We exhibited at the Interphex Week Tokyo - 9th Bio Pharmaceutical EXPO!

Pre-use post-sterilization integrity testing support filling line

We assemble various single-use parts such as tubes, bags, filters, filling needles, and RTP ports according to your requirements. After assembly, they can be sterilized and delivered. The parts undergo various tests and validations based on guidelines.

• Bio-related product packaging machine

A biomimetic system that tests by moving cultivated mini-organs.

Mechanical stimulation of cultured tissues such as 3D cardiac microtissues using actuators to mimic heartbeats and knee joint movements. Evaluation of changes in electrical activity after drug administration allows for in vitro safety assessment of drugs. *Measurement of heart rate, electrical activity, contractility, etc.

• Cell culture contract service

Using neurons as bio-digital sensors. Toxicity prediction using a digital library. High-throughput device using MEA.

Microchannel technology enables compartmentalization and co-culture. Compatibility with other companies' MEAs allows for the recording of electrical activity. Determination of toxicity and efficacy through the creation of digital signatures of compounds tested on innervated target organs. Prediction of toxicity and efficacy by comparing digital signatures of compounds using a digital library.

• Culture vessel

Alternative methods to animal testing: Pyrogenic substance testing (compatible with endotoxin and non-endotoxin testing)

Monocyte activation test kit, an alternative method to the rabbit pyrogen test and LAL test. It uses human monocytic THP-1 cells to detect the inflammatory cytokine TNF-α. Capable of detecting gram-negative bacteria, gram-positive bacteria, fungi, and viruses.

• Other analytical and testing equipment

Stirring bag for biopharmaceuticals. With stirrer. Single-use.

Single-use mixing bags are designed for quick and uniform mixing. An impeller is attached to the bottom of the bag and rotates via a magnetic drive. It can accommodate bag capacities of up to 1000L. A 4-inch or 8-inch port can be installed on the top. It is also compatible with sanitary flanges. The bags are customizable.

• Culture vessel

Newly released, TPE (thermoplastic elastomer) tubes, highly resistant to chemicals, for applications such as antibody and vaccine production. Pump tubes.

Manufactured in an ISO Class 7 cleanroom Compliant with USP Class 6, various certifications BPA, phthalate, latex, and animal-free Operating temperature: -45℃ to 135℃ Low gas permeability Thermal bonding possible Please inquire about delivery time.

• Other bio products

Sterilization applications for biopharmaceuticals and sterile preparations! Filters with high microbial retention, low protein adsorption, and extremely low elution performance.

Advanced Microdevices' sterilizing capsule filter achieves improved throughput through a pre-filter and high flow rates due to low hold-up volume. 【Features】 ■ Improved recovery rate due to low protein adsorption ■ Assurance of microbial capture performance through bacteria challenge testing ■ 100% integrity testing conducted ■ Certificate provided with each filter ■ Compatible with ethylene oxide and autoclave sterilization ■ Gamma radiation sterilization compatible

• Other bio-related products

Various lineups are prepared based on flow rate, effective surface area, and sterilization methods.

Consistent product quality using a quality management system Establishment of product traceability through lot number management Validation support through integrity tests, extractables, leachables, adsorption, and testing Compliance with various regulations such as FDA and USP Autoclave, steam sterilization Sterilization varies by each filter For details, please contact us

• Filtration Filter

Reliable single-use bags required for sterile processes such as storage and transportation of media, intermediates, buffers, etc., used in biopharmaceuticals.

AsptiBag Gold uses an inactive multilayer polyethylene film that is physically robust and inert to many chemicals and solvents, while also possessing excellent gas barrier properties. The contact surface is made of 130μm ultra-low-density polyethylene without any additives. It meets various regulatory and functional requirements, providing consistently high-quality products.

• Other bio-related products

FEP-made cell culture bags. Manufactured by TECHNOFLEX (France). Compliant with USP Class 6. DMF registered.

The SafeCell series is made of fluorinated ethylene propylene (FEP) and meets the demands of in vitro cell culture. FEP is chemically and biologically inert, making it perfectly suitable for cell suspension culture. Its anti-adhesion properties allow cells to freely float and proliferate in the medium. SafeCell bags are permeable to gases (oxygen, carbon dioxide, nitrogen), enabling the necessary exchanges for proper cell development, while also possessing another important characteristic: water impermeability. The low evaporation rate of SafeCell bags prevents issues even in humid incubators that increase the risk of bacterial and microbial growth.

