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Pharma/Biologics - Commissioning


Location: Durham, NC

Project Duration: October 2019 – Present, and previously April 2016 – October 2017.

Services Offered: Field supervision, weekend and night shift cover, system testing and walk-downs, handover document control, ETOP management, and CQV support.

Project Description
This biopharmaceutical client specializes in medicines and therapeutics in the treatment of neurological diseases. This is the second major capacity and technical upgrade project that LotusWorks has supported the GC on for this client in the last 4 years. This most recent technical upgrade is in preparation for manufacturing an Alzheimer’s therapy.

Building on our relationship and performance from the previous shutdown project, LotusWorks was able to increase the headcount supplied for this most recent project. This was accomplished with experienced personnel who were able to minimize the learning curve, hit the ground running, and assisted the construction team in keeping the project on schedule.

Given an extremely tight schedule (15 weeks), LotusWorks succeeded in meeting all the mechanical completion and handover dates for the equipment being released back to manufacturing.

Project Services:

  • Worked alongside the trade partners during the construction stages including process equipment setting, steel platform modification and install, process piping fabrication, install, testing, and passivation. (7000+ LF & 8000+ hygienic welds).
  • Construction supervision, field direction/coordination of trades, and status reporting during daily huddles.
  • Process and utility systems including;
  • 4 new filter transfer skids.
  • 3 new LPC column skids.
  • 1 new perfusion skid.
  • 1 new viral filtration skid.
  • 26 new vessels - media prep, buffer prep, buffer hold, product hold.
  • Numerous clean and plant utility systems supporting the process equipment.
  • Several CIP systems upgrades and load balancing modifications to redistribute the CIP connections and remove bottlenecks.
  • Reviewing and approving daily job plans, safety forms, permits and field documentation signoff and gathering for turnover.
  • Drafting of, getting approval and execution of LOTO plans, pressure testing plans, passivation plans, and pre-MC (mechanical completion) walk down documents.
  • Other responsibilities include: punch-list management, 3D BIM model coordination with field trades, equipment receipt inspections, material management, out of hours cover and response to field issues for trade partner direction and escalation to guarantee schedule adherence, field decision making and removal of roadblocks, weekend pass down coordination to maintain progress over weekend shifts by leading Friday and Monday coordination meetings.
  • Management and execution of the complete ETOP process for the project. This included system boundary development, ETOP binder structure, and electronic formatting of final system files including merging of vendor content with field-installed components. This was a multi-disciplinary process including mechanical, electrical, I&C, process piping, structural steel platforms, and equipment documentation. The total scope was 65 individual process and utility systems, 900+ isometric drawings, and 86,000 pages of turnover content all in 100% electronic format (OCR and bookmarking).


  • LotusWorks brought much-needed experience to the team with seasoned personnel, resulting in improved knowledge and stability.
  • LotusWorks personnel were key in supporting work outside normal hours allowing work to continue which meant the momentum of each day and week carried into nightshift and weekend shifts.
    • As an example, pneumatic testing of systems could be performed on nightshift when lower numbers of craft workers were present. This contributed to an excellent safety record and removed the need to evacuate areas during the dayshift due to the required exclusion zone around the testing circuits. More progress was made on dayshift as a result.
  • The volume of punch list items was reduced by having experienced personnel in the field 24/7. The trades had somebody to escalate to and make decisions based on drawing details, contract documents, and BIM model coordination.
  • LotusWorks understanding and experience of project completion, system handover and document turnover, client needs, and construction deliverables allowed the project to succeed on time and within budget.
  • Willingness to work and support 24/7 allowed the project to finish on the originally scheduled date despite the unexpected obstacle of the COVID-19 pandemic.
  • All QA release dates for new equipment and systems were met or improved upon with the delivery of the final turnover packages to the commissioning and validation teams. This complete process was solely executed by LotusWorks.
The scope of work continued to increase as the project progressed, and the LotusWorks team was versatile which added value, essential experience, and skills to the project.
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