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Pharma/Biologics - Start Up / Calibration

Sector/Industry: Pharmaceuticals & Biotechnology 

Location: Sligo, Ireland

Project Duration: January 2019 - Present 

Services: Start-up of Pharma/Biologics Facility, Building Calibration and Preventative Maintenance Program using Maximo 

Project Description: 

Our client creates new medicines for chronic, serious health issues by combining advanced science with deep knowledge of diseases. 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: 

  • Developing a calibration and preventative maintenance programme 
  • Developing standard operating procedures to manage the execution of calibrations and PM’s 
  • Planning, scheduling and executing all project calibrations  
  • Performing temperature mapping of warehouse, clean rooms, fridges, freezers and incubators 

Project support: 

  • Process Technician and Engineering  
  • CAD Drawing 
  • Project Management  
  • Commissioning 
  • Qualification  
  • CQV Support 

Process and Utility Systems 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 

Outcomes: Project Ongoing 

  • Calibration and Maintenance Programme developed, activated and handed over to site on time. 
  • Commissioning and Qualification of Clean Utilities, Nitrogen, High Quality Compressed Air, RO Water, WFI Generation and Distribution.  
  • Client gained comprehensive calibration expertise in their facility incorporating multiple equipment types. The LotusWorks team are experienced in determined 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  
  • 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  
  • 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. 
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