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  3. ハックジャパン
  4. [Registration Deadline 10/7] (Free Seminar) "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites"
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  • Oct 02, 2024
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Oct 02, 2024

[Registration Deadline 10/7] (Free Seminar) "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
**Seminar Held with Mr. Miyajima from Palm X Therapeutics and Mr. Fujimura from Takara Bio** Our company will hold a seminar on October 18 (Friday) in Tokyo for professionals involved in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry. ■ Title: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from Biopharmaceutical Manufacturing Sites" ■ Date and Time: October 18, 2024 (Friday) 13:30 - 17:00, Doors Open: 13:00 ■ Venue: Waim Conference Room Takadanobaba 4B (4th Floor, TD Building, 1-29-9 Takadanobaba, Shinjuku-ku, Tokyo) ■ Capacity: 50 people (planned) ■ Application Deadline: October 7, 2024 (Monday) *Registration will close if capacity is reached before the deadline. ■ Participation Fee: Free ■ Target Audience: Professionals involved in quality assurance, quality control, and manufacturing technology in the pharmaceutical manufacturing industry ■ Organized by: Hack Japan Co., Ltd. (formerly Hack Ultra)
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Related Documents

【セミナー】洗浄バリデーションの最新トレンドとTOCの有用性.pdf[987848]

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Latest Trends in Cleaning Validation and the Utility of TOC
Registration deadline: October 7 (Monday)

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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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Related catalog(1)

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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Truck berth vehicle detection

It's not too late to address the "Logistics 2024 Problem." Why not immediately reduce drivers' waiting times?

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Are you making progress on measures for the "2024 Problem"? With stricter management of drivers' working hours, reducing "waiting time" has become an urgent issue in the logistics field. To address this challenge, our company, Hotron, proposes the "Vehicle Detection Ultrasonic Sensor 'HM-UX2'," which instantly grasps the availability of loading bays. The 'HM-UX2' contributes to the resolution of waiting times by accurately understanding the availability situation, reducing unnecessary waiting and queueing, and shortening waiting times to alleviate the burden on drivers! By replacing the "eyes" of your loading bay management with this high-precision sensor, why not start addressing the "2024 Problem"? Take a look at the product features: "Can it accurately detect availability?" "Can we really use it in our company?" "I just want to know the cost, even if it's an estimate." If you have any questions or requests, please feel free to consult with us.

Aug 08, 2025

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Hidetoshi Tojo appointed as the representative executive president of the U.S. Anthropic Japan Corporation.

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Tokyo, August 7, 2025 - (JCN Newswire) - Anthropic, an AI research and development company that develops the cutting-edge AI model Claude, announced today the appointment of Hidetoshi Tojo as the Representative Executive Officer and President of its Japanese subsidiary. Tojo has extensive experience driving growth for technology companies in Japan, most recently serving as the President and Executive Officer of Snowflake's Japanese subsidiary, where he was involved from the launch of the business and achieved significant growth. He has also contributed to the advancement of data utilization in major Japanese companies by closely collaborating with various system integrators. Additionally, he has experience leading teams at Google Cloud Japan and Microsoft, both at their U.S. headquarters and Japanese subsidiaries. For more details, please refer to: https://acnnewswire.com/press-release/japanese/101731/

Aug 07, 2025

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◆Asano Corporation◆ Notice of Summer Vacation ★ Asano is a development support manufacturer for automobiles, motorcycles, bicycles, aircraft, space rockets, and more.

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We sincerely apologize for the inconvenience, but Asano Co., Ltd. will be closed for summer vacation during the following period. We appreciate your understanding. Closure Period: August 13, 2025 (Wednesday) to August 17, 2025 (Sunday) Reopening: August 18, 2025 (Monday) <Inquiries> We will respond sequentially starting from August 18, 2025 (Monday). Asano Co., Ltd. is a manufacturer that supports the development of mobility parts, including automobiles, motorcycles, bicycles, aircraft, and space rockets. We conduct in-house integrated production of sheet metal, plastic, and composite products. We offer proposals for hybrid molding and multi-material bonding, among others. ■ Inquiries ■ Asano Co., Ltd. Headquarters and Gunma Factory 2718-1 Sanwa-cho, Isesaki City, Gunma Prefecture, 372-0011 TEL: 0270-75-1700 FAX: 0270-75-1600 MAIL: salesg@asano-japan.com Official YouTube Channel: https://www.youtube.com/@asano-japan

Aug 07, 2025

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Kit 1 θ/2 Method Contact Angle Analysis Software

New Product: Simple Contact Angle Meter Kit - Amazon Exclusive Model

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Newly released: Contact Angle Meter Entry Mini Kit Model, Amazon Exclusive Model JISR3257 compliant, includes θ/2 method and contact angle analysis software. Windows PC sold separately. Complete product priced at ¥399,300 (tax included). At the same time, we have started selling individual components for the contact angle meter kit as an Amazon exclusive model: "θ/2 Method Contact Angle Analysis Software" Kit 1, "Stage + Backlight + Housing" Kit 2, and "Dedicated USB Camera" Kit 3. The contact angle meter can be integrated into the device, allowing for the combination of "θ/2 Method Contact Angle Analysis Software" Kit 1 and "Dedicated USB Camera" Kit 3 for applications. Only the necessary elements such as software and camera can be combined. These models are exclusive to Amazon and will be sold and shipped by Amazon.co.jp.

Aug 07, 2025

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Our employee was featured in a special article in the Sanyo Shimbun.

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Our company, NICS Corporation (Headquarters: 1-11-1 Uno, Tamano City, Okayama Prefecture, President: Shinichiro Yamane), had an employee featured in the special article "New Star ★ Running" in the local economy section of the Sanyo Shimbun dated August 7.

Aug 07, 2025

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