Pharmaceutical dosage forms : Parenteral medications : Volume 2 : Facility design, sterilization and processing / edited by Sandeep Nema, John D. Ludwig. - 3rd ed. - London : Informa healthcare, 2010 - xiv, 396 p. : tables, ill. figs, picture. ; 26 cm. - V-2 .

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;

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

9781420086454


Parenteral solutions
Pharmaceutical technology
Drug Delivery Systems methods
Infusions, Parenteral standards
Drugs Dosage

615.19 / NEP