TOCPAT700

TOC Analyzer PAT700

Anatel PAT700 Total Organic Carbon (TOC) and Conductivity Analyzer Product Brochure

21CFR part 11 Data Integrity for On-line WFI Instruments

ANATEL PAT700

ANATEL PAT700 TOC Analyzers are specifically designed to help demonstrate compliance to the pharmacopoeial requirements for TOC and conductivity for Purified Water and Water For Injection.

  • TOC, Uncompensated Conductivity and Temperature from just one analyzer – can be fully calibrated and validated to USP<643> and USP<645>
  • Low cost of ownership – 12 month service and calibration intervals
  • Root-cause analysis support – water sample automatically taken if there is a TOC excursion
  • All SOPs are pre-loaded into the PAT700, leading users step-by step with on-screen pictures and prompts

Features

Low cost of ownership

  • 12 month service intervals supported by auto-switching Main and Standby UV oxidation lamps with UV output monitoring
  • No chemicals/reagents required – PAT700 just uses strong UV lamps to oxidize TOC
  • No peristaltic pump tubing or pump heads to replace – PAT700 uses water system pressure to push sample into measurement cell for analysis

Root-cause analysis support

  • User can pre-program the PAT700 so that at a pre-determined TOC level, it will capture a water sample which can then be later analyzed in the QC Lab to assist root cause analysis should a TOC excursion be detected
  • On-board grab sampler allows the user to take samples from different locations/use points to support root cause analysis

Improved compliance

  • PAT700 can be fully calibrated and validated for compliance to US<643> for TOC and USP<645> for conductivity
  • Complete oxidation to EP2.2.44 requirements – the PAT700 ensures complete TOC oxidation through oxidation dynamic end-point detection
  • 21CFR part 11 support – everyday users can view TOC and Conductivity results as a Guest without the ability to make any changes to the PAT700. Initial configuration and subsequent changes are protected through multi-level user name and password protection
  • Dual-stream version available to demonstrate compliance both at the start and end of water loops simultaneously

Reduced training burden – no manual calculations/data entry

  • All SOPs are pre-loaded into the PAT700, leading users step-by step with on-screen pictures and prompts
  • All Calibration and System Suitability standards come with certified value data and use by dates programmed into an RFID tag on the bottle itself. Following the on-screen SOPs the user is prompted to load the bottles and the PAT700 then reads the RFID tags on the bottles. If the bottles have been loaded in the wrong order, or if they have expired the PAT700 provides a warning on the touch-screen. The PAT700 then uploads certified values, carries out the test and automatically calculates a pass/fail result and provides a report.

SPECIFICATIONS

PAT700 TOC Analyzer

Accuracy +/-1 ppd or +/-5% whichever is greater
Repeatability +/-0.3 ppd or +/-1% whichever is greater
Limit of Detection 0.5 ppb
Maximum Input Conductivity 0.2 uS/cm for all waters, 1.0 uS/cm for all neutral waters, 5.0 uS/cm for water with CO2 as the sole conductive species
Conductivity Conductivity Range 0.05 to 150 uS/cm (@25* C)
Display Resolution 0.01 uS/cm
Conductivity Accuracy +/-2% over full range (uncompensated)
Resistivity Resistivity Range 0.2 to 18 MQ-cm (@25*C)
Display Resolution 0.01 over full range
Available Modes Temperature compensated to 25*C, or uncompensated
Temperature Ambient Operating Range 10 to 40*C (50 to 104*F)
Measurement Accuracy +/-0.4*C
Sample Water Range 5 to 95*C (41 to 203*F)
Display Resolution 0.1 over full range
Physical Specs UV Lamps 2, with UV Detect technology
Interface/Display Color with touch screen
Maximum Altitude 4,000 m (13,125)
User I/O Wiring Three, 3/4-inch conduit openings or quick disconnect fittings
Standards System Onboard, Automated Standards Introduction System (OASIS)
Dimensions 59.7 w X 22.9 d X 25.4 h (23.5 X 9 X 10 inches)
Weight 13.6 kg (30 lbs)
Sample Inlet Flow Rate Range 60 mL/min to 300 mL/min
Sample Inlet Pressure Range 10 to 100 psi (69 to 690 kPa)
Compliance Installation Category II
Pollution Degree 2, IEC 61010-1
CE Compliance EN 61010-1 and EN 61326
Safety Rating ETL, conforming to UL 61010-1 and CSA 22.2 No. 61010-1
Enclosure Rating Conduit version: IP56 Quick connect version: IP46
Release Tests USP <643>, USP <645>, JP 16, EP 2.2.44
New Features CIP Selectable mode for Clean-In-Place analysis
Dual Stream option Toggle or programmable stream switching
Excursion sampling Minimum flow rate to fill excursion bottle = 160 mL/min
Rouge detection Identifies oxidation cell contamination from roughing

ASX 7200 Auto Sampler

Spec Value
Physical Specs Vial Capacity 36 Grab sample bottles HDPE or Borossilicate USP Type 1 glass
Dimensions 45.7 cm X 36.6 cm X 53.7 cm (HxWxD)
Weight 21 kg (45 lbs)
Communications Communications RS232 interface with PAT700 – No external PC required
Environment Ambient Environment 10 – 40*C, 5 – 95% non-condensing RH
Power Power Requirements 100 – 240 VAC +/- 10%, 4.4A

ICH Q2 Validation of On-line TOC Analyzers

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