Managing Critical Shutdowns in the Pharma Industry
A shutdown in the pharmaceutical industry allows preventative maintenance to be completed without loss of production time if machinery malfunctions in the future. During this downtime, it is common for a facility to include additional projects for teams to work on that would otherwise impact production and the cleanliness of the facility.
Why Are Shutdowns Important?
Planned shutdowns are essential for the functionality of the facility. Facilities shut down regularly for maintenance, equipment updates, cleaning and more. For GBA, shutdowns offer an opportunity to work on a variety of projects that are not feasible while the facility is up and running.
What is a Shutdown?
When a shutdown occurs, the entire plant shuts down and will not be in operation. This time is spent ensuring that systems verify and equipment is running as intended. They are scheduled in advance but vary in the amount of time that the facility is not in operation. An average shutdown can be anywhere from one to six weeks, allowing GBA’s team to execute the work needed to be completed.
The GBA team has extensive experience completing projects inside live manufacturing facilities. They do as much of the construction as possible contained and separated from production through the installation of containment walls and barriers prior to the shutdown. During construction, when the team cannot do any more work without disrupting the production in the facility, the shutdown begins. When the facility shuts down, the plant will not be in production, meaning the team has complete access to the whole facility. The team works off a strict hour-by-hour schedule to ensure the required work is completed as intended. Once there is a set plan, the team communicates with all parties involved.
During the analysis phase, the facility will document how its systems and equipment are operating. This is called “as found” data. After the shutdown and the projects are complete, the facility is reopened for production. New data is gathered called “as left” data, to prove compliance with the FDA and other governing organizations’ requirements during the shutdown.
A Critical Shutdown Example
In 2023, GBA worked on numerous projects during shutdowns at multiple pharmaceutical facilities. These projects ranged in size from $50,000 to $1,000,000 with durations of two to six weeks. GBA was actively involved in the planning of these shutdowns for up to one year prior to the shutdown start date.
How is GBA Involved?
GBA’s Life Sciences team works as the controlling contractor throughout the entire process from start to finish. GBA Builder’s Project Manager, Cooper Link, is actively involved in the planning, design and coordination phases of the shutdown. Initially, at the planning phase the Construction Management (CM) team will work with engineering through the conceptual design through design completion. Throughout the design process, the construction team will actively work with subcontractors to secure resources while the scope/design is finalized. They will also work with the client to ensure the plan of action is within client standards and meets client expectations.
Cooper also manages progress during the shutdown and is responsible for communicating with the client. He ensures all stakeholders are informed of what work is being completed.
Challenges in the Process
A typical shutdown operation can run into obstacles. Occasionally, production at the facility will need to keep going which results in a push of the shut-down start date. The construction team will need to adapt to overcome this hurdle by moving resources until the new start date is set. While this situation is not ideal for the project team and subcontractors, the ability to adapt to meet client needs is a key reason for the shutdown’s success.
GBA Life Sciences Team
Designing, building and validating pharmaceutical and biological facilities and processes are specialized services that require a team of highly trained and experienced professionals. That is exactly what the GBA Life Sciences team brings to the table. We are proud of our history of providing design, construction and qualification services to a diverse portfolio of drug manufacturers and developers.
Cooper Link, Project Manager
Cooper has 15 years of experience in pharmaceutical manufacturing construction and an additional 15 years in construction and project management. Cooper has hands on experience with the ends and outs of the pharmaceutical world from the owner’s side and contractor’s side. He has a versatile background in construction being involved in all aspects of a project life-cycle.