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HEPA filters in non-sterile dosage forms
29 Feb 2024

Is HEPA filters required to install for air supply in areas of non-sterile dosage forms?

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No, HEPA filters does not specifically require manufacturing facilities for non-sterile drugs to maintain HEPA filtered air.
The Regulations do require the use of equipment for adequate control over air pressure, microorganisms, dust, humidity and temperature, when appropriate. In addition, this section calls for use of air filtration systems, including prefilters and particulate matter air filters on air supplies to production areas, as appropriate. objective is to prevent cross contamination in best possible way.
But many organizations may install HEPA filtered air systems as part of their dust control procedures.
For example, organizations may perform dust containment assessments and decide that such filters are warranted to prevent cross contamination of highly potent drugs that, even in small quantities, could pose a significant health hazard when carried over into other products.
HEPA stands for high-efficiency particulate air. A HEPA filter is a type of mechanical air filter; it works by forcing air through a fine mesh that traps harmful particles such as pollen, pet dander, dust mites, and tobacco smoke.

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