Aseptic Pharmaceutical Manufacturing II Applications for the 1990s
Coordonnateurs : Groves Michael J., Murty Ram
Controlled Environments in the Pharmaceutical & Medical Products Industry. Quality Systems & Total Quality, K. Stephens. Aseptic Processing of Healthcare Products. Validation of Aseptic Processes. Laboratory Techniques. Aseptic Production: Radiopharmaceuticals. Education & Training of Personnel. Predictive Sterility Assurance for Aseptic Processing. Aseptic Processing of Biopharmaceuticals. Lyophilization. Lyophilization Under Barrier Technology. Aseptic Packaging and Labeling. Barrier Isolation Technology. Hydrogen Peroxide Vapor Sterilization: Applications in the Production Environment. Appendix: USP 23 Chapter 1116: Microbiological Evaluation of Clean Rooms and Other Controlled Environments, United States Pharmacopoeial Convention, Inc.
Date de parution : 09-2019
15.2x22.9 cm
Thèmes d’Aseptic Pharmaceutical Manufacturing II :
Mots-clés :
Aseptic Processing; Terminal Sterilization; lyophilization; Dry Heat; sophisticated technology; Cycle Time; biopharmaceuticals; Clean Room; aseptic pharmaceutical manufacturing; Sterilization Cycle; Media Fill Run; Aseptic Area; Sterile Products; Primary Drying; Barrier Isolator; Low Temperature Vacuum Drying; ISO Document; Hydrogen Peroxide Vapor; Exposure Time; Seal Machine; Barrier Isolator System; Drug Product Containers; Vapor Sterilization; Spore Concentration; Total Quality System; Federal Standard 209E; Clean Room Garment; Aseptic Practices; Sterile Dosage Forms