Bio-Decontamination Of Material Transfer Systems

Material transfer into Class A environments is one of the most common causes of aseptic processing 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.

Manual disinfection of materials entering or exiting controlled areas does not provide effective and robust surface decontamination hence leads to transfer of bio-contamination. To eliminate such risk the use of HPV gassed transfers has increased. Bioquell have developed a range of Material transfer solutions to meet requirement of scale and speed of transfer time. Cycle times with 6-log sporicidal reduction of smaller transfer systems can be as low as 15 minutes. Larger scale Walk-in Transfer times can be as low as 1 hour.

Key features of the Transfer Chamber designs meet requirement for efficacy, cycle time, safety together with selectable interlock priority so that bio-decontamination can be assured at entry or exit from a controlled area.