[On-Demand Streaming] "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites"

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

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

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

Nitto Kohki will exhibit at the "H₂ & FC EXPO Spring International Hydrogen and Fuel Cell Exhibition" held at Tokyo Big Sight, West Exhibition Hall 2, from February 28 (Wednesday) to March 1 (Friday), 2024. [Booth Number: W14-63] The quick fluid coupling "Coupler" is a product that allows for the rapid connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling quick fluid coupling "HHV Coupler."

Nitto Kohki will hold the "2025 Attack Fair in Meiko" for two days from July 23 (Wednesday) to July 24 (Thursday), 2025, at the "Kowa Seminar Plaza 2F Training Room NO.12 (inside Kowa Sports Land)." The Attack Fair is an exhibition where you can actually "see, touch, and operate" Nitto Kohki's products. Additionally, there will be wonderful souvenirs for attendees and many fun activities planned. We look forward to welcoming everyone!

Recently, a variety of ceramic 3D printers have been rapidly introduced to the market, enabling the creation of complex shapes that were previously impossible, as well as hollow, porous, and lattice structures. This has led to the innovative production of ceramic parts, short-term, low-cost, high-quality manufacturing, a significant reduction in the number of parts, and a substantial decrease in production processes and workforce. On the other hand, Canon has developed a new high-performance ceramic material that excels in selective laser melting, which minimizes "shrinkage" during firing, utilizing metal 3D printers. In June of last year, Canon and the Metal Research Institute collaborated to officially launch a contract manufacturing service for high-precision, complex-shaped ceramic parts using Canon's innovative ceramic materials and 3D Systems' metal 3D printers. In this seminar, we will explain the development trends of Canon's ceramic materials compatible with metal 3D printers, the molding technology using these materials, the characteristics of the parts that can be molded, the physical properties and features of the molded products, target areas, collaboration with the Metal Research Institute, and future developments in material development. [If you apply now, the course fee is half price (9,500 yen)] When applying, please write "Other [9,500 yen]" in the "Other" section above the application form on our website.

Next-generation large and high-speed metal 3D printers that offer short production times, low costs, and high precision are being rapidly introduced to the market, leading to increased adoption and utilization. In the first session of this seminar, we will discuss the short production technology and case studies of Fuji High Frequency Industry, which has introduced a large metal 3D printer from Meltio, as well as examples of cost reduction and material savings through topology optimization. The second session will cover the overview of the Farsoon LPBF method large and high-speed metal 3D printer, which can produce up to 1500mm, along with its short production time, low cost, and high-quality manufacturing technology, as well as public production case studies. The third session will present applicable cases at JFE Engineering, which has seen a surge in requests for manufacturing from various fields after introducing a large metal 3D printer from Nidec Machine Tool, including publicly available marine and rocket engine parts, plant equipment parts, as well as applications in parts and mold repair and reverse engineering. The fourth session will provide a detailed explanation of the latest manufacturing technology and case studies from Sanko Gosei, which has introduced a large hybrid metal 3D printer from Matsuura Machinery to produce high-functionality and high-quality diverse large resin mold parts. [If you apply now, the course fee will be half price (9,500 yen)] When applying, please write "Other [9,500 yen]" in the "Other" section above the application form on our website.

[Lecture Topics] 1. Understanding SpaceX's Hardware through Patent Information - How Did They Overcome the Barriers to Mass Production? Takao Inoue, Director and Patent Attorney, AIPE Certified Senior Intellectual Property Analyst (Patents) 2. Mapping the Power Dynamics of New Space and Key Areas of Research and Development through Patent Information Kento Kawase, President, AIPE Certified Intellectual Property Analyst (Patents) Q&A / Business Card Exchange