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Pharmaceutical dosage forms : Parenteral medications : Volume 2 : Facility design, sterilization and processing / edited by Sandeep Nema, John D. Ludwig.

Contributor(s): Material type: TextTextSeries: ; V-2Publication details: London : Informa healthcare, 2010Edition: 3rd edDescription: xiv, 396 p. : tables, ill. figs, picture. ; 26 cmISBN:
  • 9781420086454
Subject(s): DDC classification:
  • 615.19 NEP
Contents:
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: 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
Item type: Books List(s) this item appears in: Pharmacy Discipline
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Holdings
Item type Current library Collection Shelving location Call number Copy number Status Date due Barcode
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-3 (I) Available 51517
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-4 (I) Available 51516
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-5 (I) Available 53839
Books Books KU Central Library Rack No. : 27 Shelve No. : B-01 Reference Section (Non-Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-1 (NI) Not For Loan 36011
Books Books KU Central Library Rack No. : 27 Shelve No. : B-03 Reference Section (Non-Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-2 (NI) Available 51515

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

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