21 CFR PART 11 COMPLIANT KARL FISCHER TITRATOR – KAFI SMART
Karl Fischer titration is an accurate, rapid and efficient method for determining the water content in samples.
When the sample is titrated in the presence of SO, I2 and organic base, moisture from the sample extracted in the solvent, can be quantitatively estimated. Dry methanol is used as a solvent in Karl Fischer titration.
The indicator-electrode is a two – pin platinum electrode across which a constant current is generated by a polarizing current source. For starting, very low volume of methanol as a needed in the specially designed vessel.
Background signal correction is done through an offset mode.
Calculated doses of Karl Fischer regent are added to the solution in a hermetically sealed vessel as per stop criteria selected and the end-point volume is evaluated automatically. The instrument continuously monitors moisture leak in the vessel and neutralizes it automatically.
The built-in reagent standardization procedure by water (H2O) or Sodium Titrate (C4H4Na2O62H2O) for titre factor / concentration (F) is incorporated.
The liquid handling path comprises Teflon tubing, Teflon-lined valve, and a gastight syringe with Teflon plunger. It creates a chemically inert system for this highly sensitive analysis.
The magnetic, adjustable- speed stirrer is a part of the system in which the sample is stirred vigorously to extract the moisture efficiently.
The result, including the leak rate, is printed in a tabulated form and is also displayed on back lighted liquid crystal display (LCD) screen.
Modes of Operation:
Karl Fischer Titration is a dead stop titration process which monitors the mV drift to be lower than the stop band, and end of the titration is detected when the leak rate is close to or less than stop band. The leak rate is displayed and also printed.
There are two main modes of operation:
- In minimum ‘Dose Mode’ where the end dose is same as the minimum dose, the titration will be stopped when mV does not rise above the stop band in specific delay time.
- In drift mode, the titration will be stopped if the calculated drift value is less than or equal to entered drift value in µl/min.
Selectable Report formats, complying with GLP requirement:
- Report giving titration parameters and result.
- Report of method Parameters.
- Condensed report of titration parameter and result
- Statics report for last 10 repeat run analysis
Report can be obtained even after resetting / power off/ power failure conditions.
- User interactive software in dialogue mode for ease of operation with protection against invalid entries.
- Quick interchangeable imported burette assemblies with intelligent recognition for its volume size. Burette validation factor for dispensing corrections available for true end point volume.
- Complete 21 CFR compliant with 6 password levels with various privilege options, audit trail & e-signature.
- Unlimited user password storage – can set Password expiry policy
- Alphanumeric entry of Sample Name and Identification Number with Date and Time for authentication. Daily Auto Incremented Run number and Factory entered CUSTOMER NAME and Instrument Sr. No. report printout make the system foolproof and GLP compliant.
- Quick monitoring and automatic neutralization of moisture leak into vessel to keep it ready for next titration.
- End point delay upto 100 sec for slow moisture releasing samples.
- Titration run can be started with last run parameters.
- On line leak rate correction available.
- Microcontroller based variable speed, magnetic stirrer with digital indication.
- Statistic function with run selectivity for finding Mean, S.D., R.S.D. and C.V. of last 10 repeat run results could be viewed or printed.
- ASTM standard compliant for analysis of oil samples
- Real Time Clock (RTC) for Date & time display and report printout with run time indication.
- Balance interface to directly transfer the sample weight.