Expert Commissioning & Operations for Critical Pharmacetical Manufacturing Facilties

From new build commissioning to 24/7 operations management, we keep your facility running at peak performance, with zero compromise on uptime.

Pharmaceutical Commissioning Services

LotusWorks’ commissioning experience in the regulated pharmaceutical environment and ability to document systems performance for compliance has allowed us to extend our involvement in the sector and execute with the latest and more advanced manufacturing support systems. LotusWorks have experience working on facilities ranging from 50,000 sq. ft. to 400,000 + sq. ft. cleanroom manufacturing space. 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. LotusWorks currently executes and offers the following commissioning solutions to pharmaceutical and biologics clients:

  • Installation Qualification
  • Operational Qualification script development & execution
  • Performance Qualification script development & execution
  • GMP Utilities Commissioning
  • Installation QA/QC Support

Systems Experience

LotusWorks has extensive experience commissioning a wide range of critical systems and utilities, including:

  • 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

Our commissioning engineers have commissioned cleanrooms with stringent environmental controls, supporting HVAC systems power generation and distribution, process & wastewater systems and integrated building management systems.

Client Testimonial

“Since our partnership with LotusWorks we have found them to be accountable, professional and compliant to the highest standards. I would have no hesitation in recommending their services”
 

Calibration Manager, Client Facility

Project Scopes Include:

  • Commissioning teams have experience working on facilities ranging from 50,000 sq. ft. to 400,000 sq. ft. cleanroom manufacturing space.
  • LotusWorks executes projects with certified commissioning professionals, ensuring the experience of operations strengthens our commissioning programs.
  • Working with design teams to provide input on commissioning specifications and on the maintainability of systems.
  • Teams highlight any potential risks to operations due to installation quality issues, non-conformance with design, or regulated environment and health & safety guidelines.
  • Recent projects include the commissioning of the world’s largest single-use biologics manufacturing facility at 48,000 sq. ft., where the team recorded no lost time and increased cost savings during the commissioning phase.

Benefits experienced when engaging expert Pharmaceutical Commissioning Teams

  • Expert Teams: Maximized efficiency in equipment operations, resulting in improved energy efficiency. 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 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 environmental 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
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