GMP-compliant Total Organic Carbon analysis for pharmaceutical water and cleaning validation, with 21 CFR Part 11-ready audit trails and system suitability testing built in.
Total Organic Carbon (TOC) is a fast, non-specific indicator of organic contamination in pharmaceutical water systems and cleaning validation samples. Where lab TOC data feeds directly into batch release or cleaning verification decisions, instrument reliability, system suitability testing, and data integrity become as important as the raw measurement itself - a weak audit trail can undermine an otherwise passing result during inspection.
USP General Chapter <643> defines the TOC test and system suitability requirements for water used in pharmaceutical manufacturing, while <645> covers the companion conductivity test. USP <1231> (Water for Pharmaceutical Purposes) provides broader context on water system monitoring expectations. Where TOC data supports batch decisions, FDA 21 CFR Part 11 governs the electronic record and signature requirements for the resulting data.
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High Quality
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Advanced Equipment
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Professional Team
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Custom Service
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
Our Solutions
Our GMP TOC analyzer performs UV-per-sulfate oxidation with differential conductivity detection with built-in USP <643> system suitability testing, and generates Part 11-compliant test data with full audit trail and electronic signature. The module is designed for lab bench top testing and inline pharmaceutical water system monitoring, and can be configured for variable sampling volume and wide 1–1000 ppb measuring range with multi-test modes. As the manufacturer, we offer semi-annual calibration service, fast spare part supply, complete validation documentation and round-the-clock global technical support.
TOC product comparison
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TOC TA-2.0
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TOC TA-3.0
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TOC TA-3.5
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TOC TA-5.0
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| Application Scenarios | online/offline/Cleaning validation | Online | Online | Multi-Pioint Monitoring(up to 100 Channels) |
| Measurement Range | 1~1000ppb | 1~1000ppb | 1~1000ppb | 1~1000ppb |
| Conductivity Detection Range | 0.055μS/cm~8000μS/cm | 0.055μS/cm~8000μS/cm | 0.055μS/cm~8000μS/cm | 0.055μS/cm~6000μS/cm |
| Resolution | 0.001mg/L | 0.001mg/L | 0.001mg/L | 0.001mg/L |
| Response Time | ≦5mins | ≦60s | ≦60s | ≦60s |
| Audit Trail | 4-level access control(21 CFR PART 11 compliant),≧3 years storage | 4-level access control(21 CFR PART 11 compliant),≧3 years storage | 4-level access control(21 CFR PART 11 compliant),≧5 years storage | 4-level access control(21 CFR PART 11 compliant),≧3 years storage |
| Weight | 8.5kg | 8.5kg | 8.7kg | 8.4kg |
| Key Advantages | Supports 3-points equential online,offline testing, low installation cost | Single/multi-point time-division monitoring IP-rated housing, meets regulatory requirements | Fast Response,long-term data storage,easy calibration ports | Supports up to 8 independant monitoring points, UV static oxidation principle, high stability |
| sizes | 400*240*270 | 300*210*250 | 300*150*400 | 300*210*250 |
| prices | $ Get Quote from Sales | $ Get Quote from Sales | $ Get Quote from Sales | $ Get Quotes from Sales |
FAQ
Q1: What is system suitability testing for TOC, and why does it matter?
A1: System suitability testing, per USP <643>, verifies the analyzer's response using a known standard and a system-suitability solution before sample testing, confirming the instrument is performing within validated limits on the day of use.
Q2: What TOC detection method is most common for pharmaceutical water?
A2: High-temperature combustion oxidation and UV/per-sulfate oxidation are the two most widely used principles, each with trade-offs in sensitivity, sample throughput, and maintenance.
Q3: Does TOC testing replace microbial testing of water systems?
A3: No - TOC measures organic carbon load as a proxy for chemical/organic contamination and is used alongside, not instead of, microbial and conductivity testing.
Q4: How does a GMP TOC analyzer support 21 CFR Part 11 compliance?
A4: Through features such as audit trails, role-based access control, electronic signatures, and secure, exportable data records tied to each test run.