With the increasing rise of personalised medicine, cell and gene therapy, and the migration of manufacturing facilities back to the United States post the COVID-19 pandemic, there has been an increased demand for the construction and renovation of additional clean space to physically accommodate the sector’s commercialisation.
Skanska has been a partner in cleanroom construction for many years in the US—and we currently work with some of the world’s leading microelectronic, semiconductor, and biotechnology companies.
Much of our experience includes expansion projects on existing and active campuses. These complex cleanroom projects include facilities with state-of-the-art equipment, mechanical, process mechanical, electrical, and control systems.
It’s important for the support teams to understand the ceiling support method being used and implemented
Skanska also brings extensive experience with high-purity pipework and classified cleanroom environments.
Regardless of the specific classification, we understand the construction protocol levels and requirements that must be adhered to in order to achieve a formal certification, including the use of third-party contractors to assist with necessary testing and documentation.
We see immense opportunity in this niche area of construction, and our extensive experience positions us to meet the increasing demand for these kinds of spaces.
Pharmaceutical space
As an example of this work, Skanska was hired by an international pharmaceutical company in the Boston metro area to convert a 140,000 sqft half-completed space into an integrated continuous biomanufacturing facility that would meet cGMP requirements.
The project created a flexible manufacturing suite with 30,000 sqft of Class 10,000 and Class 100,000 cleanrooms, with a walkable ceiling and interstitial space.
It also included the demolition of the roof, a complete gut of the interior, as well as a new floor with a 40,000 sqft mechanical penthouse. The water for injection was looped through the cleanroom space, along with several gases and chemicals required for pharmaceutical manufacturing.
There were more than 75 systems in the facility to keep track of and manage through mechanical completion
The plant was built to be validated for FDA approval, so it was important the piping and systems were installed correctly and to FDA standards. On this project, Skanska was responsible for start-up of equipment and provided support to the commissioning agent.
Furthermore, we collaborated with the client on a comprehensive equipment plan that mapped out the steps needed to prepare the systems for FDA commissioning and subsequent approval.
There were more than 75 systems in the facility to keep track of and manage through mechanical completion. Each system had two lead engineers from the client side and one member of the Skanska team assigned to it.
Logistics and coordination
For all cleanroom projects that Skanska undertakes, we engage the client early to discuss the options and preferred method of construction. This conversation and selection process factors in logistics, construction practices, cleanliness, future expansion considerations, and cost.
Additionally, pre-coordination of the electrical and gas outlets as well as wall mounted lab fixtures for gases, power, and tele-data is necessary to prevent outlet conflicts due to the thickness of the wall panels. All these factors critically impact decision-making, the construction process, and timelines.
The utilisation of single-use manufacturing skids is becoming increasingly popular
For this biomanufacturing facility, the design of the cleanroom space included single-use manufacturing skids. Instead of mixing components in fixed tanks, disposable bags are utilised and disposed of when products are manufactured and produced.
The utilisation of single-use manufacturing skids is becoming increasingly popular, as it speeds up the manufacturing process for the client versus using fixed tanks, which require extensive cleaning after each batch.
Clean build protocols
During construction, the Skanska-led team followed clean-build protocols, which is always the most crucial aspect of any cleanroom construction.
No food or drinks were allowed in any parts of the building, temporary air flow was used to create positive pressure, and there was no cutting or grinding allowed in the cleanroom space.
Controlled access was also instituted on the ceiling as the weight limit prevented limited heavy loads
There was also controlled access to the construction area using tacky mats to further avoid any contamination when teams were traveling in and out of the area.
Controlled access was also instituted on the ceiling as the weight limit prevented limited heavy loads.
Additional key elements that helped ensure FDA certifications were met included:
- Clearly identifying protocol levels in the contractual schedule along with the subcontractor RFPs and contracts.
- Posting robust signage at all entry points that clearly denoted the protocol level, with the necessary gowning supplies readily available.
- At the same entry points, ensuring there were proper wipe-down supplies.
- Identifying one subcontractor responsible for ensuring the pass-throughs were inspected and monitored regularly throughout the day and that any plastic sheeting walls were wiped down as necessary.
- Ensuring foremen were properly trained for working inside any clean space (i.e., using HEPA vacs when cutting, taping all wheels on carts, etc.)
Prefabrication
The cleanroom walls and ceilings came to the site prefabricated. The ceiling panels contained holes for HEPA filters and lights while the walls included pass-through window openings.
The two-inch panel-clad walls had a smooth plastic coating which kept dust from accumulating. With the space being modular, ceiling panels were hung from the steel above, with the walls subsequently built into the ceiling.
The construction of cleanroom space is often done in close proximity to existing operating areas, as well as areas under construction
In addition to the cleanrooms, our team installed the piping for the various systems in prefabricated racks to allow for quick installation.
Pressurisation and ventilation/HVAC
The construction of cleanroom space is often done in close proximity to existing operating areas, as well as areas under construction.
So, it’s vitally important to determine how air pressurisation changes caused by the replacement of air conditioning systems and the construction shell space affects the conditions of adjacent spaces. In addition, it’s important for the support teams to understand the ceiling support method being used and implemented, as the need to coordinate with HVAC ductwork and pipe racks serving the cleanroom spaces is vital.
Each system had two lead engineers from the client side and one member of the Skanska team
Therefore, as part of the preconstruction effort for this facility, Skanska recommended the creation of a temporary construction air profile to determine what short-term measures were needed.
The temporary ventilation and pressure control plan put in place during construction, as well as the use of existing air systems to temporarily support the necessary clean build protocol, proved essential in the final air control design for the space.
Skanska also set up a monitoring and communication system to ensure the cleanroom always remained in a positive air pressure condition to prevent any excursion into the clean space.
Safety and security
The significance of safety measures within the lab cannot be understated. During preconstruction it is imperative that the team consider and discuss how security card access interfaces with the greater campus system.
The design of the cleanroom space included single-use manufacturing skids
Skanska recommends for all projects that badge swipes be selected to consider cleanroom protocols.
This pre-plan access for card readers may have implications once the spaces are occupied with fully gowned personnel who have difficulty using badges for access.
Conclusion
Cleanroom construction is expanding throughout the US. From preconstruction to QC testing, working with an experienced team to navigate this specialised process will be critical to success and lays the foundation for future innovation.
Skanska’s participation in the successful construction of its client’s integrated continuous biomanufacturing facility, among many other complex cleanroom spaces, can serve as a blueprint for considerations and best practices within the broader complexities and specialisation of cleanroom construction.
Top image: Interior of the ICBF at the international pharmaceutical company