Calibration and SST of the miniTOC is easy and can be done by the user. Online operation is interrupted briefly for the system checks to be performed. The operator simply has to connect the inlet with the calibration standard solutions and the diluting water. The software enables the user to perform calibration and SST independently and the programmable sequence ensures the automatic procedure and data evaluation of the test. The verification of the TOC results according to the requirements of USP and Ph.Eur is realised by the periodic performance of system suitability tests.
Calibration & System Suitability Test (SST)
The miniTOC can be ordered as configuration with 4 inputs (miniTOC pro). With an additional software upgrade option the user can measure up to 3 loops sequentially.
Offline Version & autosampler
An offline configuration is available for the miniTOC. By using the offline mode of the miniTOC pro the system is also upgradable with an autosampler with 15 positions for 100 mL vials.
Check of sample flow
nitiates alarm in case of inlet flow is zero.
If the medium temperature is higher than 50 °C a heat exchanger is required.
If the medium pressure is higher than 1 bar a pressure transducer is required.
21 CFR part 11 Software
Software with 21 CFR part11 conformity for pharma applications.
|1||Method & detection||UV oxidation (partial) & conductivity|
|2||Sample volume flow||Approx. 14 mL/min|
|3||Time of measurement||2 sec (online mode) | 1 min (offline mode)|
|4||Measurement range||0.5 to 1000 ppb|
|5||Detection accuracy||~0.5 ppb or 1 % (whatever is greater)|
|6||Ports||1 for sample, 1 for SST (basic) | 1 for sample, 3 for SST (pro)|
|7||Related norms||USP <643>, EP 2.2.44, DIN EN 1484|
|8||Ambient parameters||Relative humidity: 10 to 95 %, temperature: 10 to 45 °C|
|9||Interface ports||Analog, according to Namur NE43|
|9||Dimensions, weight, power||300 x 200 x 500 mm, 14 kg, 110 - 230 V, 50 Hz, 60 Watt|
|1||Type of sample medium||Pure or ultra pure water|
|2||Medium conductivity||< 2 µS/cm (upgradable to < 30 µS/cm)|
|3||Inlet pressure||< 1 bar|
|4||Sample temperature||< 50 °C|