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Litek Pharma ATMP Isolators
Sterile and safe production of advanced therapies
Litek Pharma’s advanced therapy isolator provides a fully controlled and aseptic environment for the manufacture of cell therapies and ATMP processes. Its design ensures product protection, microbiological stability, or containment throughout all stages of the workflow.
Advanced environmental control and integrated bio decontamination
The system incorporates continuous monitoring of viable and non‑viable particles, as well as temperature and humidity, ensuring permanent control of environmental conditions. An external air handling unit (AHU) is available as an option for environments with critical temperature and/or humidity requirements.
The isolator features an integrated hydrogen peroxide (H₂O₂) generation system, enabling internal decontamination through automated and validated cycles.
This ensures the sterility levels required for critical processes while accelerating disinfection times.
Monitoring of critical parameters is directly communicated to the equipment control system, allowing process data to be collected and recorded. This integration facilitates the generation of complete and robust batch reports, reinforcing traceability, process control, and regulatory compliance.
Modular design adaptable to each project
Litek Pharma’s ATMP isolator features a modular design that allows it to be configured according to the specific requirements of each project. This modularity facilitates the production of a wide range of advanced therapies, including sample preparation, incubation, centrifugation, and Fill & Finish processes, with or without a lyophilizer.
The isolator can also incorporate additional options such as a safe filter change system (BIBO) for specific applications, enhancing operational safety and process efficiency.
Complete integration of equipment for advanced therapies
The isolator can integrate a wide range of essential equipment for cell handling, from centrifuges and incubators to microscopes, shakers, or genetic modification systems.
For Fill & Finish applications, the isolator allows the integration of filling systems such as peristaltic pumps (100% IPC), as well as fully integrated filling and finishing solutions, including lyophilization.
Integrated automation and process control
The control architecture is based on an HMI/SCADA platform operated via an industrial touchscreen. Hardware and software are compliant with 21 CFR Part 11 and allow integration with the customer’s SCADA or BMS system, ensuring traceability, data security, and readiness for GMP audits.
El aislador también puede incorporar opciones adicionales como un sistema de cambio seguro de filtros tipo BIBO para aplicaciones específicas, aumentando la seguridad operativa y la eficiencia del proceso.
Integrity control with Glove Tester & RTP Tester
Litek Pharma’s Advanced Therapy Isolator can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester , enabling verification of glove integrity and leak‑tightness testing of rapid transfer ports
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