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Cleanroom

Meaning

A Cleanroom, in the pharmaceutical and clinical compounding domain, is a highly controlled environment engineered to minimize the presence of airborne particulates, microorganisms, and pyrogens, ensuring a sterile or non-sterile preparation is created under optimal conditions. These specialized spaces are classified by the level of air cleanliness, often adhering to International Organization for Standardization (ISO) standards, which dictates the maximum permissible number of particles per cubic meter of air. Maintaining a cleanroom environment is mandatory for pharmacies engaged in compounding sterile hormonal preparations, such as injectables or ophthalmic solutions, to prevent patient harm from contamination.