• Culture vessel

Gamma-ray irradiated disposable sampling system. Customizable.

The sterile sampling system can be customized to meet user requirements for tube size, sampling ports, and sampling containers.

• Other bio products

Aseptic sampling system with adapter

The disposable sampling port cartridge eliminates the need for time-consuming assembly of multi-port adapters. This allows for direct attachment to the container's port, creating a simple, fast, and immediately usable sampling system. It is a gamma-irradiated disposable system for aseptic liquid sampling at various stages of pharmaceutical and biopharmaceutical processing. These systems minimize the potential for false positives compared to traditional sampling systems and reduce the need for cleaning. A sealed system that maximizes operator safety and eliminates contamination. A simpler, faster, and completely disposable ready-to-use solution for sampling applications. There is no need for the cumbersome and time-consuming assembly of sampling system ports and multi-port adapters within the cartridge.

• Animal cells

To reduce contamination risks and streamline the cleaning process.

Single-use assembly tubes for biopharmaceuticals. Tube material, length, connector type, filters, etc. can be customized according to customer requirements. Manufactured in a Class 7 cleanroom. The facility is ISO 13485 and FDA certified. Compatible with gamma sterilization, with various certificates included.

• Filtration Filter

No need for centrifugation‼ Cultivation filtration depth filter

The combination of deep filtration and alluvial filtration allows for the removal of CHO cells, bacteria, etc., in a single step without the need for a centrifugation step. This reduces the cost and downtime of the bioprocess.

• Protein Extraction Kit

Frozen storage bags for blood products, antibody drugs, vaccines, and biosimilars.

The products are manufactured in a controlled environment compliant with ISO 7 by specially trained personnel. Some of the products adhere to strict quality control protocols, including particle count, microscopic observation, and individual bag pressure tests.

• Culture vessel

EVA freezing storage bag (-196℃). Made by TECHNOFLEX (France). Compliant with USP Class 6 and ISO 10993.

EVA-based high-frequency welded tubes and connectors ensure the integrity of a completely sealed system once filling is complete. This process is already used in Technoflex's sterilization bags, preventing the risk of contamination and issues related to the transfer between the container and its contents, while also controlling the assembly costs of the fillers. EVA bags manufactured in an ISO 8 cleanroom undergo numerous tests in accordance with good manufacturing practices, including endotoxin level assessments and airtightness tests. The capacity of the bags ranges from 5 to 500 ml. Sterilization using beta or gamma rays is also available upon request. Technoflex provides global "all-in-one" sterilization for bags, tubes, and connectors.

• Human cells

Sustained-release formulation testing apparatus USP Apparatus 3

BIO-DIS is a dissolution tester for conducting release rate tests, compliant with USP Apparatus 3 and EP Reciprocating Cylinder tests. It is an ideal dissolution tester for formulations that require sustained release formulations and dissolution profiles at multiple pH levels.

• Dissolution Tester

● The production time for casting prototypes can be shortened! Since model making is not required, the production time for prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly creating sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! Different products, such as similar shapes or variations in dimensions, can be created in a single molding process. This allows for the verification of multiple types in a short period.

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without affecting the base material with heat. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

Dear Sir/Madam, I would like to express my congratulations on the continued prosperity of your company. Thank you very much for your exceptional support. We would like to inform you that our company will be closed for winter holidays during the following period. We apologize for any inconvenience this may cause and kindly ask for your understanding. 1. Winter Holiday Period From Thursday, December 28, 2023, to Thursday, January 4, 2024. 2. Business Operations After the Winter Holiday Period We will resume normal operations from Friday, January 5, 2024.

● This is a leak testing device for small electronic components that does not use fluorinated inert liquids (PFAS-free). ● There is no longer a need for unstable visual confirmation through liquid immersion testing. It adopts a quantitative testing method that allows for stable pressure leak testing. ● It is a tabletop leak testing device specifically for gross leaks, with accuracy equal to or greater than that of liquid immersion testing. ● The detectable range is approximately 1×10⁻² Pa·m³/s to 1×10⁻⁶ Pa·m³/s (varies depending on the target product). ● It is suitable for sealed structures ranging from a few millimeters to a maximum of 80 × 70 mm. Please feel free to contact us for more information!

● The production time for casting prototypes can be shortened! Since model production is not required, the time needed to create prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly producing sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! With one molding process, different products with similar shapes or varying dimensions can be molded at the same time. This allows for the verification of multiple types in a short period.