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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

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

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 30th Mechanical Components Technology Exhibition [Tokyo] ■ [July 9 (Wed) - July 11 (Fri), 2025]"

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  • SEMINAR_EVENT

Nitto Kohki will exhibit at the "30th Mechanical Components Technology Exhibition [Tokyo]" held at Makuhari Messe Hall 5 from July 9 (Wednesday) to July 11 (Friday). [Booth Number: Hall 5 31-32] At this exhibition, we will showcase a variety of products, including the electric suction hand "e-VEE" with a built-in pump that does not require compressed air, a cordless belt sander, the electric driver "Delvo" that can be mounted on robots, and the "Flow Monitor" that allows for easy visualization of the flow of cooling water in molds and other applications.

Dec 08, 2025

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■Notice of the "2025 Attack Fair in Meiko"!■ 【July 23, 2025 (Wednesday) - July 24, 2025 (Thursday)】

  • NEW
  • SEMINAR_EVENT

Nitto Kohki will hold the "2025 Attack Fair in Meiko" for two days from July 23 (Wednesday) to July 24 (Thursday), 2025, at the "Kowa Seminar Plaza 2F Training Room NO.12 (inside Kowa Sports Land)." The Attack Fair is an exhibition where you can actually "see, touch, and operate" Nitto Kohki's products. Additionally, there will be wonderful souvenirs for attendees and many fun activities planned. We look forward to welcoming everyone!

Dec 08, 2025

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PIAB [Booth: West Hall 2 W2-32] will be exhibiting at iREX 2025 "2025 International Robot Exhibition"!

  • NEW
  • SEMINAR_EVENT

[Exhibition Display] Demonstration of pineapple adhesion dynamics using collaborative robots Dynamic display using collaborative robots and tool changers for gripping Static display of a 5kg dual-sided gripper Comparison of ejector compressed air consumption Various suction pads Foam gripper, etc. We recommend visiting on the first or second day when you can view the exhibits with relative ease. *The third day (Friday) is expected to be very crowded. 【Gripper Sale Event】 We will be selling the following two products at a discounted price at the exhibition booth. Please inquire about the special prices at the venue. ■ 'KENOS Gripper KVGL.400.100, N214.FR6.S2' URL: https://www.youtube.com/watch?v=HsNRwrDtjW0 ■ 'Collaborative Robot Hand KCS.Q110.N301.110.FR6.SX422.V1.X.X' URL: https://www.youtube.com/watch?v=GFKg3blZzdQ These products are ideal not only for actual applications but also for use as test machines. How about taking this opportunity?

Dec 05, 2025

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[Seminar] The Megatrends of Mobility Indicated by CES 2026

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  • SEMINAR_EVENT

[Speaker] Innovation Analyst Andy Kondo [Key Lecture Content] *The latest content will be added as appropriate based on on-site research at CES. The following may change depending on the event status.* CES has now become "the world's largest mobility exhibition," comparable to an auto show. The focus for 2026 will be on the social implementation of autonomous driving, the rise of Software-Defined Vehicles (SDV), the proliferation of AI-equipped vehicles, and the rapid growth of Chinese OEMs, all of which are converging to rewrite the industrial structure. In this lecture, from the perspective of an analyst who has been on-site for over 10 years, we will interpret where the global mobility industry is headed based on the "real scene of CES 2026." Furthermore, we will discuss how these changes will impact and create opportunities in the Japanese market, which is finally beginning to embrace electrification, while aligning with the latest international trends.

Dec 05, 2025

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[Seminar] Know-how for Creating Materials: The Basics

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  • SEMINAR_EVENT

[Speaker] Representative of Infonavi Instructor at Business Breakthrough University, Ms. Yoshie Ueno [Lecture Topics] 1. What is a document? - The role of "documents" 2. The success or failure of document creation lies at the entrance - There are procedures for information research - Planning the research 3. Thinking about document creation with a framework - Preventing omissions and eliminating waste - Examples of framework utilization 4. Considering from information sources - There are different types of information - Main information sources for business research 5. How to read and assess documents - Criteria for evaluating information 6. How to create effective documents - Enhancing persuasiveness and trustworthiness 7. Q&A / Business card exchange

Dec 05, 2025

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  • 12/14までに無料掲載を申し込むだけ 抽選で20名様にAmazonギフトカード5,000円分プレゼント!
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