MSD, Sterile Manufacturing Facility Upgrade

About this project

The scope of the project addressed 4 major strands:

• Compliance to ensure that facility meets core quality requirements for sterile processing facilities including segregated gowning & degowning, movement between rooms, segregation of waste flows and separate entry airlocks for personnel and materials
• Sustainability to ensure that process equipment and utilities are capable of providing reliable supply through 2020
• Capacity to ensure that the long range operational plan for production can be met through 2020
• Installation of New Capper

Process/support systems/facility

The OPS1 Facility has been operating as a sterile processing facility for 30 years and has benefited from a several extensions and refits. The 2020 upgrade project identified the changes required to meet current GMP standards and maintain operability through 2020, these changes are both facility and process focused. Construction was staged over 4 phases starting in July 2013 and completing in January 2016. Over all 4 phases, 93,000 manhours were expended with No Lost Time Incidents.

During Phase 4 the main facility area of 600m² was completely stripped out and rebuilt to new layout during a 10 week Construction Period (workforce peaking at 124 persons). The new layout included:

• Installation of new clean room facility with Grade A,B,C and D areas,the grade A area is approximate 400m²
• New Equipment
• Complete rerouting of ducting
• New Fan Filter units
• New Electrical and Instrumentation to support
• New LSS
• The facility has full particle monitoring both Grade A and B areas

Achievements

• Best in Class compliant GMP processing facility
• Improved Material Flows
• Improved Personnel Flows
• Improved Segregation
• Increased Storage
• Upgrade Administration Areas
• Minimum production down time with over 50% of works completed in operating sterile facility
• The Last Planner system was successfully implemented for phase 4 construction