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Lab Manufacturers China

TOC Analyzers

制药总有机碳分析仪

TAN · Pharmaceutical Analysis Equipment · 5 models

By Lab Manufacturers China Technical TeamLast reviewed Standards: USP <643>, USP <645>, Ph. Eur. 2.2.44

Standards referenced

  • USP <643>
  • USP <645>
  • Ph. Eur. 2.2.44
  • ICH Q2(R2)
  • IEC 61010-1
  • ISO 17025

What are TOC Analyzers?

TOC analyzers for pharmaceutical analysis measure total organic carbon in purified water, water for injection and cleaning samples. Pharmaceutical water system operators and quality control laboratories use them to demonstrate that water and cleaned surfaces meet pharmacopoeial and GMP limits.

5 models of TOC Analyzers

The 5 models below are current configurations; specifications are confirmed on quotation.

TOC Analyzer for Pharmaceutical Purified Water

纯化水总有机碳分析仪

  • TAN-0001
  • TOC Analyzers
  • CE (to be confirmed)
  • IEC 61010-1 compliance (to be confirmed)
  • ISO 13485 manufacturing (to be confirmed)
Measuring range:
0.001–50 mg/L
Limit of detection:
about 0.001 mg/L
Oxidation principle:
UV persulfate or combustion
Inorganic carbon handling:
Sparging or differential measurement
Analysis time:
about 3–10 min per sample
Calibration standard:
Potassium hydrogen phthalate or sucrose

A TOC analyzer for pharmaceutical purified water measures organic carbon against the pharmacopoeial limit during routine water testing. It is chosen for batch checks of purified water used in production and laboratory work.

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TOC Analyzer for Water for Injection

注射用水总有机碳分析仪

  • TAN-0002
  • TOC Analyzers
  • CE (to be confirmed)
  • IEC 61010-1 compliance (to be confirmed)
  • ISO 13485 manufacturing (to be confirmed)
Measuring range:
0.0005–10 mg/L
Limit of detection:
about 0.0005 mg/L
Oxidation principle:
Combustion or UV persulfate
Inorganic carbon removal:
Acid sparge or differential
Carryover:
Rinse between low-level samples
Analysis time:
about 4–12 min per sample

A TOC analyzer for water for injection measures very low organic carbon levels in high-purity water. It is chosen where sensitivity and reliability must support a critical water specification in sterile production.

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Online TOC Analyzer for Pharmaceutical Water Systems

制药用水系统在线总有机碳分析仪

  • TAN-0003
  • TOC Analyzers
  • CE (to be confirmed)
  • IEC 61010-1 compliance (to be confirmed)
  • ISO 13485 manufacturing (to be confirmed)
Measuring range:
0.001–50 mg/L
Limit of detection:
about 0.001 mg/L
Sampling interval:
programmable, 1–60 min
Oxidation principle:
UV persulfate or combustion
Conductivity range:
0.05–20 µS/cm
Interface:
4–20 mA, digital or SCADA

An online TOC analyzer is installed in a pharmaceutical water loop and samples automatically at set intervals. It is chosen to monitor a water system continuously with trend data and alarms rather than periodic grab samples.

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Laboratory TOC Analyzer for Cleaning Validation

清洁验证实验室总有机碳分析仪

  • TAN-0004
  • TOC Analyzers
  • CE (to be confirmed)
  • IEC 61010-1 compliance (to be confirmed)
  • ISO 13485 manufacturing (to be confirmed)
Measuring range:
0.001–100 mg/L
Limit of detection:
about 0.001 mg/L
Oxidation principle:
UV persulfate or combustion
Sample types:
Rinse water and swab extract
Swab recovery:
Validated per surface and analyte
Carryover:
Low, with rinse between samples

A laboratory TOC analyzer for cleaning validation measures organic residue in rinse and swab samples from cleaned equipment. It is chosen when residue limits must be demonstrated after pharmaceutical equipment cleaning and many samples are measured.

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Portable TOC Analyzer for Pharmaceutical Water Testing

制药用水检测便携式总有机碳分析仪

  • TAN-0005
  • TOC Analyzers
  • CE (to be confirmed)
  • IEC 61010-1 compliance (to be confirmed)
  • ISO 13485 manufacturing (to be confirmed)
Measuring range:
0.01–100 mg/L
Limit of detection:
about 0.01 mg/L
Oxidation principle:
UV persulfate or UV oxidation
Analysis time:
about 2–8 min per sample
Power supply:
Battery or 220 V, 50 Hz
Weight:
about 3–8 kg

A portable TOC analyzer is used for on-site spot checks at points of use in a pharmaceutical facility. It is chosen when water quality must be verified immediately at the sampling point or during investigations.

