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  1. Home
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  3. ハックジャパン
  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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multi EA 5100 Elemental Analyzer

Web Seminar: Analytical Instrument Course - Basic Edition [Held on May 16] Sulfur, Nitrogen, Chlorine Analyzers, and TOC Analyzers

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  • SEMINAR_EVENT

We are pleased to announce the upcoming webinar "Analytical Instruments Course - Basic Edition." This course is designed for anyone who will be involved in analytical work starting this spring, as well as those who wish to revisit the principles of analytical methods. This time, we will explain sulfur, nitrogen, and chlorine analysis instruments, as well as total organic carbon analysis instruments. If you are interested, please register for participation through the details and registration button. Start times: 14:00 - Nitrogen, Sulfur, and Chlorine Analysis Instruments 15:00 - Total Organic Carbon Analysis Instruments

Apr 10, 2026

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Web Seminar: Analytical Instrument Course - Basic Edition [Held on May 23] Microwave Sample Decomposition Device, Atomic Absorption, ICP Emission

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  • SEMINAR_EVENT

We are pleased to announce the upcoming webinar "Analytical Instrument Course - Basics Edition." This course is designed for anyone who will be involved in analytical work starting this spring, as well as those who wish to revisit the principles of analytical methods. We believe that everyone will find the content satisfying. If you are interested, please register for participation using the application button. This time, the program will be held as follows: 1:00 PM - Microwave Sample Digestion System 2:00 PM - Atomic Absorption Spectrophotometer 3:00 PM - ICP Emission Spectrometer

Apr 10, 2026

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[Notice of Exhibition Participation by Fukuda Co., Ltd.] 2025 YOKOHAMA Automotive Technology Exhibition

[Notice of Exhibition Participation by Fukuda Co., Ltd.] 2025 YOKOHAMA Automotive Technology Exhibition

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  • SEMINAR_EVENT

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely invite you to visit us during this busy time. 【 Exhibition Name 】 Automotive Technology Exhibition 2025 YOKOHAMA https://aee.expo-info.jsae.or.jp/ja/yokohama/ (An "online exhibition" will also be held during and around the event period) 【 Dates 】 May 21 (Wednesday) - 23 (Friday), 2024 10:00 AM - 6:00 PM *On the final day, 9:00 AM - 4:00 PM (Online exhibition: May 14 (Wednesday) - June 4 (Wednesday)) 【 Venue 】 Pacifico Yokohama (1-1-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa Prefecture) Our booth number: "Concourse 505"

Apr 10, 2026

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[Notice of Exhibition Participation by Fukuda Co., Ltd.] 27th Interphex Week Tokyo

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  • SEMINAR_EVENT

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 27th INTERPHEX Week Tokyo https://www.interphex.jp/tokyo/ja-jp.html 【 Dates 】 July 9 (Wednesday) - 11 (Friday), 2025 10:00 AM - 5:00 PM 【 Venue 】 Tokyo Big Sight (3-11-1 Ariake, Koto-ku, Tokyo 135-0063)

Apr 10, 2026

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Web Seminar: "How to Communicate Effectively" Speaking and Writing Seminar

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To help the other party clearly understand our intentions, it is necessary to construct logical content and to communicate in a way that is easy for the listener to follow. In the workplace, opportunities to write and speak are increasing, whether it be daily reports, weekly reports, documents, proposals, approval requests, presentations to clients, reports to superiors, guidance for subordinates, or presentations in meetings. With the rise of online meetings, effectively conveying information has become essential. However, due to differences in values and generational gaps, there are times when what we intend to communicate does not get through, leading to misunderstandings or a lack of understanding. So, how can we ensure that the other party clearly understands our intentions? This course focuses on two aspects: "speaking" and "writing," teaching the points of constructing logical content and communicating in a listener-friendly manner through practical and enjoyable short case exercises, making it the definitive guide to overcoming poor communication skills! *For more details, please download the PDF or contact us.

Apr 09, 2026

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