DATA
Function | Medical device manufacturing facility |
---|---|
Overview | (Total floor area) approx. 51,700㎡, 5 floors |
Location | Yamaguchi City, Yamaguchi Prefecture |
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
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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.
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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.
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During basic design stage, in addition to the basic design, we created a validation plan to clarify the requirements for the contract.
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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.
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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.
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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.
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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.
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By carefully coordinating the arrangements between the customer purchased equipment and the building, the production equipments were started up smoothly.
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Based on LQA (Lean Qualification Approach), we supported the creation of validation documents for buildings, air conditioner, and logistics equipment.
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