ザルトリウス・ステディム・ジャパン List of Products and Services

You can view this as a guideline for selecting the optimal filter.

By using Sartorius's pre-filter, which has a high capacity and excellent clarification performance, significant cost reductions and optimization of process flow can be achieved. Utilizing our wide range of pre-filtration solutions enhances the product lifecycle of downstream unit operations.

Virosart virus filters provide industry-leading solutions in the field of virus removal, ensuring protection and efficiency in biopharmaceutical manufacturing. Virosart meets diverse process needs and enables consistently stable and effective virus filtration.

■ Sartocon (Flat Membrane Cassette) A high-performance filter optimized for the biopharmaceutical industry, featuring excellent hydrophilicity and broad chemical compatibility. ■ Hollow Fiber (Hollow Fiber) Available in three formats: single-use, autoclavable, and alkaline-cleanable, each providing excellent performance and characteristics to meet various applications and needs. ■ TFF System (Multi | Single Use) Offers tangential flow filtration (TFF) systems at various scales, from lab and process development to clinical trials and commercial production batches.

We support the resolution of issues such as capacity, flow rate, and yield by providing cutting-edge filtration and sterilization filters, while also promoting the acceleration of process development through process optimization services.

This is a free small-scale test to select the optimal types and sizes of final filters and pre-filters for the "filtration" that the customer will implement. The test will be conducted by experienced application specialists in accordance with the customer's filtration process conditions. Tests based on rich experience ensure reliability and guarantee the credibility of the data. Filtration characteristic tests offer various benefits to customers, such as improved workability and cost reduction. Customers with the following needs are encouraged to consider this test: ■ Selection of the optimal filter for chemical solutions ■ Downsizing of filters ■ Functional evaluation of various filter membranes ■ Extension of filter life ■ Increased flow rate ■ Improved product recovery rate

The Zaltcheck series is the most widely used in the pharmaceutical industry and has gained the trust of many users as a proven integrity testing device. The Zaltcheck 5 Plus is the latest model in the series, released in 2019. With new technology, we have further enhanced usability, compliance with the latest regulations, and error detection capabilities. It sets a new standard for integrity testing devices that meets the needs of customers seeking higher levels of testing. 【Main Features of the Product】 ■ Specifications that exceed QRM legal requirements - Automatic detection of test setting errors and abnormal test conditions ■ Highest level of data integrity - Customized Linux OS - Data encryption and dual data backup ■ Intuitive and excellent operability - Large touchscreen with a clear viewing angle and intuitive user interface - First in the series to support Japanese display ■ Achievement of Health, Safety, and Environment (HSE) - Explosion-proof specifications (ATEX IECEx & FM certified) that allow safe testing of alcohol-wetted filters *For more details, please contact us or download the PDF materials.

The Zaltclear Depth Filter product family is a cellulose-based filter that contains diatomaceous earth. It is used in the biotechnology and pharmaceutical industries, where high solid removal capabilities are required to meet strict standards. In a dual-layer (DL) format, it can filter cell culture media with a cell density of less than 15×10⁶/mL from the process development stage to the commercial production stage.

By using Virosart HF, high viral safety is provided for biopharmaceuticals. Virosart HF is based on a uniquely modified PES membrane, which offers extremely excellent processing capacity and very high flow rates. Due to the high packing density of the elements, the hold-up volume and flushing capacity are extremely low, minimizing the installation area. Delivered in a sterile state, it is user-friendly and allows for quick installation of the filter elements. Virosart HF can capture small non-enveloped viruses (such as PPV, MVM) at over 4 log10 and large enveloped viruses (such as MuLV) at over 6 log10. This filter demonstrates high viral retention performance throughout the filtration process, regardless of the operating pressure, without a decrease in filtration flow rate.

Product Benefits Virosart Max significantly enhances the robustness and processing capacity of final virus filters by efficiently protecting the virus removal membrane. The most troublesome molecules for the final virus removal membrane are aggregates and small hydrophobic molecules. Virosart Max can bind aggregates extremely efficiently, independent of process conditions such as conductivity, due to hydrophobic interactions. The clean three-layer membrane material exhibits excellent adsorption capacity, making it optimal for this process stage. The T-style design of Virosart Max Maxicaps is ideal for easily installing multiple filters in series or parallel.

