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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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Related catalog(13)

VPT: Visible Particle Testing

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SART System

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

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.

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

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Celsius pre-designed solutions for freezing and melting

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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[Notice of Exhibition Participation by Fukuda Co., Ltd.] TOKYO PACK 2026 Tokyo International Packaging Exhibition

  • NEW
  • SEMINAR_EVENT

We would like to express our congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will be showcasing a number of products, including our new product, the Packaging Container Air Leak Test (Pin Hole Inspection) Device | MSQ-2003 series. We sincerely apologize for the inconvenience during your busy schedule, but we would like to cordially invite you to attend this event. 【 Trade Show Name 】 【 Dates 】 【 Venue/Booth Number 】

Oct 09, 2026

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We will be exhibiting at the PIAB Manufacturing Fair 2026 [Booth Number: AS-43].

  • NEW
  • SEMINAR_EVENT

We will showcase our new product "BLFF," a palletizing foam gripper that weighs only 1.9 kg and measures 350mm×250mm, ideal for bulk picking. We will also introduce various products that cater to different work applications, including durable suction cups and solutions for bag handling. Additionally, we are implementing energy-saving proposals by replacing ejectors to reduce compressed air consumption, which has become a challenge in many industries. If you have any issues with adhesion or transport, please feel free to consult with us at the venue. ■ Lightweight Foam Gripper for Collaborative Robots "CVGC Series" Despite weighing only 1.9 kg, this gripper has a theoretical lifting force of 100 kg, maximizing the payload capacity of collaborative robots. ■ Gripper for Films This gripper is designed to transport thin films gently, minimizing marks left on the surface. By utilizing 3D printing, we can accommodate highly flexible shape designs tailored to specific workpieces and applications. ■ Energy Saving Comparison Panel "Why does a single ejector consume less compressed air compared to a multi-stage ejector?" You can actually verify the differences in compressed air consumption through a comparative display using a flow meter and actual equipment.

Oct 09, 2026

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Starting from November 18 (Wednesday): Announcement of participation in Smart Factory JAPAN! Booth number "F-20"

  • NEW
  • SEMINAR_EVENT

We will be exhibiting at Smart Factory JAPAN, held at Tokyo Big Sight from November 18 (Wednesday) to November 20 (Friday), 2026. We will introduce the 'Dr. Process Navi Series', 'Dr. Mold Cloud', and AI solutions that integrate with both products! <Introducing the latest solutions that innovate productivity in manufacturing sites!> ● 'Dr. Process Navi' Series ● 'Dr. Mold Cloud' ● 'AI Solutions' For more details, please check the related products. ■■ Smart Factory JAPAN 2026 Overview ■■ Dates: November 18 (Wednesday), 19 (Thursday), 20 (Friday), 2026 Opening Hours: 10:00 AM - 5:00 PM Venue: Tokyo Big Sight, East Hall 1-3 Our Booth Number: F-20 Registration: Nikkan Kogyo Shimbun 6 Exhibition Joint Site When visiting, please register in advance from your My Page and bring a printed admission ticket. Business meeting requests are also possible, so please make use of this opportunity.

Oct 09, 2026

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Announcement of participation in the "Monozukuri World Fukuoka Design and Manufacturing Solutions Exhibition": December 2nd - @ Marine Messe Fukuoka

  • NEW
  • SEMINAR_EVENT

We will be exhibiting at the Monozukuri World Fukuoka Design and Manufacturing Solutions Exhibition, held at Marine Messe Fukuoka from December 2 (Wednesday) to December 4 (Friday), 2026. We will introduce the 'Dr. Process Navi Series', 'Dr. Mold Cloud', and AI solutions that help improve efficiency and reform in manufacturing sites! <Introducing the latest solutions that innovate productivity in manufacturing sites!> ● 'Dr. Process Navi' Series ● 'Dr. Mold Cloud' ● 'AI Solutions' For more details, please check the related products. ■■ Overview of the 4th Monozukuri World Fukuoka Design and Manufacturing Solutions Exhibition ■■ Dates: December 4 (Wednesday), 5 (Thursday), 6 (Friday), 2026 Opening hours: 10:00 AM to 5:00 PM Venue: Marine Messe Fukuoka Our booth number: 14-18 When visiting, please register in advance through the dedicated page and bring your printed visitor badge.

Oct 09, 2026

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[Seminar] The Battery Storage Business in Japan and Europe and the Initiatives of Nippon Koei Energy Solutions

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  • SEMINAR_EVENT

[Lecture Topics] 1. Trends and Business Opportunities in Japan's Expanding Energy Storage Industry Koichiro Danno, Principal and Head of Social and Policy Design Unit, Research and Consulting Division, Japan Research Institute, Inc. 1. Background Necessitating Energy Storage Business 2. Behind the Meter (BTM) Business and In Front of the Meter (IFM) Business 3. Trends in Japan's Energy Policy Related to Energy Storage 4. Current Revenue Models in Japan 5. Verification of Profitability in Energy Storage Business 6. Summary 7. Q&A 2. Expansion of Grid-Scale Energy Storage Business in Europe and Japan and Future Prospects Takayuki Ogawa, Executive Officer, Deputy Head of Business Strategy Division, Japan Kogyo Energy Solutions, Inc. and Executive Director, Nippon Koei Energy Europe B.V. 1. Overview of the Company and Introduction to Energy Business 2. Efforts in Energy Storage Business in Europe 3. Efforts in Energy Storage Business in Japan 4. Role and Importance of Aggregators 5. Challenges and Future Prospects of Grid-Scale Energy Storage Business 6. Summary 7. Q&A

Oct 07, 2026

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