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 Clean, Unclassified Lab Areas), and filling components.
The non-aseptic lab space is where the product or reagent is exposed to the Class 100,000 or a clean unclassified 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. Whether the client provides a solution, powder or suspension, Bioserv can perform the fill/finish process. Products required to be sterile (e.g. parenterals or opthalmics), that are non-aseptically filled, are then subjected to a terminal sterilization process, for instance, gamma irradiation.