Achieving Early Equipment Start-Up During Pharmaceutical Plant Construction

By Peter Gardner

On a recent $130-million pharmaceutical manufacturing plant project, Torcon’s team implemented its innovative Set to Work program focused on addressing the initial requirements of the process equipment and associated systems. This approach is particularly appropriate for functional/utility-rich facilities, although there are clear lessons for office buildings, hotels, school facilities, hospitals and other projects.

In a pharmaceutical manufacturing environment, the building itself is secondary to the processes within. Although research labs are among the critical components of the product development process, manufacturing facilities help pharmaceutical companies cross the finish line and get medicines and other products out in the market. The process is extraordinarily long, with the vast majority of the drugs discovered through research and development never reaching commercialization. When a pharmaceutical company commits to building a production facility, there is considerable pressure to finish quickly and achieve a fully validated facility.

The manufacturing building (the envelope) is essential and must create an acceptable environment for producing pharmaceutical drug products. Its job is to maintain the proper humidity, temperature control and air purity to meet the requirements of the client’s specific process. Within each building is typically an array of process suites and support facilities. As the building is being constructed, key pharmaceutical industry vendors are hard at work manufacturing, fabricating and otherwise assembling the equipment used for the various manufacturing processes, as well as providing critical utilities and materials, such as RO water, water for injection, etc. These buildings and suites are generally designed around the process and the equipment, so the equipment is already in fabrication before the building is constructed.

The Set to Work program involves prioritizing activities at the earliest possible point in the project, and begins with an understanding of the client’s needs. It is an approach that has provided huge advantages to customers and to the overall team. It is also used to establish the most advantageous installation and rigging procedures. The vendor may be contracted to install the equipment with either their own forces or with a subcontractor. Other times, the services can be coordinated in-house. When performed using the Set to Work process, we take a leadership role in helping determine the optimal contracting strategy early, which results in a well-coordinated installation and utility connection process. Building Information Modeling has emerged as an indispensable design-phase tool for equipment installations, helping to evaluate suitable pathways for equipment movement throughout the building at various points in construction. Of course, a basic advantage of a BIM-based coordination effort is ensuring appropriate space for equipment, delivery of required services to the equipment and access for required service and maintenance.

With millions of dollars of equipment sitting for months before actually producing product, clients must environmentally protect the equipment, as well as complete a long process of startup and commissioning — just to begin the equally long process of testing and validation for FDA compliance. Torcon’s experience on similar projects has provided an understanding of the intense pressure faced by client user and engineering staff to get their process systems and equipment up and running.

Set to Work also helps the coordination team to plan an efficient calibration process for critical instruments. Under the program, the earliest starting point for calibrating each piece of equipment is identified and a logical startup schedule developed. This approach results in a controlled process and, more importantly, avoids compressing these critical startup activities into the last few months of the project’s schedule, when pressure to complete is most intense. This approach also provides additional tech support during the installation process that keeps a qualified team in place for an extended period.

Set to Work is used to identify the minimum work scope that must be completed to allow individual systems or pieces of equipment to start up and operate. The process establishes environmental conditions to support the installation of sensitive process equipment, and the actual utilities or services required to start up and operate the equipment safely.

Armed with this knowledge, Set to Work proactively expedites and prioritizes work elements to achieve early equipment startup. For the pharmaceutical manufacturing plant, the process was initiated early in the project and was fully incorporated into the schedule. As a result, there was no cost impact to the project. Challenging conditions, such as early delivery and installation of cooling systems needed for the filling equipment, was accommodated in the original schedule during the purchasing process.

Through the Set to Work approach, the team was able to achieve client startup activities well in advance of mechanical completion, facilitating more efficient commissioning and validation. Because some elements of mechanical or final completion are inconsequential to starting or operating the equipment, they didn”t impact the client’s ability to proceed.

On projects designed with sustainability goals and seeking LEED certification, the Set to Work program helps expedite the completion of the LEED commissioning prerequisite and credits. The overall effort for LEED certification can be expedited through this innovative program.

On projects in the regulated life sciences market, the terms commissioning, verification, qualification and validation are used differently by owner companies. The Set to Work program spans all these differing concepts and creates a well-planned, fully coordinated approach that helps the customer achieve full production in the most expeditious manner.

With many of the technical facilities we build, success isn”t simply achieved by turning over completed facilities within budget and schedule. Success is more tightly intertwined with our client’s objectives for equipment installation and readiness to begin operation.

Peter Gardner, P.E., LEED BD+C, is sustainability manager at Torcon, Inc.

Image by  Robert Faulkner/Faulkner Studios
Image caption: Interstitial mechanical space within a renovated R&D/process facility.