Every project manager can tell you that there are only three project drivers: schedule, cost, and quality. We see these factors in every day in tasks we do, and in everything we purchase. The operating companies are also under the same pressure on the delivery of their products: get treatments to patients faster, lower the cost, and answering the question: why can’t our medicine be defect or side effect free. As an industry, we are answering with a deeper understanding of the science of medicine and better tools to deliver medicine. A manufacturing facility, its technology, compliance, flexibility, and the capabilities are the enabling tools for production.

We need to design before we build

In every application of pharmaceutical technology a design of what we are to build is necessary to provide specifications of construction, construction methodology a fidelity of design and technology (i.e. fit for use), compliance to FDA and EU regulations, and a basis for commissioning and validation.

Our industry uses the following methods and delivery tools:

• Conceptual Design – This 1 percent of the total facility cost is the key to all designs. This provides the agreement of how we translate the technology into a constructed entity. This level of design provides the process, architectural, HVAC, utility, and facility bases. Typically, depending on the technology, greater depth is provided in the unique technology area. 
• Preliminary Engineering – This engineering stage takes the conceptual design and creates functional documents for each aspect. This stage of engineering can be attenuated if the process technology can be configured from vendor equipment and if the facility can be built with a "building block" concept.
• Detailed Design – This design stage provides detailed drawings and construction instructions. This level is required on each design discipline if and only if it is being built from scratch.

Clearly, “buy” not “build” can accelerate the design phase

Building Trade-Offs?

Schedule

• Minor renovations might be quicker with gypsum board, but particles and an affinity for mold put that construction material at risk and reduces quality.
• Modular wall systems are quick within an existing space and don’t lose speed with scale, walkable ceilings allow more parallel construction activities, and eliminate the need for detailed design.
• Modular pre-built clean rooms and support systems are the quickest for large scopes

Cost

• While in some lower cost labor markets the use of gypsum board and on-site assembled AHUs may appear to be lower in costs, the adjustments, designs and commissioning exercises add to the costs. Secondly, the labor markets within the biotech business have been increasing and the labor advantage over modular has nearly disappeared.

Quality

• Modular panels provided a robust easily cleaned solution and a long-term quality finish
• Pre-configured and pretested AHUs in modular systems provide a unique opportunity for precision and reduce installation/balancing/commissioning time.

How to Build?

Design/bid/build is the traditional method of building in the US. A firm is contracted to produce a design then the design is bid and a different firm is selected to build. This method is believed to yield the lowest price and philosophy of enforcing checks and balances.

The more modern Design/Build finds synergy of firms that offer design and construction management to reduce cost and schedule. From a contracting standpoint, it provides simplicity and clarity to owners as there is one responsible party for the whole project.

Design/assist is a method where the designing firm lays the groundwork and then engages the contractors who will be executing the work to provide assistance in completing the design. This method allows the contractors to provide input into the design to facilitate installation and prevent iterations on construction documents yielding a lower cost and quicker schedule. The general consensus is by having a constructability focus to the design the project can be done for less time and money without comprising quality.

So Where Does This Leave Us With Finding The Right Balance?

For small-scale renovations, it makes sense to match existing materials but caution is required for the HVAC system and its extension. Many of these smaller projects can benefit from a design/build approach.

For larger scopes of renovation, modular panels allow for reasonable construction schedules and the flexibility to work with spaces of existing complex geometry. For new projects and major renovations that work within a large shell space, modular clean rooms and modular systems can provide both schedule and cost reduction due to the total reduction of labor time in the field (balanced via off-site fabrication).

Some vendors have taken modularization to the next level with pre-engineered solutions that incorporate process equipment based on common process platforms to further reduce cost and schedule.

There is a place in the industry for various delivery methods and the key is matching the method to your project.