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Compare TOC Analyzers models

ModelMeasuring rangeLimit of detectionOxidation principleAnalysis timePower supply
TOC Analyzer for Pharmaceutical Purified WaterTAN-00010.001–50 mg/Labout 0.001 mg/LUV persulfate or combustionabout 3–10 min per sample220 V, 50 Hz, about 0.3 kW
TOC Analyzer for Water for InjectionTAN-00020.0005–10 mg/Labout 0.0005 mg/LCombustion or UV persulfateabout 4–12 min per sample220 V, 50 Hz, about 0.4 kW
Online TOC Analyzer for Pharmaceutical Water SystemsTAN-00030.001–50 mg/Labout 0.001 mg/LUV persulfate or combustion—220 V, 50 Hz, about 0.3 kW
Laboratory TOC Analyzer for Cleaning ValidationTAN-00040.001–100 mg/Labout 0.001 mg/LUV persulfate or combustionabout 4–10 min per sample220 V, 50 Hz, about 0.3 kW
Portable TOC Analyzer for Pharmaceutical Water TestingTAN-00050.01–100 mg/Labout 0.01 mg/LUV persulfate or UV oxidationabout 2–8 min per sampleBattery or 220 V, 50 Hz

Indicative values for this product class. Final specifications are confirmed on the quotation and in the calibration documents supplied with the instrument.

How do TOC Analyzers work?

A TOC analyzer oxidises organic carbon in a water sample to carbon dioxide and measures the resulting gas. Oxidation is achieved by ultraviolet light with a persulfate reagent, by high-temperature combustion at 680 °C or above, or by a combination of these, and the carbon dioxide is quantified by conductivity after membrane separation or by a non-dispersive infrared detector. Because inorganic carbon such as dissolved carbonate also produces carbon dioxide, most instruments measure it separately, either by acidifying and sparging before oxidation or by a parallel channel, and report total organic carbon as the difference. Conductivity of the water itself, often expressed as a conductivity-to-TOC ratio, is an additional pharmacopoeial control for purified water and water for injection.

Which TOC Analyzers variants are available?

  • TOC Analyzer for Pharmaceutical Purified Water — A TOC analyzer for pharmaceutical purified water measures organic carbon against the pharmacopoeial limit during routine water testing.
  • TOC Analyzer for Water for Injection — A TOC analyzer for water for injection measures very low organic carbon levels in high-purity water.
  • Online TOC Analyzer for Pharmaceutical Water Systems — An online TOC analyzer is installed in a pharmaceutical water loop and samples automatically at set intervals.
  • Laboratory TOC Analyzer for Cleaning Validation — A laboratory TOC analyzer for cleaning validation measures organic residue in rinse and swab samples from cleaned equipment.
  • Portable TOC Analyzer for Pharmaceutical Water Testing — A portable TOC analyzer is used for on-site spot checks at points of use in a pharmaceutical facility.

How do I choose the right variant?

Choose a TOC analyzer by the matrix, the required limit of detection and the measurement location. Laboratory instruments serve batch testing of purified water, water for injection and cleaning validation samples, and high-sensitivity combustion or UV persulfate models reach low microgram per litre levels. Online instruments are installed in a water loop, taking periodic samples automatically and alarming if the value drifts, which gives continuous assurance of a water system. Portable units are used for spot checks at points of use. Compare measuring range, limit of detection, oxidation principle, inorganic carbon handling, calibration standard, sample throughput and, for online units, interface and alarm options. Confirm compliance with pharmacopoeial chapter requirements and qualification documentation.

Where are TOC Analyzers used?

TOC Analyzers are specified in purified water monitoring, water for injection testing, cleaning validation, pharmaceutical water system control, container and closure extractables screening and environmental monitoring support.

Which standards and certifications apply?

Work with TOC Analyzers is commonly governed by USP <643>, USP <645>, Ph. Eur. 2.2.44, ICH Q2(R2), IEC 61010-1 and ISO 17025. Instrument certifications such as CE marking are confirmed per configuration and never assumed.

What are the key considerations before purchase?

Install the analyzer on a clean bench or in the water loop according to the manufacturer's requirements, and allow adequate warm-up and stabilisation before measurement. Use certified standards such as potassium hydrogen phthalate or sucrose for calibration, and verify performance with an independent standard and a blank at defined intervals. Keep sample containers clean and free of organic residue, and analyse promptly or preserve samples as the method requires, because organic contamination and microbial growth change results. For online units, maintain the sampling line, filters and valves, and verify that the reading tracks a manual reference. Record calibration, verification and maintenance, and investigate any excursion against the action limit.

Frequently asked questions about TOC Analyzers

It measures the concentration of organic carbon in water, expressed in milligrams or micrograms of carbon per litre. Organic carbon is an indicator of contamination by organic molecules or microorganisms, and pharmacopoeial limits apply to purified water and water for injection.

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