New Medical Devices Reprocessing Facility

Project Scope:

• Conceptual and the front–end engineering design of the facility which included the Cleanroom Panel infrastructure, Cleanroom Equipment, HVAC System, Epoxy Flooring, Electrical supply and distribution and Plumbing (supply and drainage).
• Demolition of the existing facility:- brick wall infrastructure, relocation of process Equipment and utilities, removal of the existing HVAC System ductwork, removal of the tiling, Electrical cable termination and socket removal and Plumbing pipe work disconnection and termination.
• Construction:- Cleanroom Panel Infrastructure installation, reinstallation of process Equipment, installation of a GMP–compliant HVAC System (ISO Class 8 and CNC Air classifications), application of the Epoxy Flooring, Electrical power supply and reticulation and Plumbing (supply and drainage installation).
• Managed Cross functional teams to achieve a common goal.
• Commissioned, Qualified the HVAC System, Electrical Works and utilities according to regulatory standards.

Final Result:

An ISO 13485 Compliant Medical device reprocessing facility