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. Commissioning teams 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, non-GMP utilities commissioning and installation QA/QC support.
- 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.
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 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 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 including ASHRAE, LotusWorks ensures the facility is operating to regulatory standards guaranteeing production safety, product quality and patient safety
Commissioning Support Activities
Commissioning & Qualification
“LotusWorks assisted me on several Pharmaceutical construction jobs and were a key player in the successful completion of the projects. They immediately took ownership of their scope of work, including punch-list management, contractor coordination, and start-up activities through commissioning. I would be happy to recommend their services.”
Project Manager, Client Pharmaceutical Facility