This document replaces the previous Parenteral Drug Assn technical documents on the validation of aseptic processing: Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products, 1980; and Technical Report No. 6, Validation of Aseptic Drug Powder Filling Processes, 1984. It addresses the validation of aseptic processing during pharmaceutical and biopharmaceutical formulation and filling activities and describes methods and procedures for the conduct of process simulation tests, including formulation and filling of aseptically processed pharmaceutical dosage forms. Aseptic operations required in the preparation of sterile bulk materials and biotechnology procedures are not a part of this document. While the focus of this document is on aseptic processing in the pharmaceutical and biopharmaceutical industry, application of the concepts to the preparation of sterile medical devices and diagnostics may be appropriate.
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