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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

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

Variable Area Flowmeters Reliable quality designed to world standards When measuring the flow of high-pressure or high-temperature liquids and gases that are not suitable for plastic, our robust "glass tube variable area flowmeter (rotameter)" allows for more accurate flow measurement. It offers a wider flow range and is suitable for various liquids and gases! Contents ■ Glass tube variable area flowmeters / Metal tube variable area flowmeter lineup ■ Custom design solutions ■ Accessories & replacement parts ■ Support for technical documentation and compliance with various regulatory requirements ■ Services and support, etc.

The pinhole inspection for packaging engineering is fully automated, eliminating packaging defects based on certain quality standards. The judgment results and operational status can be managed via a monitor screen. - Quantitative management of quality standards for the pinhole inspection process - Ensuring the quality of the product's shelf life - Establishing evaluation criteria for the manufacturing process, achieving quantitative quality assurance - Slim and space-saving design that can be connected to existing production lines - Quick changeover for product variety switching can be handled in a short time by exchanging chambers - Fully domestically produced, allowing for rapid maintenance and troubleshooting - Example target works: pillow packaging, packaged rice (packaged cooked rice), etc. *Please consult us regarding the use of this product for pharmaceuticals.

Fukuda Co., Ltd. has been pursuing leak detection for 60 years and is committed to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing properties. We will propose the appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

Fukuda's new flagship model. - Masterless type (FLA-0200 series) - General type (FLA-0201 series) Two models of air leak testers. With the mastering correction function, high-precision measurements can be achieved in a short time. Please take a look at the catalog.

● 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!