Notice of Participation in the 27th Interphex Week Tokyo from July 9 (Wednesday) to July 11 (Friday), 2025

RTRT reduces the effort of sampling, detects OOS and OOT through real-time analysis, and implements corrective actions, thereby reducing risk, labor, and operational costs.

In the pharmaceutical industry, processes that are free of waste and continuous improvement are required. Efficient processes enable the provision of safe and high-quality pharmaceuticals when needed. By adopting real-time testing of pharmaceutical water, it is possible to streamline the manufacturing process while ensuring quality. At Central Science, real-time testing of TOC and conductivity using the Sievers TOC analyzer optimizes the monitoring of pharmaceutical water systems, achieving better process control, productivity improvement, and risk management for cGMP processes. **Features** - Reduces costs, resources, contamination, lab errors, and data delays associated with traditional lab analysis - Detects and addresses OOS and OOT in real-time - Continuous control and system validation - Setting of alert levels and action levels based on trend data In the PDF data, you can find technical materials related to TOC real-time testing and information on the "Online TOC Analyzer Sievers M500" and "Sievers M9 Lab Model for Pharmaceutical Water/Cleaning Validation." *For more details, please download the catalog or contact us directly.*

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

Shall we make the bio-burden test 45 minutes?

The bio-burden test is one of the important quality control processes to ensure the safety, quality, and compliance of pharmaceuticals. The culture method requires microbial cultivation, which takes about a week to determine results. The bio-burden rapid analysis device Soleil, developed by Sievers, can detect fewer than 10 viable microorganisms in 100 mL with ultra-high purity in under 45 minutes. It has a strong correlation with the culture method, enhancing the safety of pharmaceuticals and the efficiency of the manufacturing process while minimizing risks. In 2023, the PIC/S GMP Annex 1 was implemented, and rapid methods have begun to be adopted as a means of contamination control. This will be useful for the validation of pharmaceutical water/cleaning/process samples/raw materials/final products.

• Analytical Equipment and Devices

Endotoxin measurement is semi-automated! It significantly reduces the test error rate!

The endotoxin measurement device Eclipse, developed by Sievers, aims to make endotoxin testing easy for anyone. Many users have experienced challenges with traditional endotoxin measurements, such as the time and effort required for pipetting operations and the occurrence of human errors. Eclipse has achieved semi-automation of endotoxin measurement by developing a dedicated microplate and microfluidic technology. For measuring 21 samples, pipetting operations are reduced to fewer than 30 times, and since the standard samples are pre-filled, the preparation time and effort for testing are significantly reduced. Additionally, the amount of lysate reagent used is reduced by 90% to just 1mL, contributing to the ecological protection of horseshoe crabs. The IQ/OQ can also be completed in just a few days, so you can rest assured.

• Testing Equipment and Devices

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

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

■Connecting Biomarker Discovery to Clinical Application - Explained with Real Cases of Neurodegenerative Diseases Although biomarkers are discovered, many do not reach clinical application. The reasons for this lie in multiple hurdles that arise after discovery, such as "narrowing down candidates," "reproducibility," and "connecting to clinical practice." 1. How should promising candidates obtained from comprehensive exploration be narrowed down? 2. How can reproducibility and scalability be ensured? 3. What are the key points for smoothly transitioning to clinical research? 4. What should be considered in data science throughout the overall flow? In this online seminar, we will clearly explain specific strategies for advancing from discovery to clinical application based on actual research cases of Alzheimer's disease and multiple sclerosis, in an easy-to-understand manner in Japanese. *Olink products and services are for research purposes only. Please note that they cannot be used for diagnostic purposes.

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely invite you to visit us during this busy time. 【 Exhibition Name 】 Automotive Technology Exhibition 2025 YOKOHAMA https://aee.expo-info.jsae.or.jp/ja/yokohama/ (An "online exhibition" will also be held during and around the event period) 【 Dates 】 May 21 (Wednesday) - 23 (Friday), 2024 10:00 AM - 6:00 PM *On the final day, 9:00 AM - 4:00 PM (Online exhibition: May 14 (Wednesday) - June 4 (Wednesday)) 【 Venue 】 Pacifico Yokohama (1-1-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa Prefecture) Our booth number: "Concourse 505"

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 27th INTERPHEX Week Tokyo https://www.interphex.jp/tokyo/ja-jp.html 【 Dates 】 July 9 (Wednesday) - 11 (Friday), 2025 10:00 AM - 5:00 PM 【 Venue 】 Tokyo Big Sight (3-11-1 Ariake, Koto-ku, Tokyo 135-0063)

We are pleased to announce the upcoming webinar "Analytical Instruments Course - Basic Edition." This course is designed for anyone who will be involved in analytical work starting this spring, as well as those who wish to revisit the principles of analytical methods. This time, we will explain sulfur, nitrogen, and chlorine analysis instruments, as well as total organic carbon analysis instruments. If you are interested, please register for participation through the details and registration button. Start times: 14:00 - Nitrogen, Sulfur, and Chlorine Analysis Instruments 15:00 - Total Organic Carbon Analysis Instruments

We are pleased to announce the upcoming webinar "Analytical Instrument Course - Basics Edition." This course is designed for anyone who will be involved in analytical work starting this spring, as well as those who wish to revisit the principles of analytical methods. We believe that everyone will find the content satisfying. If you are interested, please register for participation using the application button. This time, the program will be held as follows: 1:00 PM - Microwave Sample Digestion System 2:00 PM - Atomic Absorption Spectrophotometer 3:00 PM - ICP Emission Spectrometer