This filter sets high standards for the requirements needed for single-use applications and meets them. The retention of particles, retention of phages, and of course, the retention of bacteria in air and liquids are specifications that demonstrate the quality of Zaltopore Air. The integrity tests conducted on 100% of the products in the factory guarantee the quality of each filter before use. With excellent and stable flow over long periods, it provides an efficient process.

This filter sets high standards for the requirements needed for single-use applications and meets them. The specifications that demonstrate the quality of the Zaltpore Air Midizart include particle retention, phage capture, and of course, the capture of bacteria in both air and liquid (in both directions). The integrity tests conducted on 100% of the products in the factory guarantee the quality of each filter before use. With excellent stable flow over long periods, it provides an efficient process. Since it does not contain fleece, no particles are released. Its lightweight structure prevents twisting of the tubes.

■ Detailed condition examination is possible It is possible to examine important parameters regarding the behavior of molecules in the early stages of downstream process development. ■ Automated parallel testing Up to 16 channels can be managed at one control station. ■ Minimal process volume Membrane area of 10 cm² | Small-scale screening with a recirculation volume of 5 mL.

【Features】 ■ Excellent flexibility ■ Compatible with membrane areas ranging from 50 cm² to approximately 0.14 m² ■ Intuitive and user-friendly operation ■ Adopts the same operational design and sequence as the Sartoflow Advanced system ■ Maximum product yield ■ Low shear 4-piston diaphragm pump

■Continuous Dialysis Filtration: Realizing Innovation The Sartocon SP cassette evolves traditional dialysis filtration into a single-pass system. ■Versatile System for Process Control It allows for the rapid establishment of process-specific parameters for continuous dialysis filtration. ■Intuitive Control Software With touch screen operation, complete and simple parameter control, and automation, it enables process control with constant TMP or constant feed flow rate.

This system is ideal for flexible use in lab environments aimed at process development and clinical trials, as well as for small-scale manufacturing batches. With several standard options available, you can obtain the optimal system and make adjustments that perfectly match the individual needs of each customer.

**Features** - Single-use TFF specifically designed for 1 to 20L scale, providing cost-effective solutions from process development to pilot. - Ready-to-use and closed system, resulting in low bio-burden risk. **Characteristics in ADC Manufacturing** - Automation of three processes: ADC synthesis, precipitate removal, and TFF within a single system. - Reduction of funding, labor, installation space, and process risks, enabling a seamless transition from process development to small-scale commercial ADC manufacturing. - Flexible process sequence control allows for compatibility with various ADC manufacturing protocols. - Stirring optimized for minimal capacity with temperature control.

■ Design considering efficiency in the SUTFF application ■ Automation supporting advanced operations ■ Rapid exchange and cleanability of single-use flow kits maximize efficiency per batch

■ Design considering efficiency in the SUTFF application ■ Automation that supports advanced operations ■ User-friendly and quick setup

Single-use technology brings many benefits to biopharmaceutical manufacturing, enabling simpler operations. Single-use TFF systems simplify the process of ultrafiltration/diafiltration by fully controlling key parameters. ▪ Excellent engineering design that provides reliability, control performance, and ease of use ▪ Fully automated control and monitoring of process parameters ▪ Equipped with calibrated sensors, gamma-sterilized manifolds can be installed quickly and easily

The Green Line, a single-use hollow fiber module, offers an optimal solution that saves costs and time, reduces space, and features a design that can be flexibly scaled up. By matching materials, fluid pathway lengths, and performance characteristics, it achieves the expected linear scale-up from lab and pilot scales to manufacturing scale. It is scalable from batch capacities of over 10 mL to 1,500 L, with membrane areas available from 0.0052 m² to 15.42 m². The single-use line module is available with molecular weight cut-offs (MWCO) ranging from 3 kD to 750 kD, pore sizes from 0.1 μm to 0.65 μm, and hollow fiber inner diameters of 0.5 mm, 1.0 mm, and 2.0 mm.

