TOSEI
Brand Introduction
TOSEI (東成メカテク株式会社 / TOSEI Mechtec KK) is a leading manufacturer of precision pharmaceutical manufacturing equipment and sterile isolation technology headquartered in Japan (official website: https://www.tosei-mechtec.jp/).
In response to the trend of modern biopharmaceuticals, advanced cell and gene therapies (ATMPs), antibody-drug complexes (ADCs), mRNA vaccines, and personalized precision medicine towards "small-batch, high-activity, high-value, and multi-dose formulations," TOSEI, leveraging decades of Japanese precision mechanical engineering expertise, has broken through the limitations of traditional large-scale filling lines, which are characterized by large footprints, large dead volume, and time-consuming line changeover and cleaning. Specifically designed for R&D prescription development, clinical trial samples (Phase I & II), and small-scale commercial production, TOSEI has created a "Benchtop Aseptic Fill-Finish & Isolator" system that boasts extremely high flexibility, ultra-low loss, and strict adherence to aseptic standards. "Systems" is a highly trusted brand by major leading pharmaceutical companies in Japan (such as Takeda, Daiichi Sankyo, Chugai, Otsuka Pharmaceutical, etc.) and biotechnology laboratories worldwide.
Core values
Modular, multi-format flexibility:
A single machine can flexibly handle three major injection types: vials, pre-filled syringes (PFS), and cartridges .
Tool-free or minimally sized quick-release mechanisms allow for specification changes in just 15 to 30 minutes, minimizing downtime for batch clearing and line changeovers.
High Accuracy & Zero Dead-Volume:
Equipped with a top-of-the-line precision micro-peristaltic pump or servo rotary piston pump, the measurement accuracy is better than ±0.5% .
Designed with a dedicated flow path for precious, minute quantities of high-value pharmaceutical solutions, it significantly reduces fluid loss and residue in the filling tubing, ensuring that every drop of precious API is fully utilized.
100% In-Process Control (IPC) Real-Time Online Weighing and Inspection:
It integrates a high-precision electronic balance unit and has a 100% inspection IPC mechanism that includes tare before filling and reweighing after filling. It supports real-time trend feedback for fine-tuning and automatic rejection of out-of-tolerance defective products to ensure that each sample meets quality uniformity.
Compliant with the new aseptic technique using low-particulate, low-turbulence processes (EU GMP Annex 1 Compliance):
The facility is designed entirely in accordance with the latest EU GMP Annex 1, PIC/S, and FDA aseptic process guidelines .
All transmission components are located below the key operating surface (Grade A), with a streamlined and minimalist appearance, allowing unidirectional laminar flow (LAF) to pass smoothly without generating eddy currents or dust particles; the metal cap is made by flexible extrusion and rotation molding, minimizing the shedding of metal particles.
Japanese-style meticulous craftsmanship and complete data integrity (Data Integrity & Quality by Design):
All parts in contact with the disinfectant are made of AISI 316L medical-grade stainless steel, USP Class VI silicone, and PTFE ; the entire machine is resistant to VHP (vaporized hydrogen peroxide) and high-concentration disinfectant sterilization.
The control system complies with FDA 21 CFR Part 11, IEC 61131-3 and GAMP 5 , and provides complete original Japanese/English DQ/IQ/OQ/PQ verification documents .
Product direction
TOSEI's product line spans four main areas: " desktop single-head aseptic filling machines ," " multi-functional automatic filling and capping platforms ," " precision capping and rolling machines ," and " sterile glove isolators ."
1. Tabletop Single-Head Aseptic Filling and Stopping Series (Labflex FS Series)
Compact and plug-and-play machines designed specifically for the environments inside biosafety cabinets (BSCs) or workbenches:
Labflex FS-V (for vials only):
Specifically designed for filling and capping 2 to 20 mL vials (supports full capping and freeze-dried half capping modes), with a precision peristaltic pump accuracy of ±0.5%, supporting manual or automatic recirculation of up to 10 vials.
Labflex FS-X (3-in-1 Multi-functional):
Compatible vials (2-20 mL), pre-filled syringes (0.5-3 mL) and cartridges (1.5-3 mL), with optional vacuum stopping system to eliminate air bubbles and support 100% IPC online weighing.
2. Desktop Multifunctional Robotic Fill-Finish Platform
Labflex FSC FLEX30:
A desktop continuous production workstation that integrates "automatic filling, plugging, and aluminum capping".
Supports Nest boxed or bulk Vial, Syringe, and Cartridge, with a production capacity of up to 12 to 16 pcs/min.
Built-in Grade A vertical laminar flow purification and inert gas (N2) flushing function before and after filling (residual oxygen content < 1%), equipped with servo roller sealing technology.
3. Precision Vial Capping & Crimping Series
Labflexia MC-01 / MC-10 (Semi-automatic particulate suppression capping machine):
Designed specifically for internal operation of isolators, compatible with Ø 8 to 20 mm aluminum caps and flip-off caps.
Combining servo rotation and precision pneumatic stroke, it uses flexible extrusion rotation to form a seal, completely eliminating the metal particle scattering caused by traditional tappets.
ACS20 (Small Batch Fully Automatic Vial Sealing Machine):
The maximum production capacity can reach 20 pcs/min, supporting 2R to 20R vials, and features dual-station continuous capping and defective product detection and rejection.
4. Aseptic Isolator Integration with Glove Box (Aseptic Isolator Solutions)
ISO-100 (Integrated Aseptic Isolator for Filling Machines):
The interior meets ISO Class 5 / Grade A cleanliness standards and is equipped with a ULPA U15 filter (99.9998% filtration efficiency) and a liquid gel seal.
It is perfectly compatible with the VHP vaporized hydrogen peroxide sterilization system and features a dynamic micro-positive pressure (protecting sterile products) and micro-negative pressure (protecting operators, suitable for cytotoxic/anticancer drugs) switching mechanism.
Brand advantages
Shortening the time to market for advanced therapeutics (ATMP): Targeting the characteristics of cell therapy, mRNA and gene therapy, such as small batch sizes, inability to be sterilized at high temperatures and extremely short active half-lives, TOSEI provides a highly protective and easy-to-use aseptic packaging solution, which is a benchmark for setting up CPC (Cell Culture Center) and GTP laboratories.
Ultimate cleaning efficiency and flexibility: A single work platform can cover Vial, Syringe, and Cartridge through module replacement. Compared to traditional large production lines that require several days of cleaning and verification, the TOSEI system can complete line changeover and disinfection within half an hour, significantly reducing R&D and trial production costs.
One-stop international regulatory compliance verification: Whether facing the aseptic assurance requirements of the new EU GMP Annex 1 or the data integrity audit of FDA 21 CFR Part 11, TOSEI provides a rigorously tested verification document package (DQ/IQ/OQ/PQ) to help customers successfully pass official factory audits at home and abroad.
