Sterile Formulation Michael. akers. Curtis S Strother mark r Walden 1.0 INTRODUCTION Historically, sterile bulk pharmaceutical manufacturing processes prior to filling operations, have followed general bulk pharmaceutical guidelines. As technology and equipment have improved, the requirements for aseptic manufacture have increased. It is important to understand that product quality often is realized in the manufacturing phase and should be maintained throughout the remaining filling/packaging processes. It is the Food and Drug Administrations current opinion that Current Good Manu facturing Practice for Finished Pharmaceuticals apply to sterile bulk operations. 2 Adherence to the Guideline on Sterile Drug Products Produced by Aseptic Processingl3I is considered essential for non-terminally sterilized products as is the case for sterile bulk pharmaceutical dry powders. The facility design and manufacturing process should be integrated with current regulatory guidelines, the interpretation and application of which can be found in several publications- (4j-9J This chapter focuses on the preparing and filling of injectable solid bulk pharmaceutical formulations. The material presented is general in nature but with references to direct the reader to more in-depth treatment of the subject matter. Coverage includes sterile bulk product preparation, 6614 Sterile Formulation MichaelJ. Akers, CurtisS. Strother, MarkR. Walden 1.0 INTRODUCTION Historically, sterile bulk pharmaceutical manufacturing processes, prior to filling operations, have followed general bulk pharmaceutical guidelines. As technology and equipment have improved, the requirements for aseptic manufacture have increased. It is important to understand that product quality often is realized in the manufacturing phase and should be maintained throughout the remaining filling/packaging processes. It is the Food and Drug Administration's current opinion that Current Good Manu￾facturing Practice for Finished Pharmaceuticals['] apply to sterile bulk operations .L21 Adherence to the Guideline on Sterile Drug Products Produced by Aseptic is considered essential for non-terminally sterilized products as is the case for sterile bulk pharmaceutical dry powders. The facility design and manufacturing process should be integrated with current regulatory guidelines, the interpretation and application of which can be found in several publi~ations.[~1-[~1 This chapter focuses on the preparing and filling of injectable solid bulk pharmaceutical formulations. The material presented is general in nature but with references to direct the reader to more in-depth treatment of the subject matter. Coverage includes sterile bulk product preparation, 61 6