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Pharma/Biologics - Calibration

Sector/Industry: Pharmaceuticals & biotechnology

Location: Leinster

Project Duration: 2012 – present

Solution:Complete Calibration Service

Project Description:

Our client is one of the largest integrated biotechnology plants in the world and is based in West Dublin. The site is a significant research and development facility supporting processes such as cell culture, protein purification, aseptic manufacturing and vaccines conjunction for global export. LotusWorks began working with this client since 2000 during the construction period of their facility, before moving into a sustaining phase with the client. LotusWorks has been in the unique position to see our client’s requirements grow over the past 20 years and has tailored our solutions to meet our client’s requirements.

Today, LotusWorks provides a full scope of complete calibration management solutions for the client. Operating within a strict environment in terms of regulation and compliance, having reliable practices in place to ensure the quality, safety and effectiveness of their products is essential. The LotusWorks team are key in ensuring standards are adhered to and remain central to the clients manufacturing process. 

Project Services:

  • Complete calibration management.
  • Supporting the client by providing a specialist team of technicians who are present at the facility 24/7.
  • ISO 17025 accredited calibrations.
  • Liaising with different areas in the plant around process scheduling and planning.
  • Performing risk assessments and phased plans of action, while working to the client’s own specifications and procedures.
  • Performing lock out/tag out work.
  • Management of over 80 3rd party vendors and contractors for the client.
  • Calibration of specialist machinery such as bioreactors, utility systems, cooling systems, pill lines, etc.
  • Calibration of specialist lab equipment such as osmometers, spectrophotometers, thermometers, etc.
  • Maintenance of over 600 pieces of portable lab equipment.
  • Preventative maintenance & corrective maintenance.

 

Outcomes:

  • Freeing up client resources to concentrate on core processes by owning and managing the CCM solution
  • Constant support in terms of safety, operations, continuous improvement and manufacturing processes from LotusWorks expert teams on-site 24/7
  • Client concerns relating to accurate and compliant product delivery are eliminated
  • Our calibration process model has eradicated unnecessary calibration, leading to financial benefit to our client.
  • LotusWorks has long-established relationships in place with 3rd party vendors, saving our client time and money.
  • Our client never compromises on their product and ensures consistency in their manufacturing as LotusWorks has in-depth quality agreements in place with vendors and contractors.
  • LotusWorks technicians and engineers 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
  • A tailored solution to the client, LotusWorks have built our relationship from commissioning to sustaining to providing a complete calibrations services and have moulded our offering to suit the client’s needs
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