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Sterivalves aseptic powder transfer valves offer increased sterility assurance when handling sensitive ingredients and small components in fill/finish aseptic processing and biotech sterile API production. Achieving sterile transfers in Grade C / D areas Using Aseptic Isolators in conjunction with these valves can offer unmatched aseptic powder transfers in a Grade C environment
An Aseptic Performance of SAL 6 can easily be achieved.
Sterile transfers in Grade C / D areas comes with its own challenges. The Isolator can be designed to have a pre docking operation for decontamination via the underside passbox or can be done through a alternate BIO design split valve technology
During the product transfer process, the valve undergoes a VHP decontamination process in conjunction with the aseptic Isolator. The Valve disc remains open during this period ensuring that the edges of the Valve Disc is completely decontamnated. Then the Disc is cosed.
The receiving is transferred into the bottom Pass box and a separate decontamination process is done to eliminate contaminants on the disc faces that were exposed to Grade C environment. The vessel is docked after this cycle and then the powder is transferred.
This ensures there are no loss in integrity due to the exposure to grade C earlier. Decontamination process in a bottom chamber is more fool proof that doing it in a small compact area between discs. The added advantage is that one need not have a dedicated VHP system for the bottom chamber decontamination and hence saving huge costs.
