Basic Design｜Facility Construction

Basic Design in Factory Construction

In the basic design phase, we review and propose solutions to realize the concepts established during the basic planning (conceptual design). We then solidify the detailed specifications and create the blueprints. Considering the investment costs and future plans, we finalize the specifications that meet the client’s requirements and create the drawings.
As the final step in the basic design process, we conduct a preliminary estimate based on the basic design. After confirming that the selected specifications during the basic design phase fall within the client’s budget, we proceed to the next step of “Procurement.”

Implementation Items of Basic Design

Documents Created in Basic Design

Based on the basic planning (conceptual design), we create more detailed design documents for production equipment, architecture, HVAC systems, plumbing and sanitation facilities, utility facilities, and electrical installations.
These design documents are also used as specification requirements for suppliers.

Example Table of “Deliverables Content”

General Design	Basic Engineering Design Data (BEDD) Room Specifications Tables (Architecture, HVAC, Utility, Plumbing and Sanitation, Power, Monitoring) Energy-Saving Proposals (HVAC and Utility Systems, etc.)
Architecture	Temporary Construction Plan Architectural Outline Specifications Overall Layout Plan Floor Plans (for each floor) Section Drawings Interior Finish Table Architectural Key Plans
HVAC Equipment	HVAC Outline Specifications Room HVAC Specifications Tables HVAC System Zoning Diagrams HVAC System Flow Diagrams Chilled Water Piping System Diagrams HVAC Equipment List HVAC Equipment Layout Diagrams
Plumbing, Utility, and Fire Protection Equipment	Equipment Outline Specifications Piping System Diagrams (by system) Equipment List Equipment Layout Diagrams
Electrical Equipment	Electrical System Outline Specifications Layout and Exterior Facility Plans Substation Supply Conceptual Diagrams Single Line Diagrams for Substation Equipment Substation Equipment Layout Diagrams Room Electrical Equipment Specifications Tables Conceptual Diagrams for Low Voltage, Communication, and Fire Protection Systems

Preliminary Cost Estimate in Basic Design

We calculate a preliminary estimate based on the basic design. This estimate is more accurate than the one made during the basic planning (conceptual design) phase, and it serves as a final confirmation against the project budget.

Differences Between Basic Design and Detailed Design

The basic design aims to finalize specifications and quantities that will impact production capacity, product quality, costs, and schedules in preparation for project execution.
In contrast, the detailed design involves finalizing all the detailed information necessary for manufacturing and construction.

At CM Plus…

Clear Deliverables and Goals in Basic Design

The design documents we create are customized and clarified based on our company’s standard deliverable list, tailored to the project’s and client’s needs. The design documents and URS (User Requirement Specifications) produced in the basic design phase are necessary for subsequent steps such as contractor quotation requests, detailed design, and commissioning activities.
Furthermore, any issues or review items that arise during the basic design process are listed, and by the end of the basic design phase, we ensure that these issues are resolved.
For factories dealing with pharmaceuticals, medical devices, etc., we can add a validation master plan (VMP) for the project to the basic design deliverables upon request.

URS: User Requirement Specification

Furthermore, in Pharmaceutical Factories…Traceable URS for Qualification

Through pre-system classification, we identify direct impact systems and create their URS. To be utilized in QRM, the URS clearly lists CQAs, CPPs, and GMP requirements, serving as the criteria for design review and design qualification after the detailed design phase. We conduct a GMP compliance evaluation for the basic design document package, including the URS, and document and ensure that all GMP requirements are reflected in the basic design documents.

Direct Impact System: Systems expected to have a direct impact on the product quality of pharmaceuticals and subject to qualification.
QRM: Quality Risk Management
CQAs: Critical Quality Attributes
CPPs: Critical Process Parameters
GMP: Good Manufacturing Practice

Discovering Optimal Specifications and Functions for Clients

To materialize user requirements (UR), we propose the most suitable technologies based on trends and track records, while investigating the advantages and risks of the latest technologies. We also evaluate and decide on the adoption plan from various perspectives such as productivity, future potential, energy and labor savings, running cost reductions, operability, maintenance, and installation costs.
As professionals in technology and project management, CM Plus collaborates with clients from a fair standpoint, pursuing specifications that satisfy all project stakeholders.

Please refer to this for information on energy-saving, carbon neutrality, BIM, DX, etc.

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Centralized Management by the Project Manager

There are numerous items to be examined and finalized in the basic design phase, such as production equipment, manufacturing management systems, logistics systems, architecture, facility ancillary equipment, and commissioning activities. This is the most crucial period for ensuring the success of the project, yet it is often the time when the least amount of time can be allocated.

At CM Plus, experienced project managers well-versed in all these aspects will schedule and guide the process to ensure that the client’s requirements are designed within the stipulated timeframe.

Cost Management

Based on the determinations made during the basic design phase, we provide an approximate estimate. This includes not only buildings and their ancillary facilities but also pharmaceutical machinery, manufacturing management systems, and logistics systems, offering a total project cost estimate.
Upon reaching an agreement with the client on the total cost, we proceed to the next step—calling for procurement (supplier selection).

See other phases

Useful Information

Please also refer to the articles on our information dissemination site, “GMP Platform.” Although the title contains “Pharmaceutical Factory Construction,” the content is applicable to the construction of factories in various industries, not limited to pharmaceutical factories.

“How to Build a Pharmaceutical Plant”

Integrating know-how for the success of pharmaceutical factory construction projects. It provides detailed explanations and key points for each step, from overall project planning (= creating the project framework) to basic planning and basic design.

“How to Build a Pharmaceutical Plant” 　Table of Contents
(Japanese only)

“How to Build a Pharmaceutical Plant” 　[Chapter 4] Basic Design
(Japanese only)