analysis Time ~5 minutes
Sample to Sample Carry Over  (from 500ppb to blank) <0.2%
Overload Recovery (from 1,000ppm to 1ppm) 1 measurement
   

Inorganic Carbon Handling

 
Extra Inorganic Carbon Removal Module needed for samples with high levels of Inorganic Carbon? NO
Dynamic Endpoint Detection to assure complete Inorganic Carbon removal? YES
   

Instrument Self-Diagnostics to Ensure Data Integrity

 

Will Instrument report TOC value IF:

 
Lamp intensity too low NO
Carrier gas insufficient / tank runs out NO
Reagent insufficient / bottle empty NO
Sample volume insufficient / vial empty NO
   

Reagents

 
Reagent Supply Purchase or make your own
Option to prepare own reagents YES
Total number of reagents (acid, oxidizer, dilution water) One (1)
   

 Measurement Method and Assurance

 
Oxidation UV lamp + persulfate
UV lamp confirmation Broadband silicate photodiode sensor
Detector Digital NDIR
Detector stability Continuously verified against reference
Pre-Detector moisture removal Peltier cooler with continuous current monitoring
Dispense module Syringe pump, accurate to +/- 1% volume
Flow sensor Dynamic fluid detector (ensures accurate sample and reagent volume)
Carrier Gas options CO2 free Air, O2, or N2
Carrier Gas pressure confirmation Dual orifice pressure sensor
Carrier Gas valve shutoff When measurement complete, valve closes to avoid wasting gas
Autorange capability Yes
Analysis mode NPOC (Non Purgeable Organic Carbon)
   

Data Storage and Retrieval

 
Regulatory 21 CFR, part 11 all measurements recorded to encrypted database
Paperless reporting Secure FTP over Ethernet
IO 5 USB, 1 Ethernet
Data export formats PDF, CSV
   

User Interface

 
Display 10.4 inch Hi-Res color touch screen
External PC No external hardware / PC required
External keyboard / mouse Optional, not required
Ease of Operation Intuitive user interface, guides operator through measurement setup
   

Qualification Routines

 
Calibration Automated routine: 18 point calibration using KHP (6 concentrations, 3 replicates each)
Calibration Standard 5ppm KHP (single 125mL bottle), diluted to achieve 1, 2, 3, 4, 5 ppm concentrations, reagent is used as blank
Verification Tests / System Suitability Automated routines:
  • USP SST Bulk Water (blank, 500ppb as C: sucrose, benzoquinone)
  • USP SST Sterile Water (blank, 8ppm as C: sucrose, benzoquinone)
  • JP-16 <2.59> validation (blank, 500ppb as Carbon SDBS)
   

Regulatory Compliance

 
USP <643> (including Sterile Water SST), JP-16 <2.59>, EP <2.2.44>, IP, CP, KP, US EPA 5310c YES
21 CFR, part 11 YES
ICH guidelines for instrument validation including: accuracy, precision, LOD, LOQ, linearity, range, specificity, robustness YES, included in IQ/OQ
   

Autosampler

 
Capacity 64 sample vials (standard 40 mL glass TOC vials)
Style XYZ, septum piercing
Sample tray material Anodized Aluminum
   

General Technical Data

 
Instrument dimensions W 320 x D 507 x H 410 mm

Power

100-240 VAC, 47-63 Hz

Weight

10 kg (22 lbs)
Auto sampler dimensions W 366 x D 537 x H 457 mm

Power

100-240 VAC, 47-63 Hz

Weight

21 kg (45 lbs)
Operating temperature & humidity 10-35°C; up to 90% relative humidity, non-condensing
Reporting units μg/L (ppb)

Webinars & Symposiums

  • Choosing the Right Total Organic Carbon Analyzer for Pharmaceutical QC Laboratory Applications

    Tony Harrison Beckman Coulter Life Sciences

    Click to play  

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