The TOSEI (Tosei MechTec) LabFlexia MC-01 is a high-precision benchtop aseptic vial capping machine specifically designed for biopharmaceutical research and development, cell and gene therapy (CGT), ADC, and preclinical and clinical Phase I/II sample production. Addressing the needs of small to medium batch production and aseptic operation, the MC-01 features a compact, streamlined body and a modular, quick-release design, allowing for seamless integration into isolators, biosafety cabinets (BSCs), or aseptic laminar flow tables.

I. Flexible Continuous Wrapped Cap and Ultra-Low Dust Emission: The precision-cut multi-roller flexible continuous rotary wrapping cap process significantly eliminates the generation of metal debris and plastic burrs compared to traditional stamped caps, completely eliminating the risk of excessive particulate matter in Grade A (ISO Class 5) sterile areas.

II. Combined motor and pneumatic dual drive: A precision rotary motor combined with a highly stable pneumatic lifting drive provides a smooth and uniform downward sealing force and rotational torque, ensuring that the aluminum cap and rubber plug fit tightly in each batch and that the sealing ring is complete, symmetrical and without any warping.

III. Intelligent Recipe Management and One-Click Debugging: The built-in touch interface supports the storage and quick retrieval of multiple specification recipes (PF1～PF5). Key parameters (ZG.tim holding time, ZD.spd feed speed, XZ.spd rotation speed, WZ station height) can be precisely set digitally and debugged with one click.

IV. Modular tool-free quick mold change: The vial tray and capping head adopt a non-guided quick-release mechanism, supporting various aluminum caps and aluminum-plastic composite caps (flip-off / tear-off caps) of Ø 8–20 mm, greatly reducing the downtime and cleanup time for specification switching.

V. Dual triggering and ergonomic safety protection: Equipped with a dual-trigger foolproof mechanism and standard external foot switch control, the capping cycle can be quickly started without frequent hand operation, balancing operational safety and production efficiency.

Equipment Introduction

• Aseptic and highly clean capping technology

  • Specifically designed for biopharmaceuticals, cell and gene therapy (CGT/ATMP), antibody drug complexes (ADC), clinical trials (Phase I/II), and small-batch sterile vial sealing.

  • The use of multi-roller capping technology effectively prevents the generation of metal debris and plastic burrs, significantly reducing the risk of particulate contamination in Grade A sterile areas.

• Wide range of bottle types and aluminum cap compatibility

  • Supports 2R to 100R vials (Vial), compatible with aluminum caps, flip-off caps and tear-off caps, with a diameter range of Ø 8–20 mm.

  • The modular design allows for easy replacement of bottles of different heights and diameters, enabling rapid production without complex adjustments.

• Flexible deployment of sterile isolation systems

  • Designed specifically for Grade A / ISO Class 5 clean environments, it can be seamlessly integrated into stand-up glove isolators, biosafety cabinets (BSCs), or aseptic laminar flow workbenches.

  • The surface is made of anodized aerospace-grade aluminum alloy and AISI 316L medical-grade stainless steel, which can withstand VHP vaporized hydrogen peroxide sterilization and high-concentration IPA wiping disinfection.

• Intelligent formula management and dual-drive structure

  • By combining a servo motor and a precision pneumatic dual-drive system, the downward pressure and rotational torque are highly consistent, preventing overpressure from breaking the bottle or insufficient sealing.

  • Equipped with a high-resolution color touchscreen, it has multiple built-in process formulas and allows for precise digital adjustment of various coating parameters.

• Dual-trigger foolproof and human-machine safety protection

  • It is equipped with dual-button, foolproof start and foot switch control to ensure that the operator's hands are kept away from the moving work position to avoid the risk of injury.

  • It features built-in self-diagnosis, alarm prompts, and user permission level management, providing comprehensive operational safety protection.

• International regulatory compliance and effectiveness support

  • The control core complies with IEC 61131-3 and PLCopen international standards, and the software interface follows FDA 21 CFR Part 11 and GAMP 5 data integrity principles.

  • Provides a complete suite of DQ/IQ/OQ/PQ verification documents to help you quickly pass GMP inspections in various countries.