RABS

Restricted Access Barrier Systems (RABS) are a popular solution in aseptic processing as they are able to effectively protect products. They achieve this by creating a high-level separation between operators and the critical aseptic core through a combination of physical barriers and dynamic airflow.

At Litek Pharma, we specialize in designing and manufacturing customized RABS for aseptic processes. In particular for existing small-scale Fill&Finish and freeze-drying processes, where we can incorporate an assisted loading system, for vials, trays or in bulk.

Equipment Overview

Litek Pharma’s RABS brings together a suite of features designed for aseptic processing excellence:

• Rigid wall enclosure: RABS may feature a robust, enclosed structure equipped with interlocked doors, ensuring a physical barrier that effectively separates aseptic processing operations from operators and external contaminants.
• Unidirectional airflow systems: RABS incorporate (HEPA) filters, optimizing air quality and filtration efficiency. By employing unidirectional airflow technology, RABS create and maintain a controlled class A environment within the critical processing area. The airflow minimizes the risk of crossed contamination, safeguarding the integrity of the pharmaceutical products.
• Glove ports for operational access: They can be equipped with strategically positioned glove ports, facilitating operational access to all areas within the enclosure while preserving the sterile environment. This design feature enhances operator safety and process efficiency.
• Internal particle contamination monitoring: RABS can integrate sophisticated particle counting equipment for real-time monitoring of internal contamination levels. This approach to contamination control enables timely interventions and ensures product integrity throughout the manufacturing process.
• Equipment integration: Litek Pharma’s RABS offer exceptional flexibility in design, allowing the integration of third-party equipment such as freeze dryers, agitators, and more. This adaptability ensures that our RABS can be customized to meet diverse processing and customer needs.