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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Iwatalabel

Home/ Portfolio/ Projects/ Iwatalabel Pharmaceuticals and Medical Devices／Packaging Purpose: to build factory that "responds to drastically changing customer needs and stays 15 years ahead of its rivals. Iwata Label Co., Ltd(Company name changed to “IL Pharma Packaging Co., Ltd.” from April 1, 2022) DATA Facility use Label printing factory Summary Total floor space: approx. 6,000㎡ Location Ichinomiya City, Aichi Prefecture PREV NEXT 1 / 3 Services we provided The following services were provided as engineering consulting 1.URB (User Requirements Brief) development support 2.Conceptual design 3.Preparation of construction drawings 4.Support services for determining the construction contractor 5.Detailed design management 6.Construction supervision Project phase 3 months Prepare URB 4 months Prepare Conceptual Design/Quotation form 3 months Construction company quotation inquiry stage 16 months Detailed design /construction phase Our contributions to the project CM Plus prepared a URB (User Requirements Brief) for the production volume of the product to be manufactured (pharmaceutical labels), the utility conditions of the production facility, and the requirements for the facility and equipment. In the conceptual design phase, CM Plus worked with the client on a land use plan that took into account future concepts in the site utilization plan, and studied the layout plan (first phase plan).In order to realize one of the project concepts, "meeting global quality requirements" we adopted a concept that conforms to GMP-compliant facilities.Specifically, we aimed for the quality of a pharmaceutical plant, with clear and step-by-step area separation, air conditioning, insect control, and a product transfer system/plan and cross-sectional plan that links the automated warehouse and production system. In order to get the project right, we provided a rough estimate and assisted the client in developing a budget. At the construction inquiry stage, CM Plus prepared specifications and books for quotation inquiries with clear specifications. This made it possible to conduct quotations...

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Terumo Vietnam

Home/ Portfolio/ Projects/ Terumo Vietnam Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facilities that are safe and environmentally friendly for people and communities Terumo Vietnam Co., Ltd DATA Facility Use Medical device manufacturing facility Summary (Total floor area): More than 30,000㎡ including renovation for existing facility Location Hanoi, Vietnam PREV NEXT 1 / 3 Services we provided 1.Support for preparation of URB (User Requirements Brief) 2.Basic planning 3.Basic design 4.Validation planning 5.Construction company decision support 6.Detailed Design supervision 7.Construction supervision 8.Validation support Project flow Approx. 6 months Basic Plan /Basic DesignInquiry Preparation Approx. 4 months Inquiry for construction quotation Approx. 7 months Detailed Design Approx. 18 months Construction Our contributions to the project Documented required utility conditions, and requirements for facilities and equipment as URB in accordance with the expected product production volume, manufacturing environmental standards, Vietnamese national regulations, Chinese medical device regulations, MDR, 21CFRPart820 (QSR), and the Pharmaceutical Affairs Law. In the basic plan, we organized the flow lines of people and goods, environmental standards, and changing systems, and studied the floor plan and cross-sectional plans, including plans for existing renovations according to the manufacturing operations in each process, We completed the basic design with a structural plan and material selection that matched the actual conditions of the construction site (Vietnam). At the construction inquiry stage, we prepared specifications for quotation inquiries, design documents, and requirement specifications for validation with clear specifications. This made it possible to conduct quotations for multiple companies and to evaluate quotations fairly. During the detailed design and construction phase, our CM and four Vietnamese engineers were stationed at the site to supervise the construction work, including checking the construction progress, checking construction quality, confirming changes, and assessing additional construction costs, thereby contributing to ensuring good construction quality. Smooth start-up of production facilities was...

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Takasago

Home/ Portfolio/ Projects/ Takasago Food／Flavor・Fragrance Facilitate project execution between the Asia headquarters and Japan headquarters Takasago International Singapore Pte. Ltd. DATA Facility use Flavor and fragrance manufacturing factory Summary Total floor area: approx. 10,000㎡ Location Suburban Jakarta, Indonesia PREV NEXT 1 / 3 Services we provided CM Plus provided the following engineering consulting services 1.Feasibility study support 2.Conceptual design (Engineering Management services) 3.Construction contractor selection support (Project Management services) 4.Detailed design management (Project Management services) 5.Construction supervision (Construction Management services) Project flow Approx. 1 year Feasibility study Approx. 6 months Prepare Conceptual Design/ Quotation form 3 months Construction company quotation inquiry stage 14 months Detailed design / construction phase Our contributions to the project A bilingual (Japanese-English) member of CM Plus team participated in the project. We supported smooth communication between the Singapore Asia headquarters, who placed the order, and the Japanese headquarters, who has approval authority. In the feasibility study, we clarified the production workflow by visualizing the movement of people and goods in a flow diagram based on the client's requirements, and were responsible to execute the plan. Following this, we were able to estimate construction costs and calculate the required land area, and the project execution quickly progressed within the client. We also played a role in presenting multiple case studies and gathering internal client opinions. By accurately proceeding with the construction plan, we were able to present costs with few errors and the customer was able to set a budget early. At the construction inquiry stage, we prepared a document for requesting quotation inquiry with clear specifications. This allowed us to conduct inquiries from several construction companies and evaluate estimates fairly, and also helped to minimizing additional changes during construction. We were able to select the best contractor by performing cost and technical evaluations based on...

