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  1. Home
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  3. Sartorius Stedim Japan K.K.
  4. "We will send you a recorded video" Single-use system compliant with the new EMA Annex 1 Guideline.
SEMINAR_EVENT
  • Nov 08, 2023
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Nov 08, 2023

"We will send you a recorded video" Single-use system compliant with the new EMA Annex 1 Guideline.

Sartorius Stedim Japan K.K. Sartorius Stedim Japan K.K.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. We will introduce the content of the revised EU GMP Guidelines Annex 1. While reviewing this content, we aim to deepen the relationship between Sartorius and our customers through mutual understanding, particularly regarding Quality Risk Management (QRM) and Contamination Control Strategy (CCS). Additionally, we will provide information on Sartorius's sterilization validation and the latest information on Extractables and Leachables (E|L), which we hope you will find useful. [Seminar Overview] ▪ Date: December 7 (Thursday) at 3:00 PM (approximately 30 minutes) ▪ Format: Webinar recorded broadcast [Japanese, Free] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.
Date and time Thursday, Dec 07, 2023
03:00 PM ~
Capital
Entry fee Free
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VPT: Visible Particle Testing

A particulate reduction program that comprehensively addresses particulate matter risks with the aim of advancing discussions based on objective data rather than subjective risks.

Single-use systems (SUS) are increasingly being used in final filling, vaccine manufacturing, cell therapy, and gene therapy. Regulatory requirements regarding particulate matter are clear for final pharmaceuticals, but they are not clear for SUS used in the upstream processes of final pharmaceuticals. In 2016, Sartorius launched a particle reduction program to reduce uncertainty and minimize the risk of particulate matter contained in SUS being introduced into final pharmaceuticals. As a result of this initiative, the levels of particulate matter in SUS have visibly decreased.

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Flexsafe Pro Mixer Pre-Design Solution

Please check the Japanese version catalog for a significant increase in operability and stirring power!

A high-speed, flexible, and intelligent single-use mixer that accommodates all stirring processes in cGMP-compliant bioprocessing. In mixing processes within the bioprocess environment, quality and efficiency are critically important, and the choice of mixing equipment has a dramatic impact on both. A high-speed, flexible single-use mixer enhances manufacturers' competitiveness and improves productivity.

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Storage and Transportation Flexsafe 2D | 3D Pre-design Solution

Filtration, storage, and transportation in all process stages. Take Your Facility Into The Future.

【Features】 ▪ Unprecedented performance and stable quality supply ▪ Expertise in materials science and film extrusion molding ▪ Management of the entire manufacturing process ▪ Stable quality supply for wetted components ▪ Validation and quality assurance ▪ Assurance of the integrity of single-use systems ▪ Safe and reliable handling and transportation solutions from 5 L to 500 L ▪ Safe, self-deploying robust solutions

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Palletank series

Specifically developed to meet the various application requirements of fluid management in the biopharmaceutical industry.

Palletank for In-Process Fluid Handling ▪ Easy operation as continuous processes can be performed without moving the container ▪ Easy access from the front door with a double hinge and safety latch ▪ Optimal bag deployment and filling with a lifting system for large containers Palletank for Shipping ▪ Safe and robust liquid transport achieved through ASTM qualification testing of Flexsafe3D bags using Palletank for Shipping ▪ System integrity ensured by compressing and securing Flexsafe l Flexel 3D bags ▪ Removable structure saves space on-site before and after use Palletank for Storage ▪ Qualified system confirmed ▪ Stackable ▪ Technical integration support Plastic Palletank for Storage ▪ Containers made of PP and ABS ▪ Stackable when filled with liquid, foldable when unfilled ▪ Smooth and scratch-resistant plastic surface ▪ Standard product

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Celsius Commercial Scale Solution

Freeze-thaw solutions for seamless scalability to commercial production.

