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Isolator Fill & Finish with lyophilization Litek Pharma
Integrated Aseptic Processes
Litek Pharma’s Fill & Finish Isolator has been designed to integrate filling processes with or without lyophilization into a single system, ensuring a controlled aseptic environment and protecting the product throughout all critical stages. This solution enables efficient management of the entire process while minimizing contamination risks.
Continuous aseptic environment throughout the entire process
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.
Direct integration with lyophilization systems
The isolator design allows direct integration with lyophilizers and can also incorporate a semi‑automatic lyophilizer loading and unloading system, enabling the safe handling of vials or trays during loading and unloading operations.
Modular and configurable design
Litek Pharma’s modular design allows the isolator to be configured according to the specific needs of each process, incorporating preparation modules, filling modules for vials, syringes, or cartridges, as well as aseptic transfer and lyophilization systems. This versatility makes it easy to adapt the system to different production volumes and formats, optimizing operational efficiency while ensuring compliance with quality standards.
The isolator can also incorporate additional options such as a safe filter change system (BIBO) for specific applications, further enhancing operational safety and process efficiency.
Compatibility with different filling systems
The isolator is designed to integrate with a wide range of filling systems, including the installation of peristaltic pumps at the base of the unit or the integration of benchtop equipment. It also enables stoppering and capping operations for vials, syringes, or other pharmaceutical formats.
This broad compatibility ensures a versatile solution capable of adapting to multiple production processes while consistently maintaining aseptic integrity and operational reliability.
Integrated automation and process control
The control architecture is based on an HMI/SCADA platform operated via an industrial touchscreen. Both hardware and software are compliant with 21 CFR Part 11 and allow integration with the customer’s SCADA or BMS system, ensuring traceability and GMP‑compliant data security.
The filling systems integrated into the base of the isolator communicate directly with the equipment’s control system, enabling the collection and recording of critical filling process data. They also allow automatic recalibration of the filling pump, ensuring process accuracy and repeatability.
This integration facilitates the generation of a complete and robust batch report, reinforcing traceability, process control, and regulatory compliance.
Ergonomics and operator safety
The isolator design prioritizes operator ergonomics and safety, offering optimal visibility, controlled access points, and an internal layout that facilitates all operations carried out inside the isolator.
A comprehensive solution for advanced Fill & Finish processes
Thanks to the integration of filling and/or lyophilization within a single aseptic system, Litek Pharma’s Fill & Finish Isolator is positioned as a complete solution. Combined with robust engineering, modularity, and advanced automation, it meets the current demands of the pharmaceutical and biotechnology industries.
Integrity control with Glove Tester & RTP Tester
Litek Pharma’s Fill & Finish Isolator can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester , enabling verification of glove integrity in glove‑equipped chambers and leak‑tightness testing of rapid transfer ports.
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