Aseptic filling is an aseptic process that requires the close coordination and complex interaction between personnel, sterilized product, the manual fill/finish equipment system, cleanroom and support facilities (Class 10,000/Class 100), and sterilized filling components.
The aseptic core in which the sterile drug is actually exposed to the cleanroom environment is the most crucial area of a cleanroom and warrants the most detailed attention to the design of the cleanroom. This is the area where the sterile drug is transferred from the filling needles to the sterile container. Typically, the stoppering or closing of the container occurs immediately after, with the exception of when the drug requires sterile lyophilization. The requirements of the lyophilization process require the stopper be only partially seated on the vial. If the client provides a solution, powder or suspension which has been terminally sterilized, then Bioserv can perform the aseptic fill/finish process. More often, the drug is formulated as a liquid and sterilized by filtration. Typically, sterile drugs are aseptically filled and finished in molded glass bottles, tubular glass vials, and tubular glass syringes.
How does Bioserv complete the aseptic fill/finish process? Bioserv decontaminates the operational personnel, receives the client-approved active pharmaceutical ingredient (either sterilely or ready to be formulated and sterilely filtered), components, vials, stoppers, seals (either ready to us or sterilized on site), conducts equipment change parts, places needed equipment into position and sanitizes the cleanroom. Then we bring it all together with good aseptic practices.