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