The flow assembly for the Green Line single-use hollow fiber module provides a fully integrated single-use cross-flow solution that can be freely designed without the need for assembly, pre-washing, or cleaning. The sizes of the Green Line hollow fiber modules range from the Discover Lab scale module to mass production scale maximizers and Grand XL, capable of processing up to 1,500 liters per module. <The flow assembly for the Green Line includes, in addition to the Green Line hollow fiber module, the following items as standard or bags tailored to customer specifications upon request:> ■ Single-use pump head ■ Tubes for feed liquid, circulation liquid, and permeate liquid ■ Single-use pressure sensor/transducer ■ Single-use integrated flow sensor or reusable clamp-type flow meter/sensor ■ And sterile connectors ■ Easy detachable connectors

The kSep system is a fully automated single-use centrifugation system that continuously concentrates, washes, and recovers supernatant or solids (cell particles). It is ideal for cell separation from fed-batch culture, high-density culture, and concentrated culture, maintaining a high cell survival rate with minimized shear stress, addressing the challenges of traditional centrifugation and filtration-based technologies.

- In the cell centrifugation process, shear forces are kept low, allowing for a seamless transition from process development (0.1 L) to GMP-compliant manufacturing (20 L). - In the closed system cell recovery process, cell processing time is reduced by 50%. - Cell recovery rate improved to over 90%. - Robust results achieved even at a cell density of up to 108 cells/mL. - Improved cell viability due to low shear counterflow separation.

The Virus Counter platform is an advanced analytical tool that combines the Virus Counter device, dedicated software, and Virotag reagents. It enables rapid and accurate virus quantification. By utilizing flow virometry, it achieves near real-time virus counting, supporting virus-based applications such as the manufacturing of vaccines and gene therapy products.

Sartorius offers a wide range of customizable manufacturing standards designed to validate visual inspection processes used in quality assurance to address the challenges of detection through visual inspection. Sartorius's Particle Validation Standards (PVS) provide an economical and straightforward method to solve the time-consuming and complex task of creating standards in-house. They are also effective as training samples for manual inspection systems. ■ Supports reliable and efficient control against foreign matter contamination ■ Responds to customer needs with a wide lineup ■ Validation of visual inspection ■ For training inspectors ■ Economical and straightforward

▪ Conducting validation tests at a speed of 12 weeks ▪ Unique expertise in E&L ▪ Cost efficiency through a risk-based approach

As concerns about viral contamination rise, biopharmaceutical manufacturers are required to verify the effectiveness of their virus clearance processes. Sartorius's Confidence Virus Clearance Service offers consulting from experts in process design and optimization to support purification processes. By using high-purity virus stocks, we guarantee robust and reliable results, achieving a rapid turnaround time of just six weeks. This comprehensive virus clearance solution provides the "confidence" needed for your processes. Features and Benefits: ■ Evaluation of downstream unit operations for virus clearance ■ GLP testing ■ Non-GLP testing ■ High-purity virus stocks that guarantee reliable and trustworthy results ■ Time and cost savings by consolidating virus clearance products and services with a single provider ■ On-site flexibility | No need for sponsor presence

Process Intensification (PI) is a comprehensive framework aimed at maximizing overall production volume across manufacturing units, manufacturing processes, or biopharmaceutical facilities. Sartorius Stedim offers scalable and versatile modular solutions, including high-throughput process development tools. These can be implemented in current and future manufacturing facilities for a variety of upstream and downstream PI scenarios. - Enables faster drug development - Improves efficiency and productivity in GMP manufacturing - Applicable to various processes regardless of the pharmaceutical ◆ International Webinar [Process Intensification Webinar Series] This webinar series provides a comprehensive guide to maximizing process intensification. It covers upstream and downstream strategies, media management, data analysis, and more. You can watch it here: ⇒ https://bit.ly/3ihwdT1