BSENISO13408-6-2021isastandardthatspecifiesrequirementsandprovidesguidancefortheasepticprocessingofhealthcareproducts.Itfocusesonthesterilizationofproductsthatcannotbeterminallysterilizedandmustbeprocessedasepticallytoensurepatientsafety.Thestandardcoversaspectssuchasfacilitydesign,personneltraining,environmentalmonitoring,andprocessvalidationtomaintainsterilitythroughoutproduction.Compliancewiththisstandardhelpsmanufacturersmeetregulatoryexpectationsandensurethequalityofasepticallyprocessedhealthcareproducts.ThedocumentispartofaseriesofstandardsunderISO13408,whichcollectivelyaddressdifferentaspectsofasepticprocessinginthehealthcareindustry.