Sartorius, with over 15 years of experience in the design of freeze-thaw solutions, offers lab-scale and manufacturing-scale solutions for all steps of processes requiring frozen storage and frozen transport. This enables biopharmaceutical manufacturers to effectively decouple downstream processes and safely transport active pharmaceutical ingredients to drug manufacturing facilities. The Celsius Platform, equipped with options for blast freezers, horizontal freezers, and vertical plate freezers, provides an end-to-end integrated approach that enables monitoring and control to broadly ensure product quality and integrity.

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Celsius pre-design solutions for freezing and melting

A robust, complete, and scalable solution for frozen storage and frozen transportation.

Based on over 15 years of experience in the design of single-use freezing and thawing solutions, we have established Celsius pre-design solutions (PDS) for all processes requiring frozen storage and frozen transport, at both lab scale and manufacturing scale. Celsius PDS separates the downstream process and is equipped with the necessary functions for the safe transport of active pharmaceutical ingredients to pharmaceutical manufacturing facilities.

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Celsius Lab Scale Solution

Smart condition setting, a genuine end-to-end integrated freeze-thaw system.

A robust, complete, and scalable solution for frozen storage and frozen transport. Sartorius offers lab-scale Celsius solutions for smarter and earlier process decisions in the management of frozen active pharmaceutical ingredients. The Celsius Lab-scale Platform enables the characterization of freezing and thawing within single-use bags of 30 mL to 100 mL, featuring complete scalability up to the commercial-scale Celsius Platform (CFT, FFT, and FFTP).

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Significantly improved operability and mixing power: "Flexsafe Pro Mixer Pre-Design Solution"

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Palletank for In-Process Fluid Handling

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Palletank for Shipping

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Palletank for Storage

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Plastic Palletank for Storage

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Flexsafe 2D and 3D pre-designed solutions for storage and transportation.

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Celsius pre-designed solutions for freezing and melting

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Providing fully integrated products designed for the latest biopharmaceutical cold chain: 'Celsius Product Lines'

Providing fully integrated products designed for the latest biopharmaceutical cold chain: 'Celsius Product Lines'

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Speed-controlled freeze-thaw platform technology 'Celsius CFT'

Speed-controlled freeze-thaw platform technology 'Celsius CFT'

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Scalable and easy to use, the 'Celsius S³ System' enhances the validation process.

Scalable and easy to use, the 'Celsius S³ System' enhances the validation process.

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Sartorius Stedim Japan K.K.
Pharmaceuticals and Biotechnology
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ROAD 2026

ROAD 2026: The 7th Roundtable on the Purpose of Autonomous Driving, Japan

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  • SEMINAR_EVENT

About ROAD: The "Roundtable on the Purpose of Autonomous Driving (ROAD)" conference series has evolved into a unique platform for interdis-ciplinary dialogue and international collaboration in the field of autonomous driving and autonomous mobility. Established in 2016, ROAD has brought together researchers, industry leaders, and public sector stakeholders from six countries across three continents. Based on this background, the upcoming ROAD 2026 will focus on "safety” and "driving AI”—the final pieces of the autonomous driving puzzle—to advance discussions on establishing the foundational framework for ensuring safety quality and obtaining regular-tory approval for autonomous driving. We also intend to discuss the international commonalities and differences regarding the social value brought about by ADS vehicles in terms of automation, intelligent driving, and mobility. We have established a total of five compelling themes for the Round Workshops, consisting of two topics related to “The Last Piece” and three topics related to the social value of ADS, as shown below. 1) Round Workshop 1 - Horizons of E2E Driving AI → Can AI Understand the Driving Environment Like Humans? 2) Round Workshop 2 - Beyond the Unknown: Safety Cases for ADS → Can Safety Ever Be Proven? 3) Round Workshop 3 - Envisioning Smart City Mobility → Can Smart City Mobility Bridge the Mobility Divide? 4) Round Workshop 4 - Logistics Enhancement Through Autonomous Tracking → Will Logistics Become Human-Free? 5) Round Workshop 5 - The Evolution of CASE: SDV/AIDV → Will Automakers Become AI Companies? We hope you’ll all join us!

