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cRABS

Closed Restricted Access Barrier Systems

BROCHURE

 

 




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.

 

The STERILINE cRABS main features are:

  • AISI304L stainless steel for metal contact surfaces with finishes of at least Ra=0,5µm;
  • AISI304L stainless steel for panels, guards, etc. not in contact with the product and sanitizing solution;
  • AISI316L stainless steel for cleaning solution piping with tri-clamp fittings;
  • Doors made of thick security glass and sealed with inflatable gaskets. Gaskets are made of either silicone, Viton or EPDM;
  • Gloves are incorporated into the design for aseptic applications. The quantity and position of gloves is determined during the mock-up test;
  • CIP of the internal surfaces is achieved by means of spray gun fed by WFI or WFI mixed with inactivation agent;
  • Continuous monitoring of viable and non viable particles.