Conceptual Design
Background
Conceptual Design is based on business plan guidelines. It defines the products that a facility intends to manufacture, explicitly stating the lots, volumes, and pharmaceutical process. User Requirement Specifications (URSs) are created during this process. The URS provides details on the production process(es), facility overview, and regulatory requirements. Typically in collaboration with an Engineering and/or Architectural Firm, the organization will create a facility layout. Key components that need to be considered include product, personnel, materials, and waste flow. The production process can be presented through block diagrams that help create the preliminary list of equipment and potential utilities.
During Basic Engineering, the make and model of equipment is defined based on the estimated capacities of utilities. At this point in the design process, the layout and URS are approved. Utility points of use and routing are determined. Based on the information collected, the drafting of the architectural designs can begin. The engineering team or general contractor will also begin putting together the project execution schedule.
Detailed Engineering focuses on the detailed components of the facility. Critical documents like technical and functional specifications, P&IDs, and dimensions of the facility routing will all be created at this stage of the project.
Constructive Engineering is the final phase of the facility start-up process. During the construction phase, construction has commenced. Before commencement, the Conceptual Design Report (CDR) and detailed engineering documents are reviewed and confirmed for suitability. Any documents that are missing or need modification are addressed in this final phase. The project schedule is updated and the last quotation for project execution is provided.
Conceptual Design Elements
When creating a conceptual design, some key elements to consider include basic architectural drawings, process flow diagrams, utility flow diagrams, equipment layouts, and preliminary P&IDs. A Conceptual Design Report should have six to eight critical sections. The sections should include an Executive Summary, Project Overview, Cost and Budgetary Considerations, Timeline and Milestones, Site Selection and Evaluation, Process Flow Diagram and Equipment Placement, Facility Zoning and Layout, Utility and Services Planning, and Process and Work Flow Analysis.
The Executive Summary and Project Overview will provide insight into the project scope and objectives, risk analysis, and regulatory and compliance considerations. Background on the biotechnology company and the intended use of the facility should be provided. Any risks and considerations for the facility should be identified and clearly stated. This includes identifying the regulatory requirements, compliance strategies, and zoning and local ordinances or constraints.
Cost Estimations and Budgetary Considerations would be preliminary estimates for facility readiness. The budget should be broken up based on each project phase. If there are monetary constraints, cost effective alternatives should be clearly stated and highlighted. The budget is relatively high level with estimations being +/-30% accuracy.
Timeline and Milestones, similar to the previous section, would be preliminary for facility readiness. It will be very high level, with key milestones identified for facility build-out. Similarly to the estimations and budget, the timeline is relatively high level with the timeline being +/-30% accuracy.
Site Selection and Evaluation provides a detailed breakdown of why the site was selected. Descriptions of the accessibility, potential for scalability, or increased capacity in the future can be elaborated on in this section. Other important details may include environmental impacts, zoning regulations, and facility planning.
Process Flow Diagram and Equipment Placement gives a brief overview of the manufacturing process. Information describing the potential throughput of lots and volumes should be described in this section. Furthermore, any requirements for the manufacturing process and run times per lot can be elaborated upon.
Facility Zoning and Layout discusses the proposed facility layout. Descriptions of the estimated square footage for the GMP and controlled spaces should also be provided to ensure a clear breakdown of the utilization of the area. This should include a couple of facility layout options, with justification regarding the preferred option.
Utilities and Services Planning discusses the considerations and planning for all utilities. If there is equipment that requires utilities, they should be highlighted, along with the amount of each utility expected to be needed. If there are structural or industrial risks, then they should be highlighted and mitigation plans can be proposed.
Process and Work Flow Analysis provides the flow of materials, waste, products, and personnel in the preferred facility layout. Grades should be clearly identified. This will give the facility team a clear idea of how everything will move throughout the facility.
Collaboration and Communication
When working with a contractor, considerations for current and future processes should be the key focus. Any points of concern for the facility should be highlighted and discussed with the project team to clearly understand the thought processes behind important decisions. Areas that may be overlooked but can pose potential concerns include preference for specific vendors, future plans, and phasing options.
