TECHLEAD ® Aseptic filling workstation Introduction: TECHLEAD ® The aseptic filling workstation adopts a three compartment design, consisting of a transfer compartment, a filling compartment, and a capping compartment, and is equipped with an integrated hydrogen peroxide generator to meet the requirements of joint sterilization and separate sterilization of the three compartments. TECHLEAD ® The aseptic filling workstation can be fully customized according to the user's process requirements, implementing modular assembly and achieving automated production, greatly improving the efficiency of aseptic formulation production. At the same time, it can solve the contamination risk during the filling process of sterile preparations and ATMP drugs. Application field Used to isolate and protect the key operational processes of aseptic filling, plugging, and capping of formulations, in order to minimize the risk of external environmental contamination during the filling process and provide a smooth, standardized, and effective aseptic filling control process. Features: 1. Provide a continuously controllable dynamic A-class clean environment; 2. Provide fully enclosed physical barriers to prevent direct contact between operators and products, and solve the problem of microbial contamination 3. Real time monitoring of settling bacteria, temperature, humidity, pressure, and wind speed in the environment to ensure continuous control of the production environment; 4. Each compartment of the isolator is reserved with multifunctional interfaces, which can be configured with online collection/detection equipment for floating bacteria and dust particles, and have in-situ sterilization function; 5. The isolator and filling machine are integrated and controlled by an industrial computer, with multi-level login permission control, audit tracking, and electronic signature functions, in compliance with the relevant regulations of FDA CFR21 PART11; 6. The entire filling production process can be recorded with traceable data; 7. Automated and intelligent operations to reduce labor costs; 8. Integrate the latest generation of vaporized hydrogen peroxide (VHPS) ®） Sterilizers and precise hydrogen peroxide gas concentration/saturation control technology can quickly sterilize the cabin environment, ensuring a sterile environment during the filling process; 9. Flexible cabin sterilization options: Each cabin can be sterilized together or individually; 10. Adopt TECHLEAD ® Aseptic filling workstations can shorten project construction cycles and reduce operating costs; 11. Can be placed in lower clean environments (D-level) to reduce operating costs; 12. Can provide solutions for clean rooms with limited area; 13. Can provide compatibility testing and validation of sterilization processes; 14. Higher level traceability to avoid uncertainty: 15. Integrated SCADA system (audit trail, electronic signature, generating PDF production batch reports) ......) 16. More ergonomic design: 17. A brand new human-machine display interface; 18. Front open window design, sterile inflatable seal, equipped with safety lock 19. Integrated glove leak testing system 20. Easy to install other production equipment in the isolator 21. Spacious internal operating space 22. Splicing and assembly can be carried out on-site
Introduction: TECHLEAD ® The aseptic filling workstation adopts a three compartment design, consisting of a transfer compartment, a filling compartment, and a capping compartment, and is equipped with an integrated hydrogen peroxide generator to meet the requirements of joint sterilization and separate sterilization of the three compartments. TECHLEAD ® The aseptic filling workstation can be fully customized according to the user's process requirements, implementing modular assembly and achieving automated production, greatly improving the efficiency of aseptic formulation production. At the same time, it can solve the contamination risk during the filling process of sterile preparations and ATMP drugs.
