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Pharma/Biologics – Start Up / Calibration

Global Pharmaceutical Client

Sector/Industry: Pharmaceuticals & Biotechnology

Location: Sligo, Ireland

Project Duration: January 2019 – Present

Partnership Commenced: January 2013

Services: Start-up of Pharma/Biologics Facility, Calibration and Preventative Maintenance

Project Description:

LotusWorks is technical and engineering partner of choice to this global pharmaceutical client since 2013 delivering start-up commissioning, calibration and preventative maintenance services.

Our client is a specialty biopharmaceutical company that discovers, develops and manufacturers life saving medicines for the treatment of chronic and complex diseases. Our client is constantly striving to create solutions that go beyond treating the illness to have a positive impact on patients’ lives.

This facility is now a global centre of excellence for design control and precision engineering in the production of drug delivery devices.  This high containment facility has dedicated capabilities for potent API’s and drug product manufacturing. The quality control labs are equipped with the latest design technology for chemical and microbiological analytical testing to meet customer needs.

Project Services: 

  • Develop & implement calibration and preventative maintenance programmes
  • Develop standard operating procedures to manage the execution of calibrations and Predictive Maintenance (PM’s)
  • Plan, schedule and execute all calibration projects
  • Perform temperature mapping of warehouse, clean rooms, fridges, freezers and incubators

Project support: 

  • Process Technician and Engineering Services
  • CAD Drawing
  • Project Management
  • Commissioning, Qualification & Validation Support

Process and Utility Systems Support including: 

  • Clean Utilities
  • Black Utilities
  • Facilities
  • Process Lyophiliser
  • CIP Systems
  • UFDF
  • Chromatography
  • Inspections
  • Clean Systems
  • WFI Generation and Distribution
  • RO Generation and Distribution
  • High Quality Compressed air
  • Nitrogen
  • Processed Waste

Project Outcomes: 

Project Ongoing

  • Calibration and Maintenance Programmes developed, activated and handed over to site on time.
  • LotusWorks’ experts completed commissioning and qualification tasks for the client handing over a qualified which ensured that the client system was enabled with the end user in mind.
  • The Client gained comprehensive calibration expertise in their facility incorporating multiple equipment types. The LotusWorks team are experienced in determining the critical process parameters to be measured and ensure the instruments measuring those parameters are adequately calibrated to ensure they deliver their function in a compliant manner.
  • The LotusWorks team identifies and corrects costly performance deficiencies in the facility resulting in cost savings and increased equipment lifecycle
  • Enables clients to release technical staff to concentrate on the core manufacturing activity.
  • The culture of continuous improvement within the company means that our client experiences the best of value-add improvement from the LotusWorks team.