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Litek Pharma’s RABS (Restricted Access Barrier Systems) are designed to effectively protect the product during aseptic processes by creating a high‑level separation between the operator and the critical processing core. By combining rigid physical barriers with dynamic airflow control, RABS ensure a controlled environment that reduces contamination risks and preserves product integrity.
Litek Pharma’s RABS incorporate high‑efficiency HEPA filtration systems that generate and maintain a Grade A environment within the critical area.
Unidirectional airflow ensures homogeneous distribution of clean air, minimizing the risk of cross‑contamination and guaranteeing optimal conditions for aseptic processing.
The system is equipped with strategically positioned glove ports that allow operators to perform required operations without breaching the protective barrier. This solution helps maintain environmental sterility while ensuring physical separation between the product and the operator, while also improving operational efficiency in critical tasks.
RABS can integrate advanced viable and non‑viable particle monitoring systems, enabling real‑time control of contamination levels within the critical area. Continuous monitoring allows for rapid response to any deviation and ensures product quality throughout the entire manufacturing process.
Litek Pharma’s RABS are specifically designed for small‑scale Fill & Finish processes, with or without lyophilization, adapting to the specific requirements of each customer and production process.
Thanks to their modular and configurable design, they allow the integration of different types of filling equipment with 100% IPC, as well as lyophilizers, shakers, balances, and other auxiliary systems required for operation. This flexibility enables a fully customized solution while ensuring product and environmental protection in compliance with applicable regulatory standards.
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 allow integration with the customer’s SCADA or BMS system, ensuring traceability, data security, and readiness for GMP audits.
Litek Pharma’s RABS can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester, enabling verification of glove integrity in glove‑equipped chambers and leak‑tightness testing of rapid transfer ports.
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