ABSTRACT
This chapter outlines means for process control and
validation of aseptic processing for sterile products
manufactured using predominantly manual procedures.
Typical processes/products where this type of guidance
might prove beneficial include vaccine preparation, cell
culture, gene therapy, INDmanufacturing, clinical manu-
facturing, etc., where a substantial portion of the
manufacturing process is aseptically performed by
operators, and thus susceptible to adventitious contami-
nation. As the aseptic operations in these processes are
unique to the specific process and are also substantially
different from those employed for either final formu-
lations involving conventional aseptic filling equipment
or sterile bulk drugs, none of the existing regulatory or
industry guidance is fully appropriate. This chapter
addresses aseptic procedures where manual activities
constitute the majority of the process; those other
manual steps associated with more conventional aseptic
processes such as sampling or aseptic connection are
readily integrated into the simulation of those processes
and will not be addressed further here.
