Our advanced aseptic filling system delivers a compact, modular solution designed for small batches and maximum flexibility. Featuring a gloveless isolator module and an automatic robotic filling system, it ensures precision, sterility, and full data integrity throughout the process. The multiformat design supports both nests and trays with no glass-toglass contact, while 100% IPC guarantees consistent quality.
With integrated batch distribution filling and a unified Isolator Control System that manages recipes, reports, and audit trail, the system provides seamless operation within a small footprint.
Engineered for efficiency and performance, it achieves high throughput speeds of 2,000–2,500 pieces per hour.
Key Features
Fully Customized Solution
Engineered as a tailor-made solution to meet specific process, layout, and regulatory requirements, with carefully defined design parameters to ensure optimal performance and compliance. An enhanced automation module for debagging and delidding is offered by Litek, configurable to customer requirements.
Flexible Filling System Integration
Engineered for flexibility, this isolator is specifically designed to accommodate filling systems for vials, syringes, and cartridges, meeting the stringent requirements of the pharmaceutical and biotechnology industries while ensuring aseptic integrity and process reliability.
Gloveless Convenience
The isolator system offers the flexibility to operate without gloves, enhancing convenience while maintaining a stringent aseptic environment. The automated gloveless module integrates all critical operations, including denesting, filling, 100% IPC, stopper or plunger insertion, and renesting, using robotic systems within a Grade A environment to ensure high accuracy, process consistency, and full GMP compliance.
- Siemens PLC–based control architecture combined with a Zenon HMI/SCADA automation platform, featuring a 12-inch industrial operator touchscreen.
- Hardware and software fully compatible with 21 CFR Part 11, when operated in accordance with approved Standard Operating Procedures (SOPs).
- Dedicated communication port / network interface for integration with the client’s SCADA or Building Management System (BMS).
- Integration of filling equipment.
- Batch preparation module.
- Validatable software 21 CFR Part 11, GAMP5.
- Rapid transfer ports (RTP) installation.
- Viable monitoring.
- Viable and non-viable particle counter.
- Glove Tester with IRDF fully integrated into the isolator system.
- User manual
- Functional Design Specification (FDS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
- Factory Acceptance Test (FAT)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
Please do not hesitate to contact us if you require any further information.