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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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QbD1200+_mini_2web.jpg

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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Notice of Participation in "Chemical Material Japan 2025" on November 27 (Thursday) and 28 (Friday), 2025.

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Nagoya Chemical Industry Co., Ltd. will be exhibiting polyimide resins at the booth of Matsuo Sangyo Co., Ltd. during the 'Chemical Material Japan 2025' event held at Tokyo Big Sight. We also plan to showcase our developed products, including soluble polyimide, transparent polyimide, and porous polyimide, so we look forward to seeing you there.

Nov 15, 2025

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A Must-See for DX Promotion Leaders! How to Advance "Feasible Business Reform" Connecting Business Visualization to IT Concepts (Tokyo Event)

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In promoting DX and business reform projects, are your initiatives becoming "system construction first"? While you may have envisioned an ideal, it may not lead to "practical reforms" rooted in the field. For those facing such challenges, this seminar will provide hints for solutions. In this seminar, we will clearly explain the specific approach from "visualizing business processes" to "IT strategy (systemization strategy)" in business reform projects, incorporating case studies and practical steps. We will also introduce the essence of our "business process-focused, supportive consulting." Additionally, details on writing business flows, creating RFPs, and formulating systemization roadmaps will be covered in a separate seminar.

Nov 15, 2025

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Generative AI inherits the expertise of skilled professionals! Public seminar on Panasonic's successful case of DX in the Quality Assurance Department.

Generative AI inherits the expertise of skilled professionals! Panasonic's quality assurance department publishes a successful case of digital transformation.

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~AI Chatbot Breaks Through the Barriers of Business Knowledge! A Method to Achieve Both Talent Development and Business Efficiency Simultaneously~ The burden of searching through vast amounts of documentation in quality assurance operations has been dramatically improved by the generative AI chatbot "WisTalk"! In this seminar, Panasonic Industry Co., Ltd. will present a case study on how they utilized "WisTalk" to reduce the search workload for over 4,000 pages of quality assurance documents while balancing business quality and talent development. 【What You Will Learn in This Seminar】 ● How to inherit the knowledge of experienced personnel using AI ● The effects of reducing business burdens and improving performance through the efficiency of document search operations ● Key points for implementing an AI chatbot for knowledge search 【Recommended For】 ● Those who feel challenges in searching for business manuals and various regulatory documents ● Those considering the use of AI for promoting DX and talent development ● Those struggling with knowledge inheritance in quality assurance and technical departments In the first part, we will discuss actual implementation cases, and in the second part, we will provide a detailed explanation of the potential of "WisTalk" through product introductions. We hope you will join us!

Nov 14, 2025

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"Inter BEE 2025" Digital Content will be exhibited at the Akamai booth!

Finally this week! November 19-21: Exhibiting at Inter BEE 2025!

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The "Inter BEE 2025," which reflects the future of the media industry, will finally be held from November 19 (Wednesday) to November 21 (Friday) this week. DigiCon will be exhibiting at the Akamai corporate booth at this event, where the most talked-about theme in the industry right now, "the fusion of edge and cloud," can be experienced firsthand. ★☆★☆★☆★☆★☆★☆★☆★ ◆ DigiCon will exhibit at the "Inter BEE 2025" Akamai booth! ◆ ▼ Detailed Information https://www.digi-c.co.jp/news/20251104.html We will showcase demos of services such as "multi-angle streaming service" and "live streaming service"! ★☆★☆★☆★☆★☆★☆★☆★ At the booth, we will not only introduce technologies but also present "specific examples of migrating and optimizing existing products to the Akamai Connected Cloud," which directly addresses challenges in streaming infrastructure, along with easy-to-understand demonstrations. All of our staff are looking forward to seeing you at the venue. ▼ InterBEE2025 https://www.inter-bee.com/ja/

Nov 13, 2025

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Not just sticking to the current practices! System renewal advancing alongside business reform - Three key points for success - (Tokyo event)

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Is it best to carry over the current business processes into the next system? Even if we have built an optimal business operation through years of improvements, there is still room for productivity enhancement, and there are certainly not a few processes that have already become obsolete. A system overhaul presents a perfect opportunity to reassess the current business operations. Until now, the mainstream approach has been to customize large-scale systems that are fundamental to the company to include all necessary functions. However, the rapidly changing business environment today means that such systems cannot respond swiftly to changes. Additionally, system modifications require time and costs. So, how can we efficiently build a system that can adapt to the business environment? I will explain three key points to achieve this.

Nov 13, 2025

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  • 新たな発想が、ここで起動する。 課題解決に導くモーションシステムイベント MOTION MIRAI PARK 2025.12.11 Thu~12 Fri 東京国際フォーラム
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