By Christian Dunne , Aseptic Global Product Manager , Chargepoint Technology
Several techniques can be used to help ensure product sterility assurance during the transfer of pharmaceutical powders from one process stage to the next using an intermediate container (e.g., vessel or bag). One of these is split butterfly valve (SBV) technology. The ChargePoint AseptiSafe bio SBV traditionally uses hydrogen peroxide (H202) gas to bio-decontaminate and remove contamination on the two mating surfaces of the valve before the product is transferred. As shown below, the two halves of the valve create a sealed chamber by partially docking the two disc faces, allowing a decontamination to take place in a closed environment. This prevents further contamination from taking place after the decontamination process is finished, unlike the traditional sporicidal spray and wipe approach, which is generally carried out in an unsealed environment where further contamination could occur.