Parenteral Products

Preface Chapter 1 Perspective on the Use of Parenteral Solutions Introduction Routes of Administration The Effect of Route on the Duration of Drug Activity The Origins of the Intravenous Therapy The Development of Hypodermic Medication The Sterilization of Injection Solutions The United States Pharmacopoeial Clarity Test ReferencesChapter 2 The Formulation of Parenteral Products Units The Tonicity of Injection Solutions The Choice of Solvent Oily Solvents Colloidal Dispersions The Formulation of Parenteral Emulsions Amino Acids and Other Parenteral Nutrients The 'Browning' Reaction of D-Glucose on Autoclaving ReferencesChapters 3 Filtration Introduction Classification of Filtration Operations Theories of Filtration The Relative Advantages and Disadvantages of Screen and Depth Filters Pretreatment The Criteria of an Ideal Filter The Choice of Filtration Media Discussion: The Choice of A Filtration System For Parenteral Products ReferencesChapter 4 Sterilization Introduction The Meaning of Sterilization Methods of Sterilization The Kinetics of Microbial Death Factors Affecting the Survival of Micro-Organisms The Control of Sterilization Processes The Steam Autoclave Continuous Autoclaves ReferencesChapter 5 The Working Environment Introduction The Manufacturing Process Codes of Good Manufacturing Practice Clean Water Clean Containers Clean Air Laminar Flow Cabinets Clean Rooms ReferencesChapter 6 The Monitoring and Control of Particulate Contamination Introduction Sampling The Particle Size of Particulate Contamination Visual Methods of Inspection Projection Methods for the Inspection of Ampoules Machine Methods Used for the Inspection of Ampoules Made on the Large Scale Automatic or Semi-Automatic Inspection Methods for The Inspection of Ampoules Made on A Large Scale Filtration Methods and the Identification of Contamination Electrical Sensing Zone Methods of Analysis Turbidimeters and Nephelometers Other Instruments Using Light Scattering Principles of Detection Detection of Particles by the Light-Blockage Principle Detection of Particulate Contamination By Means of A Screen Filtration Pressure Method Conclusions ReferencesAppendix 1 Publications Using Electrical Zone Sensing Methods To Determine Parenteral Fluid Contamination Chapter 7 The Size Distribution of Particulate Contamination and Standards of Cleanliness Introduction The Size Distribution of Powders and Powdered Materials The Experimental Evidence for The Size Distribution of Contamination In Parenteral Solutions The Ephemeral Nature of Particulate Contamination Suggested Standards of Cleanliness Applications of Standards and the Log-Log Size Distribution Progress Towards An Objective Standard of Cleanliness Discussion: The Problems of Applying Standards for Cleanliness ReferencesChapter 8 The Nature, Origin and Hazards of Particulate Contamination Introduction Nature and Origin of Particulate Contamination The Size and Number of Contaminating Particles The Hazard Due To Injected Particulate Contamination Conclusion ReferencesChapter 9 Pharmaceutical Problems Associated With the Administration of Large Volume Parenteral Fluids Introduction: The Setting-Up of a Large Volume Drip Solution Pharmaceutical Incompatibilities of Drugs Added To Intravenous Solutions The Loss of Therapeutic Effectiveness of Drugs During Administration Microbiological Hazards Associated With Intravenous Fluid Therapy The Inspection of Containers and Giving Sets Prior To Administration The Use of Terminal Filters The Effectiveness of Terminal Filters Discussion: The Implications of Pharmaceutical Incompatibilities For The Hospital Pharmaceutical Service ReferencesIndex