STERILINE closed Restricted Access Barrier Systems (cRABS) are designed for the production of sterile products, either potent or non-potent.
These systems provide protection for operator from product and for product from operator and they prevent contamination by keeping the production process enclosed in a confined area.
The cRABS enclose a space where HEPA filtered, unidirectional air vertically flows over the process area. Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by “Bag-in Bag-out” (BIBO) filters.
cRABS shall be installed in Class B rooms.
The integrated control system of cRABS and isolators is composed of PLC and touch screen operation panel for operator interface (HMI). The electrical cabinet can be located in the technical area, while the HMI is located close to the process unit. 21CFR Part11 compliance is achieved by means of a separate PC.