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  3. セントラル科学
  4. Are you ready for the system suitability testing of the TOC analyzer compliant with the European Pharmacopoeia (EP 12.3) revision?
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  • Oct 09, 2026
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Oct 09, 2026

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

セントラル科学 セントラル科学
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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EP TOC SST Compliance | Sievers EP System Suitability Test Standard Solution | Central Science
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SST.jpg

TOC Standard Solution EP System Compatibility Test Standard Solution Set

Would you like to improve your daily work efficiency with prepared standard solutions?

This is a set of standard solutions compliant with EP 2.2.44. TOTAL ORGANIC CARBON IN WATER FOR PHARMACEUTICAL, accompanied by a NIST certificate. *On July 1, 2026, the European Pharmacopoeia (EP 12.3) was revised, and the standard solutions for sucrose and benzoquinone were changed to Chemical Reference Substances (CRS). ★EP standard material supplier: EDQM (European Directorate for the Quality of Medicines) The Sievers brand TOC analyzer can be used, as well as TOC analyzers from other manufacturers. Since it is pre-prepared, it can be used immediately.

  • Water quality testing
  • Pharmaceutical water production equipment and facilities

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SST.jpg

EP Revision Response: Explanation of New Standards for TOC Testing and Reference Values by Container Volume

Are you ready to prepare for the revision of EP 12.3? A clear explanation of the new requirements for TOC testing and the standard values by container capacity.

The European Pharmacopoeia (EP) 12.3 edition, which came into effect on July 1, 2026, has significantly revised the requirements for TOC testing of pharmaceutical water. It includes mandatory use of EP CRS reference standards and the introduction of TOC criteria based on container capacity for sterilized water for injection, which will have a major impact on quality control operations in the pharmaceutical industry. This document summarizes the key points of the revisions and explains the impact on equipment performance and operations during the transition to EP reference standards.

  • Other water quality analysis
  • Water quality testing
  • Pharmaceutical water production equipment and facilities

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M9.png

TOC Analyzer for the Pharmaceutical Industry - Sievers M9

Rapid / Easy / Accurate TOC Measurement

The Sievers M9 can accommodate a variety of applications due to its unique gas-permeable membrane conductivity measurement method and wide measurement range (0.03 ppb to 50 ppm). Features of the Sievers M9: - No carrier gas required - Stability in ultra-low concentration range - 12 months of calibration stability - Three models to choose from based on application (laboratory type/portable type/online type) - Compliance with data integrity requirements based on 21 CFR Part 11 (optional) - The sample conductivity measurement function allows simultaneous measurement of TOC and conductivity (USP<645> Stage 1) (optional) - An auto-sampler can automatically analyze up to 63 samples (40mL) (optional)

  • Analytical Equipment and Devices

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Online TOC Analyzer Sievers M500 Model

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

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Related catalog(1)

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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Hyper CLT flooring panel

Quickly resolve your questions | We have added a Q&A page for Hyper CLT flooring.

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  • PRODUCT

We have newly added a **"Frequently Asked Questions Q&A"** section to the Hyper CLT sheet website. It clearly summarizes many questions frequently asked by those considering the introduction of the product, such as "What types of civil engineering sites can it be used on?", "Can it be used on rainy days?", "Is it compatible with large machinery?", and "What is NETIS?". The Hyper CLT sheet is a lightweight wooden sheet utilizing wood CLT, suitable for a wide range of applications including temporary roads, access routes, and heavy machinery work yards. It is also registered as a **Ministry of Land, Infrastructure, Transport and Tourism NETIS registered technology "TH-250021-A"**. Since it is a new material, we will not leave any uncertainties unaddressed. We aim to create a website that makes it easy to resolve questions before introduction, including information on wood, NETIS, civil engineering, and CLT, and we will continue to enhance the Q&A section.

Oct 11, 2026

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Hyper CLT flooring panel

Added a glossary to the website to make technical terms easier to understand.

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  • PRODUCT

We have added a new **"Glossary"** to the Hyper CLT sheet website. In the civil engineering and construction industries, there are many specialized terms such as "CLT," "NETIS," "temporary roads," and "wooden lightweight sheets." Therefore, we have introduced related terms in an easy-to-understand manner so that those who are encountering Hyper CLT sheets for the first time can understand the products and technologies. Hyper CLT sheets are wooden lightweight sheets for civil engineering that utilize wood CLT and are registered under the Ministry of Land, Infrastructure, Transport and Tourism's NETIS technology as **"TH-250021-A."** We hope that by not only conveying the features of the product but also sharing the underlying technologies and terminology, users will feel a closer connection to Hyper CLT sheets. We will continue to enhance our website and provide clear information related to wood, NETIS, civil engineering, and CLT.

Oct 10, 2026

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CCS3 product photo

The new product "Vehicle Count Sensor CCS3" enables efficient occupancy management of large parking lots.

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Hotron Inc. has launched its new product, the "Vehicle Count Sensor CCS3"! This product is a ceiling-mounted sensor that combines infrared and radar technology. It reliably detects vehicles in both directions with a single unit, accommodating traffic during congestion and vehicle passing, thus achieving efficient occupancy management in large parking lots. Additionally, it can be utilized for exit warning purposes in addition to vehicle counting, contributing to the safe and smooth operation of parking facilities. 'Features' - Improved detection performance against changes in road surface during rainy weather by using both infrared and radar. - Equipped with IP67 waterproof and dustproof performance, making it effective even in salt damage areas. - Various settings can be configured from a dedicated app (for Android devices), with current settings easily understandable at a glance. - The base dimensions are the same as the previous model "CCS2," allowing for smooth replacement of existing equipment. *For more details, please refer to the product information, catalog download, or contact us.*

Oct 09, 2026

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Hyper CLT flooring panel

On September 15, we issued a press release for the hyper CLT flooring.

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On September 15, 2026, we issued a press release regarding the wooden lightweight sheet "Hyper CLT Sheet." The Hyper CLT Sheet is a civil engineering sheet that utilizes CLT (Cross-Laminated Timber) stacked in an orthogonal direction. It can be used in various locations such as temporary roads, access routes, heavy machinery work yards, and material storage areas. The 5×10 version weighs approximately 230 kg, making it relatively lightweight and easy to install, remove, and relocate. Additionally, it offers environmental benefits such as reducing glare and metallic sounds typical of wood, as well as CO2 fixation. Furthermore, it can be proposed for the use of new technologies in public works as a **registered technology with the Ministry of Land, Infrastructure, Transport and Tourism "TH-250021-A."** Through this press release, we aim to expand the new wooden lightweight sheet that combines wood, NETIS, civil engineering, and CLT to more construction sites.

Oct 09, 2026

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Notice of the issuance of ISO-related information magazine "Intertek News" Issue 94.

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  • OTHER

We have published the latest issue (No. 94) of the ISO-related information magazine "Intertek News." Intertek News delivers information and various topics related to ISO audits, certifications, and verifications. This issue features a special section titled "Interpreting Standard Revisions," which introduces key points of management system standard requirements that new personnel should understand as preparation for standard revisions. Additionally, we have included customer case studies, articles contributed by auditors, and information on certifications and standards, as well as the latest topics, so please take a look.

Oct 09, 2026

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