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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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Biosafe 110

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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 Participation in the "Advanced Power Semiconductor Subcommittee 12th Lecture" on November 19 (Wednesday) and 20 (Thursday), 2025.

  • NEW
  • SEMINAR_EVENT

We will be exhibiting at the "12th Conference of the Advanced Power Semiconductor Subcommittee" held at the Toyama International Conference Center. We will be introducing our latest analysis technology services, so please stop by! We sincerely look forward to your visit.

Oct 17, 2025

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Measurement and Measurement Comprehensive Technology Exhibition in Hokuriku

[Line Seiki] "Measurement and Measurement Comprehensive Technology Exhibition in Hokuriku" Exhibition Announcement

  • NEW
  • SEMINAR_EVENT

Our company will exhibit at the Measurement and Measurement Comprehensive Technology Exhibition in Hokuriku, showcasing safety products with Gemba Reporter. Please be sure to stop by booth number "72" when you visit. 【Date and Time】 November 6, 2025 (Thursday) 9:00 AM - 5:00 PM 【Venue】 Ishikawa Industrial Exhibition Hall, Building 2 From JR Kanazawa Station, take the Hokutetsu Bus bound for "Shimo-Yasuhara" and get off at "Fukurobatake Town West Green Park," then walk for 5 minutes. Alternatively, take the Hokutetsu Bus bound for "Saiseikai Hospital," get off at "Seibu Green Park," and it will take about 15 minutes by taxi. 【Materials】 https://www.line.co.jp/wp-content/uploads/2025/10/MepTechhokuriku2025.pdf 【Notes】 Please register in advance using the 2D barcode in the PDF.

Oct 17, 2025

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[October 31, 2025 (Friday)] Notice of participation in the "Environmental Industry Expo 2025"

  • NEW
  • SEMINAR_EVENT

Sekiguchi Iron Works Co., Ltd. will exhibit at the "Environmental Industry Expo 2025" held at S-Bird in Iida City, Nagano Prefecture. This exhibition aims to pave the way for a sustainable future from the local community. It is a trade fair for environmental-related industries originating from the Minami-Shinshu region of Nagano Prefecture. Our company will introduce next-generation solutions for reducing environmental impact and effectively utilizing energy, including our "smokeless small incinerator" and "stove," along with product panels and case studies. No pre-registration is required, and admission is free. We sincerely look forward to your visit.

Oct 17, 2025

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November 10 (Monday) Webinar "Basics and Use Cases of Fine Bubbles"

  • NEW
  • SEMINAR_EVENT

Recently, fine bubbles, which are tiny bubbles smaller than 100 μm and are referred to as "fine bubbles," have attracted attention in various fields such as the environment, agriculture, food, fisheries, and medicine, due to their ability to impart various functions to liquids. Fine bubbles are classified into two types based on their size: microbubbles and ultrafine bubbles. Recently, there has been a growing interest in ultrafine bubbles, which have a lifespan of several weeks to months. However, listening to the voices of researchers and users reveals some skepticism, which has become one of the issues hindering the spread of fine bubble technology. On the other hand, we have challenged the elucidation of the stabilization mechanism of ultrafine bubbles from a new perspective by enabling the control of number density exceeding 10 billion particles/mL without pressure or concentration operations using our ultrafine bubble generation technology. In this seminar, we will provide a fundamental explanation of fine bubble technology, including the basic physical properties, characteristics and functions, device technology, measurement and evaluation methods, and case studies, to promote research and utilization of fine bubbles based on a correct understanding.

Oct 17, 2025

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Notice of Participation in the 'Minami Shinshu Environmental Messe 2025' from November 1 (Saturday) to November 2 (Sunday), 2025

  • NEW
  • SEMINAR_EVENT

Sekiguchi Iron Works Co., Ltd. will exhibit at the "Minami-Shinshu Environmental Messe 2025" held at S-Bird in Iida City, Nagano Prefecture. This exhibition will be held simultaneously with the "Environmental Industry Trade Fair" taking place the day before. It will be held over the weekend, with many family-friendly events planned. We encourage those who usually find it difficult to visit to take this opportunity to come. Our product exhibition area is located about 10 minutes from the venue. We sincerely look forward to your visit.

Oct 17, 2025

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