Validation and Routine Operation of a Sterile Dry Powder Filling Facility

Abstract

A facility for the filling of a sterile dry powder antibiotic is described. The facility comprises the tunnel concept for washing and sterilization of the product containers, a filling unit under laminar airflow with localized vacuum exhaust, a changing room suite, autoclave, airlock, and conventional clean room containing the filling equipment. The need to reduce the possibility of sensitization and other allergic reactions is discussed. Particulate contamination represented as a function of starting materials, container, and closure contribution is assessed. Validation of washing sterilization and filling equipment is presented and developmental data derived during qualification of these validation procedures is described. The methods used for routine evaluation of incoming starting materials containers and closures are detailed, and finished product assessment from particulate and microbiological contamination points of view are also discussed. Methodology for the media fill prior to acceptance of the filling equipment is described. The criteria for acceptance of media fill operations are reviewed. Routine monitoring of particulate and microbiological contamination is reported.