Monday 28 September 2020

Effectivity of HEPA Filters to Remove Viruses from Air Entering Cleanrooms

In the manufacture of certain pharmaceuticals, viral removal or destruction is a key part of manufacturing (such as products produced from cell lines or from blood or plasma, as per ICH Q5A). This requires a combination of viral secure areas and viral removal steps. In a previous American Pharmaceutical Review article, this author examined the ways by which viruses can be removed or inactivated from pharmaceutical products (including solvent-detergent; low pH inactivation; heat; chromatographic separation; and nanofiltration).

In terms of detection, nucleic acid-based assays such as Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) provide rapid and sensitive detection of adventitious and endogenous viruses in constituent materials and finished products. This follow-up article considers how viruses can be excluded by HEPA filtration, thereby minimizing the entry of viruses and viral particles into cleanrooms. Aspects of this review may also be of interest in the wider context of the 2019-2020 novel coronavirus pandemic (caused by the virus SARS-CoV-2).

In relation to this, Tim Sandle has written an article:

Sandle, T. (2020) Effectivity of HEPA Filters to Remove Viruses from  Air Entering Cleanrooms, American Pharmaceutical Review, 23 (4): 56-58 (

Viral contamination is a potential safety threat common to all animal- and human-derived biologics and it follows that ensuring virological safety is challenging. Contamination of the production system can occur, and the processes of viral removal are complex and require regular assessment (to avoid the incomplete inactivation or removal of viruses). A further challenge arises with creating viral secure areas. As well as the control of materials and personnel, and important factor in maintaining such an area is through effective air filtration.

For further details, please contact Tim Sandle.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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