Delivering Excellence in Facility Expansion
In order to expand to a 50,000 sq. ft. sterile manufacturing facility, our multinational Biopharmaceutical client retained the services of Sciras to lead the commissioning and qualification, and provide overall project management services.
INDUSTRY
Biopharmaceuticals CMO
AREA OF EXPERTISE
Engineering Project Management
DURATION
1.5 years
SERVICES PROVIDED
- Project Management
- Commissioning & Qualification
IMPACT
Effective project planning, coordination of several engineering firms, and execution of C&Q protocols were essential in enabling production in the newly expanded 50,000 sq. ft. facility.
Business Challenge
Faced with dynamic objectives and scope, combined with the restrictions of the COVID-19 pandemic, Sciras consultants supported our multinational Biopharmaceutical client in project management, commissioning, and qualification to enable production of a newly expanded 50,000 sq. ft. facility.
Our Approach
Sciras consultants started by developing impact assessments. Next, they developed and executed (commissioning, qualification, and environmental monitoring) documents for 10 HVAC systems, associated production area systems, and several clean utilities. For project management, the team coordinated multiple engineering firms through many milestones by producing detailed schedules and labour curves forecasting onsite activities. The Sciras team also provided status updates, progress dashboards, and hosted weekly progress meetings. Activities were closely tracked until completion to provide accurate updates.
Results Achieved
Sciras was able to provide the client with effective project management and coordination of multiple engineering firms to complete the facility expansion. The Sciras team commissioned and qualified 10 HVAC systems, multiple clean utilities, and class ISO 7 and ISO 8 clean rooms while also providing a path forward for maintaining a qualified state.
