BPOG RISK BASED APPROACHES TO USE OF CLOSED SYSTEMS IN RENOVATIONS OF EXISTING API FACILITIES скачать в хорошем качестве

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

BPOG RISK BASED APPROACHES TO USE OF CLOSED SYSTEMS IN RENOVATIONS OF EXISTING API FACILITIES Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department Followed by Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck. Companies often experience regulatory challenges during inspection of ageing 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's response have been to improve the existing classified areas or maybe even upgrade to a higher grade of classification. However, it may be more appropriate and improve product protection, instead implementing 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 the 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.