CM PLUS.CM Plus Corporation CM PLUS.

Pharmaceuticals and Medical Devices
Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation

TERUMO

DATA

Function Medical device manufacturing facility
Overview (Total floor area) approx. 51,700㎡, 5 floors
Location Yamaguchi City, Yamaguchi Prefecture
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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

  • 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.

  • Our contributions to the project

    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.

  • Our contributions to the project

    During basic design stage, in addition to the basic design, we created a validation plan to clarify the requirements for the contract.

  • Our contributions to the project

    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.

  • Our contributions to the project

    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.

  • Our contributions to the project

    At the construction inquiry stage, we created detailed specifications for inquiries, and required specifications for design documents and validation. This makes it possible to make inquiries to multiple companies and evaluate their estimates fairly.

  • Our contributions to the project

    During the detailed design and construction stages, we attended regular meetings and supervised the construction work by confirming construction progress, construction quality, changes, and assessing additional construction fees to ensuring high construction quality.

  • Our contributions to the project

    By carefully coordinating the arrangements between the customer purchased equipment and the building, the production equipments were started up smoothly.

  • Our contributions to the project

    Based on LQA (Lean Qualification Approach), we supported the creation of validation documents for buildings, air conditioner, and logistics equipment.

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