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Small-Scale Fill & Finish Isolator
Safe Aseptic Filling
Litek Pharma’s small-scale Fill & Finish Isolator is designed for aseptic filling operations that require maximum precision, microbiological control, and product protection. It is an ideal solution for small batches and development processes where sterility and ergonomics are key factors. Its design ensures a controlled environment that reduces contamination risks and guarantees product stability throughout all stages of the Fill & Finish process.
Compatible with Fill & Finish and lyophilizer loading/unloading systems
The isolator is designed to integrate with lyophilizers and dedicated Fill & Finish equipment, 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.
In addition, it can incorporate a lyophilizer loading and unloading assistance system that optimizes the ergonomics of loading and unloading operations, either in semi-automatic or fully automated mode, ensuring precision at every stage of the process.
Its flexibility allows the level of automation to be adapted to specific production requirements.
This broad compatibility provides a versatile solution capable of adapting to multiple production processes while consistently maintaining aseptic integrity, operational efficiency, ergonomics, and system reliability.
Controlled aseptic environment for filling operations
The isolator maintains aseptic conditions by providing a GRADE A environment suitable for dosing, stoppering, closing, and handling vials or syringes.
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) can be optionally integrated to manage 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 required sterility levels for critical processes while significantly reducing disinfection times.
Monitoring of critical parameters is directly communicated to the equipment control system, allowing process data to be collected and recorded. This integration supports the generation of complete and robust batch reports, strengthening traceability, process control, and regulatory compliance.
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.
Custom-designed isolator
The small-scale Fill & Finish Isolator is designed to adapt to the specific processes of each customer. Its architecture allows integration with different filling equipment and operational configurations, adjusting to specific working requirements while ensuring maximum safety during handling.
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 process accuracy and repeatability.
This integration eases 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. The 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
The small-scale Fill & Finish Isolator can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester, which enable verification of glove integrity in glove-equipped chambers and leak-tightness testing of rapid transfer ports.
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