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Medreich Limited

Home/ Portfolio/ Projects/ Medreich Limited Pharmaceuticals and Medical Devices Pharmaceutical manufacturing factory: Expansion for manufacturing line Medreich LimitedMeiji Seika Pharma Co., Ltd. Group DATA Facility Pharmaceutical manufacturing factory Location Bangalore, India PREV NEXT 1 / 3 Services we provided The following services were provided as engineering consulting 1.Conceptual Design (Engineering Management services) 2.Contractor selection support (Project Management services) 3.Detailed Design Management (Project Management services) 4.Construction Supervision (Construction Management services) 5.Validation support (Validation Management services) Project flow Approx. 4 months Prepare Conceptual design/ Contract documents 2 months EPC company’s basic design Approx. 3 months EPC company’s detailed design phase 6 months Construction phase Our contributions to the project CMP’s Japanese – English bilingual members participated Prepared documents for concluding a contract with the design and construction company. Reviewed the detailed design of the design and construction company. Two Japanese staff and two Indian staff were stationed at the site to supervise construction and validation, and the project was completed within the scheduled period. Checked the completion of the Validation Final Report and ensured that the necessary documents were in place. Services related to this project Engineering, Project Management Other Projects Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting Jitsubo CO., LTD. Pharmaceuticals and Medical Devices／Packaging Aiming to create a factory that "responds to rapidly changing customer demands and stay ahead of the competition for 15 years" Iwata Label Co., Ltd.(currently IL Pharma Packaging Co., Ltd.) Cosmetics “Show” cosmetics factory Toyo Beauty Co., Ltd. Data Centers System module type data centerRealizing short construction period and low cost Internet Initiative Japan Inc. Pharmaceuticals and Medical Devices Large-scale...

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Toyobeauty

Home/ Portfolio/ Projects/ Toyobeauty Cosmetics “Showcase” cosmetics factory TOYO BEAUTY CO., LTD. DATA Facility use Cosmetics factory Summary Total floor area: approx. 39,000㎡, 4 floors Location Kanzaki-shi, Saga Prefecture PREV NEXT 1 / 3 Services we provided 1.Basic design services 2.Preparation of construction quotations 3.Support services for determining the construction contractor 4.Detailed design management services 5.Additional cost assessment services 6.Construction supervision services Project flow Approx. 3 months Prepare Basic Design/ Quotations form 1 months Construction company quotation inquiry stage Approx. 4 months Review detailed design 13 months Construction phase：CM service Our contributions to the project In the basic design, we worked with the client to realize the client's concept of a "showcase cosmetics factory”. In addition to examining the flow lines and zoning of the manufacturing area, we proposed a variety of cases for considering layouts such as aisles for customer tours and presentation rooms, and worked with the client to conclude a layout. When selecting a construction contractor, we prepared a contractor comparison chart to visualize the evaluation. We supported the contractor selection by matching the evaluation criteria, such as adding up the amount that was missing from the estimate. We assessed the huge amount of additional costs submitted by the contractor, settled an acceptable price for both parties through negotiation and reduced the additional costs. During the construction phase, a construction supervisor was stationed on site to manage the schedule and quality on a daily basis, and the project was completed on schedule. We focused on designing a beautiful facade required by the client and completed the exterior to the client's satisfaction. Services related to this project Engineering, Project Management Other Projects Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Manufacturing facility for bio-based...

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Iij

Home/ Portfolio/ Projects/ Iij Data Centers System module type Data Center –Achieve short construction period and low cost Internet Initiative Japan Inc. (IIJ) DATA Facility use Data center Summary Maximum total floor space: approx. 80,000㎡ (6,000 racks) Location Shirai City, Chiba Prefecture About Client IIJ was founded in 1992 as Japan's first domestic Internet service provider, and since then has continued to take the initiative in technology as a pioneer of the Internet in Japan. Shirai Data Center Campus was built to meet the growing demand for data centers in response to the explosive growth of digital data due to 5G/IoT/AI/cloud services. PREV NEXT 1 / 3 Services we provided It is said that more than 90% of data center construction in Japan has to be done by major design firms and general construction companies. However, with CM Plus' support, IIJ was able to build its data center without relying on either of these resources. 1.FS consideration support: Compile client considerations and calculate rough budget for investment costs. 2.RFI support (Engineering Management services): Gathering information on the latest technology 3.Support for RFP/RFQ issuance (project management services): Support for document preparation for construction inquiries, conduct inquiries from multiple construction companies 4.Detailed design management (Project Management services): Implementation of regular meetings, review of design documents 5.Construction management: support for construction progress and quality control, and client completion inspections Project flow Approx. 6 months FS Approx. 3 months RFI 3 months RFP/RFQ Approx. 6 months Detailed Design Administration Approx. 9 months CM Our contributions to the project Supports architectural, electrical, and HVAC engineering resources to develop project master schedules and develop project tasks to completion dates. Supported in calculating estimated costs based on facility size assumptions. CM Plus identified the requirements for the latest DC, gathered technical proposals from relevant vendors, and conducted...

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