Process Architects: Bringing Value to Pharmaceutical Projects
This article was published in the May/June 2016 edition of Pharmaceutical Engineering® Magazine. A continuous collaborative effort is critical to the delivery of a well-designed pharmaceutical facility. One of the best ways to create this collaboration is to include process architects at the project onset.
Process architecture
Process architects play a vital role in the design of pharmaceutical manufacturing facilities. In addition to complex architectural requirements, these sites require the integration of essential process engineering, mechanical, electrical, and plumbing (MEP) engineering, and regulatory compliance. Involving a process architect as part of the team from the beginning of the project can help ensure that it is planned, designed, and executed to meet requirements within a limited budget and on schedule. Architects are trained to be integrators, organizers, and collaborators. As building designers with three-dimensional thinking, they have a global view of all disciplines and are able to link the various players involved in a project. Trained to work within a technical engineering context, process architects are key to integrating process engineering, MEP engineering, specialized construction requirements, building code compliance, and overall building design.
Process architects are key players in the coordination of project design with engineering requirements and regulatory compliance.
Facility planning
As with any building, a pharmaceutical facility design must incorporate design elements, functionality (flow and adjacencies), and space (environment and human scale). All of these are balanced against regulatory concerns. To balance these competing concerns, process architects can leverage three-dimensional thinking and building information modeling (BIM) to develop optimal design solutions. At the Canadian architectural firm NFOE Inc., the design of a pharmaceutical facility begins with an understanding of the company’s corporate vision. Aligning these business objectives at the project outset is important. Questions posed at this time may include:
- What products are to be manufactured and what are the target commercial markets?
- Single or multiple products?
- What is/are the proposed product(s)?
- Confinement levels, toxicity, etc.?
- Have regulatory requirements been satisfied to sell the product(s) in the proposed markets?
Once products and markets have been identified, regulatory guidelines— such as FDA good manufacturing practice (GMP), building code regulations, local biosafety requirements—and corporate facility guidelines—including health, safety, and environment standards (HSE)—are incorporated into the project design.
GlaxoSmithKline’s (GSK) vaccine production facility in Ste-Foy, Québec, Canada, was the site of several NFOE projects from 1997 to 2014.
Functional design begins with an understanding of product fabrication. At this time the project site masterplan is reviewed, developed, and refined. The existing context and future plans are examined and explored. The process architect follows the process engineer and the process flow diagram to collect, synthesize, and analyze base information to prepare early functional blocking. The process architect leads the data collection effort, and produces the space program to create a common understanding of the project requirements. Room cards—documents that summarize the functional, equipment, architectural, MEP, and information technology/telecom requirements for each space—are often used to compile this information. These requirements are distributed to all project stakeholders for review and comment; they serve as base documentation for development of the design. Once this information has been documented and confirmed, the process architect analyzes, synthesizes, identifies, and graphically communicates the relationships between various building components, space groupings, adjacency relationships, circulations, etc.
Example graphic representation of key components in a pharma facility
It is essential to address equipment integration early in the design process, and get it right the first time—it’s expensive if not done properly. Once the equipment has been selected, operating heights, clearance, maintenance access, servicing strategy, and delivery logistics are addressed. Initial design is typically based on generic equipment models or, if the parameters are unknown, by using worst-case scenarios. Early communication about personnel flow and gowning is essential to promote a common understanding. The process architect shares the protocols of the various gowning steps, together with their related accessories, to all project stakeholders by means of pictograms, diagrams, and plans. Standard operating procedures such as handwashing or sanitizing and the use of use of personal protective equipment should be defined and simplified. Sterility concerns should be reviewed with all stakeholders, including HSE. Airlocks and their respective circulation spaces for material and personnel transfer within the facility require significant amounts of expensive space. Planning for an adequate number of airlocks requires accurate information about required current GMP (cGMP) zone classifications, biocontainment, and pressurization. Choices about linens management for airlocks and interlocks will have major effects on project planning and engineering. Other design criteria to be reviewed include ergonomic design and product manipulations, as well as biological and toxicity levels for dangerous products such as flammable corrosive substances.
Process architects integrate product flows and equipment early in the design.
