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  6. Online TOC Analyzer Sievers M500 Model

Online TOC Analyzer Sievers M500 Model

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Sievers M500

last updated:May 26, 2025

セントラル科学
セントラル科学
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An online TOC analyzer that adopts the "gas permeable membrane conductivity measurement technique" in accordance with the Japanese Pharmacopoeia General Test Method <2.59 Organic Carbon Test Method>.

The online TOC analyzer Sievers M500 is the third generation of online TOC analyzers that has developed Sievers' long-standing reagent-free gas permeable membrane conductivity measurement technology. While inheriting the conventional "accuracy," "reproducibility," and "stability," it has achieved rapid measurement and enhanced data management functions. 【Unique technology compliant with the Japanese Pharmacopoeia】 - Complies with the Japanese Pharmacopoeia General Test Method <2.59 Organic Carbon Test> - Complies with various national pharmacopoeias (USP <643>, EP 2.2.44) - Measures by separating carbon dioxide: gas permeable membrane conductivity measurement method - Calibration using potassium hydrogen phthalate - Detects sodium dodecylbenzenesulfonate with a recovery rate of over 90% 【High performance & high functionality】 - Real-time measurement at 3-minute intervals - Flexible sampling functions - Abundant system protocols - Data integrity compliant with 21 CFR Part 11

    Analytical Equipment and Devices
M500_iOS_CKC作.png

Online TOC Analyzer Sievers M500 Model

M500_iOS_CKC作.png
M500_iOS_CKC作.png
  • Central Science Corporation HP
  • Special site - Product/service details - https://pr.mono.ipros.com/aqua-ckc/product/

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basic information

【TOC】 Measurement Principle: Ultraviolet Oxidation + Gas Permeable Membrane Conductivity Measurement Method Measurement Range: 0.03 to 2,500 ppb TOC Detection Limit: 0.03 ppb Quantification Limit: 0.1 ppb Accuracy: ±5% of the measured value or ±0.1 ppb, whichever is larger Reproducibility: ±1% of the measured value or ±0.03 ppb, whichever is larger 【Conductivity】 Measurement Range: 0.01 to 800 μS/cm Accuracy: ±1% or ±0.005 μS/cm, whichever is larger Reproducibility: Within 1.0%

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Applications/Examples of results

**Real-Time Testing of Pharmaceutical Water** Real-time testing of TOC and conductivity using Process Analytical Technology (PAT) enables a better understanding and control of the pharmaceutical water system, improving quality and productivity. PAT utilizes real-time measurement data to design, analyze, and manage processes, ensuring product quality. To maximize the benefits of PAT, validation of the analytical method for TOC meters is necessary. The Sievers M500 provides documentation and standard solutions to support the implementation of analytical method validation. Adopting real-time testing for pharmaceutical water offers the following benefits: - Reduction of costs/resources/contamination/lab errors/data delays associated with traditional lab analysis - Real-time detection of out-of-specification and out-of-trend test results - Root cause analysis utilizing TOC/inorganic carbon/conductivity - Technology transfer from lab testing to online testing using Sievers TOC measurement technology.

Detailed information

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    "Selectivity of Carbon Dioxide Using Sievers' Unique Gas Permeable Membrane Conductivity Measurement Method" In the TOC measurement method, the conductivity indicated by the carbon dioxide (carbonate ions) generated after the oxidation and decomposition of organic matter is measured to calculate the carbon concentration. The Sievers M500 enables accurate TOC measurement by using a carbon dioxide separation measurement mechanism called the "gas permeable membrane module," which separates carbon dioxide from the sample water to the pure water line within the analyzer using a Teflon thin film, thereby eliminating the influence of other ions.

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Online TOC Analyzer Sievers M500

Online TOC Analyzer Sievers M500

PRODUCT
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Real-time TOC testing of PAT and pharmaceutical water

Real-time TOC testing of PAT and pharmaceutical water

TECHNICAL
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TOC Analyzer Sievers M500 compliance with 21 CFR Part 11 and data integrity

TOC Analyzer Sievers M500 compliance with 21 CFR Part 11 and data integrity

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Real-time test validation support package for pharmaceutical water.

Real-time test validation support package for pharmaceutical water.

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Sievers TOC Sensor CheckPoint Pharma

Sievers TOC Sensor CheckPoint Pharma

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Sievers TOC Sensor CheckPoint e

Sievers TOC Sensor CheckPoint e

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Bridging study for RTT process validation

Bridging study for RTT process validation

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Best practices for risk assessment applicable to RTT.

Best practices for risk assessment applicable to RTT.

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Best Practices for Out of Specification (OOS) Investigation Results

Best Practices for Out of Specification (OOS) Investigation Results

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Maintaining data integrity during the transfer to RTT.

Maintaining data integrity during the transfer to RTT.

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TOC Analyzer for Pharmaceuticals Sievers M9

TOC Analyzer for Pharmaceuticals Sievers M9

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Revision of EP regulations: New standards for TOC testing and new standard values by container capacity.

Revision of EP regulations: New standards for TOC testing and new standard values by container capacity.

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News about this product(1)

Are you ready for the system suitability testing of the TOC analyzer compliant with the European Pharmacopoeia (EP 12.3) revision?

  • Catalog news

The revision of the EP that came into effect on July 1, 2026, has significantly changed the requirements for the system suitability test (SST) of TOC analyzers. After the implementation of EP 12.3, in order to clarify standardization and traceability within the EP, the standard solutions for the system suitability test of TOC analyzers must use sucrose and 1,4-benzoquinone, which are certified as EP reference substances (Chemical Reference Substances: CRS). With the EP standard solution becoming the new standard, if USP standard solutions are to be continued, it is necessary to explain the validity of adopting USP reference substances. We have published a page on our website that explains the key points of the revision, necessary responses, considerations for continuing to use USP standard solutions, and ways to utilize EP standard solutions to reduce operational burdens. If you are considering how to respond to the EP revision, please take a look at the related links. Additionally, in the related materials, we provide detailed information on the requirements for standard solutions, reference values by container type, and comparative evaluation results using Sievers TOC analyzers, highlighting key points for quality control and regulatory compliance of pharmaceutical water.

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セントラル科学

セントラル科学

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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.

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