RISK BASED APPROACHES TO USE OF CLOSED SYSTEMS IN RENOVATIONS OF EXISTING BIOPHA - ERP Spain.com - España y América Latina

Companies often experience regulatory challenges during 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 have 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 utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs. This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.