Sector / Industry: Pharma / Biologics
Location: Dundalk, Ireland
Project Duration: August 2019 – ongoing
Services offered: Engineering support, Calibration support, Startup support, Sustaining
Project description:
This state-of-the-art manufacturing facility is one of the first and largest green-field pharmaceutical projects in Ireland. It features single-use bioreactors for commercial bio-manufacturing and is equipped with next-generation processing technology. This project is the world’s largest single-use biological manufacturing facility.
In August 2019, LotusWorks joined the client in building a Sustaining and Calibrations Team to support the project startup with a vision of sustaining the team long-term on-site.
Project Services:
- Performing 5000+ initial calibrations across utilities and manufacturing
- Development of Calibration Program alongside client engineering specialists
- Documentation set up
- SOP’s
- URS
- EWI
- Job plans
- Risk Assessments
- Organizing and planning vendor training
- LotusWorks planners work alongside the overall project planners to ensure all dates and milestones are captured and attainable. Our planners then add the necessary line items required by the startup / sustaining team to be 100% system ready. This schedule is updated daily to capture site changes.
- As the project schedule only provided dates for milestones, as in construction complete and hand over dates etc., the LotusWorks planner developed a schedule to include all the line items necessary for the team to be “operationally ready”.
- Process and Utility Systems including:
- Electrical installation from MV to ELV
- Wet Utilities
- Black utilities
- CUB equipment
- Chillers
- Cooling towers
- Boilers
- Compressors
- Process air and water
- CIP
- Clean steam
- WFI
- HVAC units
Outcomes: Project ongoing
- Fully competent technical teams carried out over 5000 calibrations to regulatory standards
- Access to a LotusWorks Online Calibration Instrument Tracker, allowing clients to track the progress of their instrument throughout the calibration process creating real-time accurate information to generate the facility calibration schedules
- Ensuring product safety and concerns relating to accurate and compliant product delivery are eliminated
- Our clients gain comprehensive calibration expertise in their facility incorporating multiple equipment types as the LotusWorks team is skilled in the calibration of all equipment & products from different providers
- Our teams have developed processes, programs and templates from years of experience in similar settings. This allows the LotusWorks team to “hit the ground running” on any new startup.
- This knowledge, continually adapted from lessons learned, ensures the LotusWorks team will deliver the clients objectives in an efficient and timely manner, putting safety and quality to the forefront.
