Regulatory Aspects of Clean Room Design

Clean Room Design

Clean 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 is the facility ordinarily utilized as a part of specialized industrial production or scientific research. For that, clean room design is under the expertise is more important.

Clean Room Design:

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 ISO 13485, ISO 14644 Clean Room Design Standards.

As a medical device Clean Room Design Consultant, we Operon Strategist help in designing the medical device clean room as per the desired levels of air quality. In addition, of controlling the air particle count, environmental factors such as humidity, temperature, and pressure are also considered while designing a clean room.

Clean Room Design

Clean Room Design

We undertake projects of clean room validation service and design services, which meet international standards and norms. We offer the expertise to help you set up new manufacturing unit as well as regulatory support to your facility and clean room design service.

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To Design Clean Room Under Expert Guidance Of As Per ISO 14644 -1

As a clean room consultant, we have assisted numerous effective completion of clean room projects. Our team can give Auto CAD clean room design services for the manufacturing industry, scientific lab, R&D and primary packaging industry.

We as Clean Room Design Consultant, guide Medical Device manufacturers on supporting elements to maintain their clean room conditions suitable for manufacturing like entry-exit procedures, gowning procedures etc.