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Gloveless Multiformat Fill & Finish Isolator
Aseptic Precision
Litek Pharma’s robotized multiformat Fill & Finish Isolator is a system that provides an advanced aseptic environment designed for fully automated filling and closing operations of small batches of vials, syringes, and RTU (ready‑to‑use) cartridges under the most demanding aseptic conditions (ISO 5 / Grade A), in full compliance with GMP guidelines and Annex 1.
Its compact and modular design enables maximum operational flexibility, ensuring sterility, process integrity, and comprehensive management of critical parameters throughout all stages of the filling process.
Gloveless aseptic system for enhanced operational efficiency
The isolator incorporates a gloveless module that enables all critical operations to be carried out within a Grade A environment, eliminating the need for direct manual intervention.
This gloveless technology reduces risks, minimizes human intervention, and lowers the potential for contamination, while maintaining a strict aseptic environment throughout the entire process.
Multiformat design with no glass-to-glass contact
The isolator’s multiformat design supports the processing of both nests and trays, avoiding glass-to-glass contact and ensuring controlled handling of containers. This architecture allows vials, syringes, and cartridges to be processed within the same system, ensuring consistent quality through 100% IPC control.
Robotic automation for high precision processes
The isolator incorporates automated modules for all critical operations within the Fill & Finish area, including denesting, filling, weighing, stoppering, and re‑nesting stations, all performed using advanced robotic systems. This automation ensures high repeatability, reduces process variability, and enables high efficiency levels while maintaining sterility and full traceability.
Custom solution tailored to each customer
The gloveless Multiformat Fill & Finish Isolator has been designed as a fully customized solution, adapting to the specific requirements of each process. Litek Pharma offers different tailor‑made configurations and can integrate advanced automation systems for operations such as debagging and delidding, ensuring optimal performance in every installation.
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 controlled 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.
Multiformat flexibility
Litek Pharma’s robotic module offers multiformat flexibility, adapting to different container types such as vials, syringes, and cartridges. Its programming is tailored to the specific process carried out within the module, allowing filling and closing operations to be adjusted according to batch requirements. Thanks to its multiformat capability, the system can be adapted to different processes while ensuring they are performed efficiently and safely.
Full process control and data management
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 accuracy and repeatability of the process.
This integration facilitates the generation of a complete and robust batch report, reinforcing traceability, process control, and regulatory compliance.
Industrial automation and regulatory compliance
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.
Integrity control with Glove Tester & RTP Tester
Litek Pharma’s Multiformat 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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