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Pharma/Biologics – Calibration & Utilities Maintenance

Global Pharmaceutical Client

Location: Dublin, Ireland 

Project Duration: September 2019-Present 

Service Offered: Calibrations, Instrumentation Setup and Troubleshooting Assistance, CQV Support, Mechanical and Electrical Support in Utilities Area 

Project Description: 

This Pharma & Biologics client specialises in medicines and therapeutics in the treatment of oncology drugs. The existing 31,700m² facility will be expanded to a floor area of approximately 43,700m². An existing 13,000m² warehouse will also be extended and transformed for manufacturing operations. New laboratories and a warehouse will be built and the existing production and packaging facilities at the site will be extended. The facility will produce various therapeutics, including immune-oncology treatments and mammalian cell culture-based protein therapeutics.  

Project Services: 

  • Performing the approximate 3500 calibrations during the project phase and shifting in sustaining calibrations as the schedule rolls around. Projecting 500 more in 2023.
  • Successful development and ongoing maintenance of Calibration Programme alongside client Engineering Specialists
  • Commenced Calibration & Instrumentation reduction programme with the goal of reducing calibrations by 10%
  • Offering Instrumentation assistance to vendors during commissioning activities
  • Supporting the client Utilities team during commissioning stages by completing system walk-downs as well as sustaining maintenance activities on systems/areas handed over to the client.

Process and utility systems including:

  • Vessel maintenance – media prep, buffer prep, buffer hold, product hold.
  • Provide Clean Utilities support
  • Ultra-filtration systems
  • Clean steam generators
  • HVAC units
  • Training with vendors
  • Instrumentation VTOP reviews
  • Purified water (WFI) storage
  • Coolers / Chillers
  • Creating SOPs / Work Instructions
  • CAPA/QM to support calibration programme which has extended to the Engineering teams on site

Outcomes: Project ongoing 

  • LotusWorks’ highly skilled mechanical technicians maintain critical utilities equipment, which helps to increase equipment up-time, enhances efficiency when running, reduces overall costs and maintains the value and lifespan of the equipment.  
  • The LotusWorks team has achieved a significant safety milestone of 20,000 hours on-site without a lost-time incident. 
  • In response to COVID-19 and with limited access to site, specialist smart glasses have connected LotusWorks on site representatives to vendors making remote working possible. Through the use of this technology, LotusWorks continued to meet client project timelines and ensured no delays were experienced. 
  • 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 
  • Fast turnaround on critical instruments leads to increased equipment availability and minimises client facility downtime 
  • The flexibility involved in having a calibration team on hand for scheduled shutdowns, emergency call outs and project support work, means that the client can have increased calibration expertise without increasing their headcount 
  • Fully competent technical teams carry out calibrations to regulatory standards – ensuring compliance 
  • The LotusWorks team identifies and corrects costly performance deficiencies in the facility resulting in cost savings and increased equipment lifecycle 
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