[Technical Seminar] Latest Data Analysis and PAT Data Management

Integration of the Latest Data Analysis and PAT Data Management System for QbD/PAT: ICH Lifecycle Approach

Quality Design held a seminar on "Latest Data Analysis and PAT Data Management" at Interphex Japan in June 2018. In summary, we introduced various PAT tools and real-time analysis software for data integration from PLCs, in accordance with the ICH lifecycle as applied to PAT/QbD. We also conducted presentations within our booth on the following topics, which attracted a large audience. [Presentation Topics] ■ Examples of Biopharmaceutical Analysis Management Using Integrated Systems ■ Big Data and Its Integration and Knowledge Management through PAT Systems ■ Latest Data Analysis and PAT Data Management *For more details, please refer to the PDF. Feel free to contact us with any inquiries.

• Other operation management software

High-speed, non-destructive, and non-contact measurement! Near-infrared spectroscopy unit for pharmaceutical companies.

The 'LUMINAR Series' handled by Quality Design quickly feeds back analysis results to the lab and production site using AOTF-NIR (acousto-optic tunable filter near-infrared). By employing unique measurement technology, it is possible to detect composite components and their characteristics non-destructively and without contact. With a compact design that is highly practical for production sites, it can measure liquids, powders, and solids from raw materials to final packaged products. 【Features】 ■ High-speed, non-destructive, and non-contact measurement ■ 21CFR/Part11 compliant software ■ Capable of multi-point and multi-component measurements ■ Robust structure suitable for all production environments ■ No moving parts, eliminating the influence of vibrations *For more details, please refer to the catalog. Feel free to contact us with any inquiries.

• Analytical Equipment and Devices

An orchestration system for integrated management of QbD/PAT that contributes to the visualization of complex spectra!

"synTQ" is a QbD/PAT integrated management system that is useful for quality control and product development. It contributes to the visualization of complex spectra by connecting various PAT tools, multivariate statistical analysis tools, and upper-level systems. It has a proven track record in major pharmaceutical companies in Europe and the United States. 【Features】 ■ Connectable with PAT tools, multivariate statistical analysis tools, and upper-level systems ■ Customizable according to user requirements ■ Numerous achievements in major pharmaceutical companies in Europe and the United States *For more details, please refer to the catalog. Feel free to contact us as well.

• Other operation management software

The perfect unit for PIC/S raw material acceptance inspection and initial PAT review!

■Features - Overwhelmingly compact size - More than 40,000 hours of long light source lifespan - Analysis model fully integrated with CAMO Software's The UnscramblerX - Calibration compliant with USP1119, supports IQ/OQ - Various expansion units available

• Spectroscopic Analysis Equipment

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

In recent years, the implementation of maintenance DX to achieve "non-stop factories" has become an urgent necessity in manufacturing sites. Amid the trend of factory IoT and data utilization, the use of remote I/O, which can remotely aggregate and collect sensor information and control signals from equipment and sensors dispersed inside and outside the factory, is gaining importance as a foundation for predictive maintenance and condition monitoring. On the other hand, the installation environment for remote I/O is not necessarily limited to control panels or well-conditioned factory interiors. There is an increasing need to collect data in harsh environments, such as outdoor equipment and conditions involving high temperatures, low temperatures, vibrations, and strong electrical noise. Conventional remote I/O systems have struggled to operate stably under such conditions, requiring measures like installation location constraints and additional protective enclosures. Environmentally robust remote I/O with wide temperature support and noise resistance can address these challenges, enabling the expansion of the scope of factory IoT and predictive maintenance to outdoor and remote equipment. In this seminar, we will introduce the lineup of Contec's environmentally robust remote I/O, the "CONPROSYS(R) Robust I/O Series," which includes a total of 23 products.

[Speaker] Miyamoto Mariko, Senior Researcher, Public Policy Research Department, SOMPO Institute Plus Inc. [Lecture Items] 1. Overview and Latest Trends of Green Infrastructure (1) Background of Growing Attention and Market Expansion Outlook (2) Current Situation and Challenges for Promotion 2. Economic Effects of Green Infrastructure (1) Domestic Examples (Parks, Road Facilities, etc.) (2) International Examples 3. Evaluation and Certification Systems (1) Systems Related to Buildings (2) Systems Related to Sites and Urban Spaces 4. Financing Methods for Green Infrastructure (1) PPP/PFI (2) Sustainable Finance 5. Q&A / Business Card Exchange

[Lecturers] Nishimura & Asahi Law Offices, Foreign Law Joint Enterprise Attorney and Associate Iku Akamatsu Attorney and Associate Yasukazu Yamazaki (Note: "Saki" is a variant character) [Key Lecture Content] In the logistics sector and other areas, discussions are underway regarding the social implementation of drone flight routes. Drone flight routes involve various stakeholders, including drone route operators, drone operation businesses, surrounding municipalities, and ground-related parties, who collaborate and divide roles to realize these routes. Therefore, drone route operators and businesses utilizing drone routes need to enter into contracts regarding the use of drone routes with relevant parties, clarify roles, and implement appropriate risk management. This lecture will explain the legal points that must be considered when entering into contracts for the use of drone flight routes. [Lecture Items] 1. Overview of drone flight routes and recent examination status 2. Stakeholders and their roles related to drone flight routes 3. Items to consider specifying in contracts for the use of drone flight routes 4. Legal points to be aware of in contracts for the use of drone flight routes 5. Q&A / Business card exchange

[Speaker] Keiichi Koga, Senior Development Manager, Innovation Strategy Center, Japan Research Institute, Ltd. [Key Lecture Content] After the transition to the Trump administration, significant changes have emerged in the global business environment concerning the oceans, particularly regarding decarbonization and nature conservation. On the other hand, considering the accumulation of knowledge and shared understanding of the realities of the marine environment, what growth strategies should companies outline? In the financial sector, which is focusing on the expansion of the blue economy, there is a growing recognition that advancing nature-positive businesses can lead to sustainable corporate value enhancement. The sectors related to the ocean encompass not only fisheries and shipping but also a wide range of areas such as water pollution, plastic waste, tourism, and energy-related industries. This lecture will discuss the seeds for considering how businesses can transform. [Lecture Items] 1. The Blue Economy so far 2. International Trends 3. Financing Trends related to the Blue Economy 4. Directions for Business Transformation based on the Blue Economy 5. Case Studies 6. Q&A / Business Card Exchange