Litek Pharma’s aseptic isolators are engineered to provide a controlled Grade A environment for small-scale aseptic processing.
This specific configuration is designed exclusively for manual and semi-automatic operations.
The system supports only RTU (readyto-use) components, such as vials, syringes, and cartridges, offering a reliable solution.
Filling System Integration
Integration of a peristaltic pump with 1% accuracy and automatic dose calibration adjustment.
Semi-Automatic Process
Vials enter in RTU format, where debagging of the second bag is performed, followed by an automatic VHP disinfection cycle.
100% IPC Integration
The system includes a weighing position on a scale, allowing for filling calibration
Lyophilizer Integrated into the Isolator – Assisted Loading System
Lyophilizer integrated at the rear of the isolator, with a semi-automatic assisted loading system to facilitate vial loading and unloading.
Main features:
- From 0.09 m² to 0.9 m², a complete turnkey solution with integrated freeze dryer inside the isolator, featuring semi-automatic vial loading, automatic recipes with final stoppering, and precise control of all the parameters of the lyophilization process to ensure high final product quality.
- From freezing to stoppering: customer can create automatic recipes with final stoppering
- Multiple options and configuration adapt to the requirements for precise control of all the parameters of the process
and product - Possibility of Lyosuite SCADA with 21 CFR
- Precise control of all the parameters of the lyophilization process to ensure high final product
- Easy cleaning without coil inside the condenser.
Solution for Processing High-Potency Products
The isolator features a HEPA H14 filtration solution at the chamber outlet with a safe change BIBO (Bag-In, Bag-Out) system. Similarly, the lyophilizer is equipped with a HEPA H14 filtration system with a BIBO safe change solution.
Integrated Control and Monitoring System
Includes a comprehensive reporting and data logging system that records all critical parameters of the isolator, Fill & Finish system, and lyophilizer, in compliance with CFR 21 Part 11 and Audit Trail requirements.
Integrated VHP Disinfection System for Isolator and Lyophilizer
The disinfection system can operate alternately with the entry airlock, the main chamber, the lyophilizer, and the condenser, achieving effective, validatable disinfection equivalent to 6 log.
Please do not hesitate to contact us if you require any further information.