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  4. Seminar Announcement: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from the Biopharmaceutical Manufacturing Field" (October 2024)
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  • Sep 03, 2024
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Sep 03, 2024

Seminar Announcement: "Latest Trends in Cleaning Validation and the Utility of TOC - Case Studies from the Biopharmaceutical Manufacturing Field" (October 2024)

ハックジャパン ハックジャパン
In the guidance on process validation (PV) announced by the FDA in 2011, PV is classified into three stages: Stage 1, process design; Stage 2, verification of the functionality of the designed process in the actual manufacturing site; and Stage 3, verification of functionality according to design during the production phase after product launch. The importance of process validation throughout the entire product lifecycle is increasing. This seminar will focus on the latest trends in cleaning validation in Stage 3, which is emphasized as a measure against cross-contamination, particularly with the increase in many pharmaceuticals and highly active pharmaceuticals manufactured on shared lines. We will also highlight the usefulness of Total Organic Carbon (TOC) analysis methods and present practical examples from biopharmaceutical manufacturing sites. Additionally, in the latter part of the seminar, there will be time for discussion led by the speakers. If you have any topics or questions you would like to be addressed, please include them in the application form.
Date and time Friday, Oct 18, 2024
01:30 PM ~ 05:00 PM
Opening: 13:00
Capital Waimu Rental Conference Room Takadanobaba 4B (4th Floor, TD Building, 1-29-9 Takadanobaba, Shinjuku-ku, Tokyo) 2-minute walk from Toyama Exit of Takadanobaba Station on the JR Yamanote Line and Seibu Shinjuku Line 5-minute walk from Exit 5 of Takadanobaba Station on the Tokyo Metro Tozai Line
Entry fee Free
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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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[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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[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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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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Invited Lecture: Seminar on the Current State of PFAS Analysis with 5 Speakers

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We will have customers who are active at the forefront of PFAS research and analysis take the stage to introduce their efforts and case studies on PFAS research and management using pretreatment and analytical techniques. Additionally, we will provide an opportunity for information exchange with the speakers, so please join us. ■Invited Lectures Introduction of research on PFAS emission control in the waste treatment and resource recovery process and future prospects Hidetoshi Kuramochi, National Institute for Environmental Studies Analysis of 44 PFAS substances in water quality Jun Yamamoto, Ideah Co., Ltd. Case studies of environmental burden substance analysis using LC/MS at NOK Emi Hoshikawa, NOK Corporation Practical approaches to improving the reliability of PFAS analysis in food Shunsuke Zama, Japan Food Analysis Center Food safety initiatives viewed from the perspective of the entire food chain Mihane Sato, Zensho Holdings Co., Ltd.

Oct 01, 2025

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[Notice of Exhibition Participation by Fukuda Co., Ltd.] JAPAN PACK 2025 Japan Packaging Industry Exhibition

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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 introduce a number of products, including our new product, the Pillow Packaging Full Air Tightness Inspection Machine MSQ-2003. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to visit us at this opportunity. 【 Exhibition Name 】 JAPAN PACK 2025 Japan Packaging Industry Exhibition https://www.japanpack.jp/ 【 Dates 】 October 7 (Tuesday) to October 10 (Friday), 2025 *4 days 10:00 AM to 5:00 PM 【 Venue / Booth Number 】 Tokyo Big Sight / East Hall 8, Booth 8-505

Sep 30, 2025

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Water Treatment Seminar - From Virus Measurement to Digital Optimization

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The measurement technology for viruses in water has made remarkable progress since the introduction of PCR methods in the 1990s, with ongoing technical improvements aimed at ensuring quantitativeness. It is now possible to measure wild viruses in actual treatment facilities, allowing for the actual measurement of virus removal capabilities, which significantly contributes to ensuring water safety. Professor Hiroyuki Katayama from the University of Tokyo will provide a clear explanation of the utilization of these technologies, incorporating specific treatment case studies. Additionally, advancements in digital technology have enabled efficient and advanced water quality management in the fields of water supply and wastewater treatment, attracting attention for future developments. We will share practical insights gained from the field regarding the latest water treatment technologies utilizing AI and the use of online water quality meters.

Sep 29, 2025

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[Seminar] Conditions for Leaders to Survive in Times of Dramatic Change

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[Speaker] Akira Miyoshi, Organizational Development Consultant, Self-Directed Evolution Organization Research Institute [Lecture Topics] 1. What is "proactive leadership" that dramatically enhances team performance even in times of drastic change? 2. Essential skills for new era leaders: the ability to become a transparent presence 3. The reason why employees' eyes do not shine even when setting goals and having 1-on-1 meetings 4. What kind of leadership allows young employees to act vibrantly without having to set goals? 5. The formula to stop turnover completely! How to become a self-directed organization in 7 months starting today 6. Managers solving problems themselves! A communication model that remarkably enhances autonomy 7. Learning from failure cases: blind spots of leaders that hinder transformation 8. Concrete action plan to enhance management skills that can be implemented starting tomorrow! 9. Q&A

Sep 29, 2025

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Announcement of Prince Eftax's participation in the "Agriculture WEEK Tokyo Exhibition 2025" (October 1st (Wed) to 3rd (Fri), 2025)

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From October 1st for three days, Oji Futech will be exhibiting at "Agriculture WEEK (commonly known as J-AGRI Tokyo Exhibition)" held at Makuhari Messe. Agriculture WEEK is an exhibition where agricultural materials, smart agriculture products, livestock materials, and more are showcased, facilitating active business discussions between exhibiting companies and visitors. At Oji Futech's booth within the Agricultural Materials EXPO, we will introduce our paper-based agricultural mulching sheet, "OJI Sustainable Mulch." Oji Futech's "OJI Sustainable Mulch" is a mulching sheet made primarily from cellulose. After use, it decomposes in the soil, which not only reduces waste disposal costs but also helps suppress soil temperature rise, leading to increased yields for summer and autumn crops. We will also be showcasing our freshness-preserving and antibacterial OPP film, "Calfresh," at the same booth. We look forward to your visit!

Sep 29, 2025

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