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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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Hyper CLT flooring panel

Quickly resolve your questions | We have added a Q&A page for Hyper CLT flooring.

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  • PRODUCT

We have newly added a **"Frequently Asked Questions Q&A"** section to the Hyper CLT sheet website. It clearly summarizes many questions frequently asked by those considering the introduction of the product, such as "What types of civil engineering sites can it be used on?", "Can it be used on rainy days?", "Is it compatible with large machinery?", and "What is NETIS?". The Hyper CLT sheet is a lightweight wooden sheet utilizing wood CLT, suitable for a wide range of applications including temporary roads, access routes, and heavy machinery work yards. It is also registered as a **Ministry of Land, Infrastructure, Transport and Tourism NETIS registered technology "TH-250021-A"**. Since it is a new material, we will not leave any uncertainties unaddressed. We aim to create a website that makes it easy to resolve questions before introduction, including information on wood, NETIS, civil engineering, and CLT, and we will continue to enhance the Q&A section.

Oct 11, 2026

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Hyper CLT flooring panel

Added a glossary to the website to make technical terms easier to understand.

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  • PRODUCT

We have added a new **"Glossary"** to the Hyper CLT sheet website. In the civil engineering and construction industries, there are many specialized terms such as "CLT," "NETIS," "temporary roads," and "wooden lightweight sheets." Therefore, we have introduced related terms in an easy-to-understand manner so that those who are encountering Hyper CLT sheets for the first time can understand the products and technologies. Hyper CLT sheets are wooden lightweight sheets for civil engineering that utilize wood CLT and are registered under the Ministry of Land, Infrastructure, Transport and Tourism's NETIS technology as **"TH-250021-A."** We hope that by not only conveying the features of the product but also sharing the underlying technologies and terminology, users will feel a closer connection to Hyper CLT sheets. We will continue to enhance our website and provide clear information related to wood, NETIS, civil engineering, and CLT.

Oct 10, 2026

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CCS3 product photo

The new product "Vehicle Count Sensor CCS3" enables efficient occupancy management of large parking lots.

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Hotron Inc. has launched its new product, the "Vehicle Count Sensor CCS3"! This product is a ceiling-mounted sensor that combines infrared and radar technology. It reliably detects vehicles in both directions with a single unit, accommodating traffic during congestion and vehicle passing, thus achieving efficient occupancy management in large parking lots. Additionally, it can be utilized for exit warning purposes in addition to vehicle counting, contributing to the safe and smooth operation of parking facilities. 'Features' - Improved detection performance against changes in road surface during rainy weather by using both infrared and radar. - Equipped with IP67 waterproof and dustproof performance, making it effective even in salt damage areas. - Various settings can be configured from a dedicated app (for Android devices), with current settings easily understandable at a glance. - The base dimensions are the same as the previous model "CCS2," allowing for smooth replacement of existing equipment. *For more details, please refer to the product information, catalog download, or contact us.*

Oct 09, 2026

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Hyper CLT flooring panel

On September 15, we issued a press release for the hyper CLT flooring.

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On September 15, 2026, we issued a press release regarding the wooden lightweight sheet "Hyper CLT Sheet." The Hyper CLT Sheet is a civil engineering sheet that utilizes CLT (Cross-Laminated Timber) stacked in an orthogonal direction. It can be used in various locations such as temporary roads, access routes, heavy machinery work yards, and material storage areas. The 5×10 version weighs approximately 230 kg, making it relatively lightweight and easy to install, remove, and relocate. Additionally, it offers environmental benefits such as reducing glare and metallic sounds typical of wood, as well as CO2 fixation. Furthermore, it can be proposed for the use of new technologies in public works as a **registered technology with the Ministry of Land, Infrastructure, Transport and Tourism "TH-250021-A."** Through this press release, we aim to expand the new wooden lightweight sheet that combines wood, NETIS, civil engineering, and CLT to more construction sites.

Oct 09, 2026

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Notice of the issuance of ISO-related information magazine "Intertek News" Issue 94.

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We have published the latest issue (No. 94) of the ISO-related information magazine "Intertek News." Intertek News delivers information and various topics related to ISO audits, certifications, and verifications. This issue features a special section titled "Interpreting Standard Revisions," which introduces key points of management system standard requirements that new personnel should understand as preparation for standard revisions. Additionally, we have included customer case studies, articles contributed by auditors, and information on certifications and standards, as well as the latest topics, so please take a look.

Oct 09, 2026

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