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Medical Device Commissioning

Medical Device Commissioning

LotusWorks provides enhanced value to medical device building owners by providing experienced commissioning teams with technical expertise who help design, deliver, operate and maintain the owner’s building. Our commissioning services deliver commissioning methodology with the attention to detail to maximise the positive potential in the medical device building design. Our teams are experienced in both maximising safety and running efficiency, while highlighting any potential risk to future operations due to installation quality issues, non-conformance with design, environment or health and safety guidelines.

Our specialist multidisciplinary commissioning teams include: Electrical Commissioning, Mechanical Commissioning, Commissioning Leads, Managers, Engineers and Technicians and are experienced in issue resolution, risk elimination and facility uptime. Commissioning teams have experience working on facilities ranging from 50,000 sq. ft. to 400,000 sq. ft. cleanroom manufacturing space.

Systems Experience

  • Cleanrooms, MV/LV Electrical Systems, UPS, Generators, Cooling Towers, Chillers, Plant Steam, Clean Steam, Compressors, Heating Hot Water, Process Waste, HVAC, CRAH Units, Gas systems

Project Scopes Include

  • Installation qualification, operational qualification script development & execution, performance qualification script development & execution, non-GMP utilities commissioning, installation QA/QC support
  • Incomplete utility systems at the time of testing
  • Pre-commissioning field reports
  • Factory acceptance tests, commissioning lists, issue resolution meetings
  • Development of site instrumentation equipment lists, equipment commissioning and start-up procedures, and plant performance testing procedures for acceptance by owner
  • Provide 24/7 shift support to production

Benefits experienced when engaging expert Medical Device Commissioning Teams

  • Expert Teams: Maximised efficiency in equipment operations resulting in improved energy performance. Problems are identified and rectified throughout all stages of the LotusWorks commissioning process, resulting in no lost time and increased cost savings further enhancing the results and overall medical device facility outcomes

  • Cost Savings: Removal of design faults due to full assessment and quick identification of obstacles before they become major issues to the client in the construction phase as a result of LotusWorks’ broad knowledge and experience. Highlighting any potential risk to future operations due to installation quality issues, non-conformance with design, or environment and health & safety guidelines.

  • Guaranteed Compliance: Complying to commissioning standards, LotusWorks ensures the facility is operating to regulatory standards guaranteeing production safety, product quality and patient safety

Timely Execution

“LotusWorks were hired on a project to coordinate completion of punch list items, execute system start-up of major equipment, and turnover to the client for commissioning and qualification activities. The LotusWorks team were very professional and timely with the execution of their scope of work.”

Senior Systems Engineer, Client Facility

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