Modern ultrapure water, purified water, and water for injection systems demand TOC analyzers that provide the lowest detection limits, most accurate results, maximum sensitivity to the smallest changes in water quality, and a measure of reliability that meets the most rigorous quality standards.
Real-Time Release Testing
The Anatel PAT700 TOC Analyzer is specifically designed to help demonstrate compliance to the pharmacopoeial requirements for TOC and conductivity for Purified Water (PW) and Water For Injection (WFI). It can be used for Real-Time-Release, “defined as” the ability to evaluate and ensure the acceptable quality of in process and/or final product based on process data. Real-Time-Release-Testing ensures faster and saver batch release while at the same time realizing savings because expensive laboratory analyses of grab samples can be limited or completely unnecessary.
Low Cost of Ownership
- 12 month service intervals supported by DUAL UV oxidation lamps
- UV lamp output monitoring
- No chemicals/reagents required – PAT700 only uses strong UV to oxidize TOC
- No peristaltic pump tubing or pump heads to replace
- No heat exchanger required, water up to 95 °C can be sampled
PAT Framework
The PAT framework (Process Analytical Technology) is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the US Food and Drug Administration FDA. The PAT700 fully complies to all pharmacopoeias for TOC analysis like USP <643>, EP <2.2.44> and JP XV <2.59>. The PAT700 has a built-in conductivity sensor which complies to USP <645> which saves costs for implementation of an extra conductivity sensor, both measurements are available via a serial signal or an analogue 4..20mA output for easy integration.
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
Service by CMI
CMI has a large team of engineers that can service your TOC analyzers on-site with calibration and system suitability testing. We keep track of your due dates and inform you in time when recalibration is required.
PAT700 for online TOC Monitoring of PW and WFI
- Real-Time-Release
- Proces Analytical Technology
- Compliance to USP <643>, USP <645>, EP <2.2.44>, JP 16 <2.59>
- Low Total cost of ownership
- DUAL UV-Lamps with output monitoring/li>
- 21 CFR part 11 Compliance and Annex 11
Improved compliance
- PAT700 can be fully calibrated and validated for compliance to USP<643> for TOC and USP<645> for conductivity
- Complete oxidation to EP 2.2.44 requirements – the PAT700 ensures complete TOC oxidation through oxidation dynamic end-point detection, for more information visit
- 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 SOP’s 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 SOP’s 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