Operation, Calibration & Performance Verification Shimadzu TOC-L

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STANDARD OPERATING PROCEDURE

Operation, Calibration and Performance Verification of Shimadzu TOC-L Total Organic Carbon Analyzer


1.0 Purpose

To describe the procedure for operation, calibration, system suitability testing, performance verification, and shutdown of the Shimadzu TOC-L Total Organic Carbon (TOC) analyzer to ensure accurate, precise, and reproducible TOC results in accordance with applicable pharmacopoeial and regulatory requirements.

2.0 Scope

This SOP applies to the analysis of Purified Water (PW), Water for Injection (WFI), and cleaning validation samples using the Shimadzu TOC-L series in the Quality Control Laboratory.

3.0 Responsibility

Designation Responsibility
QC AnalystOperation, calibration, SST, sample analysis, and documentation
QC SupervisorReview and verification of results
QAOverall GMP compliance and SOP control
EngineeringInstrument maintenance and servicing

4.0 Accountability

The Quality Assurance department shall be accountable for implementation, monitoring, and compliance of this SOP.

5.0 References

  • USP <643> – Total Organic Carbon
  • European Pharmacopoeia (EP) 2.2.44
  • Indian Pharmacopoeia (IP)
  • Japanese Pharmacopoeia (JP)
  • ICH Q2(R1) – Validation of Analytical Procedures
  • WHO Good Manufacturing Practices (GMP)
  • ISO/IEC 17025
  • Shimadzu TOC-L Manufacturer’s Instruction Manual

6.0 Definitions and Abbreviations

Term Description
TOCTotal Organic Carbon
TCTotal Carbon
ICInorganic Carbon
NPOCNon-Purgeable Organic Carbon
SSTSystem Suitability Test

7.0 Safety and Precautions

  • Use only TOC-grade reagents and water.
  • Avoid contamination of samples and glassware.
  • Ensure carrier gas and electrical connections are secure.
  • Follow laboratory safety and GMP requirements.

8.0 Instrument Description

The Shimadzu TOC-L is an automated analyzer for determination of total organic carbon in pharmaceutical water and cleaning validation samples based on high-temperature catalytic oxidation and non-dispersive infrared detection.

9.0 Operating Procedure

  1. Ensure the instrument is properly installed and connected.
  2. Switch ON the main power supply.
  3. Press the POWER button on the front panel.
  4. Turn ON the carrier gas supply.
  5. Allow the system to complete initialization and warm-up.
  6. Verify that the instrument status displays “Ready”.

10.0 Calibration and Verification

10.1 Calibration Frequency
  • Initial installation
  • After major maintenance
  • As per laboratory calibration schedule
10.2 Calibration Standard Preparation
  • Prepare blank using TOC-grade water.
  • Prepare Potassium Hydrogen Phthalate (KHP) standards.
  • Use clean, contamination-free TOC-certified glassware.
10.3 Calibration Execution
  1. Run blank to establish baseline.
  2. Analyze standards from lowest to highest concentration.
  3. Generate calibration curve.
10.4 Acceptance Criteria

Correlation coefficient (r) shall be ≥ 0.995.

11.0 System Suitability Test

  • Prepare sucrose solution as organic carbon source.
  • Prepare benzoquinone solution as easily oxidizable compound.
  • Analyze both solutions and calculate response efficiency.

Acceptance Criteria: Response efficiency shall be 85% – 115%.

12.0 Sample Analysis Procedure

  1. Rinse sample vials with TOC-grade water.
  2. Collect and seal samples immediately.
  3. Load samples into autosampler or manual position.
  4. Select TOC / NPOC / TC-IC mode.
  5. Start analysis and review results against specifications.

13.0 Deviations and Corrective Actions

  • Do not use the instrument if calibration or SST fails.
  • Inform QC Supervisor and QA immediately.
  • Initiate deviation and corrective actions as per site procedures.

14.0 Cleaning and Maintenance

  • Complete all analyses before shutdown.
  • Stop autosampler operation.
  • Turn OFF carrier gas supply.
  • Switch OFF instrument power.
  • Perform routine cleaning and preventive maintenance as scheduled.

15.0 Documentation and Records

Record operation, calibration, SST, analysis, maintenance, and deviations in the instrument logbook or electronic system in accordance with ALCOA+ principles.

© SOPNest | Quality Control Documentation

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