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 companies and evaluate their estimates fairly.

When selecting the construction company, we evaluate the cost and technique. Together with the customer, we reviewed each company’s projects, and interviewed their staff in charge of design and construction. As a result, we were able to select the most suitable construction company and members.

At the construction stage, we helped prepare the comprehensive drawings basing on thoroughly discussion on necessary utilities for each production room, including those for separately ordered equipment and analytical apparatus .

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.

Validation was conducted based on LQA (Lean Qualification Approach), we carried out confirmation on buildings, air conditioner, and logistics equipment until final validation report had been completed to make sure that all the necessary documents were well prepared.