TECHLEAD® Aseptic Filling Workstation Introduction: The TECHLEAD® Aseptic Filling Workstation features a three-chamber design, consisting of a transfer chamber, filling chamber, and capping chamber. It is equipped with an integrated hydrogen peroxide generator to meet the requirements for both simultaneous and individual sterilization of the three chambers. The TECHLEAD® Aseptic Filling Workstation can be fully customized according to the user's process requirements, utilizing modular assembly to achieve automated production, significantly enhancing the efficiency of sterile drug manufacturing. Additionally, it effectively mitigates contamination risks during the filling process of sterile drugs and ATMPs. Application fields To isolate and protect critical operations such as aseptic filling, stoppering, and capping of pharmaceutical preparations, thereby minimizing the risk of external environmental contamination during the filling process and ensuring a smooth, standardized, and effective aseptic filling control procedure. Features: 1. Provide a continuously controlled dynamic Class A cleanroom environment; 2. Provide a fully enclosed physical barrier to prevent direct contact between operators and products, addressing microbial contamination issues 3. It enables real-time monitoring of airborne 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 equipped with multifunctional interfaces, allowing the installation of online airborne microorganism and dust particle collection/detection devices, and features in-situ sterilization capabilities; 5. The industrial computer integrates control over the isolator and filling machine, featuring multi-level login permission management, audit trail, and electronic signature functions, complying with the relevant provisions of FDA CFR21 PART11; 6. The entire filling production process can be fully recorded, with data traceability; 7. Automated and intelligent operations reduce labor costs; 8. Integrated with the latest generation vaporized hydrogen peroxide (VHPS®) sterilizer and precise hydrogen peroxide gas concentration/saturation control technology, it enables rapid sterilization of the cabin environment, ensuring a sterile condition during the filling process; 9. Flexible cabin sterilization options: All cabins can be sterilized together or each cabin can be sterilized individually; 10. The adoption of TECHLEAD® aseptic filling workstations can shorten project construction cycles and reduce operational costs; 11. Suitable for use in lower cleanliness scenarios (Grade D), reducing operational costs; 12. It can provide solutions for cleanrooms with limited space; Sterilization process compatibility testing and validation can be provided; 13. High-efficiency VHP catalytic external decomposition unit, achieving lower safe discharge concentration (optional); 14. Higher-level traceability to avoid uncertainty 15. Integrated SCADA system (audit trail, electronic signatures, generation of PDF production batch reports, etc.) 16. More ergonomic design: 17. A brand-new human-machine interface display; 18. Front upper opening 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. Can be assembled and spliced on-site
TECHLEAD® Aseptic Filling Workstation Introduction: The TECHLEAD® Aseptic Filling Workstation features a three-chamber design, consisting of a transfer chamber, filling chamber, and capping chamber. It is equipped with an integrated hydrogen peroxide generator to meet the requirements for both simultaneous and individual sterilization of the three chambers. The TECHLEAD® Aseptic Filling Workstation can be fully customized according to the user's process requirements, utilizing modular assembly to achieve automated production, significantly enhancing the efficiency of sterile drug manufacturing. Additionally, it effectively mitigates contamination risks during the filling process of sterile drugs and ATMPs.
