کتاب داروهای استریل

Sterile Drug Products
Formulation, Packaging,
Manufacturing, and Quality
Michael J. Akers, Ph.D.
Baxter BioPharma Solutions
Bloomington, Indiana, U.S.A.

کتاب داروهای استریل

 Introduction, scope, and history of sterile products
. Characteristics of sterile dosage forms
Types of sterile dosage forms 20
۴. Sterile product packaging systems 29
۵. Overview of product development 48
۶. Formulation components (solvents and solutes) 58
۷. Sterile products packaging chemistry 72
۸. Formulation and stability of solutions 96
۹. Dispersed systems 115
۱۰. Formulation of freeze-dried powders 138
۱۱. Overcoming formulation problems and some case studies 169
۱۲. Overview of sterile product manufacturing 180
۱۳. Contamination control 194
۱۴. Sterile manufacturing facilities 211
۱۵. Water and air quality in sterile manufacturing facilities 221
۱۶. Personnel requirements for sterile manufacturing 236
۱۷. Sterilization methods in sterile product manufacturing 247
۱۸. Sterile filtration 267
۱۹. Sterile product filling, stoppering, and sealing 278
۲۰. Freeze-dry (lyophilization) processing 294
۲۱. Aseptic processing 313
۲۲. Inspection, labeling, and secondary packaging 328

۲۳. Barrier and other advanced technologies in aseptic processing 346
۲۴. Stability, storage, and distribution of sterile drug products 362
۲۵. Good manufacturing practice 372
۲۶. Quality assurance and control 382
۲۷. Microorganisms and sterility testing 400
۲۸. Pyrogens and pyrogen/endotoxin testing 415
۲۹. Particles and particulate matter testing 434
۳۰. Sterile product-package integrity testing 455
۳۱. Administration of injectable drug products 473
۳۲. Clinical hazards of injectable drug administration 481
۳۳. Biopharmaceutical considerations with injectable drug delivery 486