Merck was facing a new dilemma: How would they produce much-needed vaccines for both shingles and chicken pox with their current, limited production capacity? They quickly realized that, for the benefit of customers and citizens, they would need to increase their Varicella production capabilities.
Once they realized that production needed to be accelerated, they were immediately faced with other impasses. Mainly, how would they increase their production capacity quickly enough? Within four years, patients were going to require more than double the current Varicella output. In order to meet demand, Merck decided that they would need to design, build and license a facility in less than four years — a feat that, according to the Monte Carlo analysis conducted by Independent Project Analysis (IPA) Inc., had a less than three-percent chance of success, considering its size and schedule.
How did Merck accomplish their ambitious goals? According to Merck’s Brian Morrissey, the plan ran smoothly partly because “the stakeholders, Merck, Jacobs, and the major subcontractors EAS and AdvanceTec worked as peers, as a true team.” Due to this teamwork, “the steep learning curve was handled very well.” He explains that coordinating meetings so that “all parties were in the same location was critical, as was the location of AE/CM and owner in the same office space” throughout the construction process.
Thanks to Merck’s teamwork, innovation and planning, they have been awarded the Facility of the Year Award for Facility Integration for their Vaccine Bulk Manufacturing Facility (VBF) Program of Projects, which is located in Durham, North Carolina.
Fast-Track Construction
Merck knew that they would need to speed up the construction process in order to reach their goals. To do this, they utilized a novel concept: To increase the speed of construction, Merck “decoupled” the interior from the exterior, therefore allowing construction to be completed on both the inside and outside, simultaneously.
“This was a not a new concept for Merck,” explains Morrissey. “It was the second time a project was executed using this approach by the Jacobs/Merck team. It was [also] not a novel concept in the industry, but never used at this scale.” Merck took a chance by using the concept at such a large scale, but the gamble definitely paid off, allowing them to save a great deal of time during construction.
The plan involved a substantial amount of overlap. Processes that would usually be carried out in succession, such as basis of design (BOD) and detailed design, were instead carried out in unison at the Merck facility. This strategy saved many hours of labor, leading to an accelerated construction timeline.
Collaboration with Equipment Vendors
Merck’s success was not achieved alone. They organized all of the project’s contributors — Merck, Jacobs, subcontractors and vendors — into an integrated partnership, titled “One Team” jointly led by Merck’s Global Engineering Group and Jacobs’ EPCM team. They credit a great deal of their fast-track success to their integrated-team strategy.
“We relied on input from our major suppliers and subcontractors,” says Morrissey. "We asked them to sometimes work outside of their standard practice, providing partial information to allow parts of the project to proceed, before they had finalized their design. Leveraging their industry and current market knowledge played a major part in the success of the project.” Merck was able to include everyone: the owners, engineers, contractors and vendors, to create a single, integrated project team. Integration was accomplished despite the 50 equipment suppliers and 46 subcontractors that were executing the project.
Because of the strict time constraints, scheduling and coordination complexities, LEAN project delivery was used. The team also optimized the Continuous Quality Verification (CQV) approach. They formed several high-energy, high-impact teams for each of the main areas or production suites of the facility. These “suite teams” were made up of representatives from Technical Operations and Production, and involved support from Maintenance, Quality, Process Engineering, Automation, Validation and/or Commissioning and Construction. Daily tier meetings helped the team stay on track and follow the project’s process.
“I’m the most proud of the fact that we stayed together as a team throughout the challenges of the project,” says Morrissey. “We would have never met the budget or schedule if the “team” devolved into traditional client/CM/subcontract roles. The key personnel from Merck, Jacobs, and major subcontractors were with the project from detailed design until project completion.”
Remarkable Results
The team was able to cut the industry benchmark schedule down by 40 percent, accomplishing their goals in 24 months from charter to operational qualification for the $315-million, 214,000-square-foot facility.
This was achieved despite the hurdle of losing over one month of work days due to a wet North Carolina winter season, since decoupling the activities made it possible for progress to continue at the off-site fabricators. In fact, one-third of the craft hours were moved off-site. The combined benefits of this original hybrid modular approach cut five months off of the schedule and helped save $43 million in project and business spending.
The project’s success and unique construction approach has made a great impression on the pharmaceutical community. “We have had several tours through the facility with pharmaceutical companies and other industrial companies,” Morrissey says. “We have also conducted two tours through the facility with local ISPE members, and NC State Graduate Class in Construction Management.”
Merck’s vaccine manufacturing facility was constructed to fill an urgent need, but it was not constructed hastily. Through detailed planning, a unique manufacturing approach and expert collaboration, Merck created a facility that is as novel as it is necessary. The world-class facility will provide preventative vaccinations to millions of patients.
Morrissey sums up the reasons why Merck was awarded their FOYA recognition: “The team was recognized for safety, speed of design, speed of construction and speed of delivery for a functioning facility. It has set new benchmarks for project realization for our company and the industry at large. These are achievements by themselves, but together they are truly special.”