Medical Device Clean Room Design Consultant
Medical Device Turnkey Project ConsultantOperon Strategist is a Leading regulatory & quality assurance consultant for Medical Device & primary packaging manufacturers. Working out of Pune, India, Operon Strategist has a global presence with an international client base.
Medical Device Plant Layout Design ConsultantWe are a leading service provider of facility plant setup, medical device unit design, pharma setup and clean room design facility plant setup services.
Medical Device Process ValidationProcess Validation For HVAC validation , Equipment validation , Process validation , Facilities validation , Cleaning validation , Analytical method validation.
Clean Room Design ConsultantClean room helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Clean room helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Presence of unwanted air particles may adversely affect the performance and safety of a product and hence Medical Device manufacturers are advised to manufacture under classified areas.Clean rooms of different sizes and complexity are designed to maintain low levels of air particles as per the as per the ISO 14644 clean room standards.
As a Medical Device clean room design consultant, Operon Strategist helps in the design of Medical Device clean room as per the desired levels of air quality. In addition, to controlling the air particle count, environmental factors such as humidity, temperature, and pressure are also considered while designing a clean room.
We as clean room design consultant, guide Medical Device manufacturers on supporting elements to maintain the clean room conditions suitable for manufacturing like Entry exit procedures, Gowning procedures etc.