Title: SOP for Operation, Calibration, Cleaning and Maintenance of TOC Analyzer

1.0 OBJECTIVE:

The objective of this SOP is to lay down a procedure for Operation, Calibration, Cleaning and Maintenance of TOC Analyzer used in Microbiology Laboratory, Quality Control Department.

2.0 SCOPE:

This SOP is applicable to TOC Analyzer in Microbiology Laboratory, Quality Control Department.

6.0 PROCEDURE:

6.1 General Instruction:

1. Sonication shall be performed for preparation of stock and standard solutions used in 2- point and 4-points calibrations.

6.2 Pre-Start up checks before operating the equipment (Make: Shimadzu, Model: L _CPH )

1. Ensure that the pressure of the Nitrogen Air is within the range of 3 –5 kg / cm². If necessary, use the outlet pressure regulator to adjust the pressure.
2. Set the supply pressure of carrier gas to 200±10 kPA and the flow rate of the gas is maintained at 150 ml/min.
3. Ensure that the water level in the humidifier is within required levels
4. Ensure that the dehumidifier present at the rear end is completely filled.
5. All the dilution bottles should be filled with Milli Q water.
6. Ensure that the drain reservoir is empty and drain tube is not immersed in the drain.

6.3 Operating Procedure:

1. Switch on the computer.
2. Double Click on TOC-Control L icon on desktop.
3. Double click on “Sample Table Editor” icon and enter the User ID & Password.
4. TOC-L sample table window will open.
5. Select “New” from the File Menu or click the “New” icon on the tool bar.
6. Click on the “Sample Table” icon and then click OK.
7. General information window will appear.
8. Enter the System as “TOC_L_CPH” and click on OK.
9. Give the File name as “Sample Analysis DD.MM. YYYY” and click on the save icon to save the sample table.
10. TOC_ L Sample Window for the entered date will open.
11. Switch on the instrument and click on the “Connect” icon on the tool bar.
12. Sequence dialog window will open.
13. Initialization Window will disappear after Auto Initializing.
14. Click on the “Monitor” icon.
15. The Background Monitor consists of the following, which should retain the said parameters

NDIR: Baseline Position, Baseline Fluctuation, Baseline Noise

Furnace temperature: 680 ºC

Dehumidifier temperature: 1.2 ºC (0.2 º to 5ºC)

1. All the parameters for the above should attain the green light which would take around 20-30 min.
2. After the green light is attained in all the above parameters close the Background Monitor.
3. Click on Insert menu and select “Sample”.
4. Sample Wizard (Page 1) Parameter Source will open.
5. Select the Calibration Curve and click on Browse icon.
6. Select the required Calibration curve and click on the Open button.
7. Click on Next button.
8. Sample Wizard (Page 2) Analysis Information opens.
9. Select type of analysis as NPOC.
10. Enter the required Sample Name and Sample ID and then click on Next button.
11. Sample Wizard (Page 3) Calibration Curve window appears. Click on next button.
12. Sample Wizard (Page 4) Injection Parameters window appears.
13. Enter the parameters for the Injection as mentioned below:

          Analysis     : NPOC

          Unit           : ppb

          Injection Volume:816µl

          No. of Injection:3-5

          SD : 0.5

          CV : 3.0

          No. of Washes : 2

          Auto dilution : 1

          Sparge Gas Flow : 80 ml

          Sparge time : 30 seconds

          Acid Addition : 1.5 %

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Title: SOP for Calibration of High Performance Liquid Chromatography (HPLC)

1.0 OBJECTIVE:

The objective of this SOP is to provide a procedure for the Calibration of High-Performance Liquid Chromatography (HPLC).

2.0 SCOPE:

This SOP is applicable HPLC (Make: Agilent, Model: Infinity1260 II) installed in to the Quality Control Department.

6.1 PROCEDURE:

1. Pump Calibration: Following parameters shall be calibrated for pump calibration:
   1. Flow Rate: Purge the channel A, B, C and D with degassed water, set 0.5 mL/minute flow rate and allow running about 15 minutes at 0.5 mL/minute flow rate prior to checking the flow rate. Set the flow 0.5 mL/min. and start the pump with solvent channel A, B, C and D with 25% composition each.
   2. Ensure that the system pressure is constant.
   3. Start to collect water in 10 mL clean and “Class A” dry volumetric flask. Keep the drain tube in such a way that the water drop falls in to the flask without touching the walls of the flask and start immediately the calibrated stop watches when first drop falls in to the flask.
   4. Start the calibrated stopwatch at the same time and note down the time required to collect 10 mL of effluent.
   5. Repeat the same process by changing flow rate to1.0 mL 2.0 mL and 3.0 mL.
   6. Acceptance Criteria: ± 2 % of set flow rate.
   7. Compositional Accuracy: Connect dead volume connector in place of column, set wave length at 254 nm and flow rate to 2.0 mL/minute
   8. Purge and equilibrate the channel (A, B, C, D) with mobile phase mentioned and prepare time program -1 and time program -2.
   9. Chromatographic Parameters:

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1.0 OBJECTIVE:

To lay down the procedure Operation and Calibration of the Fourier Transform Infrared Spectrophotometer (FTIR).

Make        : Shimadzu

Model      : IRXross

2.0 SCOPE:

This SOP is applicable for the operation and Calibration of Fourier Transform Infrared Spectrophotometer (FTIR) (Make: Shimadzu) with software LabSolution-IR in the Quality Control department.

3.0 RESPONSIBILITY:

1. Quality Control personnel is responsible to follow this procedure.
2. Head QC/designee is responsible to ensure the implementation of this procedure.

4.0 PROCEDURE:

4.1 PRECAUTIONS:

1. Check that the instrument is connected to a stabilized power supply.
2. Keep the sample chamber clean.
3. Switch ON IR before 10 min of analysis.
4. Do not close ATR tip while making background scan.
5. Check silica regularly.
6. After use off the instrument from switch provide to instrument not from main electric power supply.

4.2 INSTRUMENT CONFIGURATION:

1. Instrument consists of ATR accessories & pellet sample holder.
2. Fix the ATR accessories or pellet sample holder as per requirements.
3. While using ATR accessories, check the proper connection with instrument.
4. After successful connection, ATR accessory serial number will display green color status in software.
5. Directly use sample powder or liquid in small amount for ATR accessory.

4.3 STARTING AND SHUTTING DOWN THE SYSTEM

1. Turning the Power ON.
2. Turn ON the main switch of the instrument.
3. Turn ON power to the PC

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1.0 OBJECTIVE :

To lay down the procedure for Operation and Calibration of Karl Fischer & Potentiometric Titrator (Dual Station).  

Make : Metrohm

Model : 905 Titrando.

2.0 SCOPE :

This SOP is applicable for the Operation and Calibration procedure for Karl Fischer & Potentiometric Titrator in the Quality Control department.

3.0 RESPONSIBILITY :

1. Quality Control personnel is responsible to follow this procedure.
2. Head QC/designee is responsible to ensure the implementation of this procedure.

4.0 PROCEDURE :

4.3 Operating Procedure

The program menu will be displayed on the screen. Double click on the ‘tiamo 2.5’

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