Non-Aseptic Fill & Finish

Non-aseptic filling is a non-aseptic process that requires the coordination and interaction between personnel, product, the manual fill/finish equipment system, laboratory space and support facilities (Class 100,000 or Uncontrolled Lab Areas), and filling components.

The non-aseptic core is where the product or reagent is exposed to the Class 100,000 or an uncontrolled environment. These are the areas where the product is formulated and manually filled into the proper container. Typically the stoppering or closing of the container occurs immediately after, with the exception of when the product requires 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, then Bioserv can perform the fill/finish process.

 

 


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