BPOG RISK-BASED APPROACHES TO USE OF CLOSED SYSTEMS IN RENOVATIONS OF EXISTING BIOPHARMA API FACILITIES

Companies often experience regulatory challenges during an inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time, the company response has been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilized, then a CNC space can be used. As well as reducing the complexity of operations, this will reduce capital and operating costs.