Facility Construction

Home/ Services/ Engineering, Project Management/ Facility Construction Engineering, Project ManagementFacility Construction Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation STEP01 Business Concept In the business conceptual phase of the project, factors such as market research, setting business objectives, technical considerations, financial planning, and legal and regulatory confirmation are taken into account to lay the foundation for the factory construction project. CM Plus assists clients in technical considerations and legal and regulatory confirmations, helping them make informed decisions. Read more about business concept STEP02 Conceptual Design In the conceptual design phase, important elements include clarifying the needs and objectives for factory construction, site suitability surveys, conceptual design considerations, budget estimates, and legal and regulatory investigations. By establishing a solid plan at this stage, the direction and basic design of the factory construction project can be determined, leading to smooth execution. Read more about conceptual design STEP03 Basic Design In the basic design phase, the design standards are established, equipment layouts are constructed, equipment specifications are determined, architectural designs are considered, and the budget is scrutinized. This phase involves deciding the specific design details of the factory construction project. Read more about basic design STEP04 Procurement The procurement phase for construction companies is a critical stage where estimates for the construction work are received from various construction companies, and the optimal proposal is selected. This phase includes the process from requesting quotations to selecting a construction company, receiving and evaluating the quotations, and negotiating and finalizing the contract. Choosing the appropriate construction company and establishing a good contractual relationship are essential for the success of the factory construction project. Read more about procurement STEP05 Detailed Design / Production Management In the detailed design and production management phase, specific design details for buildings and equipment...

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Facility Construction｜Business concept

Home/ Services/ Engineering, Project Management/ Facility Construction/ Business Concept Facility ConstructionBusiness Concept Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Business Concept for Factory Construction When considering the construction of new production facilities, increasing production capacity, or renovating aging factories due to the progress of new product development, the first step is to formulate a business plan and conduct a feasibility study.At this stage, before proceeding with specific designs, a business plan is formulated by referring to similar cases. Additionally, in many scenarios, multiple options such as different construction sites, utilization of existing factories, and the use of CDMOs are compared. Therefore, at this point, detailed design activities are not conducted, and comparisons are made using estimated construction durations and costs based on past examples. Flow of Business Concept STEP01 Organize the Requirements for the Business Concept. Define requirements for production items, types, and production capacity. Define business requirements such as location and achievement timing. Define relevance to the company’s medium- to long-term plans. STEP02 Exploring and Organizing Business Concept Proposals Explore possibilities at a broad level based on basic requirements. In the case of launching new product production or increasing production capacity: ① Construction of a new factory, ② Renovation/expansion of an existing factory, ③ Production outsourcing to CDMO, etc. In the case of renovating aging facilities: ① Construction/relocation of a new factory, ② Renovation of an existing factory, etc. Benefits and Risks Benefits Business Risks ① Construction of a New Factory Few constraints on the plan Initial investment amount is large If sales do not reach the plan, the impact of the initial investment remains Wide verification required for personnel recruitment plans ②-1 Major Renovation of Existing Factory Effective use of existing resources (production equipment, warehouse, skilled workers) The range...

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Facility Construction｜Conceptual Design

Home/ Services/ Engineering, Project Management/ Facility Construction/ Conceptual Design Facility ConstructionConceptual Design Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Basic Planning (Conceptual Design) in Factory Construction Once the business concept is solidified, the next step is to move to the basic planning stage. During this stage, the overall approach to the factory is designed. In addition to the basic requirements outlined in the business concept, the factory’s concept, a list of relevant regulations, and internal company rules are used as the basis for specifying production volumes, product types, and other details. This information is then used to design process flows, layout diagrams, and floor plans. At the end of the basic planning stage, a design review is conducted with all stakeholders present to ensure that the created design documents meet the basic requirements. Flow of Basic Planning (Conceptual Design) STEP01 Organizing the Concept and Relevant Regulations Confirm the concept and review the regulations. Verify the consistency between the mid/long-term plan and the factory concept. List relevant regulations and confirm specific requirements for each regulation. List applicable internal standards and confirm specific requirements for each standard. STEP02 Confirming Conditions Related to Production Specifically set the conditions related to production and create the process flow. Clarify conditions related to production such as production volume, product types, production methods, operational plans, staffing plans, and logistics plans. Regarding production methods (manufacturing processes), create a Process Flow Diagram (PFD) for API factories and a Material Flow Diagram (MFD) for formulation factories. STEP03 Confirming the Factory Layout Based on the process flow, concretize the factory layout. Based on the PFD or MFD, create a layout diagram of the production area. Consider the flow of personnel and materials and the cleanliness zones, and create a functional relationship diagram...

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Facility Construction｜Basic Design

Home/ Services/ Engineering, Project Management/ Facility Construction/ Basic Design Facility ConstructionBasic Design Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation 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...

