Total Organic Carbon (TOC) analysis is critical for monitoring the organic load in Pharmaceutical Water Systems (PW, WFI, HPW) and ensuring compliance with global pharmacopeial standards. PrimeGMP provides precise, traceable, and audit-ready calibration and verification services for TOC analyzers to ensure accurate and reliable measurements.

Scope of TOC Calibration Services

1. Instrument Review & Setup

• Verification of analyzer model, detection principle (UV-persulfate / high-temperature combustion)
• Review of flow paths, reagent lines, spargers, sampling connections
• Verification of software parameters & method configuration

2. Calibration as per USP & Ph. Eur.

Calibration is performed according to:

• USP <643> Total Organic Carbon
• USP <645> Conductivity (where integrated)
• Ph. Eur. – Water for Pharmaceutical Use
• ICH Q2 (where applicable)

Calibration steps include:

• System suitability test (SST)
• Response efficiency test using Sucrose & 1,4-benzoquinone
• Oxidation efficiency verification
• Blank (reagent water) verification

3. Operational Verification

• Low-range and high-range TOC standards verification
• Linear range verification (optional)
• Noise & baseline stability check
• Analyzer response time check
• Carryover test
• Auto-sampler (if applicable) performance testing

4. Performance Verification

Performed at actual sampling locations:

• TOC verification at PW / WFI use-points
• Conductivity verification (if combined analyzer)
• Temperature and flow confirmation
• Trending review of historical TOC results

Documentation Provided

• Calibration Certificates (NIST-traceable standards)
• System Suitability Test Reports
• Oxidation Efficiency Test Results
• Blank Response Reports
• Instrument Logbook Records
• Raw data printouts / electronic data backup
• Updated Calibration Labels & Stickers
• Final Calibration Summary Report

Regulatory Standards Followed

• USP <643> TOC
• USP <645> Conductivity
• Ph. Eur. Water Monographs
• ICH Q2 (Analytical Validation Principles)
• 21 CFR Part 11 (For data integrity of electronic records)
• WHO TRS 961 / 1019

Why Choose PrimeGMP for TOC Calibration?

• Use of NIST-traceable TOC & benzoquinone standards
• Full compliance with USP/Ph. Eur. methodologies
• Accurate calibration of both online & offline TOC analyzers
• Strong documentation aligned with audit expectations
• Troubleshooting support for drift, baseline noise, and SST failures
• Expertise in WFI, PW, Loop Systems, and Point-of-Use TOC testing