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Pharma/Biologics – Calibration and Sustaining of Utilities Systems

  • Sector / Industry: Pharma / Biologics
  • Location: Dundalk, Ireland
  • Partnership Commenced: August 2019.
  • Project Duration: August 2019 – ongoing
  • Services Offered: Engineering support, Calibration support, Start-up support, Utilities Sustaining Maintenance and Operations, Calibrations Sustaining Services. 

Project description: 
This state-of-the-art research, development and manufacturing facility represents a major step in our client’s investment in Europe and marks one of the largest investments of this scale by the company outside of China. It features single-use bioreactors for commercial bio-manufacturing and is equipped with next-generation processing technology.  The facility will be installed with 48,000l fed-batch bioreactors and 6,000l perfusion bioreactors. It will be one of the world’s largest facilities equipped with disposable bioreactors. 

In 2019, the LotusWorks team commenced partnership with this client on the green field site assisting in getting the world’s largest single-use biological facility up and running. After 4 years in partnership with this global bio-pharmaceutical client, the LotusWorks team has grown from a team of 5 to 53 supporting the project start-up and long-term sustaining of the facility.  

Project Services:  

  • Participation in HAZOPs, FATs, and System shakedowns 
  • The LotusWorks team worked alongside the Project Planners to ensure all dates and milestones were captured and attainable. Our team then adds 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 construction completion milestones and handover dates etc., the LotusWorks team developed a schedule to include all the line items necessary for the team to be “operationally ready”. 
  • CMMS & Documentation setup:
  1. URS.
  2. SOP’s.
  3. EWI’s
  4. Job plans.
  5. Risk Assessments.
  6. SLA Review and set-up.
  7. Asset Build.
  8. Spare Parts Build.
  9. PM & PDM Build.

Project Outcomes:  

  • All Utility Systems handed over for operation and maintenance purposes 
  • P&ID walks during construction phase to ensure any non-conformances were corrected early which avoided schedule impact – Utility and Manufacturing Process Systems 
  • Ensuring equipment is installed to standards and specification and in a manner to ensure ease of maintenance and calibration in the forthcoming sustaining phase 
  • Fully competent technical teams carried out over 5,000 calibrations to regulatory standards 
  • The client had access to a LotusWorks Online Calibration Instrument Tracker, allowing the client to track the progress of their instrument throughout the calibration process which created real-time accurate information to generate the facility calibration schedules 
  • Our client gains 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. 
  • Our team, continually adapt from previous projects and lessons learned, ensuring we deliver clients objectives in an efficient and timely manner, putting safety and quality to the forefront. 

Sustaining Services 

  • 24/7 Utilities CUB and Associated Equipment Ownership, Operations & Reporting 
  • Utilities CUB and Associated Equipment Maintenance – PMs, CMs & PDMs 
  • 12/7 Calibrations Execution – Process, Utilities & QC & MSAT Portable Lab Equipment 
  • Vendor Management, Utilities and Calibrations Specialist Providers 
  • Permit Issuance, Management & Equipment Ownership 
  • Continuous Improvement Program with the realisation of significant OPEX Savings and Cost Avoidance 
  • PM Rationalisation & absorption of vendor PMs in-house 

Networking of Site and Discipline Leads with the wider LotusWorks Sites to ensure the benefits of group knowledge are realised. 

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