Home> Solutions > Fill&Finish solutions > Isolator for robotized Fill&Finish
Isolator for robotized Fill&Finish Litek Pharma
Litek Pharma’s Robotic Fill & Finish Isolator is a system that provides an aseptic environment designed for automated small-batch Fill & Finish operations involving RTU (ready-to-use) vials, syringes and cartridges under the most stringent aseptic conditions (ISO 5 / Grade A), in compliance with GMP guidelines and Annex 1.
Its compact, modular design delivers maximum operational flexibility while ensuring sterility, process integrity and comprehensive monitoring of critical parameters throughout every filling stage.
To find out more about its features, automated processes and customisation options, please visit the equipment’s dedicated page.
Available configurations
Isolator with manual preparation module
The manual preparation module is designed for the controlled opening of RTU tubs by the operator under fully aseptic conditions.
The tubs are introduced into the working area, where they are decontaminated using VHP. Once decontaminated, the operator uses the isolator gloves to perform the debagging and delidding process manually, ensuring the controlled removal of the bag, lid and protective liner.
Once prepared, the tubs containing the nest are transferred to the robotic filling system, where the Fill & Finish operations are carried out with high precision and repeatability. The system ensures seamless integration between manual handling and automated stages, maintaining a continuous, safe process flow that is fully compatible with aseptic manufacturing requirements.
Key benefits:
- Operational flexibility for different tub formats and configurations
- Full operator control over the preparation process
- Seamless integration with robotic Fill & Finish systems
- Ergonomic design and compliance with GMP and aseptic processing requirements
Isolator with automatic preparation module
The operator removes the outer bag and introduces the tub into the debagging module, where the inner bag is opened in a controlled manner using a guillotine-type cutting system.
The tub is then conveyed to the delidding station. There, a heated plate applies controlled heat to facilitate separation of the lid, which is subsequently removed together with the protective liner by a robotic system. Both components are automatically deposited in an integrated waste container, eliminating the need for manual handling.
Once opening is complete, the tub is ready for transfer to the Fill & Finish stages. The entire process is carried out automatically and under containment, minimizing operator intervention, reducing the risk of contamination and ensuring safe, repeatable preparation in compliance with aseptic manufacturing requirements.
Key benefits:
- Controlled debagging with no direct contact
- Fully automated delidding, liner removal and waste management
- High process repeatability and precision
- Eliminates manual intervention
- Full integration with robotic Fill & Finish systems
Isolator with lyophilization and automatic or manual preparation module
The system can optionally incorporate a lyophilization module, compatible with both manual and automatic preparation configurations.
In the robotic version, the lyophilizer loading module automatically collects the nests from the Fill & Finish process and transfers them into the lyophilizer using a high-precision robotic system. Once the lyophilization cycle is complete, the nests are automatically unloaded and reintroduced into a tub for transfer to subsequent process stages. This configuration uses RayDyLyo® stoppers, specifically designed for lyophilization processes. They allow the vials to be fully sealed after the closing operation performed by the lyophilizer shelves, eliminating the need for additional stoppering or sealing stages.
In the manual version, the system enables lyophilizer loading using a lift, supporting the operation through a semi-automatic system that optimizes ergonomics and improves process efficiency.
Key benefits:
- Automatic or semi-automatic lyophilizer loading and unloading
- Compatible with manual and automatic preparation configurations
- Safe and stable nest handling
- Optimized integration with lyophilization processes
Glove-less aseptic system with robotic automation for greater efficiency and precision
The robotic Fill & Finish isolator incorporates glove-less robotic modules for all critical operations in the Fill & Finish area, including debagging, denesting, filling, weighing, stoppering and re-nesting. All operations take place within a Grade A environment, eliminating the need for direct manual intervention.
This automation ensures high repeatability, reduces process variability and delivers high levels of efficiency while maintaining sterility and traceability at all times.
Multi-format design with no glass-to-glass contact
The isolator’s multi-format design supports the processing of both nests and trays, preventing glass-to-glass contact and ensuring controlled handling of containers. This architecture enables vials, syringes and cartridges to be processed within a single system, ensuring consistent quality through 100 % IPC control.
Full process control and data management
The control architecture is based on a 21 CFR Part 11-compliant HMI/SCADA platform, enabling integration with the customer’s SCADA or BMS systems.
The system continuously records critical parameters, facilitating the generation of complete batch reports, improving traceability and ensuring regulatory compliance.
Integrity testing 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
Shall we talk about your project?
We look forward to hearing your questions or suggestions.
Ready to work together?
Let’s discuss your next project.
If you want to tell us about your project or simply get in touch, write to us!
© 2026 | All rights reserved.
Another website created by Palabra de Ciervo