Material transfer into Class A environments is one of the most common causes of aseptic processing & aseptic production failure. Keeping an aseptic process supplied with components and materials requires numerous operator interventions that present a contamination risk.
Traditional wipe-down procedures are subjective and, hence, are difficult to validate. Transfers of this type rely on quality operator training and accurate execution of standard operating procedures (SOPs).
Regulation is supporting the use or validatable, automatic robust transfer technology that reduces the risk of contamination from multiple material transfers into the Class A environment.