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Facility Construction｜Procurement

Home/ Services/ Engineering, Project Management/ Facility Construction/ Procurement Facility ConstructionProcurement Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Constructing a new factory involves an investment on the order of several billion yen, and even renovations can reach hundreds of millions of yen. A crucial factor in making such a substantial investment effective is the selection of the construction company. It is also essential to provide evidence and transparency that can convince all stakeholders within the client’s organization regarding the selection of the construction company.Additionally, setting appropriate conditions for estimates from suppliers, not only from a technical perspective but also from the viewpoint of project execution, is key to carrying out the project according to plan.CM Plus proposes a procurement plan (procurement plan) that includes the outline of the entire process from initiating competitive bidding to selecting the contracting company. We provide a clear outline initially. During this process, we support the client in all stages, including the preparation of bidding documents, explanation of the solicitation, Q&A sessions, review of estimate content, and estimate assessment, including technical evaluation. Flow of Procurement STEP01 Consideration of Procurement Plan We decide on major policies, such as whether to adopt a lump-sum contract, a separated contract, or a partial separated contract, taking into account the client’s requirements for load, schedule, and cost. Based on this policy, we plan a detailed schedule for the bidding process and designate candidate companies for the inquiry. We request estimates from at least two companies to create a competitive environment and allow for the selection of a supplier. Lump-sum Contract   Partial Separated Contract (Production Equipment Separation)   STEP02 Creation of Bid Documents In addition to the technical specifications confirmed in the basic design, we set and document estimate conditions for key...

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Facility Construction｜Detailed Design / Production Management

Home/ Services/ Engineering, Project Management/ Facility Construction/ Detailed Design / Production Management Facility ConstructionDetailed Design /Production Management Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Detailed Design to Construction in Factory Construction The three major elements that need to be managed during the construction phase are quality, cost, and schedule. Once construction work starts, a multitude of drawings, such as construction plans and procedures, inspection procedures, and construction and fabrication drawings, will be submitted, and the client will be required to approve them. These approval actions must be performed promptly to ensure quality while keeping the project on schedule. Furthermore, in pharmaceutical factories…Awareness of GMP It is also important to comply with GMP requirements. Even if the construction company (contractor) has extensive experience in building pharmaceutical factories, its construction managers might not fully understand the characteristics of formulation factories and the essence of GMP. Amidst inevitable design changes, the client (factory owner/user) must accurately judge whether GMP requirements are being adhered to. CM Plus is a professional in pharmaceutical factory construction. We support the client in these tasks, reduce the client’s workload, ensure construction quality, evaluate the validity of additional claims, and manage proper construction progress. Read more Close Detailed Design to Construction Phase Implementation Building the Framework for Project Execution - “Project Execution Procedure” (PEP) The Project Execution Procedure (PEP) is a document that clarifies the project’s objectives, processes, related construction companies, contact points, and document management procedures. It serves as a reference for smooth project operations by sharing an understanding among stakeholders on how the project will be executed. Examples of items to be included in the PEP are as follows. Items are set as needed, considering the characteristics of the project. 1）Project objectives 2）Master schedule 3）Related company organizations 4）Contact...

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Facility Construction｜Trial operation　-Commissioning & Qualification-

Home/ Services/ Engineering, Project Management/ Facility Construction/ Trial Operation -Commissioning & Qualification- Facility ConstructionTrial Operation-Commissioning & Qualification- Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Commissioning & Qualification and Validation Process Commissioning & Qualification represent the final stages in the trial operation phase. However, it is important to conduct checks at each stage from the initial design phase to maintain quality and ensure the project proceeds smoothly.   See the Flow of Facility Construction In a pharmaceutical factory…Validation (Commissioning & Qualification) According to the GMP ordinance, “Validation” is defined as “the action of verifying that the structure, equipment, and procedures of a manufacturing site, as well as the methods of manufacturing and quality control procedures, produce the expected results, and documenting this verification.” Achieving high-quality and efficient validation in new construction or renovation projects of pharmaceutical factories is one of the most important tasks to accomplish. Validation Support by CM Plus CM Plus possesses “Validation Management Technology,” which enables efficient validation through a consistent philosophy from the initial stages of the project. Flow of Validation Consulting See other phases Business Concept Conceptual Design Basic Design Procurement Detailed Design / Production Management Construction Trial Operation Operation Related Contents Projects Performance by Numbers 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” This article discusses how to minimize the burden of validation, which requires substantial time and cost in pharmaceutical factory construction projects, while achieving both GMP compliance and cost rationality in the deployment of qualification. We propose the concept of Lean Qualification. More details can be found...