Everyone engaged early
A front-loaded design process is based on the "everyone engaged early" axiom. It’s an integrative interdisciplinary effort that allows all stakeholders, including the process architect, to share information and work together toward common goals and objectives—not in separate silos. Involving the process architect early in the design allows him or her to act as an advisor on hazard and operability concerns, "what-if" situations, Lean Six Sigma issues, and GMP reviews. This can help avoid costly process flow diagram redesign, and keep both cost and schedule on track. Process architects also drive project team coordination and optimize various building elements. Good pharmaceutical manufacturing design should aim beyond integration to promote synergy between systems. 3D BIM can leverage the power of three-dimensional thinking and check for interference among components. Using BIM at NFOE Inc., has helped ensure the success of several pharmaceutical projects.
Quality control facilities
Designing a quality control laboratory requires a design process similar to that of production facilities: listening and gathering information, examining and optimizing sample analysis flows, integrating bench equipment servicing, designing for ergonomics and environmental conditions, as well as envisioning strategies for lab storage and solvent management. Sampling area design requires an understanding of reception protocols and secure storage. Testing areas should accommodate raw materials active pharmaceutical ingredients, sample testing, as well as laboratory, incubator, cold process, and microbial environmental testing. Narcotics management requires consideration of Constructability solutions regulatory requirements. Once the facility’s essential requirements have been determined, the process architect prepares layouts that correspond to the required cGMP classification (Grades A, B, C, D). Major differences in planning are possible depending on which GMP standards (FDA, Health Canada, EU, Japan) are followed; this has important implications for the facility layout.
Exemplary pharmaceutical facility architecture: GSK, Ste-Foy, Québec, Canada.
In addition, different pharmaceutical companies tend to interpret the GMP regulations in various ways. All project team stakeholders should have a common understanding of GMP requirements. Questions to be considered in the GMP review could include "Do airborne particle counts apply to production rooms at rest or in operation?" Confinement is another important issue in the context of toxic compounds or biocontainment. However, pressurization planning can conflict with confinement requirements. An experienced process architect with a good understanding of the relevant issues can resolve these conflicts. Segregation between clean and dirty areas should be identified, agreed on, and incorporated into the layouts to avoid impeding product, material, personnel, and waste flows. These flows should be considered in facility design. By documenting them with clear diagrams, circulations can be identified, and pinch points, conflicts, crossovers, or bottlenecks reconciled and resolved. Interior building systems and material selection involve stick build vs. prefab, flexibility, modularity, and future proofing. Partitions and ceilings should be designed for impact and differential pressure resistances. Spaces should be designed for easy operation and maintenance.
There is no formal training for process architecture; it is generally learned by field experience.
During the design process, it is critical that planning for ventilation and plumbing infrastructure permit easy access to service points. Service rooms can be located in a basement, a mechanical penthouse, or in separate structures. Interstitial spaces can facilitate the relocation and maintenance of services to minimize facility shut-downs. The process architect, working with the project engineers, confirms that the infrastructure supports production. Full-size panel mock-ups are suggested to ensure optimization of integrated MEP and architectural systems.
Renovations and retrofits
Designing for alterations, renovations, and retrofits presents the process architect with a different set of challenges. These can include negative air pressure zones, erection of temporary partitions, construction in operational plants, decontamination of spaces, dust management, and clean waste removal. "Surprises" are inevitable when working in existing conditions; rapid problem solving is often required.
Creating extraordinary architecture
Although the process architect possesses specialized knowledge in the planning and construction of a pharmaceutical facility, the issues of human scale, workplace aesthetics, and functional productive planning remain foremost considerations, as they do in any architectural project. At its best, a well-planned pharmaceutical facility can be extraordinary architecture that creates a sense of place, facilitated by good engineering and team players. We see process architects as key team players that bring value to pharmaceutical projects. Author’s note: This article is based on the presentation "Architectural Design Facilitated by Good Engineering: The Role of the Process Architect" by Mark Brooker, architect, and Enrik Blais, engineer, at NFOE, at the 2015 Canada Affiliate Educational & Product Symposium, 21 September 2015 in Ottawa, Ontario.
Pharmaceutical Engineering® Magazine is ISPE’s bi-monthly technical magazine published for Members engaged in all aspects of research, development, and manufacture of safe and effective medicines and medical devices. The magazine covers topics important to the global pharmaceutical industry across all sectors, including traditional pharmaceuticals, biotechnology, innovator and generics. Join ISPE today to receive your exclusive copy of the May/June 2016 edition of Pharmaceutical Engineering® Magazine.
