The TOSEI (Tosei MechTec) ISO-100 system from Japan is a high-end sterile glove isolator system specifically designed for small-batch aseptic dispensing of biopharmaceutical research and development, cell and gene therapy (CGT), ADC, antibody drugs, and clinical trials (Phase I/II). This system is tailored for Labflex desktop equipment (FS-X, FS-V, FSC FLEX30, and MC-01/10, etc.), providing a completely closed, ultra-clean, dynamically protected environment that meets EU GMP Annex 1 Grade A (ISO Class 5) standards, supporting complete VHP sterilization cycles and stringent data integrity management.

I. The chamber is equipped with an ultra-high efficiency ULPA U15 filter (filtration efficiency up to 99.9998%), combined with advanced gel seal technology, to eliminate the risk of particulate bypass leakage and provide uniform and stable vertical unidirectional laminar flow protection.

II. Seamlessly integrates with mainstream international VHP/HPV sterilization systems such as Tosei, Bioquell, and Steris, enabling fully automated biological decontamination cycles (achieving a 6-log kill rate); features a built-in dedicated hydrogen peroxide catalyst converter, significantly reducing post-sterilization decomposition time.

III. It has a precise dynamic micro-pressure differential adaptive control system, which can be set to positive pressure sterile protection (sterile preparations) or negative pressure encapsulation protection (highly active toxic drugs) according to process requirements; it has a built-in high-precision temperature and humidity sensor and hydrogen peroxide concentration monitoring interface.

IV. Optional accessories include a dedicated aseptic pass-box, a rapid transfer door (RTP), a continuous bag feeder, and a glove integrity tester to ensure zero contamination of materials entering and exiting the system.

V. The internal contact surfaces and main structure are strictly made of AISI 316L stainless steel with mirror polishing, leaving no dead corners for cleaning and resisting strong corrosive disinfectants; the front-opening tempered safety glass is paired with an elliptical ergonomic glove flange, providing a wide field of vision and conforming to ergonomics.

VI. The color industrial-grade PLC touch interface complies with IEC 61131-3 and PLCopen specifications, fully complies with FDA 21 CFR Part 11 and GAMP 5 computerized system verification requirements, has multi-level access control, electronic signatures and audit trail, and provides complete original manufacturer DQ/IQ/OQ/PQ validation documentation.

Equipment Introduction

• Grade A Aseptic Environment & Vertical Laminar Airflow

  • Provides an ISO Class 5 (EU GMP Annex 1 Grade A) ultra-clean operating environment with uniform and stable vertical unidirectional laminar airflow.

  • It uses ULPA U15 medical-grade ultra-high efficiency air filter with a filtration efficiency of up to 99.9998%, and is equipped with gel seal technology to prevent particulate leakage.

• Integrated VHP Decontamination & Catalyst Aeration

  • Fully supports 6-log vaporized hydrogen peroxide (VHP/HPV) biological decontamination circulation, compatible with mainstream sterilization systems such as Tosei, Bioquell, and Steris.

  • Built-in highly active hydrogen peroxide catalyst decomposer, which quickly decomposes hydrogen peroxide gas into water and oxygen after sterilization, greatly shortening the exhaust ventilation circulation time.

• Positive/Negative Pressure Dual-Mode Dynamic Control

  • It has the ability to freely switch between positive pressure protection mode (sterile product protection) and negative pressure protection mode (high activity/toxicity/ADC/CGT drug personnel and environmental protection).

  • It has a built-in high-precision dynamic micro-pressure differential sensor that automatically adjusts the fan speed in real time to maintain the set pressure differential in the cavity, and has an audible and visual alarm mechanism for abnormal pressure differential.

• Real-Time Environmental Monitoring & Ergonomic Glove Ports

  • It has a built-in high-sensitivity temperature and humidity and micro-pressure differential continuous monitoring module, and reserves an integrated interface for hydrogen peroxide concentration monitoring sensors.

  • The front-opening, high-transmittance reinforced safety glass window, combined with an ergonomic elliptical glove operating flange and medical-grade chemical-resistant protective gloves, allows for flexible and unobstructed operation.

• Pharmacopeia-grade stainless steel with excellent chemical resistance.

  • The internal cavity is made of AISI 316L medical-grade mirror-polished stainless steel with a rounded bevel design that eliminates dead angles, completely preventing the accumulation of particles and facilitating cleaning and sterilization.

  • The external structure is made of AISI 304 stainless steel and high-specification corrosion-resistant sealing materials, and the entire machine can withstand high concentrations of VHP sterilization gas and high concentrations of IPA surface wiping.

• Modular expandability and transfer system options.

  • Depending on the process requirements, you can choose to equip a dedicated aseptic pass-box, a rapid aseptic pass-through (RTP) door, and a continuous aseptic bag dispensing system.

  • It supports optional wireless glove leak tester and built-in high-precision dynamic electronic balance to meet all-round sterile isolation requirements.

• Seamless integration with Bench-Top Processing Equipment

  • It is specially designed to be used with the FS-X and FS-V benchtop single-head filling machines, the FSC FLEX30 three-in-one filling and capping platform, and the MC-01 / MC-10 benchtop manual/semi-automatic capping machines.

  • The compact chassis (L 2175 × W 986 × H 2022 mm, 250 kg) perfectly enables aseptic, integrated, closed-loop production of small-batch R&D and clinical trial drugs.

• Computerized System Compliance & Validation Support

  • The control core complies with IEC 61131-3 and PLCopen international program standards.

  • Data recording and electronic signatures fully comply with FDA 21 CFR Part 11 and GAMP 5 requirements.

  • Provides complete original manufacturer DQ, IQ, OQ validation folders and on-site PQ verification testing technology support.