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Terumo Yamaguchi Corporation

Home/ Portfolio/ Projects/ Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation DATA Function Medical device manufacturing facility Overview (Total floor area) approx. 51,700㎡, 5 floors Location Yamaguchi City, Yamaguchi Prefecture PREV NEXT 1 / 3 Services we provided 1.Helping create the URB (User Requirement Brief) 2.Basic planning 3.Basic design 4.Validation planning 5.Helping select the construction company 6.Detailed design supervision 7.Construction supervision 8.Validation support Project flow Approx.7 months Basic Plan/ Basic Design Preparation for Inquiry Approx.4 months Construction Inquiry Approx.6 months Detailed Design Approx.16.5 months Construction Our contributions to the project We summarized the planned production volume, manufacturing environmental standards, necessary utility conditions, requirements for facilities and equipment in accordance with the Pharmaceutical and Medical Device Act/QMS Ministerial Ordinance 21CFR Part 820 (QSR) and MDR as a URB. During basic planning, we discussed automating logistics within the building as well as coordination with the existing building. According to the operation of each process, we figure out the material flow and personnel flow, environmental standards, and changing systems, and discussed layout plans and cross-sectional plans tailored to the level of automation. During basic design stage, in addition to the basic design, we created a validation plan to clarify the requirements for the contract. To build an optimal logistics system complying with smart factories/Industry 4.0, we investigated the latest information and arranged tours to the latest facilities at the beginning of the basic plan. Furthermore, we reviewed the technical proposals and estimates from each logistics equipment manufacturer, coordinated with the construction company, and supported direct ordering to logistics equipment manufacturers. To ensure a smooth project progress, we provided a rough estimate when the basic planning and basic design were completed to help the client's budget making. At the construction inquiry...

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CoreTissue BioEngineering Inc.

Home/ Portfolio/ Projects/ CoreTissue BioEngineering Inc. Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. DATA Function Medical devices manufacturing facility complying with QMS Overview Total floor area approx. 420㎡ Location Yokohama City, Kanagawa Prefecture PREV NEXT 1 / 3 Services we provided 1.Helping create the URB (User Requirement Brief) 2.Selecting candidate site 3.Conceptual design 4.Preparing basic plan and construction inquiry document 5.Helping select construction contractor 6.Basic/detailed design management 7.Construction supervision 8.Validation support Project flow Approx.5 months Candidate sites selectingURB creatingConceptual Design Approx.3 months Basic PlanInquiry SpecificationsCreating Approx.2 months Construction Inquiry Approx.9 months Basic Design/Detailed Design/Construction Our contributions to the project We summarized the planned product (Artificial Ligament used for ACL reconstruction) production volume, necessary utility conditions on production equipment and analysis apparatus, requirements on facilities and equipment as a URB (User Requirement Summary). When selecting the candidate site for relocation, we provide advice on expected size, infrastructure based on URB from an engineering perspective, and finally work with the customer on selecting the candidate site considering the occupancy conditions, conditions on construction contracting, etc. At the conceptual design stage, we discussed the floor layout, material/personnel flow and equipment system with consideration to expansion from clinical trial stage to commercial production. To realize the concept of this project “Medical device facility complying with QMS”, we have adopted the thinking on GMP-compliant facilities. Specifically, these include clear and step-by-step area zoning and air conditioning systems, room pressure control, environmental monitoring, uninterrupted power outage measures, and insect control, like those used in pharmaceutical facilities. To proceed with the project accurately, we provided a rough estimate so as to help the customer in creating a budget. At the construction inquiry stage, we created detailed specifications for inquiries. This makes it possible to make inquiries to multiple...

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Jitsubo

Home/ Portfolio/ Projects/ Jitsubo Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting JITSUBO Co., Ltd. DATA Function Peptide drug research center Overview Total floor area approx. 700㎡ (4th floor)Due to business expansion, it is necessary to move from an incubation facility within the university to an independent research and development center. Location Yokohama City, Kanagawa Prefecture PREV NEXT 1 / 3 Services we provided 1.Basic design 2.Inquiry supporting 3.Detailed design management 4.Construction supervision Project flow Approx.3 months Basic Design/Inquiry creating Approx.1 months Construction Inquiry Approx.7 months Detailed Design/Construction Our contributions to the project At the planning stage, we figure out the detailed equipment layout basing on laboratory engineering. And we conducted construction management after the it was divided and contracted out to 4 companies separately. We provided advice from an engineering perspective from the stage of selecting potential relocation sites. We made careful plan of the layout of each research center/laboratory, including equipment layout. We ensured that our customer's requirements have been fulfilled. Communication has been improved by consolidating research centers/laboratories that were previously dispersed in different places on the same floor. At the inquiry stage, since construction of building and building equipment are contracted out separately, we summarized the total amount of estimates from each construction company within our customer's budget. At the detailed design stage, we cooperated with the construction companies and helped the preparation of comprehensive drawings. During construction, we coordinated the construction schedule among construction companies through regular meetings.In addition, we proceeded with the project as we obtained the approval on comprehensive drawings from the user and fulfill construction supervision by ensuring all the requirements were met. Services related to this project Medium-Molecule API Manufacturing Facility Other Projects Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo...

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