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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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[Seminar] Initiatives for the Construction of Automated Logistics Roads

  • NEW
  • SEMINAR_EVENT

[Speaker] Ministry of Land, Infrastructure, Transport and Tourism, Road Bureau, Planning Division, Road Economic Research Office Planning Specialist Yuki Endo [Key Lecture Content] The Ministry of Land, Infrastructure, Transport and Tourism is advancing discussions on the realization of automated logistics roads as a new form of logistics in response to recommendations from the "Interim Summary on the State of High-Standard Road Networks," addressing logistics crises and carbon neutrality. This lecture will introduce the final summary on the state of automated logistics roads published in July of the 7th year of Reiwa, as well as the demonstration experiments planned for the 7th year of Reiwa. [Lecture Items] 1. Final summary on automated logistics roads 2. Demonstration experiments for the 7th year of Reiwa 3. Q&A / Business card exchange

Mar 18, 2026

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[Seminar] The Core of Connectivity Supporting SDV

  • NEW
  • SEMINAR_EVENT

[Speaker] NTT Docomo Business Inc. 5G & IoT Services Department Director in charge of Global Connected Cars, Yuji Tamai [Key Lecture Content] The value of SDV lies in continuously cycling 'updates × data × cloud', and connectivity is a prerequisite for this. In this presentation, we will organize the barriers of quality, cost, and regulation faced in global expansion, and explain the design principles and operational models from roaming enhancement, eSIM/RSP (SGP.32), integrated management (CMP), NTN, to Network API. Additionally, we will delve into security aspects related to connectivity, introducing phenomena observed in actual service operations and their countermeasures, as well as exploring other operational updates (staged delivery, avoiding simultaneous activation, monitoring/observability). [Lecture Items] 1. Positioning of connectivity in SDV 2. Barriers to global connectivity 3. Designing to "strengthen" roaming 4. eSIM/RSP and SGP.32 5. Integrated connectivity management (CMP) and operations 6. Further connectivity - NTN and Network API 7. Security and update operations 8. Q&A

Mar 18, 2026

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Graduating from a workplace that doesn't move unless you say so. How to change the field with a system.

  • NEW
  • SEMINAR_EVENT

"Even though I'm communicating, nothing changes." "When I give a warning, the atmosphere gets worse." — Are you trying to solve these problems just by changing how you interact? What you need is not to move people, but to create a workplace that is easy to navigate. I will explain based on numerous examples of on-site improvements that I have supported. Held on May 27 (Wednesday). Please check the LP for more details. ▼ For more information and registration (free), see below.

Mar 18, 2026

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Free Dry Fog Humidification System Demo Experience Event

  • NEW
  • SEMINAR_EVENT

At the Dry Fog Humidification System Free Demo Experience, you will have the opportunity to actually experience our Dry Fog, as well as our single-fluid and dual-fluid humidifiers. We will explain the differences from conventional humidifiers and the effects of implementation. In addition to introducing the latest case studies, we will also provide time for you to consult directly with our specialized staff. Please select a convenient venue and date from the application page and apply. * The "morning session" and "afternoon session" contain the same content. Please participate at a time that suits you. * This event is intended for users only. Participation from trading companies, other companies in the same industry, or for sales purposes to our company is not permitted. Venues: ■ Yamagata Venue: 3/12 (Wed) at Yamagata International Exchange Plaza 3/13 (Thu) at Sakata Chamber of Commerce and Industry ■ Sendai Venue: 3/14 (Fri) at Kiri no Ikeuchi Sendai Branch ■ Tokyo Venue & Osaka Venue: 3/18 (Tue), 3/19 (Wed), 3/21 (Fri) at Kiri no Ikeuchi Tokyo Sales Office & Kiri no Ikeuchi Osaka Headquarters ■ Nagoya Venue & Fukuoka Venue: 4/9 (Wed), 4/10 (Thu), 4/11 (Fri) at Kiri no Ikeuchi Nagoya Sales Office & Kiri no Ikeuchi Fukuoka Sales Office

Mar 18, 2026

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A Thorough Explanation of How to Proceed with AS/400 Rewrite through Q&A! - The Path to Project Success Revealed through On-Site Questions -

  • NEW
  • SEMINAR_EVENT

In recent years, as many companies are considering modernization, exploring methods for system renewal has become an important issue. This seminar will focus on "Rewrite," one of the solutions to such challenges, and will explain questions and issues encountered during project promotion in a Q&A format. <Program> - Opening - How to advance system renewal through "Rewrite" and key points for problem-solving - Introduction of unique tools to support migration <Recommended for> - Those who are struggling with specific methods for system renewal - Those who are concerned about the continuity of maintenance for existing systems and a shortage of personnel - Companies that own IBM i (AS/400) *We may refuse applications from competing companies or those not eligible to participate.

Mar 18, 2026

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