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STERILINE CLOSED RESTRICTED ACCESS BARRIER SYSTEMS (cRABS) are a containment device used for the production of sterile products, either toxic or not. cRABS provide protection from contamination and keep the production process enclosed in a confined area. STERILINE CLOSED RESTRICTED ACCESS BARRIER SYSTEMS maintain the ISO 5 Class inside the protection hood while at the same time keeping the air pressure cascade controlled as well as the temperature inside the hood and the humidity. The contact surfaces of the cRABS are AISI304L or AISI316L stainless steel, with finishes of at least Ra=0,5 pm.
STERILINE also produces ISOLATORS, as standalone equipments (i.e. quality control, sampling, compounding, etc) or designed to fully integrate into the STERILINE sterile filling lines, in compliance with FDA and cGMP Regulation. Both cRABS and ISOLATORS control systems are developed in accordance with cGMP, GAMP and 21CFR Part11 requirements.
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