Like reading, writing and 'rithmetic, the three Rs of constructing a biotech/life science facility are constructability, efficiency in the field, and investing only in what you need today while providing scalability for tomorrow. Quality construction and meeting schedules and budgets are the expected deliverables for any construction services provider. Foundations, superstructure, infrastructure and systems, current Good Manufacturing Practice (cGMP) finishes, and all the components that comprise a facility are a given. The differentiator is a builder that approaches the project from the owner's perspective, as a vested partner in the owner's business model rather than as just a services provider.
Speed to market is the cardinal rule, and it is critical that the contractor not simply espouses this, but manages the process to achieve it. There is no single silver bullet. The successful contractor must be adept at squeezing maximum efficiency at each juncture - minimizing lags at every step in the sequence, minimizing time in the field, minimizing wait time for equipment - while never compromising quality or losing sight of the final steps of commissioning and qualification.
A fundamental issue for the contractor - and indeed the entire project team - to understand when approaching a biotech/life science project is that the facilities are designed from the process out to the site, but are constructed from the site back to the process. The latter ends up being the driving force behind scalability.
Built for Today, Scalable for Tomorrow
Equipment selection and arrangement dictate the scope of the project. Skid-mounted or modular components - such as clean-in-place (CIP) or steam-in-place (SIP) systems - and the type of process control systems must all be decided early by the team. Will the product be produced in a closed system? Can the suites be planned, designed, and built to accommodate greater flexibility utilizing "plug-n-play" concepts? What services and utilities are required for the main purpose of the space? These decisions have a significant impact on the room classification and, therefore, major critical systems. This then becomes a major budget driver. Reducing the complexity of the required HVAC systems saves the owner money on a first-cost and life-cycle basis.
Scalability is a paramount issue for the owner, and thus the team - an issue that strongly impacts the team's equipment decisions. The ideal facility provides the owner with the flexibility to change both process and product as the business evolves - possible moves from bench-top research to test run, to small batch to small train, to full production and, possibly, even changes from parenteral to lyophilized products. The right contractor plays an integral role in the successful installation and efficacy of such scalable processes.
Discussions on scalability relative to future expansion need to take place early on, with a perspective on how additional future capacity will be installed without disrupting ongoing operations or dramatically changing room/suite/facility classifications. Contractor involvement in these decisions is critical so that significant capital investment is not needlessly put in place only to be taken out later to accommodate additional capacity.
Critical utility systems such as HVAC, steam, chillers, boilers, and DI and WFI have significant impact on the cost efficiency and success of the scalability of any facility. The capital dollars required for base building systems are much less than those required for special equipment. The key is to program the facility by classification of individual spaces and move from lower to higher as the facility evolves. It is not necessary to build entire suites to class 100 standards if this level is only required for specific processes/equipment and class 10,000 is appropriate for the remainder of the facility. These decisions are critical, and this is where the value engineering (VE) and constructability processes engaged in by the contractor prove crucial.
The Project Fulcrum
Through the value engineering/value management process, the life cycle of systems (building structure, foundation, exterior treatments, vibration and noise control, mechanical, electrical, life safety, process utilities, etc.) and the appropriateness of their capacity versus the facility purpose are critically evaluated. By analyzing systems - as opposed to finishes, fixtures, and components - large dollar items/concepts are identified and thoroughly scrutinized to ensure best value for the capital investment, both short- and long-term. Formal value engineering and constructability sessions ideally include the owner's end user, facility manager, maintenance and engineering personnel, the design team and the construction team, and regulatory, commissioning, and qualification team members.
In the constructability review phase, the contractor evaluates the approach to every phase of work through the lens of the schedule as well as the most appropriate means and methods to accomplish the work. It is also at this time that the contractor scrutinizes the means and methods of how the facility will be built, with a particular view on serviceability (for example, valve locations), future use, and how to best accommodate tomorrow's needs in light of what is being built and installed today. For example, three-dimensional modeling of critical systems, such as piping, performed early in the constructability review process facilitates the order, release, and verification of dimensional controls so that equipment arrives ready to rig in place.
A trend in the marketplace is increased use of 3-D design assist drawings from the trades that are incorporated into Building Information Management (BIM) programs and systems. Utilizing this tool is a decision that has to be made by the entire team at the very beginning of the project, as the design team will be required to prepare their documents using a 3-D program. With this approach, the design development level documents are given to qualified subcontractors in critical trades (usually structural, HVAC, piping, and electrical) who use the documents to prepare dimensioned routing plans and shop drawings. These are then incorporated into what become the construction documents that are, in turn, updated to become as-builts incorporated into the owner's BIM system. The keys to success for this approach are a design team that uses 3-D design, a contractor that understands what to request from the trades, and qualified subcontractors that have in-house 3-D design capability.
Other possible means and methods discussions revolve around current market conditions relative to building commodities and trades. For commodities, investigations may focus on current supplies of steel, concrete, copper, stainless steel, sheetrock, and sheet metal, among others, and the availability and delivery time frame for each. For trades, analysis revolves around the availability of qualified critical tradespeople. If a sufficient pool of skilled craftsman is not local, the contractor must identify where they will come from and at what potential premium.