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Pharma/Biologics - Calibration / Project Support / 3rd Party Vendor Management

Sector/Industry: Pharmaceutical  
Location: Carlow, Ireland 
Project Duration: 2013 – present 
Solution: Process Calibrations / Project Support / 3rd Party Vendor Management

Project Description: 
This client is one of the largest pharmaceutical companies in the world, providing innovative products and developing new therapies that treat and prevent disease. Dedicated to providing leading innovations and solutions for the future, LotusWorks provides technical and project support to this vaccine and biologics facility.

Project Services:

  • Implementation of a calibration and preventative maintenance programme
  • Execution of calibration scope in line with CCMS requirements
  • Planning, scheduling and executing all project calibrations
  • Support asset reliability and capacity of process and utility equipment   
  • Assist in the generation of facility protocols and reports
  • Development and execution of validation protocols for new and existing equipment
  • Prepare, review and approval of technical documents and procedures
  • Responsible for planning, co-ordinating, implementing and finalising projects
  • Actively engage in culture of continuous improvement
  • Comply with and maintain all regulatory standards
  • Developing standard operating procedures to manage the execution of calibrations and PM’s 

Project Support: 

  • Calibration
  • Operation & Maintenance  
  • Validation & Qualification 
  • Engineering Support 

Process and Utility Systems including: 

  • Clean Utilities 
    • WFI Generation and Distribution  
    • RO Generation and Distribution 
    • High Quality Compressed air 
  • Black Utilities 
    • Boilers
    • Chillers
    • Cooling Towers
  • Sterilisation 
  • CIP Systems 
  • Inspection Machines 
  • Nitrogen 
  • Waste Systems
  • Chemical 

Project Timeline:

Outcomes:

  • Calibration and Maintenance Programmes developed, tested and implemented in order to support project deadlines and facilitate production start dates
  • Developed Instrumentation Criticality Assessments for each system and identified the correct criticality, tolerance, range and calibration frequency for the instruments
  • Identified the correct test equipment and quantities required, for the calibration department, to maximise efficiencies and reduce recertification costs
  • Developed a methodology for CMMS equipment builds that incorporates tag association for spare parts assignments. This in turn allows technicians to easily identify the part required for correct maintenance activities which in turn reduces equipment downtime
  • Our culture of continuous improvement allows clients to benefit from cost savings, time savings & process improvements initiatives that drive value into the organisation
  • Our calibration process model has eradicated unnecessary calibration, leading to financial benefit to the  client
  • 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
  • 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
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