A cleanroom is a controlled environment where Drugs and Medical Device are manufactured. It is a room in which the concentration of airborne particles is controlled to specified limits.
The only way to control airborne particles is to control the total environment like air flow rates and direction, pressurization, temperature, humidity and specialized filtration all need to be tightly controlled.
Designing the Cleanrooms is a complex process which needs lot of study and understanding about the products to be manufactured and the local regulatory requirement.
To successfully complete any cleanrooms project it is essential that the project starts with risk analysis, lean manufacturing practice, good Layout and planning.
The clean room design and installation process is too complex in the case of renovating the existing facility without tampering the regular production. MedDeviceCorp utilizes its resources to advice clients during risk analysis and layout design. Our consultants have years of experience within pharmaceutical and Medical device Industry and particularly with complex projects.
Remember their experiences help in designing a world class facility, accepted by US FDA, EMA, TGA, WHO with less Installation and operational cost. Further, beyond limitations.
Contact us for guidance