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Acknowledgements We thank S

The agency noted that the airflow studies of its manufacturing procedures, intended to ensure they were produced in aseptic conditions, failed to show unidirectional airflow, and instead, it was observed that the airflow reentered the filling line

[DOI] [PMC free article] [PubMed] [Google Scholar] 97.Celestino I., Checconi P., Amatore D., De Angelis M., Coluccio P., Dattilo R., Alunni Fegatelli D., Clemente A.M., Matarrese P., Torcia M.G., et al