Engineering services for life science industries
Since its foundation, CM Plus has been working for a number of life science-related projects thus developed the first-rate knowledge and skills. We ensure and maintain quality not only for GMP compliance in designing and construction phases but also for Commissioning & Qualification activities which start from the early designing phase. We also establish various supporting structures such as a tie-up with consultation till the process of supporting inspections after launch. CM Plus guides your construction project to success through those efforts.
Characteristics
In life science industries, products which may affect human health are handled. Therefore, quality control required for the products needs to be more strict than that for other types of products. Characteristics of manufacturing facilities are as follows:
- Compliance with GMP is required. (PIC/S, cGMP, EU-GMP and local GMP)
- Advanced environmental control (cleanliness control, temperature and humidity control, room pressure control, manufacturing water control, etc.) is required.
- Advanced hazard control (against chemical hazards and biohazards) and poisonous material/narcotics control may be required.
- Complicated coordination is required as production equipment and facilities, and buildings and their facilities function together.
- Commissioning and Qualification (C&Q) activities are required to be implemented based on accurate risk analyses.
Keys to success
CM Plus values the following things for successful construction project for life science industries:
- To check specifications at each step from the early phase of the plan including validation for sure in terms of GMP compliance.
- To design buildings and their facilities suitable for environmental control and hazard control to appropriately carry out flow plans and containment plans.
- To ensure coordination for production facilities and equipment, and buildings and their facilities.
CM Plus guides you to success in projects through the following actions:
- CM Plus starts C&Q activities from the basic designing phase thus ensures quality including quality in GMP compliance.
- CM Plus utilizes our expertise to propose the best plans and to develop conceptual designs and basic designs.
- CM Plus minimizes extra works at site by making coordination among production equipment, buildings and building facilities before actual works.
- CM Plus make plans of and controls the project master schedule including designing, manufacturing oversight and installation plans and coordination for production facilities.
Working for your issues with our excellent skills and technologies called Professional Management.
