TY - BOOK AU - Nema,Sandeep[Editor] AU - Ludwing,John D.[Editor] TI - Pharmaceutical dosage forms : Parenteral medications: Volume 2 : Facility design, sterilization and processing SN - 9781420086454 U1 - 615.19 PY - 2010/// CY - London PB - Informa healthcare KW - Parenteral solutions KW - Pharmaceutical technology KW - Drug Delivery Systems methods KW - Infusions, Parenteral standards KW - Drugs Dosage N1 - Includes bibliographical references and index; Chapter 1 Aseptic manufacturing facility design; Chapter 2 Personnel and their impact on clean room operations; ; Chapter 3 The fundamentals of an environmental control program; ; Chapter 4 Water systems for parenteral facilities; ; Chapter 5 Particulate matter: subvisible ; Chapter 6 Endotoxin testing ; Chapter 7 The compendial sterility tests ; Chapter 8 Industrial sterilization technologies: principles and overview ; Chapter 9 Steam sterilization ; Chapter 10 Gas, vapor, and liquid chemical sterilization ; Chapter 11 Dry heat depyrogenation and sterilization ; Chapter 12 Radiation sterilization; ; Chapter 13 Filters and filtration; ; Chapter 14 Processing of small volume parenterals and large volume parenterals; ; Chapter 15 Freeze-drying: principles and practice N2 - Summary:"A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. - An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. - A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. - A definitive chapter on container-closure integrity. - New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins"--Provided by publishe ER -