ABSTRACT
Sterile pharmaceuticals are either by aseptic processing techniques or by terminal sterilizationmethods. Inaseptic processing, thedrugproduct, container, andenclosure are presterilized and the filling operations are performed in high quality environments, traditionally called cleanrooms. Aseptic processing can provide products with a high degree of sterility assurancewhen they are carried out under stringent aseptic processing conditions with well-defined standards. In the 1960s and 1970s, the aseptic processing methods, even when performed under optimal conditions, could only be validated to ensure that the contamination rate is no greater than one contaminated unit per thousand (103) filled. Today, processing technologies have emerged and are capable ofminimizing or eliminating human interventionwith proper techniques, proper gowning, effective sanitization of surfaces, and sterile materials.
