1.0 OBJECTIVE : To laid down the procedure for operation of Total Organic Carbon Analyser (Sievers-900).
2.0 SCOPE : This procedure is applicable to determine the Total Organic Carbon in purified water & water for injection samples.
3.0 RESPONSIBILITY : Q.C. Chemist , QC Officer, QC Executive, Q.C In charge.
4.0 REQUIREMENTS : Cleaned Bottles, Aluminum foil etc.
5.1 PRECAUTIONS :
5.1.1 Do not touch the screen other then dry finger.
5.1.2 Always keep the sipper tube immersed in the WFI, when not in use.
5.1.3 Do not touch the tip of the sipper tube.
5.1.4 Keep separate glassware for TOC analysis.
5.1.5 Always use glassware thoroughly cleaned & finally rinsed with WFI.
5.1.6 Sample should be covered properly with aluminium foil to avoid expose in air.
5.1.7 Always draw fresh sample and analyse immediately.
5.1.8 Do not change/Disturb other parameters in the system. Other than written below.
5.2 OPERATING PROCEDURE :
5.2.1 Switch on the ‘Mains’ of printer attached online through TOC Analyser. And attached the A4 Size paper in printer.
5.2.2 Switch on the power and ‘Mains’ of the instrument. ‘Sivers-900’ main screen display
5.2.3 After initialization touch ‘Main’ to select on the screen.
5.2.4 Select the ‘Menu’, then touch ‘setup’, tab and then touch ‘Configure’.
5.2.5 In the configure screen, select ‘Reagent manual’ and then select ‘Manual’.
5.2.6 Select the ‘Acid flow’ and set 0.3 on the numerical key and then touch ‘Enter’.
5.2.7 Similarly, touch the ‘Oxidizer’ & set 0.0 on the numerical key & then touch ‘Enter’.
5.2.8 Now touch ‘Reps’ and select the number of repetitions from numerical key as ‘5’ then touch ‘Enter’.
5.2.9 Now similarly touch ‘Rejects’ and select the number of rejections from numerical key as ‘2’ then touch ‘Enter’.
5.2.10Now touch ‘Menu’, and touch ‘Maintenance’ tab and touch ‘Advanced’.
5.2.11Now touch ‘Advanced Location’ to set the Location/Batch Number of the sample
5.2.12Select ‘Alpha/Number’ and write the desired sample location/Batch number and then touch ‘Enter’
5.2.13Now touch ‘Back’, ‘Menu’ and then ‘Main’ the main screen is displayed where the analysis is to be start.
5.2.14Now bring the freshly sampled water for injection to be analyse in the closed container and deep the sampling tube in the sample and properly cover with aluminium foil.
5.2.15 Now touch ‘Start Analysis’ the on line printer will start the printing of on line analysis report.
5.2.16 During analysis time laps for analysis will appears on lower right corner on the screen. And the last analysis results of TOC, IC and TC in ppb will appears on upper side.
5.2.17 After completion of sample measurement automatically online final report will be print, which display the all repetitions TOC, IC, TC readings, and also shows the repetitions RSD and last three readings average.
5.2.18 The average of TOC result shows the actual result of the sample this should not more than 500ppb in water for injection sample purified water samples.
5.2.19 If the instrument is out of order, then alternate method oxidisable test should be performed for SWFI and purified water.
5.2.20 If there is no any further analysis is required then switch off the instrument and printer.
5.3 SYSTEM SUITABILITY TEST
5.3.1 TOC water:
Use highly purified water complying with the following specifications,
Conductivity: not greater than 1.0 µS cm–1 at 25°.
Total organic carbon: not greater than 0.1 mg/l.
5.3.2 TOC water control
Use TOC water obtained at the same time as that used to prepare the standard solution and the system suitability solution.
5.3.3 Standard solution:
Dried sucrose at 105° for 3 hours, and weigh 119 mg in 1000 ml volumetric flask and dissolve in 500ml TOC water and makeup to 1000ml with TOC water. Pipette 5 ml in 500 volumetric flask and make up to 500 ml with TOC water.
5.3.4 System suitability solution:
Weigh 75mg in 1000 ml volumetric flask and dissolve in 500ml TOC water and makeup to 1000ml with TOC water. Pipette 5 ml in 500 volumetric flask and make up to 500 ml with TOC water.
5.3.5 System suitability
Run the following solutions and record the responses: TOC water (r w); standard solution (r s); system suitability solution (r ss). Calculate the percentage response efficiency using the expression:
The system is suitable if the response efficiency is not less than 85% and not more than 115% of the theoretical response & record in Annexure.
Perform the system suitability quarterly.