Carolina Weidler

	When pharmaceutical companies choose to tackle a relocation of their current operations, they are looking not only to remedy their current space needs, but also allow for future expansion. Relocating operations often results in disruption, reinvention, and recertification for most companies: a daunting process that may take years of planning before a company decides to take the leap. Add good manufacturing practice (GMP) processes to the mix, and now there’s a long list of goals that have to be identified, classified, distributed, and achieved.

	Looking for the right space is usually the task that takes the longest to complete. The new space needs to account for all GMP and current good manufacturing practices (cGMP) considerations, such as adequate space for equipment, lockable areas, adequate laboratory spaces, layouts that minimize and eliminate cross contamination, and correct quality controls.

	Cleanrooms, R&D spaces, test areas, laboratories, raw material storage, inventory, and quarantine areas all need special detailing, specifications, and heavy coordination. The constructability of these spaces must be on point so that a general contractor can seamlessly begin work to create an end product that aligns with the client’s expectations.

	It is often the case that the specifications for the components for these rooms is not correct. Mistakes often happen when an inexperienced designer specifies the incorrect thicknesses of walls to accommodate low wall air returns or space for utility routes. Also, the location of utilities is commonly left to the last minute, creating conflicts on the field or even at the time of certification. Best practices for the industry need to be researched and applied when putting together the requirements for these spaces. This ensures the planner is correctly introducing them early in the design and the general contractor accounts for them in their budget and schedule.

	Because of the complexity of these spaces and the amount of capital that goes into them, an accurate design done right the first time not only saves time and money but creates opportunities for improvement and flexibility without compromising quality and results. An architect that researches new technologies, building materials, utility connections, and ancillary equipment solutions enables the team to work cohesively toward the right integration of technologies.

	When a company is considering a relocation of their current operations, the design process can start as early as engaging a design professional to aid during the selection of the new space and perform test fitting for one or many possible locations being considered. Early test fits for different spaces being considered allow the company to visualize the potentials and the constraints of the candidate spaces being considered. By actually drawing functional areas, adjacencies, and support spaces, for example, the company is able to evaluate in a more empirical way the true commitment that the space will require. This method, though not the norm, is effective and the best way to approach the selection process.

	Companies usually don’t realize that by engaging a design professional early in the process, they can use their knowledge to identify and quantify the potential or the constraints of the new location being considered. Utility connections, structural integrity, adequate parking, potential for exterior areas, and zoning ordinances all play integral parts of the success of a project. But many companies fail in this step, and these are issues are not fully discovered until an architect is brought on board to investigate.

	When these aspects are assessed after the location is already selected, the team then must work with constraints. Resulting problems can include the need for an electrical service upgrade because the building doesn’t have enough capacity to support the new equipment being brought in, or capital expenditures like retrofitting a significant portion of a roof to structurally support heating, ventilation, and air-conditioning units for cleanrooms. Sometimes the design team may even encounter instances where the project just doesn’t fit the building zoning or parking requirements, and a lengthy process of a conditional use permit ensues.

	By evaluating these considerations at the project’s onset, many issues can be identified early to determine if the location should even be considered or if additional budget is needed so that there are no surprises down the road.

Carolina Weidler is Project Director for Science and Technology at H. Hendy Associates, 

Articles

An architect's evaluation early in a pharmaceutical facility relocation and design process can help identify potential problems.