Aseptic Fill & Finish

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 can provide a solution, powder or suspension which has been subject to terminal sterilization, then Bioserv can perform the aseptic fill/finish process. Typically sterile drugs are aseptic fill/finish 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 terminally sterilized client-approved drug product, fills components, conducts equipment change parts and sanitizes the cleanroom and in-place equipment. Then we bring it all together with good aseptic practices, and the simplified process looks like the aseptic process map below.

 


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