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  4. [On-Demand Streaming] "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites"
SEMINAR_EVENT
  • Nov 29, 2024
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Nov 29, 2024

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

ハックジャパン ハックジャパン
Hack Japan held a seminar (in-person) on October 18 (Friday). In response to requests from those who could not attend this seminar, we will be offering three sessions of lectures and presentations on a limited-time on-demand basis. "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites" ■ Distribution Deadline: December 11, 2024 (Wednesday) ■ Content: ◎ Lecture 1 (Viewing Time: Approximately 1 hour) "Efforts in Cleaning Validation Utilizing TOC" Katsuharu Miyajima, Palmex Therapeutics Co., Ltd. ◎ Lecture 2 (Viewing Time: Approximately 45 minutes) "Current Status and Challenges of Cleaning Validation in Biopharmaceutical Manufacturing" Shinichi Fujimura, Takara Bio Inc. ◎ Presentation (Viewing Time: Approximately 20 minutes) "Lab TOC Meter QbD1200 + - Regarding High-Quality Data Integrity Compliance" Masatsugu Okada, Hack Japan Co., Ltd. ■ Target Audience: Personnel in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry. *Please note that applications from other companies in the same industry will not be accepted. Thank you for your understanding.
Date and time Friday, Nov 29, 2024 ~ Wednesday, Dec 11, 2024
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Entry fee Free
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Lab TOC meter QbD1200+

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.

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[Overseas Case] Total Organic Carbon (TOC) Analyzer for Laboratory QbD1200+

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.

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[Case Study] Pharmaceutical Factory Lab-type TOC Meter 'QbD1200'

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.

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Lab TOC Meter QbD1200+ Catalog (Pharmaceuticals, Purified Water, Cosmetics, etc.) | Hack Japan

Lab TOC Meter QbD1200+ Catalog (Pharmaceuticals, Purified Water, Cosmetics, etc.) | Hack Japan

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[Case Study] Pharmaceutical Factory Lab-type TOC Meter 'QbD1200'

[Case Study] Pharmaceutical Factory Lab-type TOC Meter 'QbD1200'

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[Seminar] Understanding Supply Risks of Critical Minerals: Circular Economy as a Resource Strategy

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[Speaker] Masamichi Miyanohara, Senior Analyst, Strategic Research Team, Economic Division, Sumitomo Corporation Global Research [Key Lecture Content] With the advancement of decarbonization, electrification, and digitalization, the stable procurement of critical minerals such as lithium and rare earths has become a challenge related to corporate supply chain strategies. This lecture will reframe the circular economy not only in terms of waste and environmental response but also from the perspective of resource procurement and supply chain resilience. Using lithium-ion batteries and rare earth magnets as subjects, we will organize how to incorporate source procurement, recovery, recycling, market and policy requirements, and information certification into the supply chain, while considering the policy trends of major countries and regions, and explore the direction of corporate responses required. [Lecture Items] 1. Background of the growing attention to the circular economy as a resource strategy 2. Policy trends of major countries and regions regarding lithium-ion batteries and rare earth magnets 3. Five functions in corporate responses - from source procurement to information certification 4. Case studies of corporate responses regarding lithium-ion batteries and rare earth magnets 5. Insights for companies 6. Q&A / Business card exchange

Sep 17, 2026

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[Seminar] The Cutting Edge of Mass Production and Implementation of Physical AI in China

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[Speaker] Zhang Yi, Chief Researcher, ICT Research and Consulting Department, National Institute of Information and Communications Technology [Key Lecture Content] As the global competition for physical AI development accelerates, China is rapidly advancing in mass production and social implementation by leveraging its strengths in supply chains and other areas. It is enhancing its presence not only in the robots themselves but also in the construction of AI foundational models and data infrastructure. This lecture will provide an overview of the current state of China's robotics market and industrial policy, analyzing the industry structure and key players from the main body and components to models, data, and infrastructure, as well as the forefront of implementation across different industries. Additionally, it will organize the challenges of implementation and efforts to address them, offering insights for Japanese companies. [Lecture Items] 1. What is Physical AI? 2. Market Overview and Industrial Policy of Physical AI in China 3. Structure of the Physical AI Industry in China and Key Players 4. Implementation in Progress in China 5. Challenges of Implementation 6. Future Outlook 7. Q&A / Business Card Exchange

Sep 17, 2026

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[Seminar] Learning from Japan's Amazing Technological Innovations: Winning Strategies for "Business Strategy, Technology Strategy, and Intellectual Property Strategy"

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[Speaker] Hajime Hiraki, CEO of Chemistry Cube Co., Ltd., Innovation Consultant [Key Lecture Content] Japanese companies possess numerous products with world-class technology and high market shares. However, merely developing excellent technology does not guarantee the establishment of sustainable competitive advantage. In this lecture, we will examine case studies of technological innovation from Japanese companies such as Murata Manufacturing, Tokyo Electron, Terumo, Shimano, Daikin, Hitachi, Komatsu, and Nitto Denko. We will unravel "why that technology succeeded as a business" and explain how to create a "winning strategy" to connect technology to business outcomes and build sustainable competitive advantage from the three perspectives of business strategy, technology strategy, and intellectual property strategy.

Sep 17, 2026

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Notice of Participation in the 'Industrial Exchange Exhibition 2026' from November 11 (Wednesday) to November 13 (Friday), 2026

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Akimoto Machinery Co., Ltd. will be exhibiting at the "Industrial Exchange Exhibition 2026" held at Tokyo Big Sight. This exhibition is a comprehensive showcase where small and medium-sized enterprises, startups, and ventures with excellent technologies and products from the metropolitan area gather to expand sales channels and foster inter-company collaboration. We sincerely look forward to your visit.

Sep 17, 2026

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Notice of Participation in the 13th Town Factory Exhibition from December 16 (Wednesday) to December 18 (Friday), 2026

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Akimoto Machinery Co., Ltd. will be exhibiting at the 13th Town Factory Exhibition held at Tokyo Big Sight. This exhibition is aimed at small and medium-sized manufacturing companies in the Katsushika area, as well as the eastern Tokyo area and neighboring regions. Manufacturers and small and medium-sized enterprises in sectors such as "machinery and equipment," "metal processing," "rubber," "plastic," "glass," "leather," "paper and printing," "textiles," and "plating" will be exhibiting, providing a venue for business discussions with visiting companies, government agencies, business development, and financial institutions. We sincerely look forward to your visit.

Sep 17, 2026

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