Sartorius Stedim Japan K.K. List of Products and Services

Climate Change Measures: How efficient manufacturing strategies impact the climate Water Use Efficiency: How single-use equipment can significantly reduce water consumption Materials and Circularity: The importance of understanding a product's environmental footprint and how to promote circularity Partnerships: Industry associations that Sartorius collaborates with to achieve transformation both within and outside the industry

■Reduction of Risks and Improvement of Performance There is no risk of contamination between batches or products. Mycap bottle closures have passed integrity tests for bacterial immersion. ■One-for-All Closure System All Mycap closure systems are built using the same high-performance platinum-cured silicone seal, regardless of tube material, tube size, port configuration, bottle type, or bottle size. By implementing Mycap throughout the entire manufacturing process, validation becomes easier, and regulatory burdens are reduced. ■Easy Implementation Choosing pre-assembled single-use Mycap bottle closures can reduce the burden of validation and parts management.

TakeOne Flex is a series of modular sampling solutions designed to meet complex needs such as process monitoring and regulatory compliance.

The Takeone sterile sampling device is a key component of an effective microbial control program. Samples collected using Takeone are used to measure purity attributes such as bioburden, sterility, and endotoxin concentration, as well as important process parameters like metabolites, nutrients, osmotic pressure, and pH. ▪ Independent sterile sampling in a closed system ▪ Accurate sampling ▪ Pre-assembled and ready to use ▪ On-demand sample collection ▪ Ergonomically designed for ease of use by operators ▪ Completely single-use, disposable type

Biowelder TC is a fully automated device for connecting thermoplastic tubes through aseptic welding operations. This innovative technology enables aseptic connections of tubes with outer diameters ranging from ¼ inch to 1 inch.

"Biosealer TC" is the latest model in the Biosealer series, which has received high praise from many users. This series has been used in various single-use product applications as a heat sealing machine for tubes compatible with different tube diameters. The latest model features a touch screen, making it even easier to use. We invite you to experience the enhanced operability.

Liquid Transfer is an essential part of bio-manufacturing processes. For every transfer between different single-use, multi-use or hybrid systems, you will get the right solution for your biopharmaceutical process. With Tuflux Tubing, you benefit from the purest Silicone and TPE tubing for the transfer of your critical fluids. Both tubing types have excellent extractable/leachable profiles and guarantee the highest cleanliness and safety across all process steps.

Features and Benefits ■ Simplification of dispensing tasks ■ Rapid preparation of small-scale batch media ■ Elimination of contamination risks ■ Assurance of reproducible dispensing ■ Paperless record management ■ Cost reduction through plug-and-play single-use setup

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

■Mixing Force: Rapid powder dissolution or homogenization of high-viscosity products ■Low Shear: Floating impeller supports gentle mixing for delicate products sensitive to shear ■Modular: One Flexsafe Pro Mixer base unit can accommodate three different sizes of bag holders ■Scalable: Wide mixing performance up to 1,000L

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.

【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

Features and Benefits ■ Special design covering all steps of CGT liquid handling manufacturing from upstream to final filling ■ Excellent biocompatibility and robustness support with Flexsafe film ■ Qualified and flexible design space ■ Support for regulatory compliance

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.

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.

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).

Celsius FFT | FFTp with Safecore Technology is a groundbreaking single-use sterilized bag-in-plate design (cassette) that demonstrates excellent performance in the protection of biopharmaceuticals during freezing, storage, handling, and transportation. 【Features and Benefits】 ■ Outstanding protection throughout the entire lifecycle ■ Maximum robustness up to 80°C, inspection and cleaning functions, easy operation, and compatibility with various sterile connectors ■ Flexible and stable freezing and thawing that can accommodate scalable and diverse processes ■ Bulk processes (storage | 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.

Octoplus FF is a sterilized, ready-to-use single-use final filling set that can be configured with various components and connectors. 【Main Features】 ■ High reliability in filling accuracy ■ High drainage rate ■ Enhanced foreign matter control during assembly ■ Lot release testing ■ Clean, sterilized, and 100% integrity tested

The Biosafe Rapid Transfer Ports (110 mm and 200 mm diameter) are a reliable and user-friendly solution for the safe transfer of materials and liquids, maintaining the integrity of critical areas such as isolators, RABS, and clean rooms. Features and Benefits • Unique magnetic technology without rotation prevents foreign matter generation • Designed to protect the suspicious ring, reducing potential contamination risks • External opening port configuration allows for glove-free operation • Compact and space-saving port fittings for isolators (optional 90° lever available)