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Pharma/Biologics – Calibration & Sustaining

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 with 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 Programme alongside client engineering specialists
  • Documentation set up
    • SOP’s
    • URS
    • EWI
    • Job plans
    • Risk Assessments
  • Organising 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, programmes 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.

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