SOP for Operation and Calibration of Total Organic Carbon analyzer. (TOC)

SOP for Operation and Calibration of Total Organic Carbon analyzer in Pharmaceutical Industry

• SOP covers below points :
  • Operation of TOC Analyzer
  • Calibration of TOC Analyzer
  • System Suitability
  • Linearity
  • Safety And Precautions

1.0 OBJECTIVE :

• To lay down a procedure for operation and calibration of Total Organic Carbon analyzer.

2.0 SCOPE :

• This SOP is applicable for operation and calibration of Total Organic Carbon analyzer in Quality Control Department.

3.0 RESPONSIBILITY :

• The QC Staff shall be responsible for:
  • Following the procedure for operation & calibration of Total Organic Carbon analyzer.
• The Manager-QC shall be responsible for:
  • Ensuring compliance of the SOP

4.0 ACCOUNTABILITY:

• Quality Control Head 

5.0 PROCEDURE :

5.1 Operation of TOC Analyzer:

• Open the zero-air cylinder. Switch on the Total organic carbon analyzer. The ‘Initial display’ is displayed.
• After ready position comes, place the water sample which is to be analyzed.
• Press ‘Measure sample’ key, the ’Measurement Parameters’ screen is displayed, enter the sample name and press the F5 (NPOC) KEY.
• Select the calibration curve & run the sample with following parameters:

No of inj.	2
Max. of inj.	3
SD	0.2
CV	2.0 %
Dil. Factor	1
Acid ratio	1.5 %
Sparge time	1.0

• Press the ‘Next’ key & press ‘Start’ key after start key starts blinking.
• After completion of test, Press F6 (Exit measurement) key & take the print of result.
• To switch off the instrument press F1 (Standby option) key & then F5 (Power off) key & than press F6 (Execute) key and again F6 (yes) key.

5.2 Calibration of TOC Analyzer:

• Reagents / Equipments Required:
  • Reagent water for calibration (TOC level less than 100 ppb)
  • Sucrose
  • 1,4-Benzoquinone
• Frequency:  Quarterly  ± 5 days
• Preparation of 500 ppb Carbon Solution prepared with Sucrose :
  • Weigh 0.1190 gm of Sucrose, dissolve and dilute to 1000 ml with Reagent Water.
  • Take 1 ml of above solution and dilute to 100 ml with Reagent Water.
• Preparation of 500 ppb Carbon Solution prepared with 1,4-Benzoquinone :
  • Weigh 0.075 gm of 1,4-Benzoquinone, dissolve and dilute to 1000 ml with Reagent Water.
  • Take 1 ml of above solution and dilute to 100 ml with Reagent Water.
• Press the ‘Cal’ key for starting the calibration. Press F2 (TC) key.
• Select the number where Calibration curve is to be saved.
• Insert the two points with arrow key, take following parameters;

	Point 1	Point 2
Std. Conc.	0.0 ppb	500.0 ppb
Inj.	2	2
Max of Inj.	3	3
SD	0.2	0.2
CV	2.0 %	2.0 %

• Press the ‘Next’ key & place the Reagent Water & start the measurement. After completion 0.0 ppb concentration, place 500 ppb carbon Solution & press F6 (Go to next Point) key.
• After completion of calibration press F6 (Data report). Again press F6 (cal. Curves List) key. Select the calibration curve no. where graph is saved. Press F6 (edit) & then F4 (curve shit status) & pass the curve to origin by pressing F4 key.
• Press F6 (OK) key & press F1 (Return) key.

5.3 System Suitability:

• Place the 500 ppb of Carbon solution prepared with 1,4-Benzoquinone.
• Operate the instrument as per operation procedure and find out the area in triplicate.
• Calculation:
  • Area of 1,4-Benzoquinone – Area of Water / Area of Sucrose – Area of water X 100
• Acceptance Criteria: Between 85.0% and 115.0%.

5.4 Linearity:

• Prepare the solution of different concentrations with sucrose.
• Solution Preparation
  • Stock Solution: Weigh 0.1190 gm of Sucrose, dissolve and dilute to 1000 with reagent water.
  • Dilute 1 ml of stock solution to 200 ml with reagent water. (250 ppb carbon solution)
  • Dilute 1 ml of stock solution to 100 ml with reagent water. (500 ppb carbon solution)
  • Dilute 1.5 ml of stock solution to 100 ml with reagent water. (750 ppb carbon solution)
  • Dilute 1 ml of stock solution to 50 ml with reagent water. (1000 ppb carbon solution).
• Operate the instrument as per operating procedure and find out area of each solution in triplicate.
• Calculate % relative standard deviation and relative standard deviation of area of each solution should not be more than 2.0%.
• Plot a graph of standard concentration against peak area.
• Calculate the linearity correlation co-efficient.
• Acceptance criteria: Correlation coefficient should be not less than 0.99.

5.5 Safety And Precautions:

• Always open zero air gas cylinder before switching on the instrument.
• The air flow must be 150ml/min & pressure should be 200kpa.
• Check the water level of humidifier.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
No.	Number
QC	Quality Control
QA	Quality Assurance
Dept	Department
No.	Number
Ml	Milliliter
Min	Minutes
kpa	kilopascal
TOC	Total Organic Carbon
ppb	Part per billion
gm	Gram
SD	Standard deviation

7.0 ANNEXURES:

Annex. No.	Title
01	Calibration Protocol for TOC Analyzer
02	Usage log for TOC Analyzer

8.0 SOP REFERENCES

• In-House

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Calibration Protocol for TOC Analyzer

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Annex. No. 02 Usage log for TOC Analyzer

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