Jun 28, 2026

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[Seminar] Practical Implementation of Liquid Cooling Design and Energy-saving Operations for AI Data Centers

  • NEW
  • SEMINAR_EVENT

[Speaker] Masashi Sugita, President and CEO of LEX Style Co., Ltd. [Key Lecture Content] The power consumption of AI servers used in data centers has significantly increased, making traditional air cooling insufficient for operation. This lecture will organize the requirements for introducing a liquid cooling system into air-cooled data centers and explain the implementation method using free cooling with specific design details. When handling high-density AI servers, energy efficiency is required, and the widely used energy efficiency indicator, as well as the Ministry of Economy, Trade and Industry's Resource and Energy Agency's PUE regulation of "1.3 or below," will be explained along with practical operational insights. [Lecture Items] 1. Heat dissipation methods for high-density, high-heat AI servers 2. Basics and importance of PUE/pPUE 3. PUE regulation of "1.3 or below" by the Ministry of Economy, Trade and Industry's Resource and Energy Agency 4. AI server implementation and requirements for new data centers 5. Summary and future outlook 6. Q&A / Business card exchange

Jun 26, 2026

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[Seminar] Measures for Promoting SAF and the Frontlines of Aviation Decarbonization

  • NEW
  • SEMINAR_EVENT

[Key Lecture Content] 1. Promotion of SAF Introduction Yasushi Yamashita, Director, Carbon Neutral Promotion Office, Aviation Bureau, Ministry of Land, Infrastructure, Transport and Tourism 1. Importance of SAF in the decarbonization of the aviation sector 2. Initiatives to promote the introduction of SAF 3. Q&A / Business card exchange 2. Japan Airlines' Challenge Towards Net Zero CO2 Emissions by 2050 Kazuki Hirotani, Group Leader, GX Planning Group, Sustainability Promotion Department, Japan Airlines Co., Ltd. 1. Introduction of our five initiatives for CO2 emission reduction 2. Initiatives for reducing fuel consumption (introduction of fuel-efficient aircraft, operational improvements) 3. Initiatives for fuel transition (sustainable aviation fuel SAF) 4. Initiatives for reductions outside the value chain (carbon credits, new removal technologies) 5. Initiatives to deepen collaboration with society 6. Q&A / Business card exchange

Jun 26, 2026

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[Seminar] Design and Operation of Civil Liability and Governance in AI Development and Use

  • NEW
  • SEMINAR_EVENT

[Instructor] Yuichiro Kabushiki, Partner Lawyer at TMI Comprehensive Law Office [Key Lecture Content] With the spread of AI, there is growing attention on the civil liability of developers, providers, and users of AI. The Ministry of Economy, Trade and Industry will publish "Guidelines on the Interpretation and Application of Civil Liability in AI Utilization" in April 2026, and the Ministry of Justice will also establish an expert meeting to examine civil liability related to unauthorized use of images and voices generated by AI in the same month. As the full enforcement of the AI Promotion Act and the revision of AI guidelines are underway, it is necessary to design and operate governance based on the potential responsibilities that may arise retrospectively. In this seminar, based on the guidelines from the Ministry of Economy, Trade and Industry and drawing on litigation practice experience as a judge and lawyer, we will organize the basic framework for assessing civil liability and explain fundamental methods for designing and operating governance based on risk analysis. Furthermore, we will examine the framework for civil liability and the design and operation of governance using hypothetical cases that are likely to pose practical issues.

Jun 26, 2026

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Winning Through Era-Defining On-Site Improvements! AI Utilization Seminar for Automotive Parts Suppliers in Manufacturing Sites

  • NEW
  • SEMINAR_EVENT

In this seminar, we will welcome Mr. Satoru Hayami from Waseda University, who will explain the latest trends in AI utilization in manufacturing, as well as the evolution of technologies such as agent-based AI and physical AI, and the opportunities and key points for practical application in the manufacturing industry. Furthermore, Mr. Tsubasa Shibata, representative of Next Opt, will introduce processes aimed at practical implementation, incorporating actual case studies from manufacturing sites. We hope you will envision the "potential for AI utilization in your company" and take home hints that will lead to improvements in your operations starting tomorrow. We look forward to your participation.

Jun 26, 2026

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