Pharmaceutical Cleanroom Design Basics

Pharmaceutical Cleanroom Design Basics

To satisfy the assurances required by regulatory agencies, pharmaceutical products are manufactured in a controlled environment. Cleanrooms are an example of a controlled environment and are employed to reduce the contamination risk and variability of potential production environment. As controlled environments, cleanrooms can be regulated to meet specific standards. GMP regulations require that these environments are rigorously monitored to ensure that there is full and constant awareness of current environmental conditions for both viable and nonviable contamination.

A cleanroom is the fundamental starting point for contamination control. A cleanroom is defined as a room in which air filtration, air distribution, utilities, materials of construction, and equipment are maintained in a controlled manner. Operational procedures are defined and regulated for airborne particle concentrations to meet appropriate particulate cleanliness classifications.

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