Sector/Industry: Pharma/Biologics
Project Duration: 2000 to Present
Solution: Facilities/Process Commissioning, and Sustaining Operations.
Project Description:
This project saw the LotusWorks team working with one of the largest integrated Bio-Technology campuses in the world, and one of the only facilities in Europe to manufacture biopharmaceuticals, pharmaceuticals & vaccines within the same facility.
LotusWorks started on site at the beginning of the construction phase, and were heavily involved during the start-up and Commissioning stage. As the site matured into a manufacturing facility in 2005, LotusWorks transferred into a sustainability role and currently remain a key part of the sustaining support group across the plant today.
The client manufacturing processes are subject to rigorous control to assure the quality of processes and products and that each batch meets its requirements for safe and effective patient use. The LotusWorks team on site play a pivotal role in ensuring these standards are adhered to, which in turn eliminates any site downtime.
LotusWorks also provide project support on an ongoing basis to the client for upgrades, expansions, process improvements etc and were instrumental in the commissioning stages of the 2007 expansion of the sites development facility.
Project Services:
- Systems walk downs for snag-listing
- Coordinated and scheduled vendor commissioning and start-up activities & dealing with vendors in handover of documentation
- Developed process overview training modules to standardize induction for new employees
- Developed site instrumentation equipment lists, equipment commissioning and start-up procedures, and plant performance testing procedures for acceptance by owner
- Conducted rigorous integrated systems testing (IST) to test the plant in failure, safety, emergency and unplanned test modes to verify systems
- Compliance of the quality procedures in line with various regulatory authorities
- Provide 24/7 shift support to production
Outcomes:
- The LotusWorks LEED accredited teams assisted the client in creating energy efficient facilities to meet environmental standards
- The client was supported with engineering expertise which enabled a smooth handover from construction to manufacturing and experienced reduced downtime and increased productivity
- Complying to Commissioning standards including ASHRAE, LotusWorks ensured the facility is operating to regulatory standards guaranteeing production safety and product quality
- LotusWorks managed and coordinated all third-party vendors and the design team during the construction stage of the project, leaving the client to focus on their core business activity
- The client avoided the considerable costs of late occupancy, liquidated damages, extended equipment rentals, and other costs associated with delays due to fewer change orders, delays, and reworks
- Improved expansion of the team on site due to the standardized training for new employees reducing training time required and reducing the potential for costly human error mistakes
- The LotusWorks team identified and corrected costly performance deficiencies in the facility resulting in cost savings and increased equipment lifecycle
- LotusWorks performed sophisticated processes and tests to verify that all facility components work together as an integrated system
- LotusWorks provided Operations & Maintenance teams who could hit the ground running who were familiar with the facility, the instruments and the equipment allowing sustaining work to be carried out quickly and efficiently
- LotusWorks plant personnel have a strong understanding of their responsibilities and safe work practices and have the knowledge and practical abilities necessary to operate the plant safely and reliably
- Cost savings are achieved by utilizing a risk-based approach which classifies each piece of equipment within the facility in terms of its impact on product quality – categorizing equipment into four categories – direct impact/indirect impact/ No impact & safety environment impact
