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  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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【Panorama Memo】Notice of Business Days During Golden Week

Notice of Holidays During Golden Week

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Thank you for your continued support of Panorama Memo. We would like to inform you about our support's "business days during the Golden Week holiday period." Holiday period: April 29, 2026 (Wednesday) to May 10, 2026 (Sunday) Responses to inquiries received during the above period will be addressed sequentially starting from May 11, 2026 (Monday). We apologize for any inconvenience this may cause and appreciate your understanding and cooperation.

Apr 20, 2026

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Notice of Golden Week Holiday in 2026 (Nikken Coating Industry Co., Ltd.)

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Thank you very much for your continued support. We regret to inform you that our company will be closed for the Golden Week holiday during the following period. 【Holiday Period】May 2, 2026 (Saturday) to May 6, 2026 (Wednesday) *We will resume normal business operations on May 7, 2026 (Thursday). Inquiries received during the holiday period will be addressed sequentially after the start of business on the reopening date. Please note that depending on the content of the inquiry, it may take some time to respond. We appreciate your understanding in advance. We apologize for any inconvenience this may cause and thank you for your understanding.

Apr 20, 2026

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Factory No. 1 (Panorama)

New factory completed, operations commenced.

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We have newly constructed an additional factory building due to business expansion. The location is across from our headquarters (602-1 Oohira, Kikuchi City, Kumamoto Prefecture) at 631-1 Oohira, Kikuchi City, Kumamoto Prefecture. You can confirm this on Google Maps and other services. Site area: approximately 1,000 square meters Building area: approximately 300 square meters (25m x 12m) Ceiling-mounted crane: 2.8t lifting height 6m

Apr 18, 2026

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Samak Corporation Interpack 2026

Trikno, represented by SAMAC as the general agent in Japan, will exhibit at Interpack 2026.

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Trikno, represented by Samac Corporation in Japan, will exhibit at Interpack 2026. Showcasing high-performance chocolate depositors Trikno, known for its high-performance chocolate depositors, will participate in Interpack 2026, one of the world's largest trade fairs, to be held in Germany in May 2026. The exhibition will feature two product lines aimed at artisans and industrial applications, showcasing equipment that meets a wide range of manufacturing needs. Trikno's booth will provide a valuable opportunity to see the latest chocolate manufacturing technology that achieves high quality, high efficiency, and minimal waste in action.

Apr 18, 2026

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KELLER will exhibit at the International Space Business Expo SPEXA! May 27-29, 2026, at Tokyo Big Sight, South Hall 3-4, S8-40.

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KELLER Pressure is a leading manufacturer of piezoresistive pressure sensors. We will showcase high-precision pressure sensors, compact pressure sensors, and high-speed response pressure sensors with the specifications listed below, focusing on pressure sensors and digital pressure gauges that have a proven track record in the aerospace and aviation fields. We will explain why KELLER Pressure products are chosen in the aerospace and aviation sectors and what sets them apart from competitors using the exhibited products. 【Example of Achievements】 Rocket (fuel, oxidizer), satellites (atmospheric pressure measurement during re-entry), combustion pressure measurement, aircraft attitude control, detonation, International Space Station (ISS), etc. For those who wish to have meetings or product introductions at our booth on the day of the event, we are accepting reservations in advance. Interested parties can contact us at sales.jp@keller-pressure.com. 【Exhibition Content】 We offer a variety of pressure sensors suitable for a wide range of measurements:  〇 Low pressure to high pressure (0.5 kPa to 200 MPa)  〇 Low temperature to ultra-high temperature (-50℃ to 1000℃)  〇 High precision (± 0.01%FS and above)  〇 Compact (Φ 1.4 x 3.1 cm and above)  〇 Ultra-fast response  〇 Digital display pressure gauges

Apr 17, 2026

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