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Isolators for Manual and Semi-Automatic Fill&Finish Litek Pharma
Isolators for Fill&Finish
Litek Pharma’s Fill & Finish Isolators provide a Grade A aseptic environment for sterile filling, stoppering and closing operations involving vials and bags. Designed for small-scale production, clinical batches and advanced process development, these systems protect the product throughout every critical manufacturing stage while minimizing contamination risks.
Their modular architecture allows each isolator to be configured according to specific process requirements, integrating filling technologies, stoppering systems, crimping stations, aseptic transfer solutions and lyophilization interfaces within a single containment platform.
Material transfer and GMP-compliant debagging
Vials and bags are introduced through a dedicated airlock where debagging operations are performed under controlled GMP conditions. A Rapid Transfer Port (RTP) enables the segregated removal of packaging materials, minimizing contamination risks and particle generation. Following debagging, materials are transferred into the processing chamber through interlocked transfer systems that maintain environmental segregation and aseptic integrity throughout production.
Su arquitectura modular permite configurar cada aislador en función de los requisitos específicos del proceso, integrando tecnologías de llenado, sistemas de colocación de tapones, estaciones de capsulado, soluciones de transferencia aséptica e interfaces de liofilización en una única plataforma de contención.
Available Configurations
Isolator for Manual Fill&Finish
The Manual Fill & Finish Isolator is designed for processes requiring maximum flexibility and direct operator control. It provides a fully aseptic environment for filling, stoppering, capping and handling operations involving vials and bags.
The system can be configured with peristaltic pumps, tabletop filling equipment and manual handling stations, allowing manufacturers to process multiple container formats while maintaining product sterility and operational reliability. This configuration is particularly suitable for clinical production, process development and low-volume manufacturing where adaptability is a priority.
Key advantages
- Maximum flexibility for small-batch production.
- Direct operator control throughout the process.
- Ideal for clinical manufacturing and process development.
- Easy adaptation to different container formats and filling equipment
This configuration is particularly suitable for clinical production, process development activities and low-volume manufacturing where flexibility is a priority.
The Semi-Automatic Fill & Finish Isolator combines operator flexibility with automated process steps to improve repeatability, ergonomics and batch consistency.
Depending on the process configuration, vials or bags are transferred to the filling area, where filling is performed using a peristaltic pump and an automatically controlled filling nozzle. For vial applications, containers can be positioned on calibrated load cells, enabling 100% in-process control (IPC) of the filled volume and ensuring high dosing accuracy.
Following filling, the system can incorporate semi-automatic stoppering and automatic crimping operations, reducing operator intervention while maintaining closure consistency and process reliability. To preserve aseptic conditions, filling and crimping areas can be physically segregated, preventing particle migration into critical processing zones.
Key Advantages:
- Reduced operator intervention in critical process steps.
- 100% in-process control (IPC) of filling volume.
- Enhanced dosing accuracy and process repeatability.
- Improved ergonomics and operational efficiency.
Litek Pharma Fill & Finish Isolators can be directly integrated with lyophilizers, creating a continuous aseptic process from filling to freeze-drying while minimizing manual transfers between critical production stages.
Assisted Loading System
The system incorporates a lift-assisted loading solution that facilitates product transfer into the lyophilizer. Through a semi-automatic loading system, operators can handle vials or trays with improved ergonomics, reduced physical effort and greater process efficiency, while maintaining full aseptic control.
Available configurations
- Manual filling with semi-automatic lyophilizer loading.
- Semi-automatic filling with semi-automatic lyophilizer loading.
Key advantages:
- Continuous aseptic transfer from filling to lyophilization.
- Improved operator ergonomics through assisted loading.
- Reduced manual handling and contamination risks.
- Enhanced process efficiency and repeatability.
Continuous Aseptic Environment and Process Control
The isolator incorporates continuous monitoring of viable and non-viable particles, temperature and humidity to maintain controlled environmental conditions. For applications requiring critical climate control, the system can be equipped with an external air handling unit (AHU).
An integrated H₂O₂ bio decontamination system enables automated and validated decontamination cycles, ensuring sterility while reducing turnaround times. All critical process parameters are communicated directly to the control system, enabling comprehensive data collection, batch reporting, traceability 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 can be integrated with the customer’s SCADA or BMS system. The platform also supports automatic filling pump recalibration and centralized management of process data, reinforcing accuracy, repeatability and GMP compliance.
Additional options, such as BIBO filter change systems, can be incorporated to further enhance containment and operational safety.
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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