COLLABORATIVE INNOVATION: FLEXIBLE ISOLATION TECHNOLOGY INTEGRATED TO FILLING LINES BY FEDEGARI

Berkshire Sterile Manufacturing (US) can be considered the unique CMO that incorporates 100% isolator technology to the filling lines utilizing state-of-the-art equipment. This technology allows to remove the risk of human contamination from the filling and formulation process as highly suggested by FDA, EMEA and other regulatory bodies. Fedegari has proudly collaborated with BSM on engineering a cost-effective and innovative solution that helps pharma industries to advance their product candidate into the pre-clinical or clinical setting.

The result of BSM-Fedegari collaborative innovation is an isolator based filling system that is able to fill the following primary containers: bulk glass vials, pre-sterilized nested vials (glass and plastic) and syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic), and custom containers (glass and plastic). The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator.

 

fedegari_sterile_manufacturing_SCADA_integration_isolator_autoclave_oven_filling_line_CMO

 

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