Seminar Announcement: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from the Biopharmaceutical Manufacturing Field" (October 2024)

Data integrity compliance for pharmaceuticals, public bathhouse law, water quality testing for drinking water, tap water, and well water, cleaning and water quality management, TOC testing of plastic components.

The Hach QbD1200+ is a laboratory TOC analyzer that supports a wide range of TOC measurements, including ultrapure water and pharmaceutical water in the pharmaceutical industry, cleaning validation, TOC testing of plastic materials/plastic packaging systems, and compliance with regulations concerning tap water, drinking water, well water, and water quality management in cosmetics manufacturing, as well as cleaning line management. Specifically, it complies with various guidelines and implementation requirements, such as 3rd party conformity, PIC/S GMP, 21 CFR Part 11, and data integrity, making it ideal for regulatory compliance. Additionally, even for non-regulatory matters, it serves as a benchmark for internal standards (SOP) related to quality management within the company, allowing for the regular management and accurate, efficient recording of TOC values. Its compact design and intuitive operation have also received positive feedback.

• Other electronic measuring instruments

Introducing a case study of the implementation of TOC (Theory of Constraints) that achieved a reduction in labor hours and costs for examiners!

We would like to introduce a case study of Company A, a pharmaceutical factory that has implemented the lab-type TOC analyzer "QbD1200." The company conducts TOC testing at 12 use points from purified water and water for injection each time, but occasionally the TOC values would be negative or show results below the usual threshold of 10 ppb. After the implementation, they reported, "We are getting stable results below 20 ppb, and we have established a system that allows direct data transfer from the device without going through a PC." [Case Overview] ■ Benefits of Implementation - Stable TOC measurement values of 10 to 20 ppb have been confirmed. - The operation screen is easy to understand, resembling a tablet interface. - There is an automated testing procedure that covers everything from daily inspections to TOC measurements. - Measures such as automatic carryover prevention have reduced the workload for testers. - It is beneficial to receive direct support and information from the manufacturer, Hack. *For more details, please refer to the PDF document or feel free to contact us.

• Analytical Equipment and Devices

Significantly improved inspection efficiency! A case that ensured the consistency and traceability of standard samples!

We would like to introduce a case where a pharmaceutical industry inspection equipment manufacturer in Sichuan Province has implemented our lab TOC analyzer "QbD1200+". The company conducted high-precision testing and data calibration for each batch of various TOC standard samples developed in-house. Using the custom calibration curve function of this product, they created a calibration curve that met the performance indicator of a linear correlation R2 ≧ 0.999 within the range of 0 to 2000 ppb. Additionally, regarding accuracy and reproducibility, it also met the performance specifications for low-concentration TOC samples. 【Case Overview】 ■ Background - A highly advanced contamination control strategy is required to meet the performance levels demanded by the pharmaceutical industry. - Capable of rapid, efficient, accurate, and stable TOC measurements. - Assurance of high-quality standard sample production. *For more detailed information, please refer to the related links. For further inquiries, feel free to contact us.

• Other measurement, recording and measuring instruments

We will be exhibiting at "INTERPHEX JAPAN" held at Makuhari Messe. During the event, we will showcase various products. We invite all relevant parties to come and visit us. 【Suppliers】 ・LAUDA

We will be exhibiting at the "Pharma Lab EXPO 2026" held at Makuhari Messe. During the event, we will showcase various products. We invite all relevant parties to come and visit us. 【Suppliers】 - Strassburger - Erhfeld - nNano - Rheosense - SOTAX - Novasina - Alit Biotech - Endress Hauser

We will be exhibiting at the "NEW Environmental Exhibition 2026" held at Tokyo Big Sight. During the event, we will showcase various products. We invite all related parties to come and visit us. 【Suppliers】 - MAAG - Ettlnger

KELLER Pressure is a leading manufacturer of piezoresistive pressure sensors. We will showcase high-precision pressure sensors, compact pressure sensors, and high-speed response pressure sensors with the specifications listed below, focusing on pressure sensors and digital pressure gauges that have a proven track record in the aerospace sector. We will explain why KELLER Pressure products are chosen in the aerospace field and what sets them apart from competitors using the displayed products. [Example of Achievements] Rocket (fuel, oxidizer), satellites (atmospheric pressure measurement during atmospheric entry), combustion pressure measurement, aircraft attitude control, detonation, International Space Station (ISS), etc. For those who wish to have meetings or product introductions at our booth on the day of the event, we are accepting reservations in advance. Interested parties can contact us at sales.jp@keller-pressure.com. [Exhibition Content] We offer a variety of pressure sensors suitable for a wide range of measurements: - Low pressure to high pressure (0.5 kPa to 200 MPa) - Low temperature to ultra-high temperature (-50°C to 1000°C) - High precision (± 0.01% FS and above) - Compact (Φ 1.4 x 3.1 cm and above) - Ultra-fast response - Digital display pressure gauges

[Instructor] EY ShinNihon LLC Head of the Digital Strategy Department, Client Services Division Leader of the Space Business Support Office, Space Tech Lab Partner, Certified Public Accountant Nobuhiko Kato Senior Manager, Space Business Support Office Attorney and Certified Public Accountant Tatsu Fushimi [Key Lecture Content] The Space Strategy Fund is now widely recognized as essential for research and development in the space sector. After completing the first and second rounds of selections, the third round has begun, reaching 800 billion yen out of a total of 1 trillion yen. The utilization of satellite data has transitioned from mere demonstration to implementation in more specific fields. The space industry is on the verge of blooming, and many companies and stakeholders have begun to look toward "what comes next." In this seminar, we will analyze the trends and results of the Space Strategy Fund, discuss its future developments, and provide insights into the challenges and future prospects derived from unique experiences in planning and implementing satellite data utilization while advancing digital transformation (DX) in audit and assurance services. Experts familiar with public-private partnerships in space and the utilization of satellite data will offer suggestions to accelerate and develop your company's space business.